What the label lists and what reports show
Chlordiazepoxide side effects
Chlordiazepoxide's FDA label lists its adverse reactions in its own words. FAERS holds 107 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 dizziness (9 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the chlordiazepoxide FDA label on DailyMed (effective December 10, 2025, Chartwell RX, LLC); 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 chlordiazepoxide hydrochloride?Chlordiazepoxide hydrochloride may cause serious side effects, including: See “What is the most important information I should know about chlordiazepoxide hydrochloride?” Chlordiazepoxide Hydrochloride 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 chlordiazepoxide hydrochloride affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking chlordiazepoxide hydrochloride without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, chlordiazepoxide hydrochloride may make your sleepiness or dizziness much worse. […]
Source: FDA drug label, Chartwell RX, LLC, effective December 10, 2025 (SPL set dd5f82b0-5a56-4728-941a-c8c2a0d51cc4), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported. Other adverse reactions reported during therapy include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent, and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after chlordiazepoxide treatment. …
Source: FDA drug label, Chartwell RX, LLC, effective December 10, 2025 (SPL set dd5f82b0-5a56-4728-941a-c8c2a0d51cc4), via openFDA; the full label on DailyMed
What do FAERS reports show?
107 reports list chlordiazepoxide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 35 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 19 reactions below, 2 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.
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?
- Chlordiazepoxide: 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