This page shows what was measured, who it was measured in, and what that does not settle.
What Pregabalin does in the body
Used for some nerve pain, fibromyalgia and as added treatment for seizures.
Pregabalin binds a helper protein on the calcium gates of nerve endings. With the helper occupied, fewer gates get delivered to the surface, less calcium enters when an over-excited nerve fires, and less pain-signalling chemical is released. Unlike gabapentin, the gut absorbs it in proportion to how much is swallowed, so the dose and the blood level track each other.
What happened in people
For nerve pain after shingles, pregabalin roughly doubled or tripled the chance of having pain cut in half.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
Benefits were smaller for diabetic nerve pain, and a direct study found no benefit for sciatica.
Where it acts
Presynaptic terminals in dorsal horn and cortex; alpha-2-delta-1 subunit
Kind of result
Symptoms and quality of life
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
Its recorded molecular formula is C8H17NO2, weighing 159.23.
US prescribing information · 47d08b8f-a24d-4159-ab43-2eb67a93559b · 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.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 92 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 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.
Leg-pain intensity score at week 8 in sciatica
✗ The study did not show it
Who was studied
PRECISE (ACTRN12613000530729)
How many people
209
Study design
Phase 3 randomised placebo-controlled trial
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
P = 0.19 at week 8 (adjusted mean difference 0.5, 95% CI -0.2 to 1.2)
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. 227 adverse events in the pregabalin group versus 124 on placebo; dizziness significantly more common.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule, oral solution, and extended-release tablet; two or three times daily
Interval reported. 95% CI -0
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.
Where a source records it acting
Brain: Binds with high affinity to the alpha2-delta site, an auxiliary subunit of voltage-gated calcium channels, in central nervous system tissues
US prescribing information · 0101cd1f-4a95-40e9-86a8-ccde8d656e3d · read 2026-08-27
Start
Pregabalin
What a person takes: Oral capsule, oral solution, and extended-release tablet; two or three times daily.
The measurement behind this step
Immediate-release capsules are given two or three times daily; an extended-release tablet exists for once-daily dosing in some indications. Absorption is rapid and dose-proportional, so blood levels are predictable and dose adjustment for renal function is mandatory.
Getting in
Absorbed rapidly and in proportion to dose
Unlike gabapentin, doubling the pregabalin dose roughly doubles the amount in the blood. That predictability is the main practical difference between the two drugs.
──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
Bioavailability above 90% and independent of dose, with peak plasma concentration around one hour. Absorption is transporter-mediated but not saturable across the therapeutic range, giving linear pharmacokinetics.
The liver leaves it alone. It passes into the brain and spinal cord and then leaves the body through the kidneys in the form it arrived.
╌╌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
Negligible metabolism in humans; more than 90% is excreted unchanged in urine, so dosing must be reduced according to creatinine clearance. No cytochrome P450 interactions.
Binds alpha-2-delta-1 with higher affinity than gabapentin
It sticks to the same helper protein as gabapentin, and sticks harder.
╌╌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
Binds the alpha-2-delta-1 auxiliary subunit encoded by CACNA2D1 with higher affinity than gabapentin. Only the (S)-enantiomer binds. No meaningful GABA-A or GABA-B receptor activity.
Presynaptic calcium entry and transmitter release fall
Fewer calcium gates reach the nerve ending, so an over-firing pain nerve releases less of its signalling chemicals.
╌╌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
Reduced forward trafficking of alpha-2-delta-1-associated calcium channels lowers depolarisation-evoked calcium influx and decreases release of glutamate, substance P and calcitonin gene-related peptide in the dorsal horn. Effect develops over days rather than with the first dose.
Pain falls in some conditions and not in others, and dizziness follows everywhere
Strong effect in shingles pain, weak effect in diabetic nerve pain, nothing in sciatica. Dizziness and drowsiness in roughly a third of people at higher doses regardless.
╌╌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
NNTB 5.3 for at least 50% relief in postherpetic neuralgia at 300 mg against NNTB 22 in painful diabetic neuropathy, and no separation from placebo at 8 or 52 weeks in sciatica. Dizziness reached 35% and somnolence 25% at 600 mg in the neuropathic pain trials.
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 diabetic peripheral neuropathic pain, postherpetic neuralgia, neuropathic pain after spinal cord injury, or fibromyalgia, and adults and children aged one month and older as add-on treatment for partial-onset seizures.
