Drug · FAERS side-effect profile with label screen
Vigabatrin side effects: what 14,490 FDA adverse event reports show
Who reports
14,490 reports · 70% serious · 1,381 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin tablets are not indicate.
FDA label, Indications and Usage
What it is
Vigabatrin USP is an oral antiepileptic drug and is available as a white to off-white film-coated tablet.
FDA label, Description section
Boxed warning
PERMANENT VISION LOSS Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )].
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 1Labeled adverse reaction 3Labeled (related wording) 7Likely indication confounding 6Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 19
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 959 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Intramyelinic oedema | 10 | 3,567.4 1,119.0–11,373.4ROR 3,569.9 · χ² 9,193 / p <1e-300 | 345.3 EB05 200.5 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=9 | no trial data cached |
| Infantile spasms | 305 | 1,085.4 936.0–1,258.5ROR 1,108.7 · χ² 187,067 / p <1e-300 | 593.8 EB05 539.9 · IC025 +8.1 3/3 methods agree | Labeled — boxed warning exact term | serious n=304 | no trial data cached |
| Retinogram abnormal | 113 | 1,053.9 826.9–1,343.2ROR 1,062.2 · χ² 67,766 / p <1e-300 | 549.8 EB05 469.9 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=113 · 96% clinician | no trial data cached |
| Magnetic resonance imaging head abnormal | 199 | 648.3 548.7–766.0ROR 657.3 · χ² 87,996 / p <1e-300 | 427.7 EB05 380.1 · IC025 +7.5 3/3 methods agree | Labeled (related wording) related wording | serious n=134 · 100% clinician | no trial data cached |
| Cortical visual impairment | 17 | 638.4 360.4–1,130.7ROR 639.1 · χ² 7,040 / p <1e-300 | 294.9 EB05 195.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Drug withdrawal convulsions | 476 | 528.2 476.1–586.0ROR 546.1 · χ² 182,431 / p <1e-300 | 379.9 EB05 352.1 · IC025 +8.0 3/3 methods agree | Labeled (related wording) related wording | serious n=475 | no trial data cached |
| Infantile spitting up | 79 | 259.7 204.5–329.9ROR 261.2 · χ² 17,009 / p <1e-300 | 208.8 EB05 173.0 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | no trial data cached |
| Epileptic encephalopathy | 26 | 193.2 128.3–291.0ROR 193.6 · χ² 4,211 / p <1e-300 | 151.6 EB05 108.7 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=25 · ♀ 29% (drug 49%) | no trial data cached |
| Ophthalmological examination abnormal | 20 | 186.5 117.1–297.2ROR 186.8 · χ² 3,102 / p <1e-300 | 142.9 EB05 97.6 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=11 · 90% clinician | no trial data cached |
| Coma blister | 10 | 178.4 92.4–344.1ROR 178.5 · χ² 1,414 / p <1e-300 | 122.3 EB05 71.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Tuberous sclerosis complex | 11 | 170.6 91.3–318.8ROR 170.7 · χ² 1,509 / p <1e-300 | 121.0 EB05 72.1 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Lennox-gastaut syndrome | 23 | 164.9 107.1–253.9ROR 165.2 · χ² 3,214 / p <1e-300 | 132.0 EB05 92.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Magnetic resonance imaging brain abnormal | 17 | 147.9 89.8–243.7ROR 148.1 · χ² 2,116 / p <1e-300 | 116.8 EB05 77.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Abdominal wall cyst | 10 | 129.7 67.9–247.8ROR 129.8 · χ² 1,056 / p 7e-232 | 97.4 EB05 56.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Change in seizure presentation | 41 | 96.4 70.3–132.2ROR 96.7 · χ² 3,537 / p <1e-300 | 86.8 EB05 66.7 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=39 | no trial data cached |
