Clorazepate dipotassium: adverse event reports filed with FDA

753

reports as suspect product

0% of all reports · about 33 a year

108

reports, 12 months to June 2026

94 in the 12 months before

87.6%

marked serious by the reporter

88.1% across the class

18.9%

record death among outcomes, as reported

142 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 Clorazepate dipotassium reports recording the termmedian drug in benzodiazepine

1. Intentional overdosea deliberate overdose9.4%71
2. Somnolencedrowsiness8.5%64
3. Toxicity to various agentspoisoning or toxic effect of one or more substances8%60
4. Depressed level of consciousness7.6%57
5. Drug interactionan interaction between medicines7.3%55
6. Suicide attempta suicide attempt6.9%52
7. Drug abusemisuse of a medicine6.8%51
8. Drug ineffectivethe medicine did not work as expected6.1%46
9. Coma5.7%43
10. Off label useused for a purpose or in a way not on the label5.3%40
11. Nauseafeeling sick4.8%36
12. Diarrhoealoose or frequent stools4.2%32
13. Metabolic acidosistoo much acid in the body fluids4.2%32
14. Anxietyanxiety4.1%31
15. Toxic epidermal necrolysisa severe skin reaction with peeling3.9%29
16. Overdosea dose above the recommended amount3.6%27
17. Blistera blister3.5%26
18. Condition aggravatedthe condition being treated got worse3.5%26
19. Confusional stateconfusion3.5%26
20. Acute hepatic failure3.3%25
21. Shockshock, a collapse of the circulation3.3%25
22. Hypotensionlow blood pressure3.1%23
23. Acute kidney injurysudden loss of kidney function2.9%22
24. Product physical issuea physical defect in the product2.9%22
25. Seizurea fit or convulsion2.8%21
26. Respiratory depressionslow or shallow breathing2.7%20
27. Dizzinesslight-headedness or unsteadiness2.5%19
28. Stevens-Johnson syndromea severe skin and mucous-membrane reaction2.5%19
29. Pyrexiafever2.4%18
30. Multiple organ dysfunction syndromeseveral organs failing2.3%17

Top 30 of 322 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. 23.5% 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 753 reports.

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 Clorazepate dipotassium as a suspect or interacting product; reports listing it only as a concomitant medication (1,216) 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.