Phenytoin: adverse event reports filed with FDA

12,618

reports as suspect product

0.1% of all reports · about 561 a year

464

reports, 12 months to June 2026

734 in the 12 months before

92.9%

marked serious by the reporter

78.1% across the class

13.8%

record death among outcomes, as reported

1,746 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Phenytoin reports recording the termmedian drug in anti-epileptic agent

1. Drug ineffectivethe medicine did not work as expected17%2,149
2. Drug interactionan interaction between medicines10.5%1,331
3. Toxicity to various agentspoisoning or toxic effect of one or more substances10.1%1,270
4. Seizurea fit or convulsion7.4%940
5. Off label useused for a purpose or in a way not on the label5.7%715
6. Convulsion5.6%706
7. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement4.8%601
8. Status epilepticus4.5%565
9. Pyrexiafever3.5%441
10. Ataxia3.4%433
11. Dizzinesslight-headedness or unsteadiness3%383
12. Condition aggravatedthe condition being treated got worse3%376
13. Falla fall2.8%359
14. Hypotensionlow blood pressure2.8%359
15. Rashskin rash2.8%357
16. Stevens-Johnson syndromea severe skin and mucous-membrane reaction2.8%353
17. Completed suicidedeath by suicide2.8%350
18. Nystagmus2.7%346
19. Confusional stateconfusion2.6%326
20. Multiple-drug resistance2.5%318
21. Somnolencedrowsiness2.5%313
22. Epilepsy2.4%309
23. Vomitingbeing sick2.4%299
24. Overdosea dose above the recommended amount2.2%281
25. Toxic epidermal necrolysisa severe skin reaction with peeling2.2%275
26. Drug resistance2.2%274
27. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.1%266
28. Drug hypersensitivityan allergic-type reaction to a medicine2%256
29. Anticonvulsant drug level increased2%255
30. Gait disturbancedifficulty walking2%252

Top 30 of 1,610 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 23 drugs in the anti-epileptic agent class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 269,757 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 37.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 12,618 reports.

Drugs most often listed in the same reports

Other products listed in reports where Phenytoin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the anti-epileptic agent class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Phenytoin as a suspect or interacting product; reports listing it only as a concomitant medication (7,093) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.