Triazolam side effects: what 3,986 FDA adverse event reports show
Who reports
3,986 reports · 81% serious · 638 with death outcome · 59% female
Used for
Triazolam is indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults. Triazolam is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
What it is
Triazolam is a triazolobenzodiazepine. Triazolam is a white crystalline powder, soluble in alcohol and poorly soluble in water. It has a molecular weight of 343.21.
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. 187 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 |
|---|---|---|---|---|---|---|
| Sopor | 208 | 83.1 72.8–95.0ROR 87.7 · χ² 16,545 / p <1e-300 | 81.3 EB05 72.4 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 58.5 · 91% clinician | no trial data cached |
| Intentional self-injury | 87 | 22.8 18.5–28.1ROR 23.3 · χ² 1,784 / p <1e-300 | 22.6 EB05 18.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 16.4 | no trial data cached |
| Drug abuse | 336 | 21.2 19.1–23.5ROR 23.1 · χ² 6,450 / p <1e-300 | 21.1 EB05 19.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 15.3 · 94% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 32 | 14.2 10.0–20.0ROR 14.3 · χ² 378 / p 1e-84 | 13.8 EB05 10.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 100% clinician | no trial data cached |
| Myocardial ischaemia | 26 | 11.9 8.1–17.5ROR 12.0 · χ² 249 / p 2e-56 | 11.3 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · ♀ 79% (drug 59%) | no trial data cached |
| Altered state of consciousness | 45 | 11.0 8.2–14.7ROR 11.1 · χ² 399 / p 5e-89 | 10.6 EB05 8.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Completed suicide (death by suicide) | 170 | 10.6 9.2–12.3ROR 11.1 · χ² 1,479 / p <1e-300 | 10.5 EB05 9.2 · IC025 +3.1 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 7.6 | no trial data cached |
| Ventricular extrasystoles | 21 | 10.6 6.9–16.3ROR 10.7 · χ² 174 / p 6e-40 | 9.7 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Suicide attempt | 119 | 10.3 8.6–12.3ROR 10.6 · χ² 993 / p 3e-218 | 10.2 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 | no trial data cached |
| Intentional overdose | 117 | 9.7 8.1–11.6ROR 9.9 · χ² 902 / p 2e-198 | 9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · 90% clinician | no trial data cached |
| Serotonin syndrome | 34 | 9.4 6.7–13.1ROR 9.4 · χ² 246 / p 1e-55 | 8.7 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 100% (drug 59%) | no trial data cached |
| Hypokinesia | 25 | 9.1 6.1–13.4ROR 9.1 · χ² 171 / p 2e-39 | 8.2 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 30% (drug 59%) · 100% clinician | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 16 | 8.3 5.1–13.5ROR 8.3 · χ² 95 / p 9e-23 | 7.0 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Blood creatine phosphokinase increased | 42 | 7.6 5.6–10.2ROR 7.6 · χ² 233 / p 8e-53 | 7.1 EB05 5.4 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 · ♀ 33% (drug 59%) · 90% clinician | no trial data cached |
| Poisoning | 18 | 7.5 4.7–11.9ROR 7.5 · χ² 95 / p 9e-23 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Hepatic encephalopathy | 13 | 7.3 4.3–12.6ROR 7.4 · χ² 65 / p 4e-16 | 6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Delusion | 21 | 7.1 4.7–10.9ROR 7.2 · χ² 105 / p 7e-25 | 6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 100% clinician | no trial data cached |
| Urinary incontinence | 38 | 6.8 4.9–9.3ROR 6.8 · χ² 181 / p 2e-41 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · ♀ 33% (drug 59%) | no trial data cached |
| Electrocardiogram qt prolonged | 46 | 6.7 5.0–9.0ROR 6.8 · χ² 219 / p 8e-50 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Depressed level of consciousness | 50 | 6.7 5.1–8.8ROR 6.7 · χ² 236 / p 2e-53 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Psychomotor hyperactivity | 21 | 6.6 4.3–10.2ROR 6.7 · χ² 95 / p 1e-22 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Atelectasis | 12 | 6.5 3.7–11.5ROR 6.5 · χ² 51 / p 6e-13 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Sleep apnoea syndrome | 23 | 6.3 4.2–9.5ROR 6.4 · χ² 98 / p 2e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · ♀ 22% (drug 59%) | no trial data cached |
| Toxicity to various agents | 201 | 6.3 5.5–7.2ROR 6.6 · χ² 898 / p 1e-197 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 95% clinician | no trial data cached |
| Coma | 57 | 6.3 4.9–8.1ROR 6.4 · χ² 249 / p 2e-56 | 6.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.5 · ♀ 92% (drug 59%) | no trial data cached |
| Blood lactate dehydrogenase increased | 19 | 6.3 4.0–9.8ROR 6.3 · χ² 79 / p 3e-19 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 | no trial data cached |
| Pneumonia aspiration | 29 | 6.1 4.3–8.8ROR 6.2 · χ² 119 / p 4e-28 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 93% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 28 | 5.9 4.1–8.6ROR 6.0 · χ² 110 / p 5e-26 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 4.9 | no trial data cached |
