Phenytoin

Common brands: Dilantin-125, Dilantin Infatabs, Phenytoin Infatabs, Keppra Xr, Keppra

Top reporter: Viatris Specialty Llc

Anti-epileptic Agent [EPC]Benzodiazepine [EPC]Mood Stabilizer [EPC]Corticosteroid [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]
20,616
Total Reports
7,033
Serious Reports
2,966
Death Reports
30
Reported Reactions
Death Report Ratio: High (14.39%)

Patient Demographics

Male
9,309
Female
8,621

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Phenytoin.

# Reaction Reports % of Total
1 DRUG INEFFECTIVE 2,699
12.4%
2 DRUG INTERACTION 1,561
7.2%
3 SEIZURE 1,400
6.4%
4 TOXICITY TO VARIOUS AGENTS 1,360
6.3%
5 CONVULSION 1,262
5.8%
6 OFF LABEL USE 1,109
5.1%
7 STATUS EPILEPTICUS 801
3.7%
8 STEVENS-JOHNSON SYNDROME 771
3.5%
9 PYREXIA 683
3.1%
10 FALL 614
2.8%
11 DIZZINESS 603
2.8%
12 DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS 603
2.8%
13 CONDITION AGGRAVATED 560
2.6%
14 SOMNOLENCE 545
2.5%
15 EPILEPSY 528
2.4%
16 HYPOTENSION 526
2.4%
17 ATAXIA 523
2.4%
18 CONFUSIONAL STATE 523
2.4%
19 VOMITING 522
2.4%
20 NAUSEA 511
2.3%
21 RASH 511
2.3%
22 DRUG HYPERSENSITIVITY 437
2.0%
23 FATIGUE 437
2.0%
24 HEADACHE 423
1.9%
25 GAIT DISTURBANCE 389
1.8%
26 OVERDOSE 389
1.8%
27 DEATH 370
1.7%
28 PNEUMONIA 369
1.7%
29 MULTIPLE-DRUG RESISTANCE 360
1.7%
30 COMPLETED SUICIDE 359
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.