Depakote: adverse event reports filed with FDA

14,219

reports as suspect product

0.1% of all reports · about 632 a year

297

reports, 12 months to June 2026

324 in the 12 months before

65.4%

marked serious by the reporter

78.1% across the class

4.2%

record death among outcomes, as reported

596 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 Depakote reports recording the termmedian drug in anti-epileptic agent

1. Seizurea fit or convulsion6.2%886
2. Painpain, site not specified6.1%874
3. Drug ineffectivethe medicine did not work as expected6.1%869
4. Weight increasedweight gain5.8%819
5. Tremorshaking5.1%732
6. Somnolencedrowsiness4.9%695
7. Foetal exposure during pregnancythe unborn baby was exposed to the medicine4.8%683
8. Convulsion4.7%670
9. Emotional distressemotional distress4.5%645
10. Anxietyanxiety4%562
11. Anhedonia3.9%551
12. Deformity3.8%547
13. Alopeciahair loss3.7%532
14. Physical disability3.7%524
15. Drug interactionan interaction between medicines3.4%481
16. Falla fall3.4%479
17. Fatiguetiredness3.3%466
18. Nauseafeeling sick3.2%458
19. Injurya physical injury3.2%450
20. Vomitingbeing sick3.1%440
21. Dizzinesslight-headedness or unsteadiness3.1%438
22. Headachehead pain3%430
23. Off label useused for a purpose or in a way not on the label3%425
24. Insomniadifficulty sleeping2.9%419
25. Depressionlow mood2.9%409
26. Spina bifida2.8%405
27. Drug hypersensitivityan allergic-type reaction to a medicine2.8%392
28. Confusional stateconfusion2.7%384
29. Feeling abnormalfeeling odd or not right2.7%378
30. Diarrhoealoose or frequent stools2.3%328

Top 30 of 1,672 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. 71.7% 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 14,219 reports.

Drugs most often listed in the same reports

Other products listed in reports where Depakote 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 Depakote as a suspect or interacting product; reports listing it only as a concomitant medication (23,521) 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.