| Hepatic function abnormal | 40 | 5.7 4.2–7.7ROR 5.7 · χ² 150 / p 1e-34 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Sedation | 28 | 5.7 3.9–8.2ROR 5.7 · χ² 103 / p 2e-24 | 5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.0 | no trial data cached |
| Blood urea increased | 18 | 5.6 3.5–8.9ROR 5.7 · χ² 64 / p 6e-16 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 | no trial data cached |
| Hypothyroidism | 34 | 5.6 4.0–7.9ROR 5.7 · χ² 125 / p 3e-29 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 100% (drug 59%) | no trial data cached |
| Vasculitis | 12 | 5.4 3.1–9.5ROR 5.4 · χ² 39 / p 2e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Parkinsonism | 10 | 5.4 2.9–10.0ROR 5.4 · χ² 32 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Thinking abnormal | 19 | 5.3 3.4–8.4ROR 5.4 · χ² 63 / p 1e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 | no trial data cached |
| Ataxia | 12 | 5.3 3.0–9.3ROR 5.3 · χ² 38 / p 4e-10 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Feeling cold | 28 | 5.3 3.7–7.6ROR 5.3 · χ² 93 / p 3e-22 | 4.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 88% (drug 59%) | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 41 | 5.2 3.8–7.0ROR 5.2 · χ² 135 / p 2e-31 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 24% (drug 59%) · 100% clinician | no trial data cached |
| Delirium | 34 | 5.2 3.7–7.2ROR 5.2 · χ² 111 / p 4e-26 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 94% clinician | no trial data cached |
| Ileus | 12 | 5.1 2.9–9.0ROR 5.1 · χ² 36 / p 1e-9 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | 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 |
|---|---|---|---|---|---|---|
| Drug abuse | 336 | 21.2 19.1–23.5ROR 23.1 · χ² 6,450 / p <1e-300 | 21.1 EB05 19.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 15.3 · 94% clinician | no trial data cached |
| Sopor | 208 | 83.1 72.8–95.0ROR 87.7 · χ² 16,545 / p <1e-300 | 81.3 EB05 72.4 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 58.5 · 91% clinician | no trial data cached |
| Toxicity to various agents | 201 | 6.3 5.5–7.2ROR 6.6 · χ² 898 / p 1e-197 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 95% clinician | no trial data cached |
| Overdose | 180 | 4.4 3.8–5.0ROR 4.5 · χ² 470 / p 2e-104 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Completed suicide (death by suicide) | 170 | 10.6 9.2–12.3ROR 11.1 · χ² 1,479 / p <1e-300 | 10.5 EB05 9.2 · IC025 +3.1 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 7.6 | no trial data cached |
| Drug interaction | 151 | 5.0 4.3–5.9ROR 5.2 · χ² 484 / p 2e-107 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial data cached |
| Somnolence (drowsiness) | 130 | 3.4 2.9–4.0ROR 3.5 · χ² 220 / p 4e-50 | 3.4 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.6 | no trial data cached |
| Suicide attempt | 119 | 10.3 8.6–12.3ROR 10.6 · χ² 993 / p 3e-218 | 10.2 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 | no trial data cached |
| Intentional overdose | 117 | 9.7 8.1–11.6ROR 9.9 · χ² 902 / p 2e-198 | 9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · 90% clinician | no trial data cached |
| Loss of consciousness | 112 | 4.6 3.8–5.5ROR 4.7 · χ² 313 / p 2e-70 | 4.5 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Depression | 106 | 2.4 2.0–2.9ROR 2.5 · χ² 90 / p 1e-21 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.1 | no trial data cached |
| Confusional state (confusion) | 106 | 3.4 2.9–4.2ROR 3.5 · χ² 183 / p 6e-42 | 3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Intentional self-injury | 87 | 22.8 18.5–28.1ROR 23.3 · χ² 1,784 / p <1e-300 | 22.6 EB05 18.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 16.4 | no trial data cached |
| Drug dependence | 68 | 2.2 1.7–2.8ROR 2.2 · χ² 44 / p 2e-11 | 2.2 EB05 1.8 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.6 | no trial data cached |
| Chronic kidney disease | 60 | 4.1 3.2–5.3ROR 4.2 · χ² 139 / p 2e-32 | 4.0 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | 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=208, PRR 83.1
- Neuroleptic malignant syndrome — n=32, PRR 14.2
- Myocardial ischaemia — n=26, PRR 11.9
- Ventricular extrasystoles — n=21, PRR 10.6
- Serotonin syndrome — n=34, PRR 9.4
- Hypokinesia — n=25, PRR 9.1
- Electrocardiogram qt prolonged — n=46, PRR 6.7
- Psychomotor hyperactivity — n=21, PRR 6.6
- Toxicity to various agents — n=201, PRR 6.3
- Pneumonia aspiration — n=29, PRR 6.1
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 Triazolam?
In FDA FAERS, the most frequently co-reported reaction terms for Triazolam are sopor, toxicity to various agents, somnolence, suicide attempt, loss of consciousness, depression. 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 Triazolam 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 Triazolam 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 5add318e-11b9-42f8-b052-0d8cebb32fcf, effective 20260710; matched on
openfda.generic_name.exact:"TRIAZOLAM") - 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, 227 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.