Diazepam: adverse event reports filed with FDA

40,060

reports as suspect product

0.2% of all reports · about 1,781 a year

2,762

reports, 12 months to June 2026

2,733 in the 12 months before

94.8%

marked serious by the reporter

88.1% across the class

41%

record death among outcomes, as reported

16,409 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 Diazepam reports recording the termmedian drug in benzodiazepine

1. Toxicity to various agentspoisoning or toxic effect of one or more substances20.7%8,303
2. Drug abusemisuse of a medicine15.1%6,032
3. Completed suicidedeath by suicide9.1%3,636
4. Drug interactionan interaction between medicines6.4%2,582
5. Drug ineffectivethe medicine did not work as expected5.8%2,339
6. Overdosea dose above the recommended amount5.8%2,323
7. Somnolencedrowsiness5.8%2,322
8. Deaththe patient died; cause not stated by this term5.5%2,223
9. Coma4.9%1,957
10. Intentional overdosea deliberate overdose4.8%1,942
11. Suicide attempta suicide attempt4%1,605
12. Cardiac arrestthe heart stopped3.6%1,452
13. Hypotensionlow blood pressure3.6%1,443
14. Off label useused for a purpose or in a way not on the label3.5%1,390
15. Drug dependencedependence on a medicine3.4%1,347
16. Respiratory arrestbreathing stopped3.2%1,300
17. Depressed level of consciousness3%1,215
18. Cardio-respiratory arrestthe heart and breathing stopped3%1,193
19. Poisoning3%1,191
20. Intentional product misusedeliberate use not as intended2.7%1,069
21. Vomitingbeing sick2.7%1,063
22. Agitationrestlessness2.6%1,043
23. Pneumonialung infection2.5%1,002
24. Anxietyanxiety2.4%957
25. Nauseafeeling sick2.4%956
26. Confusional stateconfusion2.4%948
27. Loss of consciousnesspassing out2.3%904
28. Tachycardiafast heart rate2.3%902
29. Falla fall2.2%895
30. Poisoning deliberate2.2%887

Top 30 of 2,486 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. 32.7% 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 40,060 reports.

Drugs most often listed in the same reports

Other products listed in reports where Diazepam 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 Diazepam as a suspect or interacting product; reports listing it only as a concomitant medication (49,782) 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.