Drug · FAERS side-effect profile with label screen

Flurazepam side effects: what 395 FDA adverse event reports show

Flurazepam Hydrochloride · 19 reaction terms · 394 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Flurazepam Hydrochloride (Flurazepam Hydrochloride)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

395 reports · 95% serious · 43 with death outcome · 69% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings . Since insomnia is often transient and intermittent, short-term use is usually sufficient.

FDA label, Indications and Usage

What it is

Flurazepam Hydrochloride, USP is chemically 7-chloro-1-[2-(diethylamino)ethyl]-5-( ο -fluro-phenyl)-1,3-dihydro-2 H -1,4- benzodiazepin-2-one dihydrochloride. It is a pale yellow, crystalline compound, freely soluble in alcohol and very soluble in water.

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 13 strongest signals

Labeled — boxed warning 1Labeled (related wording) 1Reporting / coding artifact 3Outcome field, not a reaction 1Not in label — unassessed 7

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.
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. 6 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
Sopor	51	203.3 157.3–262.8ROR 233.3 · χ² 10,033 / p <1e-300	188.3 EB05 148.8 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 123.3 · ♀ 96% (drug 69%) · 98% clinician	no trial data cached
Intentional self-injury	39	102.8 76.3–138.5ROR 114.0 · χ² 3,827 / p <1e-300	97.8 EB05 74.7 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 63.0 · 92% clinician	no trial data cached
Suicide attempt	55	48.1 37.6–61.5ROR 55.7 · χ² 2,494 / p <1e-300	47.3 EB05 37.7 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 29.3 · 98% clinician	no trial data cached
Drug abuse	65	41.3 33.1–51.6ROR 49.2 · χ² 2,523 / p <1e-300	40.8 EB05 33.1 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 25.4 · 97% clinician	no trial data cached
Intentional overdose	44	36.7 27.7–48.4ROR 41.1 · χ² 1,494 / p <1e-300	36.1 EB05 28.0 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 23.1 · 100% clinician	no trial data cached
Altered state of consciousness	14	34.5 20.6–57.7ROR 35.7 · χ² 423 / p 3e-94	33.1 EB05 20.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 21.2	no trial data cached
Parkinsonism	6	32.7 14.8–72.3ROR 33.2 · χ² 154 / p 1e-35	29.3 EB05 13.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 23.0	no trial data cached
Coma	26	29.0 20.0–42.0ROR 30.9 · χ² 675 / p 3e-149	28.4 EB05 20.4 · IC025 +3.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.6 · ♀ 44% (drug 69%)	no trial data cached
Sputum discoloured	5	28.1 11.8–67.1ROR 28.4 · χ² 105 / p 6e-25	23.9 EB05 8.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.3	no trial data cached
Sluggishness	5	26.2 10.9–62.5ROR 26.5 · χ² 97 / p 3e-23	22.0 EB05 7.4 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Poisoning	5	21.0 8.8–50.3ROR 21.3 · χ² 76 / p 1e-18	16.8 EB05 5.3 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Toxicity to various agents	49	15.5 11.9–20.1ROR 17.6 · χ² 655 / p 7e-145	15.4 EB05 12.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Completed suicide (death by suicide)	9	5.7 3.0–10.8ROR 5.8 · χ² 30 / p 2e-8	4.5 EB05 2.6 · IC025 +1.0 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 3.4	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
Drug abuse	65	41.3 33.1–51.6ROR 49.2 · χ² 2,523 / p <1e-300	40.8 EB05 33.1 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 25.4 · 97% clinician	no trial data cached
Suicide attempt	55	48.1 37.6–61.5ROR 55.7 · χ² 2,494 / p <1e-300	47.3 EB05 37.7 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 29.3 · 98% clinician	no trial data cached
Sopor	51	203.3 157.3–262.8ROR 233.3 · χ² 10,033 / p <1e-300	188.3 EB05 148.8 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 123.3 · ♀ 96% (drug 69%) · 98% clinician	no trial data cached
Toxicity to various agents	49	15.5 11.9–20.1ROR 17.6 · χ² 655 / p 7e-145	15.4 EB05 12.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.7	no trial data cached
Intentional overdose	44	36.7 27.7–48.4ROR 41.1 · χ² 1,494 / p <1e-300	36.1 EB05 28.0 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 23.1 · 100% clinician	no trial data cached
Intentional self-injury	39	102.8 76.3–138.5ROR 114.0 · χ² 3,827 / p <1e-300	97.8 EB05 74.7 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 63.0 · 92% clinician	no trial data cached
Coma	26	29.0 20.0–42.0ROR 30.9 · χ² 675 / p 3e-149	28.4 EB05 20.4 · IC025 +3.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 17.6 · ♀ 44% (drug 69%)	no trial data cached
Altered state of consciousness	14	34.5 20.6–57.7ROR 35.7 · χ² 423 / p 3e-94	33.1 EB05 20.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 21.2	no trial data cached
Completed suicide (death by suicide)	9	5.7 3.0–10.8ROR 5.8 · χ² 30 / p 2e-8	4.5 EB05 2.6 · IC025 +1.0 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 3.4	no trial data cached
Parkinsonism	6	32.7 14.8–72.3ROR 33.2 · χ² 154 / p 1e-35	29.3 EB05 13.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 23.0	no trial data cached
Poisoning	5	21.0 8.8–50.3ROR 21.3 · χ² 76 / p 1e-18	16.8 EB05 5.3 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Sluggishness	5	26.2 10.9–62.5ROR 26.5 · χ² 97 / p 3e-23	22.0 EB05 7.4 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Sputum discoloured	5	28.1 11.8–67.1ROR 28.4 · χ² 105 / p 6e-25	23.9 EB05 8.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 22.3	no trial data cached
Mydriasis	4	16.6 6.2–43.9ROR 16.7 · χ² 44 / p 2e-11	10.7 EB05 3.2 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Muscle rigidity	4	17.8 6.7–47.1ROR 17.9 · χ² 48 / p 3e-12	11.8 EB05 3.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.1	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.

Sopor — n=51, PRR 203.3
Toxicity to various agents — n=49, PRR 15.5

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 Flurazepam?

In FDA FAERS, the most frequently co-reported reaction terms for Flurazepam are suicide attempt, sopor, toxicity to various agents, coma, altered state of consciousness, parkinsonism. 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 Flurazepam 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 Flurazepam 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 8f476891-1346-4e8c-ac1b-f8cbdc64f5a1, effective 20241028; matched on openfda.generic_name.exact:"FLURAZEPAM HYDROCHLORIDE")
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, 19 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.