Skip to content

Mirtazapine

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Mirtazapine does in the body

Most antidepressants block a pump that recycles a neurotransmitter.

Mirtazapine does something different: it blocks a receptor that normally tells nerve cells to stop releasing noradrenaline and serotonin, so more of both comes out. It also blocks the histamine receptor that antihistamines block, which is why it makes people sleepy and hungry, and the label says so directly. What it does not do is block any reuptake transporter at all.

Why people take it. Depression — although it is very widely used off-label for its sedating and appetite-raising effects

What happened in people

Somnolence in 54% against 18% on placebo, with discontinuation for it in 10.4% against 2.2%

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That the weight gain seen as an adverse reaction in depression trials makes this a useful appetite stimulant, which a dedicated randomised trial did not confirm

Where it acts
Presynaptic alpha-2 autoreceptors and heteroreceptors in the central nervous system; the histamine H1 receptor, which the label names as the likely source of the sedation
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • Its recorded molecular formula is C17H19N3, weighing 265.36.

    US prescribing information · 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 101 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Absolute difference

An absolute difference is how many more people in a hundred were affected.

A picture of it, and where the picture fails

It is like counting heads in two rooms of a hundred.

Where that stops being true. Heads are easy to count. Study results carry a margin of error too.

What people get wrong. It is confused with a percentage change, which can look far larger.

The arithmetic difference in event rates between arms.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Reduction in Cohen-Mansfield Agitation Inventory score at 12 weeks in people with probable or possible Alzheimer’s disease and agitation unresponsive to non-drug treatment

The study did not show it

Who was studied
SYMBAD — NCT03031184 / ISRCTN17411897 (Lancet 2021;398:1487-1497)
How many people
204
Study design
Phase 3, parallel-group, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Adjusted mean difference −1.74 (95% CI −7.17 to 3.69), p=0.53 — no significant difference from placebo
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Seven deaths in the mirtazapine group by week 16 against one in the control group, with post-hoc analysis suggesting marginal statistical significance (p=0.065). Overall adverse event counts were similar between arms: 67 of 102 against 65 of 102.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 7.5, 15, 30 and 45 mg and orally disintegrating tablet at 15, 30 and 45 mg, taken once daily, usually at night

Interval reported. 95% CI −7

Written into the record, not signed off as a reviewed claim.

Reduction in Cornell Scale for Depression in Dementia score at 13 weeks in people with probable or possible Alzheimer’s disease and depression of at least four weeks

The study did not show it

Who was studied
HTA-SADD — ISRCTN88882979 (Lancet 2011;378:403-411)
How many people
326
Study design
Phase 3, multicentre, three-arm, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Mirtazapine against placebo: mean difference 0.01 (95% CI −1.37 to 1.38), p=0.99. Sertraline against placebo: 1.17 (−0.23 to 2.58), p=0.10. Findings persisted to 39 weeks
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Adverse reactions in 44 of 108 (41%) on mirtazapine and 46 of 107 (43%) on sertraline against 29 of 111 (26%) on placebo (p=0.031 and p=0.010), with fewer serious adverse events rated severe in the placebo group (p=0.003). Five patients in every group died by week 39.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 7.5, 15, 30 and 45 mg and orally disintegrating tablet at 15, 30 and 45 mg, taken once daily, usually at night

Interval reported. 95% CI −1

Written into the record, not signed off as a reviewed claim.

Change in appetite score from baseline to day 28 on mirtazapine 15 mg nightly against placebo, in patients with incurable solid tumours, anorexia and cachexia

The study did not show it

Who was studied
Mirtazapine in cancer-associated anorexia and cachexia (J Pain Symptom Manage 2021;62:1207-1215)
How many people
120
Study design
Double-blind, placebo-controlled, randomised
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Appetite increased significantly in both arms (p<0.0001 each); the between-arm difference was not significant (p=0.472 per-protocol, p=0.462 intention-to-treat)
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Higher prevalence of somnolence on mirtazapine, and significantly less increase in depressive symptoms. Quality of life, fatigue, body weight, lean body mass, handgrip strength, inflammatory markers and survival did not differ. Enrolment excluded patients with more than mild depressive symptoms, isolating appetite from mood.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet at 7.5, 15, 30 and 45 mg and orally disintegrating tablet at 15, 30 and 45 mg, taken once daily, usually at night

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Mirtazapine

    What a person takes: Oral tablet at 7.5, 15, 30 and 45 mg and orally disintegrating tablet at 15, 30 and 45 mg, taken once daily, usually at night.

    The measurement behind this step

    Dispensed as the free base rather than a salt. Desmethylmirtazapine is an active metabolite. At 75 mg, 1.67 times the maximum recommended dosage, mirtazapine does not prolong the QTc interval to a clinically meaningful extent in healthy subjects — an unusually clean cardiac profile for this class.

  2. Getting in

    A tablet at night, often chosen because it sedates

    It is taken in the evening because it makes people sleepy. That is one of the most common reasons it is picked in the first place.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Available as a film-coated tablet and as an orally disintegrating tablet. Somnolence was reported in 54% of patients in United States controlled studies against 18% on placebo, and led to discontinuation in 10.4% against 2.2%. The label states it is unclear whether tolerance develops.

  3. Reaching the cell

    No pump is blocked

    This is the antidepressant that does not touch the recycling pumps. A screening test designed for SSRIs would show nothing at all.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Mirtazapine inhibits no monoamine transporter. Its pharmacology is entirely receptor antagonism: alpha-2 adrenergic autoreceptors and heteroreceptors, 5-HT2 and 5-HT3, histamine H1, peripheral alpha-1 and muscarinic receptors, with no significant affinity for 5-HT1A or 5-HT1B.

  4. What it acts on

    A brake is released instead

    Nerve cells carry a receptor that tells them to stop releasing noradrenaline and serotonin. Blocking that receptor takes the brake off, so more of both comes out.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Antagonism at central presynaptic alpha-2 adrenergic inhibitory autoreceptors and heteroreceptors, enhancing central noradrenergic and serotonergic activity. Section 12.1 offers this as what the efficacy "could be mediated through", after stating that the mechanism is unclear.

  5. The change it makes

    And the histamine receptor is blocked at the same time

    The same receptor that antihistamines block. This is where the drowsiness and the hunger come from, and the label says so directly.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Section 12.2 states that the prominent somnolent effects may be explained by inhibition of histamine H1 receptors and the orthostatic hypotension by inhibition of peripheral alpha-1 adrenergic receptors. Appetite increase was reported in 17% against 2% on placebo and 7% weight gain in 7.5% against 0%.

  6. What that does for a person

    In depression, it performs well

    For its actual licensed use, this is one of the better-performing antidepressants in direct comparisons.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    In the head-to-head studies of the 2018 network meta-analysis of 21 antidepressants across 522 trials and 116,477 participants, mirtazapine was among the seven drugs more effective than the others (range of odds ratios 1.19 to 1.96). It did not appear among the six rated most tolerable.

  7. What that does for a person

    In everything it is borrowed for, it did not

    Tested as an appetite stimulant, it matched placebo. Tested for depression in dementia, it matched placebo. Tested for agitation in dementia, it matched placebo and had more deaths.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Cancer cachexia: appetite change at day 28 not different from placebo in 120 patients (p=0.472 per-protocol, p=0.462 intention-to-treat). Depression in Alzheimer’s: mean difference 0.01 (95% CI −1.37 to 1.38, p=0.99) at 13 weeks, persisting to 39. Agitation in dementia: adjusted mean CMAI difference −1.74 (95% CI −7.17 to 3.69, p=0.53) with seven deaths against one by week 16.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Adults with major depressive disorder. Safety and effectiveness in children have not been established, and in the one paediatric trial half the treated children gained at least 7% of their body weight in eight weeks.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of mirtazapine tablets have not been established in pediatric patients with MDD.”

    US prescribing information · 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e · read 2026-08-30

  • On older people, the label states: “Approximately 190 patients ≥ 65 years of age participated in clinical studies with mirtazapine.”

