What the label lists and what reports show
Clorazepate side effects
Clorazepate's FDA label: “The side effect most frequently reported was drowsiness.” FAERS holds 1,945 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (139 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the clorazepate FDA label on DailyMed (effective September 10, 2026, Apotex Corp.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of clorazepate dipotassium tablets?Clorazepate dipotassium tablets may cause serious side effects, including: See "What is the most important information I should know about clorazepate dipotassium tablets?" clorazepate dipotassium tablets can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clorazepate dipotassium tablets affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clorazepate dipotassium tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clorazepate dipotassium tablets may make your sleepiness or dizziness much worse. […]
Source: FDA drug label, ANDA215566 (Corepharma), as published by Apotex Corp., effective September 10, 2026 (SPL set 6e07efe5-29b6-6d1e-661a-f696c4b17f43), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe side effect most frequently reported was drowsiness.
From the label: adverse reactions, continuedThe side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. Other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, and slurred speech. There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit. Decrease in systolic blood pressure has been observed. To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Source: FDA drug label, ANDA215566 (Corepharma), as published by Apotex Corp., effective September 10, 2026 (SPL set 6e07efe5-29b6-6d1e-661a-f696c4b17f43), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,945 reports list clorazepate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 256 are coded as a death and 983 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Clorazepate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions