Vigabatrin

Common brands: Sabril, Vigadrone, Vigafyde, Vigabatrin For Oral Solution, Keppra Xr

Top reporter: Lundbeck Pharmaceuticals Llc

Anti-epileptic Agent [EPC]Benzodiazepine [EPC]Mood Stabilizer [EPC]Corticosteroid [EPC]Kinase Inhibitor [EPC]
14,291
Total Reports
4,502
Serious Reports
1,370
Death Reports
30
Reported Reactions
Death Report Ratio: High (9.59%)

Patient Demographics

Male
6,449
Female
6,100

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Vigabatrin.

# Reaction Reports % of Total
1 SEIZURE 2,593
19.7%
2 DRUG INEFFECTIVE 1,387
10.5%
3 DRUG DOSE OMISSION 990
7.5%
4 DEATH 873
6.6%
5 SOMNOLENCE 569
4.3%
6 PNEUMONIA 534
4.0%
7 DRUG WITHDRAWAL CONVULSIONS 471
3.6%
8 VOMITING 466
3.5%
9 OFF LABEL USE 439
3.3%
10 PRODUCT DOSE OMISSION ISSUE 347
2.6%
11 HOSPITALISATION 327
2.5%
12 INFANTILE SPASMS 303
2.3%
13 EPILEPSY 299
2.3%
14 CONDITION AGGRAVATED 285
2.2%
15 IRRITABILITY 278
2.1%
16 PYREXIA 271
2.1%
17 CONVULSION 268
2.0%
18 STATUS EPILEPTICUS 264
2.0%
19 ADVERSE EVENT 254
1.9%
20 INSOMNIA 234
1.8%
21 FATIGUE 228
1.7%
22 MAGNETIC RESONANCE IMAGING HEAD ABNORMAL 198
1.5%
23 PRODUCT USE ISSUE 176
1.3%
24 VISUAL IMPAIRMENT 171
1.3%
25 MALAISE 170
1.3%
26 MULTIPLE-DRUG RESISTANCE 168
1.3%
27 DRUG RESISTANCE 165
1.3%
28 RESPIRATORY FAILURE 161
1.2%
29 AGGRESSION 160
1.2%
30 DECREASED APPETITE 146
1.1%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.