This page shows what was measured, who it was measured in, and what that does not settle.
What Bupropion does in the body
Depression, and help with quitting smoking
Most antidepressants act on serotonin. Bupropion does not. It slows the removal of two other messengers, dopamine and norepinephrine, from the gaps between nerve cells. Separately, it plugs the receptor that nicotine binds to, which is why the same molecule sold under a different name helps people stop smoking: the cigarette stops delivering as much of a reward.
What happened in people
A 64% relative increase in six-month smoking abstinence over placebo, high-certainty, across 45 trials and 17,866 participants
✎ 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.
That naltrexone-bupropion is cardiovascularly safe — LIGHT was terminated before it could assess its own non-inferiority margin
Where it acts
Dopaminergic and noradrenergic terminals in prefrontal cortex and striatum; nicotinic receptors in ventral tegmental area
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 C13H18ClNO•HCl, weighing 276.2.
US prescribing information · d5469d64-5e74-4b7a-b4cd-551665f6adaa · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 84 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.
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 people◇Read 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.
Incidence of moderate-to-severe neuropsychiatric adverse events in psychiatric and non-psychiatric cohorts
✓ The study showed what it set out to show
Who was studied
EAGLES (NCT01456936)
How many people
8144
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Bupropion-placebo risk difference -0.08 (95% CI -1.37 to 1.21) non-psychiatric; 1.78 (-0.24 to 3.81) psychiatric
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Insomnia was the most frequent adverse event in the bupropion group, 12% of 2,006 participants.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet: immediate release, sustained release (SR) and extended release (XL)
Interval reported. 95% CI -1
Written into the record, not signed off as a reviewed claim.
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 body◇Read 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.
Start
Bupropion
What a person takes: Oral tablet: immediate release, sustained release (SR) and extended release (XL).
The measurement behind this step
Three release profiles with different dosing schedules. The release profile is clinically relevant rather than cosmetic, because seizure risk tracks peak plasma concentration, and it is why a 300 mg generic that failed bioequivalence was withdrawn rather than relabelled.
Getting in
Swallowed, then largely converted to something else
Most of what reaches the bloodstream long-term is not bupropion itself but a chemical the liver makes from it.
──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
Extensive hepatic metabolism, principally by CYP2B6, to hydroxybupropion, which circulates at far higher concentrations than the parent and has a longer half-life. Threohydrobupropion and erythrohydrobupropion are also formed. The pharmacology patients experience is largely metabolite pharmacology.
Both the drug and its main breakdown product reach brain tissue.
╌╌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
Bupropion and hydroxybupropion cross the blood-brain barrier and reach dopaminergic and noradrenergic terminal fields in prefrontal cortex, striatum and the ventral tegmental projection system.
It slows the clearance of dopamine and norepinephrine from the gaps between nerve cells, and separately plugs the receptor nicotine uses.
╌╌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
Inhibits the dopamine transporter (SLC6A3) and norepinephrine transporter (SLC6A2), and acts as a non-competitive antagonist at nicotinic acetylcholine receptors including the alpha-4 beta-2 subtype. The nicotinic action is the mechanistic basis for the smoking cessation indication and is largely attributed to hydroxybupropion.
Two effects at once: more of the alerting messengers stay around, and a cigarette delivers less of a kick.
╌╌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
Raised synaptic dopamine and norepinephrine underlie the antidepressant and pro-attentional effects; nicotinic blockade blunts nicotine-evoked dopamine release in the nucleus accumbens, which reduces the reinforcing value of smoking and the intensity of withdrawal.
Mood scores fall, or abstinence holds — and the seizure threshold falls with them
The measurable results are depression scale scores and verified quit rates. The measurable cost is a dose-dependent risk of seizure.
╌╌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
Efficacy endpoints are rating-scale change and biochemically verified continuous abstinence. Seizure risk is dose- and peak-concentration-dependent, which is why the immediate-release ceiling is 450 mg per day in divided doses and why extended-release formulations exist at all.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 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 unclear◇Read 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 depression, particularly where sexual side effects or sedation have been a problem; adults with seasonal affective disorder; and people trying to stop smoking.