    US prescribing information · 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e · read 2026-08-30

  • On people who are pregnant, the label states: “Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.”

    US prescribing information · 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Data from published literature report the presence of mirtazapine in human milk at low levels with relative infant doses for mirtazapine ranging between 0.6 and 2.8% of the maternal weight-adjusted dose (see Data ) .”

    US prescribing information · 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e · read 2026-08-30

Where the result stopped carrying

  • SYMBAD found no benefit for agitation in dementia and seven deaths on drug against one on placebo by week 16
  • HTA-SADD found no benefit for depression in Alzheimer’s disease at 13 or 39 weeks, with more adverse reactions than placebo
  • A dedicated randomised trial found no appetite benefit over placebo in cancer-associated anorexia and cachexia
  • Safety and effectiveness in paediatric depression have never been established, while the paediatric weight gain rate is nearly nine times the placebo rate
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral tablet at 7.5, 15, 30 and 45 mg and orally disintegrating tablet at 15, 30 and 45 mg, taken once daily, usually at night

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

Dispensed as the free base rather than a salt. Desmethylmirtazapine is an active metabolite. 67 times the maximum recommended dosage, mirtazapine does not prolong the QTc interval to a clinically meaningful extent in healthy subjects — an unusually clean cardiac profile for this class.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Boxed warning for suicidal thoughts and behaviours in children, adolescents and young adults; safety and effectiveness in paediatric patients not established. Agranulocytosis, with discontinuation directed if sore throat, fever, stomatitis or infection occurs alongside a low white cell count. Serotonin syndrome, including with other serotonergic drugs and when taken alone. Angle-closure glaucoma in untreated anatomically narrow angles. QTc prolongation caution in patients with risk factors. Increased appetite and weight gain. Somnolence, with caution advised for driving and machinery. Activation of mania or hypomania. Seizures. Orthostatic hypotension, attributed on the label to peripheral alpha-1 antagonism. Contraindicated with monoamine oxidase inhibitors.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral tablet at 7.5, 15, 30 and 45 mg and orally disintegrating tablet at 15, 30 and 45 mg, taken once daily, usually at night

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Desmethylmirtazapine is an active metabolite. 67 times the maximum recommended dosage, mirtazapine does not prolong the QTc interval to a clinically meaningful extent in healthy subjects — an unusually clean cardiac profile for this class.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 166 products list this as an active ingredient in the United States drug directory. 166 of them contain it and nothing else.

    FDA National Drug Code directory · 72578-104 · read 2026-08-29

  • They are sold as powder, tablet, tablet, film coated and tablet, orally disintegrating, taken oral.

    FDA National Drug Code directory · 72578-104 · read 2026-08-29

  • 92 published labels name it as an active ingredient. 92 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e · read 2026-08-29

  • Mirtazapine is film-coated tablets at Tablets: 7.5 mg unscored, 15 mg scored, 30 mg scored and 45 mg unscored, recorded as prescription product; fda label in effect 2022-08-01 in the United States.

    US prescribing information · 0f19ab40-1a30-4ac2-9bd7-c2f8199e29e1 · read 2026-08-27

  • Recorded price in US: 0.06454–0.42925 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 87 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Mirtazapine studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That the weight gain seen as an adverse reaction in depression trials makes this a useful appetite stimulant, which a dedicated randomised trial did not confirm

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the sedation makes it a good choice for depression with insomnia; sedation is measured as a reason people stopped the drug, not as an endpoint anyone tested

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That alpha-2 autoreceptor blockade explains the antidepressant effect — offered on the label as something that "could" be the mechanism, in a section that opens by calling it unclear

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That its good head-to-head efficacy ranking in general depression transfers to depression in dementia, where a dedicated trial returned p=0.99

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Mirtazapine are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

