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Vigabatrin Side Effects

The most commonly reported side effects of vigabatrin include seizure, drug dose omission, and death, based on 16,614 FDA adverse event reports from 2004 to 2025. 9.6% of reports found the drug to be ineffective.

Vigabatrin side effects

Percentages show how often each reaction appears relative to total reports for vigabatrin.

1
Seizure15.9%2,642
2
Drug Ineffective9.6%1,602
3
Drug Dose Omission7.5%1,245
4
Death5.4%889
5
Convulsion3.8%636
6
Pneumonia3.6%604
7
Somnolence3.5%589
8
Vomiting3.0%499
9
Drug Withdrawal Convulsions2.9%481
10
Off Label Use2.6%435
11
Hospitalisation2.3%389
12
Infantile Spasms2.1%349
13
Product Dose Omission Issue2.0%335
14
Pyrexia1.9%308
15
Irritability1.8%300

These are voluntary reports and do not establish that vigabatrin caused these reactions.

Report severity

68.8%Serious11,437 reports
31.1%Hospitalizations5,168 reports
9.1%Fatal1,517 reports

Seriousness is determined by the reporter, not by OpenClaim.

Vigabatrin drug interactions

Other drugs that appear in adverse event reports alongside vigabatrin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Levetiracetam6.8%1,132
2
Topiramate4.4%739
3
Clobazam4.0%663
4
Carbamazepine3.4%567
5
Lamotrigine3.3%542
6
Cannabidiol3.1%516
7
Phenobarbital-sodium3.0%505
8
Valproic-acid3.0%496
9
Lacosamide2.6%427
10
Phenytoin2.3%390
11
Clonazepam2.2%362
12
Everolimus1.8%305
13
Valproate-sodium1.8%301
14
Oxcarbazepine1.5%247
15
Zonisamide1.3%216

Taken alongside

1
Levetiracetam14.7%2,439
2
Topiramate9.4%1,559
3
Clobazam7.7%1,277
4
Clonazepam6.7%1,119
5
Phenobarbital-sodium6.0%1,002
6
Lamotrigine4.4%724
7
Diazepam4.3%720
8
Lacosamide3.8%639
9
Zonisamide3.8%628
10
Oxcarbazepine3.2%538
11
Divalproex-sodium3.2%526
12
Albuterol2.5%422
13
Phenytoin2.2%370
14
Valproic-acid2.2%361
15
Cannabidiol2.1%343

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports vigabatrin side effects

43.0% of vigabatrin adverse event reports involve female patients and 45.6% involve male patients. The largest age group is child at 36%. These figures reflect who reports side effects, not underlying risk.

Sex

Female43.0%
Male45.6%
Unknown11.4%

Age group

< 237.6%
2–1136.1%
12–176.7%
18–6418.8%
65+0.9%

What is vigabatrin used for

Conditions and purposes for which patients were taking vigabatrin when the adverse event was reported.

Accidental ExposureAccidental Exposure To ProductAcute Kidney InjuryAicardi^s SyndromeAltered State Of ConsciousnessAmino Acid Metabolism DisorderAndrogen Insensitivity SyndromeAspirationAsthmaAstrocytoma, Low GradeAtonic SeizuresAtrial FibrillationAttention Deficit/hyperactivity DisorderAtypical Benign Partial EpilepsyAutism

Showing 15 of 333 indications

Vigabatrin brand names and reporting trend

Vigabatrin is sold under the brand name Sabril.

Brand names

Sabril6,049

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking vigabatrin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.