What the label lists and what reports show
Vigabatrin side effects
Vigabatrin's FDA label: “Most common adverse reactions in controlled studies include (incidence ≥5% over placebo): Adults: blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue ( 6.1 ) Pediatric patients (3 to 16 years of age): weight gain ( 6.1 ) …” FAERS holds 14,491 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is somnolence (581 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the vigabatrin FDA label on DailyMed (effective October 20, 2021, Lundbeck Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions in controlled studies include (incidence ≥5% over placebo): Adults: blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue ( 6.1 ) Pediatric patients (3 to 16 years of age): weight gain ( 6.1 ) Infantile Spasms (incidence >5% and greater than on placebo) Somnolence, bronchitis, ear infection, and acute otitis media ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 5. Adverse Reactions in Pooled, Adjunctive Trials in Adults with Refractory Complex…
| Body System Adverse Reaction | 3000 [N=134] % | SABRIL dosage (mg/day) 6000 [N=43] % | Placebo [N=135] % |
|---|---|---|---|
| Tinnitus | 2 | 0 | 1 |
| Vertigo | 2 | 5 | 1 |
| Blurred vision | 13 | 16 | 5 |
| Diplopia | 7 | 16 | 3 |
| Asthenopia | 2 | 2 | 0 |
| Eye pain | 0 | 5 | 0 |
| Diarrhea | 10 | 16 | 7 |
| Nausea | 10 | 2 | 8 |
| Vomiting | 7 | 9 | 6 |
| Constipation | 8 | 5 | 3 |
| Upper abdominal pain | 5 | 5 | 1 |
| Dyspepsia | 4 | 5 | 3 |
| Stomach discomfort | 4 | 2 | 1 |
| Abdominal pain | 3 | 2 | 1 |
| Toothache | 2 | 5 | 2 |
| Abdominal distension | 2 | 0 | 1 |
| Fatigue | 23 | 40 | 16 |
| Gait disturbance | 6 | 12 | 7 |
| Asthenia | 5 | 7 | 1 |
| Edema peripheral | 5 | 7 | 1 |
| Fever | 4 | 7 | 3 |
| Chest pain | 1 | 5 | 1 |
| Thirst | 2 | 0 | 0 |
| Malaise | 0 | 5 | 0 |
| Nasopharyngitis | 14 | 9 | 10 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious and otherwise important adverse reactions are described elsewhere in labeling: Permanent Vision Loss [see BOXED WARNING and Warnings and Precautions ( 5.1 ) ] Magnetic Resonance Imaging (MRI) Abnormalities in Infants [see Warnings and Precautions ( 5.3 ) ] Neurotoxicity [see Warnings and Precautions ( 5.4 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.5 ) ] Withdrawal of Antiepileptic Drugs (AEDs) [see Warnings and Precautions ( 5.6 ) ] Anemia [see Warnings and Precautions ( 5.7 ) ] Somnolence and Fatigue [see Warnings and Precautions ( 5.8 ) ] Peripheral Neuropathy [see Warnings and Precautions ( 5.9 )] Weight Gain [see Warnings and Precautions ( 5.10 ) ] Edema [see Warnings and Precautions ( 5.11 )] Refractory Complex Partial Seizures Most common adverse reactions in controlled studies include (incidence ≥5% over placebo): Adults: blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue ( 6.1 ) Pediatric patients (3 to 16 years of age): weight gain ( 6.1 ) Infantile Spasms (incidence >5% and greater than on placebo) Somnolence, bronchitis, ear infection, and acute otitis media ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Lundbeck Pharmaceuticals LLC, effective October 20, 2021 (SPL set a88ac1b4-e2c9-45c0-b321-4785902172e3), via openFDA; the full label on DailyMed
What do FAERS reports show?
14,491 reports list vigabatrin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,381 are coded as a death and 4,609 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 15 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vigabatrin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions