Oxazepam: adverse event reports filed with FDA

10,709

reports as suspect product

0.1% of all reports · about 476 a year

1,200

reports, 12 months to June 2026

1,279 in the 12 months before

99.1%

marked serious by the reporter

88.1% across the class

30.3%

record death among outcomes, as reported

3,246 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 Oxazepam reports recording the termmedian drug in benzodiazepine

1. Toxicity to various agentspoisoning or toxic effect of one or more substances24.1%2,584
2. Drug abusemisuse of a medicine13.4%1,440
3. Falla fall10.6%1,136
4. Hypotensionlow blood pressure10.4%1,109
5. Coma9.3%993
6. Depressed level of consciousness7.8%832
7. Cognitive disorderproblems with thinking or memory7.1%765
8. Somnolencedrowsiness6.9%742
9. Sedationdrowsiness from a medicine6.7%720
10. Orthostatic hypotension6.6%712
11. Balance disorderproblems with balance6.1%657
12. Constipationconstipation6.1%654
13. Drug interactionan interaction between medicines6%641
14. Overdosea dose above the recommended amount5.8%618
15. Painpain, site not specified5.4%583
16. Intentional overdosea deliberate overdose5.3%571
17. Mobility decreasedreduced ability to move about5.3%563
18. Poisoning deliberate5.2%560
19. Sedation complication5%538
20. Blood calcium decreased5%531
21. Creatinine renal clearance decreased4.9%530
22. Deaththe patient died; cause not stated by this term4.8%519
23. Confusional stateconfusion4%425
24. Drug dependencedependence on a medicine3.9%422
25. Suicide attempta suicide attempt3.8%412
26. Drug use disorder3.6%383
27. Aggressionaggressive behaviour3.3%349
28. Poisoning3.2%345
29. Completed suicidedeath by suicide2.9%311
30. Asphyxia2.8%302

Top 30 of 1,159 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. 3.5% 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 10,709 reports.

Drugs most often listed in the same reports

Other products listed in reports where Oxazepam 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 Oxazepam as a suspect or interacting product; reports listing it only as a concomitant medication (10,731) 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.