Midazolam: adverse event reports filed with FDA

11,299

reports as suspect product

0.1% of all reports · about 504 a year

872

reports, 12 months to June 2026

1,173 in the 12 months before

92.6%

marked serious by the reporter

88.1% across the class

17.6%

record death among outcomes, as reported

1,988 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 Midazolam reports recording the termmedian drug in benzodiazepine

1. Drug ineffectivethe medicine did not work as expected18.4%2,078
2. Off label useused for a purpose or in a way not on the label11.1%1,258
3. Hypotensionlow blood pressure6.3%717
4. Drug interactionan interaction between medicines5.2%582
5. Toxicity to various agentspoisoning or toxic effect of one or more substances5.1%575
6. Seizurea fit or convulsion4.8%539
7. Cardiac arrestthe heart stopped3.6%409
8. Drug ineffective for unapproved indication3.4%386
9. Status epilepticus3.3%376
10. Deaththe patient died; cause not stated by this term2.8%319
11. Condition aggravatedthe condition being treated got worse2.8%318
12. Pyrexiafever2.8%316
13. Product use in unapproved indicationused for a purpose not on the label2.6%299
14. Tachycardiafast heart rate2.6%298
15. Anaphylactic reactiona severe, sudden allergic reaction2.5%283
16. Respiratory failurethe lungs could not supply enough oxygen2.4%273
17. Agitationrestlessness2.3%258
18. Nauseafeeling sick2.3%256
19. Hypoxialow oxygen2.2%245
20. Drug abusemisuse of a medicine2.2%244
21. Anaemialow red blood cells2.1%238
22. Overdosea dose above the recommended amount2.1%238
23. Multiple-drug resistance2.1%236
24. Maternal exposure during pregnancythe mother took the medicine during pregnancy2%230
25. Somnolencedrowsiness2%227
26. Deliriumsudden confusion2%225
27. Bradycardiaslow heart rate2%224
28. Foetal exposure during pregnancythe unborn baby was exposed to the medicine2%223
29. Oxygen saturation decreased2%222
30. Therapeutic product effect incomplete1.9%215

Top 30 of 1,468 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. 33.8% 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 11,299 reports.

Drugs most often listed in the same reports

Other products listed in reports where Midazolam 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 Midazolam as a suspect or interacting product; reports listing it only as a concomitant medication (12,982) 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.