Clorazepate Dipotassium side effects: what 1,945 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,945 reports · 85% serious · 256 with death outcome · 64% female
Used for
Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures.
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 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 107 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 |
|---|---|---|---|---|---|---|
| Toxic epidermal necrolysis (severe skin peeling reaction) | 34 | 24.4 17.4–34.0ROR 24.8 · χ² 737 / p 1e-162 | 24.0 EB05 18.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · ♀ 41% (drug 64%) · 94% clinician | no trial data cached |
| Acute hepatic failure | 29 | 23.0 16.0–33.1ROR 23.4 · χ² 589 / p 3e-130 | 22.7 EB05 16.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · ♀ 100% (drug 64%) · 100% clinician | no trial data cached |
| Tenderness | 21 | 21.7 14.2–33.3ROR 21.9 · χ² 394 / p 5e-88 | 21.3 EB05 14.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Respiratory depression | 23 | 20.3 13.5–30.4ROR 20.5 · χ² 401 / p 1e-89 | 19.9 EB05 13.9 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.2 · 95% clinician | no trial data cached |
| Serotonin syndrome | 35 | 19.8 14.2–27.4ROR 20.1 · χ² 604 / p 1e-133 | 19.5 EB05 14.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 100% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 20 | 19.5 12.6–30.1ROR 19.7 · χ² 332 / p 2e-74 | 19.0 EB05 12.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 15.0 | no trial data cached |
| Depressed level of consciousness | 71 | 19.4 15.5–24.4ROR 20.1 · χ² 1,222 / p 4e-268 | 19.3 EB05 15.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 95% clinician | no trial data cached |
| Splenomegaly | 21 | 19.4 12.7–29.6ROR 19.6 · χ² 347 / p 8e-78 | 19.0 EB05 12.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 | no trial data cached |
| Spinal pain | 21 | 19.4 12.7–29.6ROR 19.6 · χ² 347 / p 9e-78 | 19.0 EB05 12.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Pulmonary congestion | 23 | 18.8 12.5–28.2ROR 19.0 · χ² 369 / p 2e-82 | 18.4 EB05 12.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 | no trial data cached |
| Poisoning deliberate | 16 | 18.6 11.4–30.3ROR 18.7 · χ² 248 / p 3e-56 | 18.0 EB05 11.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Suicide attempt | 101 | 17.9 14.8–21.7ROR 18.9 · χ² 1,601 / p <1e-300 | 17.9 EB05 15.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.1 | no trial data cached |
| Muscle spasticity | 20 | 17.4 11.3–26.9ROR 17.6 · χ² 293 / p 6e-66 | 16.9 EB05 11.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 | no trial data cached |
| Intentional overdose | 102 | 17.3 14.3–20.9ROR 18.2 · χ² 1,550 / p <1e-300 | 17.2 EB05 14.6 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 12.2 · 96% clinician | no trial data cached |
| Metabolic acidosis | 50 | 17.1 13.0–22.4ROR 17.5 · χ² 740 / p 4e-163 | 16.9 EB05 13.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 94% (drug 64%) · 98% clinician | no trial data cached |
| Shock | 36 | 17.0 12.3–23.5ROR 17.3 · χ² 527 / p 6e-117 | 16.8 EB05 12.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · 100% clinician | no trial data cached |
| Mydriasis | 19 | 16.0 10.2–25.0ROR 16.1 · χ² 252 / p 4e-57 | 15.4 EB05 10.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Coma | 70 | 15.9 12.6–20.0ROR 16.4 · χ² 960 / p 4e-211 | 15.7 EB05 12.8 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.8 · 90% clinician | no trial data cached |
| Electrolyte imbalance | 16 | 15.0 9.2–24.5ROR 15.1 · χ² 195 / p 1e-44 | 14.2 EB05 8.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Obesity | 22 | 14.9 9.8–22.6ROR 15.0 · χ² 271 / p 3e-61 | 14.4 EB05 9.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Hypokinesia | 20 | 14.9 9.6–23.0ROR 15.0 · χ² 245 / p 2e-55 | 14.3 EB05 9.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Affect lability | 13 | 14.5 8.4–25.0ROR 14.6 · χ² 150 / p 8e-35 | 13.3 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Ataxia | 15 | 13.6 8.2–22.5ROR 13.7 · χ² 162 / p 2e-37 | 12.5 EB05 7.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 | no trial data cached |
| Sleep apnoea syndrome | 24 | 13.5 9.1–20.2ROR 13.7 · χ² 266 / p 4e-60 | 13.0 EB05 8.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 86% (drug 64%) | no trial data cached |
| Delusion | 19 | 13.2 8.5–20.7ROR 13.4 · χ² 203 / p 3e-46 | 12.4 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Psychomotor hyperactivity | 20 | 12.9 8.4–20.0ROR 13.1 · χ² 209 / p 1e-47 | 12.2 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Candida infection (yeast infection) | 20 | 12.9 8.4–20.0ROR 13.1 · χ² 208 / p 2e-47 | 12.2 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Sedation | 31 | 12.8 9.0–18.2ROR 13.0 · χ² 327 / p 3e-73 | 12.4 EB05 8.9 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.0 · 90% clinician | no trial data cached |
