Chlordiazepoxide and Clidinium side effects: what 1,919 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Chlordiazepoxide Hydrochloride And Clidinium Bromide (Chlordiazepoxide Hydrochloride And Clidinium Bromide)
Who reports
1,919 reports · 57% serious · 68 with death outcome · 81% female
Used for
Chlordiazepoxide hydrochloride and clidinium bromide capsules is indicated to control emotional and somatic factors in gastrointestinal disorders. Chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
What it is
DESCRIPTION: Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP is a fixed-combination of chlordiazepoxide hydrochloride, a benzodiazepine, and clidinium bromide, an anticholinergic.
Boxed warning
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
Causality screen of the 38 strongest signals
What the badges mean
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 88 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Irritable bowel syndrome | 38 | 19.5 14.2–26.7ROR 19.8 · χ² 646 / p 7e-143 | 19.2 EB05 14.6 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 16.5 · 71% consumer | no trial data cached |
| Gallbladder disorder | 24 | 14.7 9.8–21.8ROR 14.8 · χ² 292 / p 1e-65 | 14.2 EB05 9.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Gastrointestinal pain | 12 | 12.0 6.8–21.1ROR 12.0 · χ² 110 / p 5e-26 | 10.3 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Intervertebral disc degeneration | 10 | 11.7 6.3–21.8ROR 11.8 · χ² 88 / p 4e-21 | 9.7 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Diverticulitis | 26 | 10.3 7.0–15.1ROR 10.4 · χ² 209 / p 1e-47 | 9.5 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Bursitis | 11 | 10.0 5.5–18.0ROR 10.0 · χ² 80 / p 2e-19 | 8.1 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Cholecystectomy | 10 | 9.6 5.2–17.9ROR 9.7 · χ² 69 / p 5e-17 | 7.6 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Hiatus hernia | 11 | 9.3 5.1–16.7ROR 9.3 · χ² 73 / p 6e-18 | 7.4 EB05 4.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Oral candidiasis (oral thrush) | 11 | 9.2 5.1–16.7ROR 9.3 · χ² 73 / p 7e-18 | 7.4 EB05 4.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Intervertebral disc protrusion | 16 | 8.0 4.9–13.0ROR 8.0 · χ² 91 / p 8e-22 | 6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Haemorrhoids | 14 | 7.8 4.6–13.2ROR 7.9 · χ² 77 / p 1e-18 | 6.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Fibromyalgia | 17 | 7.6 4.8–12.3ROR 7.7 · χ² 92 / p 5e-22 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Pharmaceutical product complaint | 18 | 7.5 4.7–11.8ROR 7.5 · χ² 95 / p 1e-22 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Restless legs syndrome | 12 | 7.2 4.1–12.7ROR 7.2 · χ² 58 / p 1e-14 | 5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Economic problem | 10 | 7.1 3.8–13.2ROR 7.1 · χ² 46 / p 5e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 | no trial data cached |
| Gastritis | 16 | 6.6 4.1–10.8ROR 6.7 · χ² 71 / p 2e-17 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Activities of daily living impaired | 12 | 6.5 3.7–11.5ROR 6.6 · χ² 51 / p 5e-13 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Cholelithiasis | 19 | 6.3 4.0–9.9ROR 6.4 · χ² 80 / p 2e-19 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Dysuria (painful urination) | 21 | 6.2 4.1–9.5ROR 6.3 · χ² 87 / p 5e-21 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Rectal haemorrhage | 23 | 5.8 3.9–8.8ROR 5.9 · χ² 87 / p 5e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Kidney infection | 10 | 5.6 3.0–10.3ROR 5.6 · χ² 33 / p 4e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Flatulence (gas) | 26 | 5.0 3.4–7.4ROR 5.1 · χ² 80 / p 2e-19 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 74% consumer | no trial data cached |
| Pain in jaw | 13 | 5.0 2.9–8.6ROR 5.0 · χ² 38 / p 4e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Injury | 32 | 4.9 3.5–7.0ROR 5.0 · χ² 97 / p 3e-23 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Anhedonia | 11 | 4.5 2.5–8.2ROR 4.6 · χ² 27 / p 1e-7 | 3.9 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Frequent bowel movements | 11 | 4.5 2.5–8.1ROR 4.5 · χ² 26 / p 1e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Abasia | 10 | 4.4 2.3–8.1ROR 4.4 · χ² 23 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Abnormal dreams | 10 | 3.9 2.1–7.3ROR 3.9 · χ² 19 / p 6e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Nervousness | 18 | 3.7 2.4–5.9ROR 3.8 · χ² 34 / p 3e-9 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Injection site haemorrhage | 27 | 3.7 2.6–5.4ROR 3.8 · χ² 51 / p 4e-13 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 83% consumer | no trial data cached |
