Valproate sodium: adverse event reports filed with FDA

11,588

reports as suspect product

0.1% of all reports · about 515 a year

708

reports, 12 months to June 2026

795 in the 12 months before

97.5%

marked serious by the reporter

78.1% across the class

7%

record death among outcomes, as reported

813 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 Valproate sodium reports recording the termmedian drug in anti-epileptic agent

1. Foetal exposure during pregnancythe unborn baby was exposed to the medicine9%1,040
2. Drug ineffectivethe medicine did not work as expected8.2%947
3. Drug interactionan interaction between medicines8.2%946
4. Somnolencedrowsiness5.5%639
5. Toxicity to various agentspoisoning or toxic effect of one or more substances5%578
6. Off label useused for a purpose or in a way not on the label5%577
7. Seizurea fit or convulsion4.5%522
8. Epilepsy3.8%441
9. Dysmorphism3.3%388
10. Foetal anticonvulsant syndrome3.1%363
11. Vomitingbeing sick2.9%333
12. Anxietyanxiety2.8%324
13. Coma2.8%322
14. Disturbance in attentiondifficulty concentrating2.8%319
15. Fatiguetiredness2.7%318
16. Pyrexiafever2.7%317
17. Convulsion2.7%314
18. Condition aggravatedthe condition being treated got worse2.7%313
19. Product use in unapproved indicationused for a purpose not on the label2.6%305
20. Overdosea dose above the recommended amount2.6%304
21. Drug abusemisuse of a medicine2.5%294
22. Cognitive disorderproblems with thinking or memory2.5%290
23. Thrombocytopenialow platelets2.5%289
24. Suicide attempta suicide attempt2.4%283
25. Developmental delayslower development in a child2.4%279
26. Hyperammonaemia2.4%277
27. Tremorshaking2.4%274
28. Confusional stateconfusion2.4%273
29. Platelet count decreasedlow platelet count2.4%273
30. Neutropenialow neutrophils, a type of white blood cell2.3%272

Top 30 of 1,930 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. 4.2% 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 11,588 reports.

Drugs most often listed in the same reports

Other products listed in reports where Valproate sodium 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 Valproate sodium as a suspect or interacting product; reports listing it only as a concomitant medication (8,592) 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.