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: “Safety and effectiveness in the pediatric population have not been established.”
US prescribing information · d5469d64-5e74-4b7a-b4cd-551665f6adaa · read 2026-08-30
On older people, the label states: “Of the approximately 6,000 patients who participated in clinical trials with bupropion hydrochloride sustained-release tablets (depression and smoking cessation studies), 275 were ≥65 years old and 47 were ≥75 years old.”
US prescribing information · d5469d64-5e74-4b7a-b4cd-551665f6adaa · 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 · d5469d64-5e74-4b7a-b4cd-551665f6adaa · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Data from published literature report the presence of bupropion and its metabolites in human milk (see Data) .”
US prescribing information · d5469d64-5e74-4b7a-b4cd-551665f6adaa · read 2026-08-30
On people with reduced liver function, the label states: “In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum bupropion hydrochloride extended-release tablets (XL) dose is 150 mg every other day.”
US prescribing information · d5469d64-5e74-4b7a-b4cd-551665f6adaa · read 2026-08-30
On people with reduced kidney function, the label states: “Consider a reduced dose and/or dosing frequency of bupropion hydrochloride extended-release tablets (XL) in patients with renal impairment (glomerular filtration rate: <90 mL/min).”
US prescribing information · d5469d64-5e74-4b7a-b4cd-551665f6adaa · read 2026-08-30
Where the result stopped carrying
LIGHT terminated after interim results were disclosed, leaving the cardiovascular safety question open
Budeprion XL 300 mg withdrawn in 2012 for non-bioequivalence
The original immediate-release product carried a seizure incidence high enough to require a hard daily dose ceiling and the development of slower-release forms
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 take◇Read 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 take◇Read 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.
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
Three release profiles with different dosing schedules.
✎ 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. The rest of the recorded wording: The release profile is clinically relevant rather than cosmetic, because seizure risk tracks peak plasma concentration, and it is why a 300 mg generic that failed bioequivalence was withdrawn rather than relabelled.
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.
The recorded stepping schedule
What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.
US prescribing information · 004d8121-59d4-46c4-acb8-b2dd097bf556 · read 2026-08-27
Starting dose (major depressive disorder): 150 mg once daily in the morning
US prescribing information · 004d8121-59d4-46c4-acb8-b2dd097bf556 · read 2026-08-27
After 4 days of dosing: 300 mg once daily in the morning — Target dose as stated in the label schedule
US prescribing information · 004d8121-59d4-46c4-acb8-b2dd097bf556 · read 2026-08-27
What it would be like to take◇Read 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
The US label carries a boxed warning for suicidal thoughts and behaviours in children, adolescents and young adults. Bupropion is contraindicated in seizure disorders, in patients with current or prior bulimia or anorexia nervosa, and during abrupt discontinuation of alcohol or benzodiazepines, because all raise seizure risk. Common adverse effects are insomnia, dry mouth, headache, agitation and nausea. It should not be combined with MAO inhibitors.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
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 unclear◇Read 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.
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
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: The release profile is clinically relevant rather than cosmetic, because seizure risk tracks peak plasma concentration, and it is why a 300 mg generic that failed bioequivalence was withdrawn rather than relabelled.
No source is stored against this line.
What is recorded as being sold
399 products list this as an active ingredient in the United States drug directory. 394 of them contain it and nothing else.
FDA National Drug Code directory · 71610-708 · read 2026-08-29
They are sold as powder, tablet, tablet, extended release, tablet, film coated, tablet, film coated, extended release and tablet, multilayer, extended release, taken oral.
FDA National Drug Code directory · 71610-708 · read 2026-08-29
The regulator's established pharmacologic class for it is aminoketone [epc], dopamine uptake inhibitors [moa] and increased dopamine activity [pe].
