LEVETIRACETAM for Off label use: Side Effects & Safety Data
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There are 2,161 adverse event reports in the FDA FAERS database where LEVETIRACETAM was used for Off label use.
Most Reported Side Effects for LEVETIRACETAM
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Seizure | 9,961 | 15.9% | 272 | 2,972 |
| Drug ineffective | 8,666 | 13.9% | 477 | 2,692 |
| Off label use | 5,789 | 9.3% | 456 | 2,040 |
| Maternal exposure during pregnancy | 3,197 | 5.1% | 85 | 321 |
| Foetal exposure during pregnancy | 2,604 | 4.2% | 146 | 331 |
| Epilepsy | 2,546 | 4.1% | 86 | 794 |
| Generalised tonic-clonic seizure | 2,276 | 3.6% | 55 | 688 |
| Somnolence | 2,070 | 3.3% | 77 | 770 |
| Fatigue | 1,972 | 3.2% | 31 | 525 |
| Status epilepticus | 1,883 | 3.0% | 210 | 949 |
| Dizziness | 1,592 | 2.6% | 22 | 530 |
| Condition aggravated | 1,508 | 2.4% | 127 | 579 |
| Drug interaction | 1,443 | 2.3% | 101 | 606 |
| Abortion spontaneous | 1,392 | 2.2% | 6 | 20 |
| Aggression | 1,381 | 2.2% | 20 | 413 |
Other Indications for LEVETIRACETAM
Epilepsy (17,599)
Product used for unknown indication (14,265)
Seizure (12,072)
Partial seizures (2,926)
Generalised tonic-clonic seizure (2,753)
Status epilepticus (2,650)
Seizure prophylaxis (942)
Focal dyscognitive seizures (491)
Petit mal epilepsy (412)
Foetal exposure during pregnancy (401)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)
LACOSAMIDE (842)