Phenobarbital

Common brands: Keppra Xr, Keppra, Levetiracetam Er, Elepsia Xr 1000 Mg, Elepsia Xr 1500 Mg

Top reporter: Chartwell Governmental & Specialty Rx, Llc.

Benzodiazepine [EPC]Anti-epileptic Agent [EPC]Mood Stabilizer [EPC]Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
14,212
Total Reports
6,276
Serious Reports
1,753
Death Reports
30
Reported Reactions
Death Report Ratio: High (12.33%)

Patient Demographics

Male
5,572
Female
6,615

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Phenobarbital.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 2,425
15.8%
2 SEIZURE 1,569
10.2%
3 OFF LABEL USE 1,397
9.1%
4 DRUG INTERACTION 640
4.2%
5 TOXICITY TO VARIOUS AGENTS 629
4.1%
6 STATUS EPILEPTICUS 491
3.2%
7 MULTIPLE-DRUG RESISTANCE 453
3.0%
8 SOMNOLENCE 443
2.9%
9 CONDITION AGGRAVATED 416
2.7%
10 FALL 405
2.6%
11 EPILEPSY 404
2.6%
12 HYPOTENSION 398
2.6%
13 PRODUCT USE IN UNAPPROVED INDICATION 381
2.5%
14 PYREXIA 380
2.5%
15 CONVULSION 369
2.4%
16 FATIGUE 348
2.3%
17 DEATH 333
2.2%
18 OVERDOSE 329
2.1%
19 VOMITING 328
2.1%
20 PNEUMONIA 322
2.1%
21 PRODUCT USE ISSUE 314
2.0%
22 DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS 303
2.0%
23 DIARRHOEA 298
1.9%
24 HEADACHE 290
1.9%
25 DYSPNOEA 289
1.9%
26 NAUSEA 286
1.9%
27 DIZZINESS 285
1.9%
28 DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 276
1.8%
29 PAIN 271
1.8%
30 FOETAL EXPOSURE DURING PREGNANCY 265
1.7%

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.