Dilantin: adverse event reports filed with FDA

8,011

reports as suspect product

0% of all reports · about 356 a year

78

reports, 12 months to June 2026

78 in the 12 months before

71.7%

marked serious by the reporter

78.1% across the class

4.3%

record death among outcomes, as reported

343 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 Dilantin reports recording the termmedian drug in anti-epileptic agent

1. Convulsion16.4%1,312
2. Drug hypersensitivityan allergic-type reaction to a medicine9.6%770
3. Seizurea fit or convulsion9%719
4. Drug ineffectivethe medicine did not work as expected8.9%712
5. Dizzinesslight-headedness or unsteadiness5.4%434
6. Stevens-Johnson syndromea severe skin and mucous-membrane reaction5.4%429
7. Drug interactionan interaction between medicines5%398
8. Falla fall4.9%394
9. Headachehead pain4.2%334
10. Anticonvulsant drug level decreased3.9%316
11. Rashskin rash3.8%303
12. Anticonvulsant drug level increased3.6%291
13. Fatiguetiredness3.6%289
14. Gait disturbancedifficulty walking3.5%284
15. Balance disorderproblems with balance3.3%265
16. Feeling abnormalfeeling odd or not right3.2%259
17. Toxicity to various agentspoisoning or toxic effect of one or more substances3.2%259
18. Tremorshaking3.2%259
19. Weight decreasedweight loss2.9%234
20. Nauseafeeling sick2.9%233
21. Somnolencedrowsiness2.9%230
22. Condition aggravatedthe condition being treated got worse2.8%227
23. Malaisegeneral feeling of being unwell2.8%227
24. Pharmaceutical product complaint2.6%211
25. Memory impairmentmemory problems2.5%202
26. Astheniaweakness or lack of energy2.5%199
27. Confusional stateconfusion2.4%192
28. Drug level decreaseda low blood level of the medicine2.4%189
29. Grand mal convulsion2.2%180
30. Painpain, site not specified2.2%175

Top 30 of 1,084 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. 81.6% 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 8,011 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dilantin 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 Dilantin as a suspect or interacting product; reports listing it only as a concomitant medication (8,601) 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.