Sedation in 54% and weight gain in 7.5%, both on the label as harms
In plain words
Just over half of people on mirtazapine reported drowsiness against under a fifth on placebo, and one in thirteen gained at least seven per cent of their body weight while nobody on placebo did. Both appear as adverse reactions, not as benefits.
What was measured
Incidence of somnolence, appetite increase and 7% weight gain against placebo, and discontinuations attributable to each
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 5.7 records somnolence in 54% of patients treated with mirtazapine in United States controlled studies against 18% on placebo, with discontinuation for somnolence in 10.4% against 2.2%, and states it is unclear whether tolerance develops. Section 5.6 records appetite increase in 17% against 2%, and weight gain of 7% or more of body weight in 7.5% against 0%; across the pooled premarketing programme including long-term open-label treatment, 8% of patients discontinued for weight gain. Section 12.2 attributes the prominent somnolence to histamine H1 antagonism and the orthostatic hypotension to peripheral alpha-1 antagonism. These are the two properties for which the drug is most often chosen in practice, and on its own registration document both are counted as reasons people stopped taking it.
Source
Mirtazapine United States prescribing information, sections 5.6, 5.7 and 12.2 (NDA 020415)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
SYMBAD: no benefit for agitation in dementia, and seven deaths against one
In plain words
A publicly funded trial in 204 people with Alzheimer’s disease and agitation found mirtazapine no better than placebo at twelve weeks. By week sixteen there had been seven deaths in the mirtazapine group and one in the placebo group.
What was measured
Cohen-Mansfield Agitation Inventory score at 12 weeks and deaths by week 16, mirtazapine against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
SYMBAD (NCT03031184, ISRCTN17411897) was a parallel-group, double-blind, placebo-controlled trial across 26 United Kingdom centres, funded by the NIHR Health Technology Assessment Programme. Participants had probable or possible Alzheimer’s disease, agitation unresponsive to non-drug treatment and a Cohen-Mansfield Agitation Inventory score of 45 or more, and were randomised 1:1 to mirtazapine titrated to 45 mg or placebo. Between January 2017 and March 2020, 204 participants were recruited. Mean CMAI scores at twelve weeks did not differ: adjusted mean difference −1.74 (95% CI −7.17 to 3.69, p=0.53). Adverse events were similar — 67 of 102 (66%) on mirtazapine against 65 of 102 (64%) on placebo — but there were seven deaths in the mirtazapine group by week 16 against one in the control group, with post-hoc analysis suggesting marginal statistical significance (p=0.065). The authors concluded the data do not support using mirtazapine as a treatment for agitation in dementia. A post-hoc mortality comparison at p=0.065 in 204 people is not proof of harm, and it is a signal that a trial designed to demonstrate benefit found nothing to weigh against it.
Source
Banerjee S, High J, Stirling S, et al. Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial. Lancet 2021;398:1487-1497
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
HTA-SADD: no benefit for depression in dementia, with more adverse reactions
In plain words
A three-arm trial of mirtazapine, sertraline and placebo in depression in Alzheimer’s disease found no difference in depression scores at thirteen weeks or at thirty-nine. Both drugs produced more adverse reactions than placebo.
What was measured
Cornell Scale for Depression in Dementia at 13 and 39 weeks, and adverse reaction rates, against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
HTA-SADD (ISRCTN88882979) randomised participants from old-age psychiatry services across nine English centres 1:1:1 to sertraline (target 150 mg/day), mirtazapine (45 mg/day) or placebo, all with standard care, in people with probable or possible Alzheimer’s disease, depression lasting at least four weeks and a Cornell Scale for Depression in Dementia score of 8 or more. Decreases in depression score at 13 weeks did not differ between 111 controls and 107 allocated to sertraline (mean difference 1.17, 95% CI −0.23 to 2.58, p=0.10) or 108 allocated to mirtazapine (0.01, 95% CI −1.37 to 1.38, p=0.99), and these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111, 26%) than sertraline (46 of 107, 43%, p=0.010) or mirtazapine (44 of 108, 41%, p=0.031), and fewer serious adverse events rated as severe (p=0.003). Five patients in every group died by week 39. The authors concluded that the present practice of first-line use of these antidepressants for depression in Alzheimer’s disease should be reconsidered. A p value of 0.99 is about as clean a null as this literature produces.
Source
Banerjee S, Hellier J, Dewey M, et al. Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial. Lancet 2011;378:403-411
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The appetite effect did not reproduce when it was tested as a benefit
In plain words
Mirtazapine is widely used to help frail and cancer patients eat, on the strength of the weight gain seen in depression trials. When 120 patients with cancer-related loss of appetite were randomised to mirtazapine or placebo, appetite improved in both arms and the difference between them was not significant.
What was measured
Change in appetite score from baseline to day 28, mirtazapine 15 mg against placebo, in 120 patients with cancer cachexia