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: “Neuropathic Pain Associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and Neuropathic Pain Associated with Spinal Cord Injury Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · 47d08b8f-a24d-4159-ab43-2eb67a93559b · read 2026-08-30
On older people, the label states: “In controlled clinical studies of pregabalin in neuropathic pain associated with diabetic peripheral neuropathy, 246 patients were 65 to 74 years of age, and 73 patients were 75 years of age or older.”
US prescribing information · 47d08b8f-a24d-4159-ab43-2eb67a93559b · 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 pregabalin during pregnancy.”
US prescribing information · 47d08b8f-a24d-4159-ab43-2eb67a93559b · read 2026-08-30
On people who are breastfeeding, the label states: “A total of 65 subjects in the pregabalin group (59%) and 62 subjects in the placebo group (57%) were included in the per protocol (PP) population.”
US prescribing information · 47d08b8f-a24d-4159-ab43-2eb67a93559b · read 2026-08-30
On people with reduced kidney function, the label states: “Pregabalin is eliminated primarily by renal excretion and dose adjustment is recommended for adult patients with renal impairment [ see Dosage and Administration ( 2.7 ) and Clinical Pharmacology ( 12.3 ) ].”
US prescribing information · 47d08b8f-a24d-4159-ab43-2eb67a93559b · read 2026-08-30
Where the result stopped carrying
PRECISE: no effect on sciatica at either time point, with nearly twice the adverse events
Chronic low back pain: inferior to comparator analgesics, and no benefit as an adjuvant to tapentadol in the largest such study
Perioperative analgesia: below the minimally important difference across 281 trials
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.
There was nothing to correct
Where a level is already normal, topping it up may change nothing.
On this record: Remains a first-line option in postherpetic neuralgia, where the evidence is strongest and the number needed to treat is lowest
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 (10)
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.
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.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral capsule, oral solution, and extended-release tablet; two or three times daily
✎ 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
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Immediate-release capsules are given two or three times daily; an extended-release tablet exists for once-daily dosing in some indications. Absorption is rapid and dose-proportional, so blood levels are predictable and dose adjustment for renal function is mandatory.
✎ 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 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
Commonest adverse effects are dizziness, somnolence, peripheral oedema, weight gain and blurred vision, all dose-dependent. Respiratory depression is a recognised risk in combination with opioids and other CNS depressants and in patients with respiratory compromise. Pregabalin is Schedule V in the United States and Class C in the United Kingdom. Abrupt discontinuation can precipitate withdrawal symptoms and, in patients treated for epilepsy, seizures.
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.
The form that was studied
Oral capsule, oral solution, and extended-release tablet; two or three times daily
✎ 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
Absorption is rapid and dose-proportional, so blood levels are predictable and dose adjustment for renal function is mandatory.
✎ 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
589 products list this as an active ingredient in the United States drug directory. 589 of them contain it and nothing else.
FDA National Drug Code directory · 71610-320 · read 2026-08-29
They are sold as capsule, powder, solution and tablet, film coated, extended release, taken oral.
FDA National Drug Code directory · 71610-320 · read 2026-08-29
228 published labels name it as an active ingredient. 228 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 47d08b8f-a24d-4159-ab43-2eb67a93559b · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 47d08b8f-a24d-4159-ab43-2eb67a93559b · read 2026-08-29
PREGABALIN is capsules at 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg, recorded as prescription product; fda label in effect 2025-09-23 in the United States.
US prescribing information · 0101cd1f-4a95-40e9-86a8-ccde8d656e3d · read 2026-08-27
Recorded price in US: 0.04057–0.06438 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 211 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
Recorded price in US: 0.15466 USD per one millilitre, across 3 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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Pregabalin 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 pregabalin has one effect size across neuropathic pain, when the number needed to treat differs roughly four-fold between postherpetic neuralgia and diabetic neuropathy
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 a drug effective in peripheral neuropathic pain will work in radicular pain — sciatica is the test case and the answer was no
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 predictable absorption makes pregabalin safer than gabapentin, when it is the reason pregabalin is a controlled drug in the United Kingdom and Schedule V in the United States
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 Pregabalin 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.
Postherpetic neuralgia: 32% versus 13% substantial relief at 300 mg daily
In plain words
In nerve pain after shingles, pregabalin roughly doubled to tripled the proportion of people whose pain fell by half, depending on dose.
