Carbamazepine: adverse event reports filed with FDA

22,081

reports as suspect product

0.1% of all reports · about 982 a year

1,516

reports, 12 months to June 2026

1,495 in the 12 months before

93.6%

marked serious by the reporter

91.4% across the class

12.5%

record death among outcomes, as reported

2,765 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 Carbamazepine reports recording the termmedian drug in mood stabilizer

1. Drug ineffectivethe medicine did not work as expected11.3%2,491
2. Toxicity to various agentspoisoning or toxic effect of one or more substances9.7%2,136
3. Drug interactionan interaction between medicines9.6%2,130
4. Falla fall5.2%1,152
5. Seizurea fit or convulsion5.2%1,139
6. Off label useused for a purpose or in a way not on the label4.8%1,063
7. Hypotensionlow blood pressure4.4%973
8. Pyrexiafever4.2%934
9. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement4.2%925
10. Rashskin rash4.1%896
11. Cognitive disorderproblems with thinking or memory4%890
12. Balance disorderproblems with balance3.9%871
13. Painpain, site not specified3.8%850
14. Dizzinesslight-headedness or unsteadiness3.8%845
15. Completed suicidedeath by suicide3.8%844
16. Overdosea dose above the recommended amount3.7%822
17. Somnolencedrowsiness3.7%816
18. Sedationdrowsiness from a medicine3.7%807
19. Depressed level of consciousness3.5%782
20. Constipationconstipation3.5%775
21. Condition aggravatedthe condition being treated got worse3.5%767
22. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.3%728
23. Orthostatic hypotension3%652
24. Fatiguetiredness2.9%643
25. Vomitingbeing sick2.9%641
26. Convulsion2.9%640
27. Hyponatraemialow blood sodium2.8%620
28. Mobility decreasedreduced ability to move about2.8%618
29. Nauseafeeling sick2.7%596
30. Epilepsy2.6%575

Top 30 of 2,498 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 4 drugs in the mood stabilizer 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 57,019 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. 24.6% 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 22,081 reports.

Drugs most often listed in the same reports

Other products listed in reports where Carbamazepine 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 mood stabilizer 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 Carbamazepine as a suspect or interacting product; reports listing it only as a concomitant medication (14,477) 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.