VIGABATRIN for Infantile spasms: Side Effects & Safety Data
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There are 4,922 adverse event reports in the FDA FAERS database where VIGABATRIN was used for Infantile spasms.
Most Reported Side Effects for VIGABATRIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Seizure | 2,289 | 19.0% | 36 | 1,006 |
| Drug ineffective | 1,212 | 10.1% | 24 | 245 |
| Drug dose omission | 987 | 8.2% | 3 | 100 |
| Death | 721 | 6.0% | 719 | 31 |
| Drug withdrawal convulsions | 460 | 3.8% | 0 | 106 |
| Pneumonia | 432 | 3.6% | 28 | 368 |
| Somnolence | 427 | 3.5% | 6 | 112 |
| Vomiting | 369 | 3.1% | 2 | 129 |
| Product dose omission issue | 304 | 2.5% | 0 | 104 |
| Infantile spasms | 257 | 2.1% | 6 | 91 |
| Off label use | 248 | 2.1% | 20 | 64 |
| Adverse event | 247 | 2.1% | 74 | 153 |
| Epilepsy | 224 | 1.9% | 9 | 104 |
| Hospitalisation | 219 | 1.8% | 3 | 208 |
| Condition aggravated | 210 | 1.7% | 2 | 93 |
Other Indications for VIGABATRIN
Epilepsy (2,896)
Product used for unknown indication (1,426)
Seizure (1,255)
Complex partial seizures (705)
Partial seizures (577)
Status epilepticus (366)
Lennox-gastaut syndrome (321)
Focal dyscognitive seizures (314)
Tuberous sclerosis complex (303)
Generalised tonic-clonic seizure (195)
Other Drugs Used for Infantile spasms
SABRIL (389)
CORTICOTROPIN (354)
TOPIRAMATE (203)
LEVETIRACETAM (154)
CANNABIDIOL (128)
PREDNISOLONE (104)
CLOBAZAM (98)
VALPROIC ACID (78)
VALPROATE (59)
ZONISAMIDE (44)