| Abnormal behaviour | 13 | 3.6 2.1–6.1ROR 3.6 · χ² 21 / p 2e-6 | 3.2 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Drug effect incomplete | 10 | 3.0 1.6–5.5ROR 3.0 · χ² 11 / p 4e-4 | 2.7 EB05 1.6 · IC025 +0.4 | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Wrong technique in drug usage process | 10 | 3.0 1.6–5.5ROR 3.0 · χ² 11 / p 4e-4 | 2.7 EB05 1.6 · IC025 +0.4 | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Emotional distress | 27 | 2.4 1.7–3.5ROR 2.4 · χ² 21 / p 2e-6 | 2.4 EB05 1.7 · IC025 +0.6 | Likely indication confounding shares a disease stem with the indications wording | serious PRR 2.5 | no trial data cached |
| Drug effect decreased | 12 | 2.4 1.4–4.2ROR 2.4 · χ² 8 / p 0.002 | 2.3 EB05 1.4 · IC025 +0.2 | Reporting / coding artifact | serious PRR 5.6 | no trial data cached |
| Injection site pruritus | 14 | 2.3 1.4–3.9ROR 2.3 · χ² 9 / p 0.001 | 2.2 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Product substitution issue | 12 | 2.3 1.3–4.0ROR 2.3 · χ² 7 / p 0.003 | 2.2 EB05 1.3 · IC025 +0.1 | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Injection site erythema (redness where injected) | 23 | 2.0 1.4–3.1ROR 2.0 · χ² 11 / p 4e-4 | 2.0 EB05 1.4 · IC025 +0.3 | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Injection site pain (pain where injected) | 53 | 1.9 1.5–2.5ROR 1.9 · χ² 22 / p 1e-6 | 1.9 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 3.3 · 80% consumer | no trial data cached |
| Irritable bowel syndrome | 38 | 19.5 14.2–26.7ROR 19.8 · χ² 646 / p 7e-143 | 19.2 EB05 14.6 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 16.5 · 71% consumer | no trial data cached |
| Injury | 32 | 4.9 3.5–7.0ROR 5.0 · χ² 97 / p 3e-23 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Emotional distress | 27 | 2.4 1.7–3.5ROR 2.4 · χ² 21 / p 2e-6 | 2.4 EB05 1.7 · IC025 +0.6 | Likely indication confounding shares a disease stem with the indications wording | serious PRR 2.5 | no trial data cached |
| Injection site haemorrhage | 27 | 3.7 2.6–5.4ROR 3.8 · χ² 51 / p 4e-13 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 83% consumer | no trial data cached |
| Flatulence (gas) | 26 | 5.0 3.4–7.4ROR 5.1 · χ² 80 / p 2e-19 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 74% consumer | no trial data cached |
| Diverticulitis | 26 | 10.3 7.0–15.1ROR 10.4 · χ² 209 / p 1e-47 | 9.5 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Drug dose omission | 25 | 1.6 1.1–2.4ROR 1.6 · χ² 5 / p 0.010 | 1.6 EB05 1.2 · IC025 +0.0 | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Gallbladder disorder | 24 | 14.7 9.8–21.8ROR 14.8 · χ² 292 / p 1e-65 | 14.2 EB05 9.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Injection site erythema (redness where injected) | 23 | 2.0 1.4–3.1ROR 2.0 · χ² 11 / p 4e-4 | 2.0 EB05 1.4 · IC025 +0.3 | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Rectal haemorrhage | 23 | 5.8 3.9–8.8ROR 5.9 · χ² 87 / p 5e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Dysuria (painful urination) | 21 | 6.2 4.1–9.5ROR 6.3 · χ² 87 / p 5e-21 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Cholelithiasis | 19 | 6.3 4.0–9.9ROR 6.4 · χ² 80 / p 2e-19 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Nervousness | 18 | 3.7 2.4–5.9ROR 3.8 · χ² 34 / p 3e-9 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Pharmaceutical product complaint | 18 | 7.5 4.7–11.8ROR 7.5 · χ² 95 / p 1e-22 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Gallbladder disorder — n=24, PRR 14.7
- Diverticulitis — n=26, PRR 10.3
- Dysuria — n=21, PRR 6.2
- Rectal haemorrhage — n=23, PRR 5.8
- Flatulence — n=26, PRR 5.0
- Injury — n=32, PRR 4.9
- Injection site haemorrhage — n=27, PRR 3.7
- Injection site erythema — n=23, PRR 2.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Chlordiazepoxide and Clidinium?
In FDA FAERS, the most frequently co-reported reaction terms for Chlordiazepoxide and Clidinium are injection site pain, irritable bowel syndrome, injury, emotional distress, injection site haemorrhage, flatulence. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Chlordiazepoxide and Clidinium have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
Do FAERS signals prove that Chlordiazepoxide and Clidinium causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 01d1e922-f3a8-4af3-99ec-94b927187373, effective 20240807; matched on
openfda.generic_name.exact:"CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 126 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.