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A double-blind placebo-controlled randomised trial enrolled 120 patients with incurable solid tumours who had anorexia (appetite loss of 4 or more on a 0-10 scale), cachexia (more than 5% body weight loss over six months, or more than 2% plus a body mass index below 20) and a depression score of 3 or below on a 0-6 scale — that last criterion deliberately excluding people whose appetite loss might be driven by depression. Patients were randomised 1:1 to mirtazapine 15 mg nightly for eight weeks or placebo, with the primary endpoint the change in appetite from baseline to day 28. Appetite score increased significantly in both arms (p<0.0001 each), and the increase did not differ significantly between them in either per-protocol or intention-to-treat analysis (p=0.472 and p=0.462). Mirtazapine was associated with significantly less increase in depressive symptoms and a higher prevalence of somnolence. Changes in quality of life, fatigue, body weight, lean body mass, handgrip strength, inflammatory markers and survival did not differ. A side effect observed in one population is a hypothesis about another population, and this is what happened when the hypothesis was tested.
Source
Hunter CN, Abdel-Aal HH, Elsherief WA, Farag DE, Riad NM, Alsirafy SA. Mirtazapine in Cancer-Associated Anorexia and Cachexia: A Double-Blind Placebo-Controlled Randomized Trial. J Pain Symptom Manage 2021;62:1207-1215
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Agranulocytosis, with onset anywhere from day 9 to day 61
In plain words
Three people in the premarketing programme lost their infection-fighting white cells: two with fever and infection, one without symptoms. It happened on day 9 in one case and day 61 in another, so there is no safe window.
What was measured
Cases of agranulocytosis and severe neutropenia per patients treated in the premarketing programme, with time to onset
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Section 5.2 records that in premarketing clinical trials, 2 of 2,796 patients treated with mirtazapine developed agranulocytosis — absolute neutrophil count below 500/mm³ with associated signs and symptoms such as fever and infection — one of whom had Sjögren’s syndrome, and a third patient developed severe neutropenia (ANC below 500/mm³) without symptoms. Onset of severe neutropenia was detected on days 61, 9 and 14 of treatment respectively, and all three recovered after mirtazapine was stopped. The label directs discontinuation and close monitoring if a patient develops sore throat, fever, stomatitis or other signs of infection alongside a low white cell count. It does not direct routine blood count monitoring, so detection depends on the patient reporting the symptom and on whoever they report it to remembering which drug they are on. The spread of onset times is the operationally important detail: a normal count at two weeks does not close the question.
Source
Mirtazapine United States prescribing information, section 5.2 Agranulocytosis (NDA 020415)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Half the children in the only paediatric trial gained 7% of their body weight
In plain words
In an eight-week paediatric trial, 49% of children on mirtazapine gained at least seven per cent of their body weight, against 5.7% on placebo. The drug has never been shown to work in children.
What was measured
Proportion of paediatric patients gaining at least 7% of body weight over eight weeks, drug against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Section 5.6 records that in an eight-week paediatric clinical trial at doses between 15 and 45 mg/day, 49% of mirtazapine-treated paediatric patients had a weight gain of at least 7%, against 5.7% of placebo-treated patients. The same paragraph states that the safety and effectiveness of mirtazapine in paediatric patients with major depressive disorder have not been established. The two statements together define the problem: a measured harm at nearly nine times the placebo rate, in a population with no demonstrated benefit to weigh it against. For comparison, the adult figure for the same threshold is 7.5% against 0% — the paediatric rate is roughly six and a half times the adult one over a shorter exposure.
Source
Mirtazapine United States prescribing information, sections 5.6 and 8.4 (NDA 020415)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
A mechanism the label calls unclear, and a genuine efficacy result
In plain words
The prescribing information says the mechanism of action for depression is unclear and offers alpha-2 blockade as a possibility. Separately, in the largest comparison of antidepressants ever run, mirtazapine was one of the seven that beat the others head to head.
What was measured
That alpha-2 autoreceptor blockade is the mechanism of the antidepressant effect — offered on the label as something that "could" be the case, in a document that opens by calling the mechanism unclear
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 12.1 reads: "The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic alpha-2-adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity." Note the conditional: "could be mediated". Section 12.2 adds antagonism at 5-HT2 and 5-HT3, at H1, at peripheral alpha-1 and at muscarinic receptors, and explicitly assigns the somnolence to H1 and the orthostatic hypotension to alpha-1. Against that uncertainty sits a real comparative finding: in the head-to-head studies of the 2018 network meta-analysis, agomelatine, amitriptyline, escitalopram, mirtazapine, paroxetine, venlafaxine and vortioxetine were more effective than the other antidepressants (range of odds ratios 1.19 to 1.96). Mirtazapine did not appear in the more tolerable group. The honest reading is that this drug appears to work in depression better than most and nobody can say why, while three separate trials of the things it is borrowed for showed it does not do those.
Source
Mirtazapine United States prescribing information, sections 12.1 and 12.2 (NDA 020415); Cipriani A et al., Lancet 2018;391:1357-1366
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 92 documents were read for this substance.