FDA National Drug Code directory · 71610-708 · read 2026-08-29
258 published labels name it as an active ingredient. 256 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · d5469d64-5e74-4b7a-b4cd-551665f6adaa · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · d5469d64-5e74-4b7a-b4cd-551665f6adaa · read 2026-08-29
buPropion Hydrochloride XL is extended-release tablets at 150 mg, 300 mg, recorded as prescription product; fda label in effect 2025-11-25 in the United States.
US prescribing information · 004d8121-59d4-46c4-acb8-b2dd097bf556 · read 2026-08-27
Recorded price in US: 0.09421–0.11511 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 26 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 take◇Read 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 Bupropion 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 unclear◇Read 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 naltrexone-bupropion is cardiovascularly safe — LIGHT was terminated before it could assess its own non-inferiority margin
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 bupropion is better tolerated than an SSRI overall, when it avoids one serotonergic side effect and adds insomnia, agitation and a dose-dependent seizure risk
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 150 mg strength bioequivalence of a generic guarantees the 300 mg strength, which is precisely the extrapolation the 2012 withdrawal falsified
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 unclear◇Read 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 Bupropion 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 people◇Read 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.
High-certainty Cochrane evidence: 64% relative increase in long-term quit rates
In plain words
Across 45 trials and nearly 18,000 people, bupropion raised the chance of still being off cigarettes six months or more later by about two thirds compared with placebo.
What was measured
Smoking abstinence at six months or longer, relative risk versus placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Howes et al. included 115 studies. Bupropion increased long-term smoking cessation with high-certainty evidence: RR 1.64 (95% CI 1.52 to 1.77), I-squared 15%, 45 studies, 17,866 participants. Bupropion was inferior to varenicline (RR 0.71, 95% CI 0.64 to 0.79; 6 studies, 6,286 participants) and no different from nicotine replacement (RR 0.99, 95% CI 0.91 to 1.09; 10 studies, 8,230 participants). Dropouts due to adverse events were higher on bupropion than placebo (RR 1.37, 95% CI 1.21 to 1.56, high certainty).
Written into the record, not signed off as a reviewed claim
EAGLES removed the neuropsychiatric boxed warning that the FDA had imposed in 2009
In plain words
A trial of 8,144 smokers, half of them with a psychiatric diagnosis, found no excess of serious mood or behaviour problems on bupropion compared with placebo or a nicotine patch. The warning came off.
What was measured
Incidence of moderate-to-severe neuropsychiatric adverse events; continuous abstinence weeks 9-12
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
EAGLES (NCT01456936) randomised 8,144 smokers into psychiatric and non-psychiatric cohorts. In the non-psychiatric cohort, moderate-to-severe neuropsychiatric adverse events occurred in 22 of 989 on bupropion (2.2%) versus 24 of 999 on placebo (2.4%); bupropion-placebo risk difference -0.08 (95% CI -1.37 to 1.21). In the psychiatric cohort, 68 of 1,017 (6.7%) versus 50 of 1,015 (4.9%); risk difference 1.78 (-0.24 to 3.81). Bupropion beat placebo on abstinence (OR 2.07, 95% CI 1.75 to 2.45) and lost to varenicline (OR 1.75 favouring varenicline, 1.52 to 2.01). The trial was funded by Pfizer and GlaxoSmithKline, the manufacturers of the two drugs under investigation.
Written into the record, not signed off as a reviewed claim
LIGHT: the cardiovascular outcome trial was terminated after its interim data leaked
In plain words
A trial testing whether the naltrexone-bupropion weight-loss combination was safe for the heart was stopped early after partial results were made public, and it can no longer answer the question it was designed to answer.