What was measured
Proportion achieving at least 50% pain intensity reduction versus placebo, by dose
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Derry et al. pooled 45 studies and 11,906 participants. Postherpetic neuralgia at 300 mg daily: at least 30% pain reduction in 50% versus 25% (RR 2.1, 95% CI 1.6 to 2.6, NNTB 3.9); at least 50% reduction in 32% versus 13% (RR 2.5, 1.9 to 3.4, NNTB 5.3). At 600 mg daily: at least 30% in 62% versus 24% (NNTB 2.7); at least 50% in 41% versus 15% (NNTB 3.9). Somnolence at 300 mg was 16% versus 5.5% and dizziness 29% versus 8.1%; at 600 mg, 25% versus 5.8% and 35% versus 8.8%.
Written into the record, not signed off as a reviewed claim
Diabetic neuropathy: the same drug, a far weaker effect, and a number needed to treat of 22
In plain words
In painful diabetic nerve damage the benefit was much smaller than in shingles pain. At 300 mg, 22 people had to be treated for one extra person to get a 30% reduction in pain.
What was measured
That the effect size demonstrated for pregabalin in postherpetic neuralgia carries across to other neuropathic pain conditions
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
From the same Cochrane review: painful diabetic neuropathy at 300 mg daily gave at least 30% pain reduction in 47% versus 42% (RR 1.1, 95% CI 1.01 to 1.2, NNTB 22, range 12 to 200; 8 studies, 2,320 participants) and at least 50% reduction in 31% versus 24% (RR 1.3, NNTB 22). At 600 mg the estimates improved but the evidence was rated low quality. The clinical inference this page flags is the routine treatment of pregabalin as one drug with one effect size; the effect in postherpetic neuralgia and the effect in diabetic neuropathy differ by roughly four-fold on number needed to treat.
Written into the record, not signed off as a reviewed claim
PRECISE: pregabalin did nothing for sciatica at 8 weeks or at 52 weeks
In plain words
In a randomised trial of 209 patients with sciatica, leg pain was slightly worse on pregabalin than on placebo at both time points, and there were nearly twice as many adverse events.
What was measured
Leg-pain intensity score at week 8 (primary) and week 52
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Mathieson et al., randomised, double-blind, placebo-controlled (ACTRN12613000530729). 209 randomised, 108 to pregabalin and 101 to placebo, 2 later excluded. At week 8, mean unadjusted leg-pain intensity was 3.7 on pregabalin and 3.1 on placebo — adjusted mean difference 0.5, 95% CI -0.2 to 1.2, P=0.19. At week 52, 3.4 versus 3.0 — adjusted mean difference 0.3, 95% CI -0.5 to 1.0, P=0.46. No significant between-group difference on any secondary outcome at either time point. 227 adverse events on pregabalin against 124 on placebo, with dizziness more common.
Written into the record, not signed off as a reviewed claim
Fibromyalgia: about 9 extra people in 100 get substantial relief
In plain words
In fibromyalgia, 14 people in 100 got at least half their pain relieved on placebo and about 23 in 100 did on pregabalin — a real difference, and a modest one.
What was measured
Proportion with at least 50% pain intensity reduction after 12-13 weeks of stable treatment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Derry et al. included eight studies; five with a classic design randomised 3,283 participants. Substantial benefit (at least 50% pain intensity reduction after 12 to 13 weeks of stable treatment) at 450 mg: RR 1.8 (95% CI 1.4 to 2.1), 1,874 participants, 5 studies, high-quality evidence — about 14% on placebo and about 9 percentage points more on pregabalin 300 to 600 mg. Moderate benefit at 450 mg: RR 1.5 (1.3 to 1.7), 28% on placebo and about 11 points more on pregabalin. NNTs ranged from 7 to 14. Two enriched-enrolment randomised-withdrawal studies found maintained therapeutic response in 40% on pregabalin against 20% on placebo, but normalised to the starting population only about 10% achieved it. Between 70% and 90% of participants in all groups had an adverse event.
Written into the record, not signed off as a reviewed claim
The United Kingdom made pregabalin a controlled drug in 2019
In plain words
After deaths involving pregabalin rose, the UK reclassified it and gabapentin as Class C controlled drugs, which changed how they can be prescribed and dispensed.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The UK Home Office announced that from 1 April 2019 pregabalin and gabapentin would be controlled as Class C substances under the Misuse of Drugs Act 1971 and scheduled under Schedule 3 of the Misuse of Drugs Regulations 2001, following advice from the Advisory Council on the Misuse of Drugs. The systematic evidence behind that decision put gabapentinoid abuse prevalence at 1.6% in the general population and 3% to 68% among people who abuse opioids, with 11,940 international adverse-event reports of gabapentinoid abuse between 2004 and 2015 and more than 75% of them since 2012. Pregabalin is Schedule V in the United States.