    RNAWiki source record

  • 92 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 92 of them state the same bioavailability, and they agree.

    RNAWiki source record

  • 92 of them state the same tMax, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
A051Q2099Q
CAS registry number
85650-52-8
PubChem compound
4205
RxNorm concept
15996

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

  1. Withdrawn in United States, 2019, for "Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets." (openFDA drug enforcement Class I recall)

What the approval register records

  • 26 approved applications cover products containing this substance. The earliest was NDA020415, approved 19960614 to ORGANON.

    Drugs@FDA application register · NDA020415 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA020415 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19960614.

    FDA National Drug Code directory · 72578-104 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

7 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

An alpha-2 antagonist that raises monoamine release without blocking any transporter, producing somnolence in 54% of patients against 18% on placebo and at least 7% weight gain in 7.5% against 0% — effects widely borrowed as off-label indications, and which failed when tested directly: no appetite benefit over placebo in 120 cancer cachexia patients, no benefit for depression in dementia in 108 patients (mean difference 0.01, p=0.99), and no benefit for agitation in dementia in 204 patients with seven deaths on drug against one on placebo.

Recorded evidence blocks (10)

On the Mirtazapine label: indicated for what?


"Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults.": indications and usage on Mirtazapine's label. DailyMed label · e38c96d4-ea33-3f1a-e053-2a95a90a0903 · 2026-08-26

88 registered trials of Mirtazapine — at which phases?


Registered studies posting no result
68 of 88

88 registered studies of Mirtazapine: 30 phase2, 21 phase4, 12 phase3, 11 na, 11 phase1, 4 early phase1, 4 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

367 with a PubMed record

Show the evidence
  • phase2
    30
  • phase4
    21
  • phase3
    12
  • na
    11
  • phase1
    11
  • early phase1
    4
9 more recorded rows
  • na or unstated
    4
  • completed
    56
  • unknown
    12
  • terminated
    7
  • withdrawn
    5
  • recruiting
    3
  • active not recruiting
    2
  • not yet recruiting
    2
  • enrolling by invitation
    1

recorded 2026-09-01 · last checked 2026-09-04

10 of Mirtazapine's trials stopped: accrual/recruitment, sponsor decision unspecified, other?


accrual/recruitment (4), sponsor decision unspecified (1) and other (5): Mirtazapine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"PI decision"; 10 of 88 registered studies