What was measured
Time to first major adverse cardiovascular event
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
LIGHT (NCT01601704) randomised 8,910 overweight or obese patients at increased cardiovascular risk. At the 25% interim, MACE occurred in 59 placebo patients (1.3%) and 35 on naltrexone-bupropion (0.8%); HR 0.59, 95% CI 0.39 to 0.90. At 50% of planned events the estimate had moved to 102 (2.3%) versus 90 (2.0%); HR 0.88, adjusted 99.7% CI 0.57 to 1.34. Because of unanticipated early termination the pre-specified non-inferiority margin of 1.4 could not be assessed. Nissen et al. concluded that cardiovascular safety remains uncertain and requires a new adequately powered trial. Adverse effects were more common on the combination: gastrointestinal 14.2% versus 1.9% (p<0.001), central nervous system 5.1% versus 1.2% (p<0.001).
Written into the record, not signed off as a reviewed claim
A 300 mg generic was withdrawn in 2012 after failing bioequivalence
In plain words
One generic version of the 300 mg extended-release tablet did not release the drug the same way as the original. The FDA pulled it and changed how it approves generics of this class.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Woodcock, Khan and Yu, writing from the FDA Center for Drug Evaluation and Research, described the withdrawal of budeprion XL 300 mg for non-bioequivalence to the reference bupropion hydrochloride extended-release product. The original approval had relied on bioequivalence data from the 150 mg strength with the 300 mg strength waived by extrapolation; direct study of the 300 mg strength did not meet the standard. This is the reason the bupropion formulation on a prescription is a clinically relevant fact rather than a pharmacy detail.
Written into the record, not signed off as a reviewed claim
The "no sexual side effects" advantage is real and mostly measured indirectly
In plain words
Bupropion does not act on serotonin, and serotonin is the pathway behind SSRI sexual dysfunction. The absence of the side effect follows from the mechanism more than from a large dedicated trial programme.
What was measured
That bupropion is generally better tolerated than an SSRI, when what is well established is that it avoids one specific serotonergic side effect while adding insomnia, agitation and seizure risk
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The pharmacological premise is solid: bupropion has no meaningful affinity for the serotonin transporter, and SSRI-associated sexual dysfunction is a serotonergic class effect. The clinical evidence base is smaller and less systematic than the efficacy base — it rests on secondary endpoints and comparative trials rather than on a programme designed around sexual function as a primary outcome. The Cochrane smoking review found bupropion produced more psychiatric adverse events than placebo (RR 1.25, 95% CI 1.15 to 1.37; 6 studies, 4,439 participants), so "better tolerated" is not true across the board.
Written into the record, not signed off as a reviewed claim
Adult ADHD: a real but modest effect in the Cortese network
In plain words
In the largest comparison of ADHD medicines, bupropion beat placebo in adults on clinician ratings, but by less than the stimulants did.
What was measured
Standardised mean difference on clinician-rated ADHD core symptoms in adults
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Cortese et al. pooled 133 double-blind randomised trials. In adults, on clinician-rated core ADHD symptoms closest to 12 weeks, bupropion gave SMD -0.46 (95% CI -0.85 to -0.07), against -0.79 (-0.99 to -0.58) for amphetamines and -0.49 (-0.64 to -0.35) for methylphenidate. Bupropion is not FDA-approved for ADHD; this is an off-label use with network-level evidence behind it.
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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.
The antidepressant that skips serotonin entirely, with high-certainty Cochrane evidence that it raises long-term smoking quit rates by 64% — and a seizure risk that forced a dose ceiling, a generic that failed bioequivalence, and a cardiovascular outcome trial terminated for leaked interim data.
Recorded evidence blocks (11)
Q2
On the Bupropion label: indicated for what?
"Bupropion hydrochloride extended-release tablet (XL) is an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) ( 1.1 ) prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for…": indications and usage on Bupropion's label. DailyMed label · bcbef1b4-a135-4231-bc65-7d0b335260e8 · 2026-08-26
Q3
259 registered trials of Bupropion — at which phases?
Registered studies posting no result
158 of 259
259 registered studies of Bupropion: 72 phase4, 60 phase2, 55 phase1, 49 phase3, 32 na, 7 na or unstated, 5 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
808 with a PubMed record
Show the evidence
phase4
72
phase2
60
phase1
55
phase3
49
na
32
na or unstated
7
8 more recorded rows
early phase1
5
completed
190
unknown
23
terminated
20
recruiting
10
withdrawn
7
not yet recruiting
5
active not recruiting
4
recorded 2026-09-01 · last checked 2026-09-04
Q4
25 of Bupropion's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?
futility/efficacy (1), accrual/recruitment (15), funding/business (2) and other (7): Bupropion's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"This study was closed early due to poor accrual"; 25 of 259 registered studies
Show the evidence
Trial
NCT00032084
terminated; "This study was closed early due to poor accrual"
NCT00119210
terminated; "We were unable to recruit sufficient numbers of patients and decided that the study protocol was not feasible to implement"
NCT00181896
terminated; "Study was terminated due to lack of recruitment"
terminated; "recruitment of this population was not feasible"
14 further recorded trials
NCT00511134
terminated; "Study has been terminated due low recruitment of participant population."
NCT00958633
terminated; "Recruitment was stopped before the planned sample size was reached owing to the Covid-19 pandemic and expiration of funding."
NCT01046214
terminated; "Recruitment issues"
NCT01048983
withdrawn; "No accrual."
NCT01219673
terminated; "Low accrual."
NCT01560507
terminated; "Low Recruitment"
NCT01942187
withdrawn; "No participants enrolled."
NCT02238977
terminated; "Study stopped due to difficulty recruiting"
NCT02582008
terminated; "Slow accrual"
NCT02893371
terminated; "Per PI, this study is not a clinical trial and was inadvertently entered in the system"
NCT03132571
terminated; "Study discontinued due to funding."
NCT03278938
withdrawn; "PI Retired and no data was collected"
NCT03326128
terminated; "Due to the COVID-19 pandemic, it was difficult to recruit eligible participants."
NCT03852160
withdrawn; "New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Bupropion used Abrika Bupropion 150 mg XL Tablet, single dose — over how long?
studies of Bupropion used the recorded amount. ClinicalTrials.gov · 2026-09-01
16 recorded entries; human; tablet; also "Abrika Bupropion 150 mg XL Tablet, single dose", "Wellbutrin XL® 150 mg Tablet, single dose", "Bupropion 150 mg Extended-Released Tablet, single dose"
Show the evidence
human
NCT00863941
Abrika Bupropion 150 mg XL Tablet, single dose
NCT00863941
Wellbutrin XL® 150 mg Tablet, single dose
NCT00865111
Bupropion 150 mg Extended-Released Tablet, single dose
NCT00865111
Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose
NCT00865371
Abrika Bupropion 150 mg Extended-Released Tablet
NCT00865371
Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
10 more recorded rows
humanNCT00883155
Bupropion HCl 100 mg Tablets (Invamed Inc.)
humanNCT00883155
Wellbutrin 100 mg Tablets (Glaxo Wellcome)
humanNCT01731067
bupropion 25 mg
humanNCT02438072
Bupropion (20 mg, N06AX12)
humanNCT02698553
tablet; Bupropion HCl XL tablet 150mg
humanNCT02698553
tablet; Bupropion HCl XL tablet 300mg
humanNCT03058419
Bupropion 150 mg
humanNCT03180294
Bupropion 150 mg XL
humanNCT04553263
Naltrexone HCl/Bupropion HCl 8 Mg-90 Mg
humanNCT06609343
Bupropion Hydrochloride 150 MG
recorded 2026-09-01 · last checked 2026-09-04
Q6
Bupropion's half-life is 32±14 hours — which schedules were studied?
32±14 hours, the half-life Bupropion's label states: "The first trial demonstrated that the half-life of hydroxybupropion was significantly longer in 8 subjects with alcoholic liver disease than in 8 healthy volunteers (32±14 hours versus 21±5 hours, respectively)." DailyMed label · bcbef1b4-a135-4231-bc65-7d0b335260e8 · 2026-08-26
tmax 5 hours.
