Valproic acid: adverse event reports filed with FDA

21,177

reports as suspect product

0.1% of all reports · about 941 a year

1,031

reports, 12 months to June 2026

1,326 in the 12 months before

96.7%

marked serious by the reporter

78.1% across the class

17.4%

record death among outcomes, as reported

3,678 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 Valproic acid reports recording the termmedian drug in anti-epileptic agent

1. Drug interactionan interaction between medicines14.8%3,126
2. Drug ineffectivethe medicine did not work as expected13.8%2,931
3. Toxicity to various agentspoisoning or toxic effect of one or more substances7.9%1,679
4. Completed suicidedeath by suicide6.1%1,295
5. Off label useused for a purpose or in a way not on the label5.9%1,245
6. Depressionlow mood5%1,051
7. Seizurea fit or convulsion4.5%959
8. Foetal exposure during pregnancythe unborn baby was exposed to the medicine4.2%886
9. Somnolencedrowsiness4%850
10. Overdosea dose above the recommended amount3.3%696
11. Condition aggravatedthe condition being treated got worse3.2%685
12. Hyperammonaemia2.9%621
13. Product use in unapproved indicationused for a purpose not on the label2.5%527
14. Thrombocytopenialow platelets2.5%521
15. Hypotensionlow blood pressure2.5%519
16. Hyperammonaemic encephalopathy2.4%502
17. Status epilepticus2.3%492
18. Tremorshaking2.2%464
19. Pyrexiafever2.2%458
20. Multiple-drug resistance2.2%457
21. Coma2.1%452
22. Depressed level of consciousness2.1%444
23. Treatment failurethe treatment did not work2.1%440
24. Drug level increaseda raised blood level of the medicine2%423
25. Drug resistance2%421
26. Intentional overdosea deliberate overdose1.9%410
27. Epilepsy1.9%398
28. Fatiguetiredness1.8%386
29. Aggressionaggressive behaviour1.8%380
30. Deaththe patient died; cause not stated by this term1.8%374

Top 30 of 2,166 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. 28.6% 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 21,177 reports.

Drugs most often listed in the same reports

Other products listed in reports where Valproic acid 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 Valproic acid as a suspect or interacting product; reports listing it only as a concomitant medication (10,629) 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.