Written into the record, not signed off as a reviewed claim
Chronic low back pain: pregabalin lost to the analgesics it was compared against
In plain words
When pregabalin was compared with other painkillers for chronic low back pain, the other painkillers did better.
What was measured
Mean difference in pain intensity versus active comparator
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
In Shanthanna et al.'s systematic review, three studies comparing pregabalin with other analgesic medication (n=332) showed greater improvement in the comparator group: mean difference 0.42 units, 95% CI 0.20 to 0.64, I-squared 0, GRADE very low. Studies using pregabalin as an adjuvant (n=423) were not pooled for heterogeneity, but the largest showed no benefit from adding pregabalin to tapentadol. Verret et al. separately found no clinically significant perioperative analgesia from either gabapentinoid across 281 trials and 24,682 patients.
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What is not here
7 questions this page could not answer
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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
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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.
A predictably absorbed alpha-2-delta ligand with solid moderate-quality evidence in postherpetic neuralgia, much weaker evidence in diabetic neuropathy, a clean randomised failure in sciatica, and enough misuse to have been made a controlled drug in the United Kingdom.
Recorded evidence blocks (11)
Q1
On the Pregabalin label: indicated for what?
"Pregabalin capsules are indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic…": indications and usage on Pregabalin's label. DailyMed label · 7f29991e-3bf5-4e48-8fa3-6d4e932ed6de · 2026-08-21
Q2
448 registered trials of Pregabalin — at which phases?
Registered studies posting no result
299 of 448
448 registered studies of Pregabalin: 127 phase3, 125 phase4, 83 phase2, 69 na, 34 phase1, 17 na or unstated, 10 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01
669 with a PubMed record
Show the evidence
phase3
127
phase4
125
phase2
83
na
69
phase1
34
na or unstated
17
10 more recorded rows
early phase1
10
completed
287
unknown
60
terminated
46
recruiting
27
withdrawn
15
not yet recruiting
8
active not recruiting
3
available
1
suspended
1
recorded 2026-09-01 · last checked 2026-09-04
Q3
54 of Pregabalin's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, other?
safety (2), futility/efficacy (5), accrual/recruitment (17), funding/business (5) and other (25): Pregabalin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"Study has been completed"; 54 of 448 registered studies
Show the evidence
Trial
NCT00142883
terminated; "Study has been completed"
NCT00310765
terminated; "Study was terminated by the sponsor due to low accrual."
NCT00334685
terminated; "The Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response)."
NCT00352651
terminated; "This study should be terminated as the study has been closed for years and the investigator has since retired. No records are available. Thank you, Marlene"
NCT00372528
terminated; "This study was terminated on April 8, 2011 as Pfizer Canada could no longer supply study drug. No efficacy or safety concerns factored into this decision."
NCT00378547
terminated; "ENT surgery stopped at the recruiting hospital"
14 further recorded trials
NCT00380874
terminated; "See detailed description for termination reason"
NCT00381095
terminated; "See termination reason in detailed description."
NCT00403780
terminated; "low inclusion rate"
NCT00447369
withdrawn; "Because we did not find funds to do it"
NCT00584246
withdrawn; "Study stopped due to budget (personnel) limitations."
NCT00787462
terminated; "Restrictive inclusion criteria/limited pool of suitable subjects with SFN."
NCT00852436
terminated; "difficulty to recruit patients"
NCT00853229
terminated; "Not feasible due to low accrual"
NCT00879021
terminated; "lack of funding and patients"
NCT00891397
terminated; "Unable to recruit patients"
NCT00905437
terminated; "The Study was terminated on May 24th 2012 due to a slow recruitment rate. The study was not terminated for reasons of safety or efficacy."
NCT00954187
terminated; "PI left institution"
NCT00978341
terminated; "See Detailed Description"
NCT00998816
withdrawn; "No funding"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Pregabalin used Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks — over how long?
Human studies of Pregabalin used "Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks". ClinicalTrials.gov · 2026-09-01
20 recorded entries; human; tablet; also "Capsule Lyrica 75mg. Manufacturer company: Pfizer", "300mg/day for pregabalin with smoking cigarettes", "Pregabalin 50mg"
Show the evidence
human
NCT00310765
Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks
tablet; Sugar pill manufactured to mimic Pregabalin 300 mg tablet
humanNCT01923948
tablet; Sugar pill manufactured to mimic Pregabalin 150 mg tablet
humanNCT02215252
Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
humanNCT02215252
Pregabalin 300 mg
humanNCT02215252
PF-05089771 150 mg + Pregabalin 300 mg
humanNCT02277548
Lyrica 300 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Pregabalin's half-life is 6 hours — which schedules were studied?
