Clobazam: adverse event reports filed with FDA

8,005

reports as suspect product

0% of all reports · about 356 a year

712

reports, 12 months to June 2026

1,000 in the 12 months before

89.1%

marked serious by the reporter

88.1% across the class

7.7%

record death among outcomes, as reported

618 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 Clobazam reports recording the termmedian drug in benzodiazepine

1. Drug ineffectivethe medicine did not work as expected23.4%1,871
2. Seizurea fit or convulsion11.9%953
3. Off label useused for a purpose or in a way not on the label11.5%918
4. Somnolencedrowsiness9.2%733
5. Drug interactionan interaction between medicines8.2%655
6. Multiple-drug resistance6.4%515
7. Foetal exposure during pregnancythe unborn baby was exposed to the medicine5.7%459
8. Epilepsy4.8%381
9. Status epilepticus4.5%357
10. Drug resistance4.2%334
11. Condition aggravatedthe condition being treated got worse3.9%309
12. Fatiguetiredness3.6%290
13. Toxicity to various agentspoisoning or toxic effect of one or more substances3.3%262
14. Product use issuea problem in how the product was used3.1%249
15. Maternal exposure during pregnancythe mother took the medicine during pregnancy3%240
16. Generalised tonic-clonic seizure2.9%233
17. Treatment failurethe treatment did not work2.8%228
18. Exposure during pregnancythe medicine was taken during pregnancy2.7%219
19. Ataxia2.5%204
20. Overdosea dose above the recommended amount2.5%204
21. Sedationdrowsiness from a medicine2.5%200
22. Falla fall2.4%189
23. Respiratory depressionslow or shallow breathing2.2%179
24. Encephalopathy2.2%177
25. Product use in unapproved indicationused for a purpose not on the label2%164
26. Partial seizures2%163
27. Drug abusemisuse of a medicine2%160
28. Drug dependencedependence on a medicine1.9%150
29. Aggressionaggressive behaviour1.8%147
30. Drug ineffective for unapproved indication1.8%142

Top 30 of 1,083 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 19 drugs in the benzodiazepine 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 244,289 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 8,005 reports.

Drugs most often listed in the same reports

Other products listed in reports where Clobazam 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 benzodiazepine 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 Clobazam as a suspect or interacting product; reports listing it only as a concomitant medication (9,293) 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.