| Astrocytoma, low grade | 10 | 89.2 47.1–168.9ROR 89.2 · χ² 740 / p 3e-163 | 72.8 EB05 42.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Multiple-drug resistance | 176 | 87.3 75.0–101.5ROR 88.3 · χ² 14,064 / p <1e-300 | 81.6 EB05 72.0 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=154 · 94% clinician | no trial data cached |
| Seizure cluster | 44 | 83.7 61.8–113.4ROR 84.0 · χ² 3,319 / p <1e-300 | 76.6 EB05 59.4 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=44 | no trial data cached |
| Postictal paralysis | 12 | 75.4 42.2–134.8ROR 75.5 · χ² 768 / p 3e-169 | 64.7 EB05 39.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Sudden unexplained death in epilepsy | 26 | 73.0 49.3–108.3ROR 73.2 · χ² 1,689 / p <1e-300 | 66.3 EB05 47.5 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=26 · 100% clinician | no trial data cached |
| Tonic convulsion | 62 | 66.9 51.9–86.3ROR 67.2 · χ² 3,783 / p <1e-300 | 62.8 EB05 50.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=61 | no trial data cached |
| Atonic seizures | 34 | 64.4 45.7–90.8ROR 64.6 · χ² 1,971 / p <1e-300 | 59.7 EB05 44.7 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=33 | no trial data cached |
| Anticonvulsant drug level above therapeutic | 27 | 62.4 42.5–91.8ROR 62.6 · χ² 1,506 / p <1e-300 | 57.6 EB05 41.5 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=26 · ♀ 4% (drug 49%) | no trial data cached |
| Neonatal behavioural syndrome | 12 | 62.0 34.8–110.6ROR 62.1 · χ² 633 / p 5e-140 | 54.6 EB05 33.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Epidural lipomatosis | 14 | 60.5 35.5–103.3ROR 60.6 · χ² 730 / p 4e-161 | 54.1 EB05 34.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Body dysmorphic disorder | 14 | 56.6 33.2–96.5ROR 56.6 · χ² 683 / p 8e-151 | 50.9 EB05 32.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Brain operation | 76 | 50.4 40.2–63.4ROR 50.7 · χ² 3,510 / p <1e-300 | 48.2 EB05 39.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=73 | no trial data cached |
| Optic atrophy | 53 | 48.3 36.8–63.5ROR 48.5 · χ² 2,330 / p <1e-300 | 46.1 EB05 36.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=53 · 100% clinician | no trial data cached |
| Myoclonic epilepsy | 46 | 46.6 34.8–62.5ROR 46.8 · χ² 1,945 / p <1e-300 | 44.4 EB05 34.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=46 | no trial data cached |
| Temporal lobe epilepsy | 13 | 44.0 25.3–76.3ROR 44.0 · χ² 489 / p 1e-108 | 40.4 EB05 25.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Feeding intolerance | 13 | 43.5 25.1–75.6ROR 43.6 · χ² 484 / p 2e-107 | 40.0 EB05 24.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Plagiocephaly | 14 | 41.5 24.4–70.6ROR 41.6 · χ² 499 / p 6e-111 | 38.5 EB05 24.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Therapeutic product effective for unapproved indication | 10 | 40.8 21.7–76.4ROR 40.8 · χ² 339 / p 4e-76 | 37.1 EB05 21.5 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Vesicoureteric reflux | 11 | 40.1 22.1–73.1ROR 40.2 · χ² 371 / p 5e-83 | 36.8 EB05 21.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 | no trial data cached |
| Enterovirus infection | 23 | 40.0 26.4–60.5ROR 40.0 · χ² 813 / p 5e-179 | 37.8 EB05 26.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Retinal toxicity | 27 | 39.4 26.9–57.7ROR 39.5 · χ² 946 / p 4e-208 | 37.4 EB05 27.0 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=27 · 100% clinician | no trial data cached |
| Focal dyscognitive seizures | 30 | 39.0 27.1–56.0ROR 39.1 · χ² 1,044 / p 2e-229 | 37.2 EB05 27.3 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=30 · ♀ 74% (drug 49%) | no trial data cached |
| Anal atresia | 13 | 35.9 20.7–62.2ROR 35.9 · χ² 397 / p 1e-88 | 33.5 EB05 20.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Status epilepticus | 266 | 34.8 30.9–39.3ROR 35.4 · χ² 8,500 / p <1e-300 | 33.9 EB05 30.6 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.9 | no trial data cached |
| Febrile convulsion | 28 | 34.1 23.4–49.6ROR 34.2 · χ² 846 / p 2e-186 | 32.7 EB05 23.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=27 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Seizure | 2,627 | 33.9 32.7–35.1ROR 41.2 · χ² 82,313 / p <1e-300 | 33.1 EB05 32.1 · IC025 +5.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 27.7 | no trial data cached |
| Drug ineffective (drug did not work) | 1,401 | 1.5 1.5–1.6ROR 1.6 · χ² 282 / p 1e-63 | 1.5 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Drug dose omission | 990 | 8.6 8.1–9.1ROR 9.1 · χ² 6,644 / p <1e-300 | 8.5 EB05 8.1 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 | no trial data cached |
| Death | 882 | 1.5 1.4–1.6ROR 1.5 · χ² 144 / p 2e-33 | 1.5 EB05 1.4 · IC025 +0.5 | Outcome field, not a reaction | serious PRR 1.2 | no trial data cached |
| Somnolence (drowsiness) | 581 | 4.2 3.9–4.5ROR 4.3 · χ² 1,418 / p <1e-300 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Pneumonia (lung infection) | 540 | 2.4 2.2–2.6ROR 2.5 · χ² 455 / p 3e-101 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Drug withdrawal convulsions | 476 | 528.2 476.1–586.0ROR 546.1 · χ² 182,431 / p <1e-300 | 379.9 EB05 352.1 · IC025 +8.0 3/3 methods agree | Labeled (related wording) related wording | serious n=475 | no trial data cached |
| Vomiting | 470 | 1.5 1.3–1.6ROR 1.5 · χ² 67 / p 1e-16 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Off label use (used outside approved label) | 456 | 0.8 0.7–0.8ROR 0.8 · χ² 36 / p 1e-9 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Product dose omission issue | 357 | 1.8 1.6–2.0ROR 1.8 · χ² 132 / p 9e-31 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 4.4 · 73% consumer | no trial data cached |
| Hospitalisation | 349 | 3.3 3.0–3.7ROR 3.4 · χ² 566 / p 2e-125 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Infantile spasms | 305 | 1,085.4 936.0–1,258.5ROR 1,108.7 · χ² 187,067 / p <1e-300 | 593.8 EB05 539.9 · IC025 +8.1 3/3 methods agree | Labeled — boxed warning exact term | serious n=304 | no trial data cached |
| Epilepsy | 301 | 14.4 12.9–16.1ROR 14.7 · χ² 3,710 / p <1e-300 | 14.2 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 | no trial data cached |
| Condition aggravated | 289 | 1.4 1.2–1.6ROR 1.4 · χ² 31 / p 1e-8 | 1.4 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Irritability | 281 | 6.8 6.0–7.6ROR 6.9 · χ² 1,376 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Retinogram abnormal — n=113, PRR 1,053.9
- Lennox-gastaut syndrome — n=23, PRR 164.9
- Tonic convulsion — n=62, PRR 66.9
- Optic atrophy — n=53, PRR 48.3
- Myoclonic epilepsy — n=46, PRR 46.6
- Enterovirus infection — n=23, PRR 40.0
- Febrile convulsion — n=28, PRR 34.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Vigabatrin ↔ Visual field defect.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Vigabatrin?
In FDA FAERS, the most frequently co-reported reaction terms for Vigabatrin are seizure, somnolence, pneumonia, drug withdrawal convulsions, vomiting, infantile spasms. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Vigabatrin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: PERMANENT VISION LOSS Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity [see Warnings and Precautions ( 5.1 )].
Do FAERS signals prove that Vigabatrin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0afdc84c-f8ec-330a-31c9-fac4ed256931, effective 20200317; matched on
openfda.generic_name.exact:"VIGABATRIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 999 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.