| Hepatic steatosis | 22 | 12.8 8.4–19.3ROR 12.9 · χ² 227 / p 2e-51 | 12.1 EB05 8.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Cholecystitis | 14 | 12.7 7.5–21.4ROR 12.8 · χ² 140 / p 2e-32 | 11.4 EB05 6.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Euphoric mood | 12 | 12.6 7.1–22.1ROR 12.6 · χ² 116 / p 2e-27 | 11.0 EB05 5.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Product physical issue | 23 | 12.5 8.3–18.7ROR 12.6 · χ² 231 / p 2e-52 | 11.8 EB05 7.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious n=2 · 78% consumer | no trial data cached |
| Myoclonus | 13 | 11.8 6.8–20.2ROR 11.8 · χ² 117 / p 1e-27 | 10.2 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Economic problem | 16 | 11.2 6.9–18.3ROR 11.3 · χ² 139 / p 3e-32 | 10.0 EB05 6.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 23 | 11.1 7.4–16.7ROR 11.3 · χ² 202 / p 3e-46 | 10.3 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 0% (drug 64%) · 100% clinician | no trial data cached |
| Hyperthyroidism | 14 | 10.4 6.2–17.6ROR 10.5 · χ² 110 / p 4e-26 | 8.9 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Coagulopathy | 16 | 10.4 6.4–16.9ROR 10.5 · χ² 127 / p 1e-29 | 9.1 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Sudden death | 10 | 10.1 5.4–18.7ROR 10.1 · χ² 73 / p 6e-18 | 8.0 EB05 4.3 · IC025 +1.7 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 6.9 | no trial data cached |
| Altered state of consciousness | 20 | 10.0 6.5–15.5ROR 10.1 · χ² 153 / p 2e-35 | 9.0 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 100% clinician | no trial data cached |
| Drug abuse | 77 | 9.9 8.0–12.4ROR 10.3 · χ² 611 / p 3e-135 | 9.7 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | 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 |
|---|---|---|---|---|---|---|
| Somnolence (drowsiness) | 133 | 7.1 6.1–8.4ROR 7.6 · χ² 702 / p 6e-155 | 7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.8 | no trial data cached |
| Drug interaction | 122 | 8.3 7.0–9.9ROR 8.8 · χ² 781 / p 4e-172 | 8.1 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 · 91% clinician | no trial data cached |
| Intentional overdose | 102 | 17.3 14.3–20.9ROR 18.2 · χ² 1,550 / p <1e-300 | 17.2 EB05 14.6 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 12.2 · 96% clinician | no trial data cached |
| Suicide attempt | 101 | 17.9 14.8–21.7ROR 18.9 · χ² 1,601 / p <1e-300 | 17.9 EB05 15.1 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.1 | no trial data cached |
| Toxicity to various agents | 84 | 5.4 4.4–6.7ROR 5.6 · χ² 299 / p 3e-67 | 5.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 95% clinician | no trial data cached |
| Drug abuse | 77 | 9.9 8.0–12.4ROR 10.3 · χ² 611 / p 3e-135 | 9.7 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Depressed level of consciousness | 71 | 19.4 15.5–24.4ROR 20.1 · χ² 1,222 / p 4e-268 | 19.3 EB05 15.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 95% clinician | no trial data cached |
| Coma | 70 | 15.9 12.6–20.0ROR 16.4 · χ² 960 / p 4e-211 | 15.7 EB05 12.8 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.8 · 90% clinician | no trial data cached |
| Overdose | 66 | 3.3 2.6–4.2ROR 3.4 · χ² 104 / p 1e-24 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Seizure | 61 | 5.7 4.5–7.3ROR 5.9 · χ² 235 / p 3e-53 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.7 | no trial data cached |
| Metabolic acidosis | 50 | 17.1 13.0–22.4ROR 17.5 · χ² 740 / p 4e-163 | 16.9 EB05 13.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 94% (drug 64%) · 98% clinician | no trial data cached |
| Respiratory failure | 46 | 6.8 5.1–9.0ROR 6.9 · χ² 222 / p 1e-50 | 6.4 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Lung disorder | 39 | 8.6 6.3–11.7ROR 8.7 · χ² 255 / p 1e-57 | 8.0 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 37 | 4.4 3.2–6.0ROR 4.4 · χ² 93 / p 3e-22 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Disorientation | 36 | 9.8 7.1–13.5ROR 9.9 · χ² 275 / p 4e-62 | 9.2 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | 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.
- Toxic epidermal necrolysis — n=34, PRR 24.4
- Acute hepatic failure — n=29, PRR 23.0
- Tenderness — n=21, PRR 21.7
- Serotonin syndrome — n=35, PRR 19.8
- Depressed level of consciousness — n=71, PRR 19.4
- Splenomegaly — n=21, PRR 19.4
- Spinal pain — n=21, PRR 19.4
- Pulmonary congestion — n=23, PRR 18.8
- Muscle spasticity — n=20, PRR 17.4
- Metabolic acidosis — n=50, PRR 17.1
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 Clorazepate Dipotassium?
In FDA FAERS, the most frequently co-reported reaction terms for Clorazepate Dipotassium are somnolence, suicide attempt, toxicity to various agents, depressed level of consciousness, coma, seizure. 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 Clorazepate Dipotassium 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 Clorazepate Dipotassium 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 11b72861-64c9-4cdc-9289-c7fa9ea23bf6, effective 20260724; matched on
openfda.generic_name.exact:"CLORAZEPATE DIPOTASSIUM") - 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, 147 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.