What the label lists and what reports show
Chlordiazepoxide and clidinium side effects
Chlordiazepoxide and clidinium's FDA label lists its adverse reactions in its own words. FAERS holds 1,958 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 (187 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the chlordiazepoxide and clidinium FDA label on DailyMed (effective January 13, 2023, Bausch Health US, 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 Librax?Librax may cause serious side effects, including: See “What is the most important information I should know about Librax?” • Librax can make you sleepy or dizzy and can slow your thinking and motor skills. o Do not drive, operate heavy machinery, or do other dangerous activities until you know how Librax affects you. o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking Librax without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, Librax may make your sleepiness or dizziness much worse. […]
Source: FDA drug label, Bausch Health US, LLC, effective January 13, 2023 (SPL set f99ebf66-f207-4a97-9666-4da1d72b061c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsNo side effects or manifestations not seen with either compound alone have been reported with the administration of Librax. However, since Librax contains chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded. When chlordiazepoxide hydrochloride has been used alone the 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. …
Source: FDA drug label, Bausch Health US, LLC, effective January 13, 2023 (SPL set f99ebf66-f207-4a97-9666-4da1d72b061c), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,958 reports list chlordiazepoxide and clidinium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 70 are coded as a death and 532 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 23 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?
- Chlordiazepoxide and clidinium: 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