Show the evidence
half lifepharmacokinetics
32±14 hours; The first trial demonstrated that the half-life of hydroxybupropion was significantly longer in 8 subjects with alcoholic liver disease than in 8 healthy volunteers (32±14 hours versus 21±5 hours, respectively).
tmaxpharmacokinetics
5 hours; Absorption Following single oral administration of bupropion hydrochloride extended-release tablets (XL) to healthy volunteers, the median time to peak plasma concentrations for bupropion was approximately 5 hours.
metabolismpharmacokinetics
Metabolism Bupropion is extensively metabolized in humans.
recorded 2026-08-26 · last checked 2026-09-04
Q7
Which running trial of Bupropion could settle lifespan?
NCT05646862 measures Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS), reading out 2029-03-30.
1 open trial; n 420; "A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or…"
Show the evidence
TrialNCT05646862
"A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy"; n 420; "Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)"; 2029-03-30
Q8
Which 89 trials of Bupropion posted no result?
Posted no result
89 of 89 completed trials
Registrations
NCT00883155, NCT00000268, NCT00018187, NCT00322205, NCT00344695 and NCT00181818, and 83 more
Completion dates
oldest 1998-10; newest 2024-07-31
Show the evidence
Trial
NCT00883155
1998-10
NCT00000268
1998-11
NCT00018187
2001-06
NCT00322205
2002-03
NCT00344695
2003-04
NCT00181818
2003-12
14 further recorded trials
NCT00628225
2003-12
NCT00177567
2004-01
NCT01875172
2004-01
NCT00307203
2004-02
NCT00863941
2004-07
NCT00865462
2004-07
NCT00079469
2004-08
NCT00249509
2004-09
NCT00865371
2004-09
NCT00865410
2004-09
NCT00061087
2004-10
NCT00044434
2005-04
NCT00414180
2005-05
NCT00069251
2005-06
Q9
At the median, Bupropion's trials enrolled 74 people — anything larger?
Median enrolment
74
Largest enrolment
1037352
Registered trials counted
256
Q10
What do 20 spontaneous reports say about Bupropion — 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.
Bupropion appears in spontaneous reports to regulators. Across the 2 most-reported reaction terms, 20 reaction mentions were counted: convulsion 15; anxiety 5. FAERS via Open Targets · CHEMBL1201735 · 2026-06-24
Show the evidence
convulsion
15
anxiety
5
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 2 reactions does Bupropion's label not list?
CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical exposure, but should not exceed the maximum recommended dose.
drug_interactions
( 7.1 ) Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide).
drug_interactions
( 7.7 ) 7.1 Potential for Other Drugs to Affect Bupropion Hydrochloride Extended-release Tablets (XL) Bupropion is primarily metabolized to hydroxybupropion by CYP2B6.
drug_interactions
Therefore, the potential exists for drug interactions between bupropion hydrochloride extended-release tablets (XL) and drugs that are inhibitors or inducers of CYP2B6.
drug_interactions
Inhibitors of CYP2B6 Ticlopidine and Clopidogrel: Concomitant treatment with these drugs can increase bupropion exposures but decrease hydroxybupropion exposure.
drug_interactions
Based on clinical response, dosage adjustment of bupropion hydrochloride extended-release tablets (XL) may be necessary when coadministered with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel) [see CLINICAL PHARMACOLOGY ( 12.3 )].
2 more recorded rows
Interaction statementdrug_interactions
Inducers of CYP2B6 Ritonavir, Lopinavir, and Efavirenz: Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure.
Interaction statementdrug_interactions
7.2 Potential for Bupropion Hydrochloride Extended-release Tablets XL to Affect Other Drugs Drugs Metabolized by CYP2D6 Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors.
ChEMBL 37 — CC BY-SA 3.0 Unported · 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
✗ 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: 6 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
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