6 hours, the half-life Pregabalin's label states: "Pregabalin is well absorbed after oral administration, is eliminated largely by renal excretion, and has an elimination half-life of about 6 hours." DailyMed label · 7f29991e-3bf5-4e48-8fa3-6d4e932ed6de · 2026-08-21
tmax 1.5 hours; bioavailability 90 %.
Show the evidence
half lifepharmacokinetics
6 hours; Pregabalin is well absorbed after oral administration, is eliminated largely by renal excretion, and has an elimination half-life of about 6 hours.
tmaxpharmacokinetics
1.5 hours; Absorption and Distribution Following oral administration of pregabalin capsules under fasting conditions, peak plasma concentrations occur within 1.5 hours.
bioavailabilitypharmacokinetics
90 %; Pregabalin oral bioavailability is greater than or equal to 90% and is independent of dose.
metabolismpharmacokinetics
Metabolism and Elimination Pregabalin undergoes negligible metabolism in humans.
recorded 2026-08-21 · last checked 2026-09-04
Q6
Which running trial of Pregabalin could settle inflammatory markers?
NCT06150898 measures To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac, reading out 2027-10.
1 open trial; n 112; "Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)"
Show the evidence
TrialNCT06150898
"Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)"; n 112; "To detect a reduced increase in systemic inflammation (from baseline to up to 24 hours after surgery) using peri-operative ketorolac"; 2027-10
Q7
Which 149 trials of Pregabalin posted no result?
Posted no result
149 of 149 completed trials
Registrations
NCT00643136, NCT00631943, NCT00645398, NCT00141336, NCT00141401 and NCT00150423, and 143 more
Completion dates
oldest 2004-06; newest 2024-08-15
Show the evidence
Trial
NCT00643136
2004-06
NCT00631943
2005-03
NCT00645398
2005-06
NCT00141336
2005-07
NCT00141401
2005-07
NCT00150423
2005-07
14 further recorded trials
NCT00150436
2005-07
NCT00141362
2005-08
NCT00141388
2005-10
NCT00141414
2005-10
NCT00159679
2005-10
NCT00141245
2005-11
NCT00150293
2005-11
NCT00141375
2006-01
NCT00143143
2006-02
NCT00629681
2006-02
NCT00150449
2006-03
NCT00141427
2006-05
NCT00159731
2006-05
NCT00151489
2006-06
Q8
At the median, Pregabalin's trials enrolled 94.5 people — anything larger?
Median enrolment
94.5
Largest enrolment
6498
Registered trials counted
446
Q9
What do 36118 spontaneous reports say about Pregabalin — 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.
Pregabalin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 36118 reaction mentions were counted: drug hypersensitivity 7198; pain 5616; somnolence 4637; dizziness 4445. FAERS via Open Targets · CHEMBL1059 · 2026-06-24
Show the evidence
drug hypersensitivity
7198
pain
5616
somnolence
4637
dizziness
4445
confusional state
2726
weight increased
2719
4 more recorded rows
feeling abnormal
2513
insomnia
2401
drug abuse
2172
withdrawal syndrome
1691
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Pregabalin's label not list?
Pregabalin is a substrate for system L transporter which is responsible for the transport of large amino acids across the blood brain barrier.
pharmacokinetics
Drug Interactions In Vitro Studies Pregabalin, at concentrations that were, in general, 10-times those attained in clinical trials, does not inhibit human CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 enzyme systems.
pharmacokinetics
In vitro drug interaction studies demonstrate that pregabalin does not induce CYP1A2 or CYP3A4 activity.
pharmacokinetics
Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g. theophylline, caffeine) or CYP 3A4 substrates (e.g., midazolam, testosterone) is not anticipated.
clinical_pharmacology
However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport.
clinical_pharmacology
Pregabalin is a substrate for system L transporter which is responsible for the transport of large amino acids across the blood brain barrier.
2 more recorded rows
Interaction statementclinical_pharmacology
Drug Interactions In Vitro Studies Pregabalin, at concentrations that were, in general, 10-times those attained in clinical trials, does not inhibit human CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 enzyme systems.
Interaction statementclinical_pharmacology
In vitro drug interaction studies demonstrate that pregabalin does not induce CYP1A2 or CYP3A4 activity.
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
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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
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✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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