Show the evidence

Trial

  • NCT00600145
    withdrawn; "PI decision"
  • NCT00832520
    terminated; "Low accrual rate."
  • NCT01465919
    terminated; "Due to the recent change in standard of care for hepatitis C."
  • NCT01598584
    withdrawn; "Gemcitabine is not the first choice for most pancreatic cancer patients nowdays"
  • NCT02893371
    terminated; "Per PI, this study is not a clinical trial and was inadvertently entered in the system"
  • NCT03785691
    terminated; "Recruiting difficulties"
4 further recorded trials
  • NCT03852160
    withdrawn; "New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study"
  • NCT04155008
    terminated; "The trial was closed after 4 months due to slow to accrual. Only 1 participant was enrolled."
  • NCT04763135
    terminated; "difficulties in recruiting"
  • NCT05452174
    withdrawn; "transfer of PI to new organization"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Mirtazapine used Mirtazapine 15 mg (Orally Disintegrating) Tablets — over how long?


studies of Mirtazapine used the recorded amount. ClinicalTrials.gov · 2026-09-01

9 recorded entries; human; oral; also "Mirtazapine 15 mg (Orally Disintegrating) Tablets", "REMERON SolTab® 15 mg Orally Disintegrating Tablets", "Mirtazapine 15 mg tablets, single dose"

Show the evidence

human

  • NCT00834197
    Mirtazapine 15 mg (Orally Disintegrating) Tablets
  • NCT00834197
    REMERON SolTab® 15 mg Orally Disintegrating Tablets
  • NCT00865384
    Mirtazapine 15 mg tablets, single dose
  • NCT00865384
    REMERON® 15 mg tablets, single dose
  • NCT03254173
    oral; Mirtazapine 30 mg oral tablets
  • NCT03254173
    oral; Remeron 30 mg oral tablets
3 more recorded rows
  • human NCT03921151
    Mirtazapine 15 MG Oral Tablet
  • human NCT04547842
    Mirtazapine 30 MG
  • human NCT06213948
    Mirtazapine 15 MG

recorded 2026-09-01 · last checked 2026-09-04

Mirtazapine's half-life is 20 to 40 hours — which schedules were studied?


20 to 40 hours, the half-life Mirtazapine's label states: "Elimination Mirtazapine has a half-life of about 20 to 40 hours following oral administration of mirtazapine." DailyMed label · e38c96d4-ea33-3f1a-e053-2a95a90a0903 · 2026-08-26

tmax 2 hours; bioavailability 50 %.

Show the evidence
  • half life pharmacokinetics
    20 to 40 hours; Elimination Mirtazapine has a half-life of about 20 to 40 hours following oral administration of mirtazapine.
  • tmax pharmacokinetics
    2 hours; Peak plasma concentrations of mirtazapine are reached within about 2 hours post dose.
  • bioavailability pharmacokinetics
    50 %; Absorption Mirtazapine has an absolute bioavailability of about 50% following oral administration.
  • metabolism pharmacokinetics
    Metabolism Mirtazapine is extensively metabolized after oral administration.

recorded 2026-08-26 · last checked 2026-09-04

Which 35 trials of Mirtazapine posted no result?


Posted no result
35 of 35 completed trials
Registrations
NCT00865384, NCT00865696, NCT00177567, NCT00021528, NCT00108498 and NCT00288782, and 29 more
Completion dates
oldest 2001-09; newest 2024-05-31
Show the evidence

Trial

  • NCT00865384
    2001-09
  • NCT00865696
    2001-09
  • NCT00177567
    2004-01
  • NCT00021528
    2006-09
  • NCT00108498
    2007-03
  • NCT00288782
    2007-04
14 further recorded trials
  • NCT00080158
    2007-06
  • NCT00960830
    2008-11
  • NCT00874003
    2009-02
  • NCT00150839
    2009-12
  • NCT00878540
    2010-07
  • NCT00919295
    2011-12
  • NCT01505504
    2011-12
  • NCT01949571
    2012-09
  • NCT01240096
    2012-09-11
  • NCT01263080
    2012-12
  • NCT02191124
    2013-05
  • NCT01725048
    2013-10
  • NCT02228239
    2014-12
  • NCT01109693
    2015-12

At the median, Mirtazapine's trials enrolled 74 people — anything larger?


