Divalproex sodium er: adverse event reports filed with FDA

503

reports as suspect product

0% of all reports · about 38 a year

24

reports, 12 months to June 2026

10 in the 12 months before

85.1%

marked serious by the reporter

78.1% across the class

6.4%

record death among outcomes, as reported

32 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 Divalproex sodium er reports recording the termmedian drug in anti-epileptic agent

1. Drug interactionan interaction between medicines9.1%46
2. Toxicity to various agentspoisoning or toxic effect of one or more substances7.6%38
3. Seizurea fit or convulsion7.4%37
4. Hyperammonaemia6.6%33
5. Drug ineffectivethe medicine did not work as expected6.4%32
6. Intentional overdosea deliberate overdose4.8%24
7. Overdosea dose above the recommended amount3.2%16
8. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3%15
9. Coma2.8%14
10. Foetal anticonvulsant syndrome2.8%14
11. Hyperammonaemic encephalopathy2.8%14
12. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2.6%13
13. Encephalopathy2.6%13
14. Somnolencedrowsiness2.6%13
15. Product use issuea problem in how the product was used2.4%12
16. Headachehead pain2.2%11
17. Hypotensionlow blood pressure2.2%11
18. Insomniadifficulty sleeping2.2%11
19. Drug administered to patient of inappropriate age2%10
20. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity2%10
21. Parkinsonism2%10
22. Generalised tonic-clonic seizure1.8%9
23. Pneumonialung infection1.8%9
24. Thrombocytopenialow platelets1.8%9
25. Anticonvulsant drug level increased1.6%8
26. Cognitive disorderproblems with thinking or memory1.6%8
27. Respiratory failurethe lungs could not supply enough oxygen1.6%8
28. Rhabdomyolysismuscle breakdown1.6%8
29. Vomitingbeing sick1.6%8
30. Dizzinesslight-headedness or unsteadiness1.4%7

Top 30 of 209 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. 47.5% 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 503 reports.

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 Divalproex sodium er as a suspect or interacting product; reports listing it only as a concomitant medication (129) 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.