Estazolam side effects: what 1,940 FDA adverse event reports show

Estazolam · 113 reaction terms · 1,895 drug–reaction co-reports · data 2026-09-14

Drug class

Benzodiazepine

FDA label (Established Pharmacologic Class) · compare the class

Who reports

1,940 reports · 89% serious · 305 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Estazolam is indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY ).

FDA label, Indications and Usage

What it is

DESCRIPTION Estazolam, a triazolobenzodiazepine derivative, is an oral hypnotic agent. Estazolam occurs as a fine, white, odorless powder that is soluble in alcohol and practically insoluble 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 (see WARNINGS ).

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 40 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 2Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 7Outcome field, not a reaction 1Not in label — unassessed 25

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.
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.
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. 73 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
Inappropriate antidiuretic hormone secretion	28	29.8 20.6–43.1ROR 30.2 · χ² 749 / p 3e-165	29.2 EB05 21.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.3 · ♀ 21% (drug 59%) · 96% clinician	no trial data cached
Serotonin syndrome	50	28.3 21.5–37.2ROR 29.0 · χ² 1,288 / p 3e-282	28.0 EB05 22.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.4 · ♀ 100% (drug 59%) · 100% clinician	no trial data cached
Altered state of consciousness	44	22.1 16.5–29.6ROR 22.6 · χ² 864 / p 3e-190	21.9 EB05 17.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.0 · 93% clinician	no trial data cached
Sopor	23	18.6 12.4–28.0ROR 18.8 · χ² 366 / p 8e-82	18.2 EB05 12.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 12.0 · ♀ 96% (drug 59%) · 100% clinician	no trial data cached
Sudden death	16	16.2 9.9–26.4ROR 16.3 · χ² 213 / p 2e-48	15.5 EB05 9.5 · IC025 +2.6 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 10.4	no trial data cached
Disseminated intravascular coagulation	21	16.1 10.5–24.6ROR 16.3 · χ² 282 / p 1e-63	15.6 EB05 10.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.4 · ♀ 80% (drug 59%)	no trial data cached
Delirium	47	14.7 11.1–19.5ROR 15.0 · χ² 587 / p 6e-130	14.5 EB05 11.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 94% clinician	no trial data cached
Neuroleptic malignant syndrome	14	12.7 7.6–21.5ROR 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 8.2	no trial data cached
Suicide attempt	69	12.3 9.7–15.5ROR 12.7 · χ² 705 / p 1e-155	12.1 EB05 9.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · 95% clinician	no trial data cached
Sinus tachycardia	14	10.7 6.3–18.0ROR 10.8 · χ² 113 / p 9e-27	9.2 EB05 5.4 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Generalised tonic-clonic seizure	16	10.6 6.5–17.2ROR 10.7 · χ² 129 / p 3e-30	9.3 EB05 5.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Electrolyte imbalance	11	10.3 5.7–18.6ROR 10.4 · χ² 84 / p 3e-20	8.4 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Poisoning	12	10.3 5.8–18.1ROR 10.3 · χ² 91 / p 6e-22	8.5 EB05 4.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
Pneumonia aspiration	23	10.0 6.6–15.0ROR 10.1 · χ² 177 / p 1e-40	9.1 EB05 6.1 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.4 · ♀ 30% (drug 59%) · 95% clinician	no trial data cached
Schizophrenia	11	9.8 5.4–17.6ROR 9.8 · χ² 78 / p 5e-19	7.9 EB05 4.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.5	no trial data cached
Gamma-glutamyltransferase increased	20	9.7 6.3–15.1ROR 9.8 · χ² 148 / p 2e-34	8.7 EB05 5.7 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 6.6	no trial data cached
