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FELBAMATE
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- Postmarketing Adverse Event Reports
- Voluntary reports of adverse events in patients taking felbamate (usually in conjunction with other drugs) have been received since market introduction and may have no causal relationship with the drug(s). These include the following by body system:
- Cardiovascular: atrial fibrillation, atrial arrhythmia, cardiac arrest, torsade de pointes, cardiac failure, hypotension, hypertension, flushing, thrombophlebitis, ischemic necrosis, gangrene, peripheral ischemia, bradycardia, Henoch-Schönlein purpura (vasculitis).
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
0
42912
Other ADRs
334
14116945
Odds Ratio = N/A
Drug Property Information
ATC Code(s):
- N03AX10 - felbamate
- N03AX - Other antiepileptics
- N03A - ANTIEPILEPTICS
- N03 - ANTIEPILEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:felbamate
Active Ingredient UNII:X72RBB02N8
Drugbank ID:DB00949
PubChem Compound:3331
CAS Number:25451-15-4
Dosage Form(s):suspension; tablet
Route(s) Of Administrator:oral
Daily Dose:
- 2400.0 mg/day N03AX10
Chemical Structure: 
SMILE Code:
C1=CC=C(C=C1)C(COC(=O)N)COC(=O)N
C1=CC=C(C=C1)C(COC(=O)N)COC(=O)N
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
N/ADisclaimer:
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