Quazepam side effects: what 300 FDA adverse event reports show

Quazepam · 17 reaction terms · 182 drug–reaction co-reports · data 2026-09-14

Drug class

Benzodiazepine

FDA label (Established Pharmacologic Class) · compare the class

Who reports

300 reports · 91% serious · 46 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Quazepam Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of Quazepam Tablets has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia.

FDA label, Indications and Usage

What it is

Quazepam Tablets contain quazepam, a trifluoroethyl benzodiazepine hypnotic agent, having the chemical name 7-chloro-5- (o-fluoro-phenyl)-1,3-dihydro-1-(2,2,2- trifluoroethyl)-2H-1,4-benzodiaz.

FDA label, Description section

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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 12 strongest signals

Labeled — boxed warning 1Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 2Outcome field, not a reaction 1Not in label — unassessed 6

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 (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. 5 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Altered state of consciousness	26	84.4 58.5–121.9ROR 92.3 · χ² 2,060 / p <1e-300	79.6 EB05 57.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 49.7 · ♀ 22% (drug 45%) · 100% clinician	no trial data cached
Inappropriate antidiuretic hormone secretion	12	82.5 47.4–143.7ROR 85.9 · χ² 886 / p 7e-195	73.2 EB05 44.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 52.6	no trial data cached
Salivary hypersecretion	8	56.0 28.3–111.0ROR 57.5 · χ² 379 / p 1e-84	49.7 EB05 27.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 48.0	no trial data cached
Neuroleptic malignant syndrome	9	52.9 27.8–100.8ROR 54.5 · χ² 408 / p 5e-91	47.9 EB05 27.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 33.6	no trial data cached
Suicide attempt	27	31.1 21.7–44.5ROR 34.0 · χ² 758 / p 4e-167	30.5 EB05 22.0 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.7 · 96% clinician	no trial data cached
Blood lactate dehydrogenase increased	7	30.7 14.8–63.8ROR 31.4 · χ² 173 / p 1e-39	28.1 EB05 14.0 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious PRR 20.7	no trial data cached
Schizophrenia	5	28.7 12.0–68.6ROR 29.2 · χ² 108 / p 2e-25	24.5 EB05 8.8 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 18.8	no trial data cached
Blood creatine phosphokinase increased	12	28.7 16.5–49.9ROR 29.8 · χ² 294 / p 4e-66	27.5 EB05 16.7 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 20.2	no trial data cached
Intentional overdose	25	27.4 18.8–39.9ROR 29.8 · χ² 612 / p 2e-135	26.9 EB05 19.2 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 18.0 · 96% clinician	no trial data cached
Delusion	6	27.1 12.3–59.8ROR 27.6 · χ² 126 / p 2e-29	24.1 EB05 10.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Withdrawal syndrome	11	18.2 10.2–32.5ROR 18.9 · χ² 162 / p 2e-37	17.1 EB05 9.3 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 16.6	no trial data cached
Completed suicide (death by suicide)	17	14.1 8.9–22.4ROR 14.9 · χ² 195 / p 1e-44	13.3 EB05 8.2 · IC025 +2.5 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 8.9	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Suicide attempt	27	31.1 21.7–44.5ROR 34.0 · χ² 758 / p 4e-167	30.5 EB05 22.0 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.7 · 96% clinician	no trial data cached
Altered state of consciousness	26	84.4 58.5–121.9ROR 92.3 · χ² 2,060 / p <1e-300	79.6 EB05 57.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 49.7 · ♀ 22% (drug 45%) · 100% clinician	no trial data cached
Intentional overdose	25	27.4 18.8–39.9ROR 29.8 · χ² 612 / p 2e-135	26.9 EB05 19.2 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 18.0 · 96% clinician	no trial data cached
Completed suicide (death by suicide)	17	14.1 8.9–22.4ROR 14.9 · χ² 195 / p 1e-44	13.3 EB05 8.2 · IC025 +2.5 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 8.9	no trial data cached
Blood creatine phosphokinase increased	12	28.7 16.5–49.9ROR 29.8 · χ² 294 / p 4e-66	27.5 EB05 16.7 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 20.2	no trial data cached
Inappropriate antidiuretic hormone secretion	12	82.5 47.4–143.7ROR 85.9 · χ² 886 / p 7e-195	73.2 EB05 44.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 52.6	no trial data cached
Withdrawal syndrome	11	18.2 10.2–32.5ROR 18.9 · χ² 162 / p 2e-37	17.1 EB05 9.3 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 16.6	no trial data cached
Neuroleptic malignant syndrome	9	52.9 27.8–100.8ROR 54.5 · χ² 408 / p 5e-91	47.9 EB05 27.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 33.6	no trial data cached
Salivary hypersecretion	8	56.0 28.3–111.0ROR 57.5 · χ² 379 / p 1e-84	49.7 EB05 27.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 48.0	no trial data cached
Blood lactate dehydrogenase increased	7	30.7 14.8–63.8ROR 31.4 · χ² 173 / p 1e-39	28.1 EB05 14.0 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious PRR 20.7	no trial data cached
Delusion	6	27.1 12.3–59.8ROR 27.6 · χ² 126 / p 2e-29	24.1 EB05 10.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Schizophrenia	5	28.7 12.0–68.6ROR 29.2 · χ² 108 / p 2e-25	24.5 EB05 8.8 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 18.8	no trial data cached
Anorexia	4	21.4 8.1–56.6ROR 21.7 · χ² 59 / p 9e-15	15.3 EB05 4.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 17.8	no trial data cached
Status epilepticus	4	24.7 9.3–65.4ROR 25.0 · χ² 69 / p 5e-17	18.6 EB05 4.8 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Tardive dyskinesia (persistent involuntary movements)	3	7.4 2.4–22.7ROR 7.4 · χ² 11 / p 5e-4	4.1 EB05 1.5 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 5.6	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.

Altered state of consciousness — n=26, PRR 84.4

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 Quazepam?

In FDA FAERS, the most frequently co-reported reaction terms for Quazepam are suicide attempt, altered state of consciousness, blood creatine phosphokinase increased, inappropriate antidiuretic hormone secretion, withdrawal syndrome, neuroleptic malignant syndrome. 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 Quazepam 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 Quazepam 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 f7d63f3f-5303-48ab-bce2-35fd62c45799, effective 20251023; matched on openfda.generic_name.exact:"QUAZEPAM")
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, field patient.drug.openfda.generic_name.exact, 17 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.