Tachypnoea	12	9.6 5.4–16.8ROR 9.6 · χ² 84 / p 3e-20	7.8 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Drug interaction	138	9.4 8.0–11.0ROR 10.0 · χ² 1,035 / p 2e-227	9.3 EB05 8.0 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.8 · 99% clinician	no trial data cached
Electrocardiogram qt prolonged	31	9.3 6.6–13.2ROR 9.4 · χ² 222 / p 2e-50	8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 6.1 · 97% clinician	no trial data cached
Coma	41	9.3 6.9–12.6ROR 9.5 · χ² 296 / p 1e-66	8.8 EB05 6.6 · IC025 +2.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.0 · 98% clinician	no trial data cached
Blood creatine phosphokinase increased	25	9.2 6.3–13.6ROR 9.3 · χ² 176 / p 2e-40	8.4 EB05 5.8 · IC025 +2.3 3/3 methods agree	Lab value / disease marker	serious PRR 6.4 · 91% clinician	no trial data cached
Lymphocyte count decreased	15	9.2 5.5–15.2ROR 9.2 · χ² 101 / p 4e-24	7.8 EB05 4.8 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 7.2	no trial data cached
Intentional overdose	54	9.2 7.0–11.9ROR 9.4 · χ² 385 / p 5e-86	8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.7 · 94% clinician	no trial data cached
Rhabdomyolysis (muscle breakdown)	35	9.1 6.5–12.6ROR 9.2 · χ² 244 / p 2e-55	8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.9 · ♀ 38% (drug 59%) · 100% clinician	no trial data cached
Hepatic function abnormal	31	9.0 6.4–12.8ROR 9.2 · χ² 214 / p 9e-49	8.4 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.1 · 97% clinician	no trial data cached
Circulatory collapse	14	8.8 5.2–14.9ROR 8.9 · χ² 90 / p 1e-21	7.4 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Hallucination, auditory	13	8.8 5.1–15.2ROR 8.9 · χ² 83 / p 5e-20	7.3 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Arrhythmia	38	8.6 6.3–11.8ROR 8.8 · χ² 249 / p 2e-56	8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.6	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	12	8.6 4.9–15.1ROR 8.6 · χ² 73 / p 6e-18	7.0 EB05 4.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Blood lactate dehydrogenase increased	12	8.1 4.6–14.3ROR 8.2 · χ² 68 / p 8e-17	6.6 EB05 3.9 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 5.6	no trial data cached
Depressed level of consciousness	29	7.9 5.5–11.4ROR 8.0 · χ² 169 / p 5e-39	7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.3 · 96% clinician	no trial data cached
Drug level increased	12	7.8 4.5–13.8ROR 7.9 · χ² 65 / p 4e-16	6.3 EB05 3.8 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.6	no trial data cached
Neutrophil count decreased	29	7.7 5.4–11.1ROR 7.8 · χ² 164 / p 9e-38	7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 5.0 · 97% clinician	no trial data cached
Bradycardia (slow heart rate)	38	7.7 5.6–10.6ROR 7.9 · χ² 216 / p 3e-49	7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.9 · ♀ 91% (drug 59%) · 100% clinician	no trial data cached
Leukocytosis	12	7.2 4.1–12.6ROR 7.2 · χ² 58 / p 1e-14	5.8 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.7	no trial data cached
Blood urea increased	11	7.1 3.9–12.7ROR 7.1 · χ² 51 / p 4e-13	5.7 EB05 3.3 · IC025 +1.5 3/3 methods agree	Lab value / disease marker	serious PRR 5.0	no trial data cached
Blood sodium decreased	12	6.9 3.9–12.1ROR 6.9 · χ² 55 / p 7e-14	5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree	Lab value / disease marker	serious PRR 5.1	no trial data cached
Extrapyramidal disorder	15	6.5 3.9–10.7ROR 6.5 · χ² 64 / p 6e-16	5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Agranulocytosis (severe loss of white cells)	11	6.4 3.6–11.6ROR 6.5 · χ² 45 / p 9e-12	5.2 EB05 3.1 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.2	no trial data cached
