OpenClaim

Phenytoin Side Effects

The most commonly reported side effects of phenytoin include seizure, convulsion, and off label use, based on 43,191 FDA adverse event reports from 2004 to 2025. 9.7% of reports found the drug to be ineffective.

Phenytoin side effects

Percentages show how often each reaction appears relative to total reports for phenytoin.

1
Drug Ineffective9.7%4,201
2
Seizure7.5%3,220
3
Convulsion7.0%3,039
4
Off Label Use4.2%1,800
5
Toxicity To Various Agents4.2%1,795
6
Drug Interaction3.9%1,691
7
Drug Hypersensitivity2.8%1,190
8
Fall2.3%1,013
9
Dizziness2.2%930
10
Status Epilepticus2.1%911
11
Fatigue2.1%889
12
Headache2.0%848
13
Drug Reaction With Eosinophilia And Systemic Symptoms1.9%821
14
Stevens-johnson Syndrome1.9%800
15
Nausea1.8%782

These are voluntary reports and do not establish that phenytoin caused these reactions.

Report severity

82.2%Serious35,500 reports
37.3%Hospitalizations16,107 reports
11.0%Fatal4,764 reports

Seriousness is determined by the reporter, not by OpenClaim.

Phenytoin drug interactions

Other drugs that appear in adverse event reports alongside phenytoin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Levetiracetam15.1%6,521
2
Lacosamide6.2%2,697
3
Carbamazepine5.7%2,447
4
Phenobarbital-sodium5.2%2,227
5
Topiramate4.6%2,001
6
Lamotrigine4.6%1,994
7
Valproic-acid4.4%1,911
8
Midazolam4.3%1,867
9
Clobazam3.5%1,507
10
Propofol2.8%1,225
11
Clonazepam2.5%1,086
12
Gabapentin2.5%1,077
13
Valproate-sodium2.4%1,044
14
Diazepam2.3%973
15
Lorazepam2.1%892

Taken alongside

1
Levetiracetam7.9%3,419
2
Acetaminophen6.9%3,000
3
Aspirin5.8%2,494
4
Levothyroxine-sodium4.7%2,026
5
Lorazepam4.5%1,956
6
Phenobarbital-sodium4.3%1,843
7
Furosemide4.1%1,787
8
Gabapentin3.9%1,705
9
Clonazepam3.8%1,658
10
Omeprazole3.7%1,618
11
Atorvastatin-calcium3.7%1,598
12
Metoprolol3.6%1,534
13
Dexamethasone3.5%1,528
14
Carbamazepine3.4%1,464
15
Ergocalciferol3.4%1,462

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports phenytoin side effects

46.2% of phenytoin adverse event reports involve female patients and 43.4% involve male patients. The largest age group is adult at 61%. These figures reflect who reports side effects, not underlying risk.

Sex

Female46.2%
Male43.4%
Unknown10.5%

Age group

< 24.0%
2–115.9%
12–173.5%
18–6461.0%
65+25.6%

What is phenytoin used for

Conditions and purposes for which patients were taking phenytoin when the adverse event was reported.

Abdominal DistensionAbdominal Pain UpperAbnormal BehaviourAccidentAccidental ExposureAccidental OverdoseAcute Myeloid LeukaemiaAdjuvant TherapyAdverse Drug ReactionAdverse EventAffective DisorderAggressionAgitated DepressionAgitationAlcohol Detoxification

Showing 15 of 767 indications

Phenytoin brand names and reporting trend

Phenytoin is sold under brand names including Dilantin, Prompt Phenytoin Sodium.

Brand names

Dilantin24,546
Prompt Phenytoin Sodium5,447

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking phenytoin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.