Median enrolment
74
Largest enrolment
1037352
Registered trials counted
87

What do 5867 spontaneous reports say about Mirtazapine — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Mirtazapine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 5867 reaction mentions were counted: fall 760; somnolence 714; confusional state 686; suicide attempt 629. FAERS via Open Targets · CHEMBL654 · 2026-06-24

Show the evidence
  • fall
    760
  • somnolence
    714
  • confusional state
    686
  • suicide attempt
    629
  • toxicity to various agents
    592
  • drug interaction
    559
4 more recorded rows
  • hyponatraemia
    527
  • coma
    484
  • drug abuse
    481
  • anxiety
    435

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Mirtazapine's label not list?


anxiety, coma and confusional state and 7 more reported for Mirtazapine, absent from its label. FAERS via Open Targets · CHEMBL654 · 2026-06-24

2 label terms; 10 reported and unlisted; e38c96d4-ea33-3f1a-e053-2a95a90a0903

Show the evidence
  • anxiety
    count not stated
  • coma
    count not stated
  • confusional state
    count not stated
  • drug abuse
    count not stated
  • drug interaction
    count not stated
  • fall
    count not stated
4 more recorded rows
  • hyponatraemia
    count not stated
  • somnolence
    count not stated
  • suicide attempt
    count not stated
  • toxicity to various agents
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Mirtazapine and CYP3A, CYP1A2 and CYP2D6: shared by which compounds?


CYP3A, CYP1A2 and CYP2D6 appear in Mirtazapine's recorded interaction sentences, 8 in all. DailyMed label · e38c96d4-ea33-3f1a-e053-2a95a90a0903 · 2026-08-26

CYP1A2, CYP2D6, CYP3A, CYP3A; 4 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    John’s Wort, tramadol, tryptophan, buspirone Strong CYP3A Inducers Clinical Impact The concomitant use of strong CYP3A inducers with mirtazapine decreases the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3) ].
  • drug_interactions
    Intervention Increase the dose of mirtazapine if needed with concomitant CYP3A inducer use.
  • drug_interactions
    Conversely, a decrease in dosage of mirtazapine may be needed if the CYP3A inducer is discontinued [see Dosage and Administration (2.5) ].
  • drug_interactions
    Examples phenytoin, carbamazepine, rifampin Strong CYP3A Inhibitors Clinical Impact The concomitant use of strong CYP3A inhibitors with mirtazapine may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3) ].
  • drug_interactions
    Intervention Decrease the dose of mirtazapine if needed with concomitant strong CYP3A inhibitor use.
  • drug_interactions
    Conversely, an increase in dosage of mirtazapine may be needed if the CYP3A inhibitor is discontinued [see Dosage and Administration (2.5) ].
2 more recorded rows
  • Interaction statement drug_interactions
    Examples itraconazole, ritonavir, nefazodone Cimetidine Clinical Impact The concomitant use of cimetidine, a CYP1A2, CYP2D6, and CYP3A inhibitor, with mirtazapine may increase the plasma concentration of mirtazapine [see Clinical Pharmacology (12.3) ].
  • Interaction statement drug_interactions
    Strong CYP3A inducers: Dosage increase may be needed for mirtazapine with concomitant use of strong CYP3A inducers.
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

recorded 2026-08-26 · last checked 2026-09-04

Where it is registered

Where it’s registered

Withdrawn in United States, 2019, for "Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets." (openFDA drug enforcement Class I recall)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL654
PubChem CID
3085218
CAS number
61337-87-9
RxCUI
15996
InChIKey
RONZAEMNMFQXRA-UHFFFAOYSA-N
Also called
6-azamianserin, Avanza, Mirataz, Mirtazapin, Mirtazapina, Norset, Promyrtil, Rexer, mtz, 1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c]benzazepine, MIRTAZAPINE [EP MONOGRAPH], MIRTAZAPINE [GREEN BOOK]
Salt form
Mirtazapine anhydrous
Development code
ORG 3770
Trade name
Remeron, Remeron soltab, Zispin, Remeronsoltab, Remeron / Remeron SolTab
Sources (7)

Sources

1 more source

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work · openFDA enforcement — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.