Hyponatraemia (low sodium)	33	6.3 4.5–8.9ROR 6.4 · χ² 144 / p 2e-33	5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.2 · ♀ 35% (drug 59%) · 97% clinician	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 interaction	138	9.4 8.0–11.0ROR 10.0 · χ² 1,035 / p 2e-227	9.3 EB05 8.0 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.8 · 99% clinician	no trial data cached
Toxicity to various agents	84	5.4 4.4–6.7ROR 5.6 · χ² 300 / p 2e-67	5.3 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.6 · 99% clinician	no trial data cached
Suicide attempt	69	12.3 9.7–15.5ROR 12.7 · χ² 705 / p 1e-155	12.1 EB05 9.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · 95% clinician	no trial data cached
Overdose	54	2.7 2.1–3.5ROR 2.7 · χ² 56 / p 3e-14	2.6 EB05 2.1 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.9 · 94% clinician	no trial data cached
Intentional overdose	54	9.2 7.0–11.9ROR 9.4 · χ² 385 / p 5e-86	8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.7 · 94% clinician	no trial data cached
Serotonin syndrome	50	28.3 21.5–37.2ROR 29.0 · χ² 1,288 / p 3e-282	28.0 EB05 22.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.4 · ♀ 100% (drug 59%) · 100% clinician	no trial data cached
Delirium	47	14.7 11.1–19.5ROR 15.0 · χ² 587 / p 6e-130	14.5 EB05 11.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.4 · 94% clinician	no trial data cached
Altered state of consciousness	44	22.1 16.5–29.6ROR 22.6 · χ² 864 / p 3e-190	21.9 EB05 17.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.0 · 93% clinician	no trial data cached
White blood cell count decreased	42	4.2 3.1–5.6ROR 4.3 · χ² 99 / p 1e-23	4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.5 · 98% clinician	no trial data cached
Coma	41	9.3 6.9–12.6ROR 9.5 · χ² 296 / p 1e-66	8.8 EB05 6.6 · IC025 +2.6 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.0 · 98% clinician	no trial data cached
Bradycardia (slow heart rate)	38	7.7 5.6–10.6ROR 7.9 · χ² 216 / p 3e-49	7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.9 · ♀ 91% (drug 59%) · 100% clinician	no trial data cached
Arrhythmia	38	8.6 6.3–11.8ROR 8.8 · χ² 249 / p 2e-56	8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.6	no trial data cached
Cardiac failure (heart failure)	37	5.0 3.6–6.8ROR 5.1 · χ² 114 / p 6e-27	4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 3.2 · 97% clinician	no trial data cached
Rhabdomyolysis (muscle breakdown)	35	9.1 6.5–12.6ROR 9.2 · χ² 244 / p 2e-55	8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.9 · ♀ 38% (drug 59%) · 100% clinician	no trial data cached
Hyponatraemia (low sodium)	33	6.3 4.5–8.9ROR 6.4 · χ² 144 / p 2e-33	5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.2 · ♀ 35% (drug 59%) · 97% clinician	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.

Inappropriate antidiuretic hormone secretion — n=28, PRR 29.8
Serotonin syndrome — n=50, PRR 28.3
Altered state of consciousness — n=44, PRR 22.1
Sopor — n=23, PRR 18.6
Disseminated intravascular coagulation — n=21, PRR 16.1
Delirium — n=47, PRR 14.7
Suicide attempt — n=69, PRR 12.3
Pneumonia aspiration — n=23, PRR 10.0
Rhabdomyolysis — n=35, PRR 9.1
Hepatic function abnormal — n=31, PRR 9.0

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 Estazolam?

In FDA FAERS, the most frequently co-reported reaction terms for Estazolam are toxicity to various agents, suicide attempt, serotonin syndrome, delirium, altered state of consciousness, white blood cell count decreased. 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 Estazolam 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 (see WARNINGS ).

Do FAERS signals prove that Estazolam 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 2f349a44-6d04-01d1-c8b7-12254aead77d, effective 20240205; matched on openfda.generic_name.exact:"ESTAZOLAM")
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, 113 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.