Temazepam side effects: what 37,467 FDA adverse event reports show
Who reports
37,467 reports · 75% serious · 7,537 with death outcome · 60% female
Used for
Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days).
What it is
DESCRIPTION Temazepam, USP is a benzodiazepine hypnotic agent.
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
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,154 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 |
|---|---|---|---|---|---|---|
| Dystonic tremor | 33 | 343.1 222.2–529.9ROR 343.4 · calibrated p 2e-11 ✓ | 188.8 EB05 140.7 · IC025 +5.1 3/3 methods agree vs other Benzodiazepines: PRR 9.9 (6.1–16.0) | Not in label — unassessed | serious n=33 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Temperature regulation disorder | 420 | 133.3 119.8–148.2ROR 134.7 · calibrated p 1e-8 ✓ | 107.0 EB05 98.7 · IC025 +6.4 3/3 methods agree vs other Benzodiazepines: PRR 20.8 (17.6–24.5) | Not in label — unassessed | serious n=419 · ♀ 100% (drug 60%) | not reported in cached trials |
| Carbuncle | 47 | 111.6 81.6–152.7ROR 111.8 · calibrated p 1e-7 ✓ | 89.7 EB05 70.2 · IC025 +5.1 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=47 · ♀ 100% (drug 60%) | not reported in cached trials |
| Myocardial depression | 38 | 105.2 74.4–148.9ROR 105.3 · calibrated p 2e-7 ✓ | 84.9 EB05 64.5 · IC025 +4.8 3/3 methods agree vs other Benzodiazepines: PRR 7.2 (4.7–10.9) | Not in label — unassessed | serious n=38 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Visceral congestion | 38 | 46.5 33.4–64.8ROR 46.6 · calibrated p 3e-5 ✓ | 42.1 EB05 32.1 · IC025 +4.3 3/3 methods agree vs other Benzodiazepines: PRR 1.2 (0.8–1.7) | Not in label — unassessed | serious n=38 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Food allergy | 517 | 41.1 37.6–44.9ROR 41.6 · calibrated p 4e-5 ✓ | 38.2 EB05 35.5 · IC025 +5.1 3/3 methods agree vs other Benzodiazepines: PRR 19.8 (17.1–22.9) | Not in label — unassessed | serious n=514 · ♀ 100% (drug 60%) | not reported in cached trials |
| Soft tissue injury | 43 | 33.6 24.7–45.7ROR 33.6 · calibrated p 2e-4 ✓ | 31.3 EB05 24.2 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=43 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Post-traumatic neck syndrome | 46 | 33.5 24.9–45.1ROR 33.5 · calibrated p 2e-4 ✓ | 31.3 EB05 24.4 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=44 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Wrist deformity | 35 | 33.4 23.8–47.0ROR 33.5 · calibrated p 2e-4 ✓ | 31.1 EB05 23.4 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=35 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Sensitisation | 43 | 33.2 24.4–45.2ROR 33.3 · calibrated p 2e-4 ✓ | 31.0 EB05 24.0 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: PRR 1.6 (1.2–2.2) | Not in label — unassessed | serious n=43 · ♀ 100% (drug 60%) | not reported in cached trials |
| Toxicologic test abnormal | 32 | 30.8 21.6–43.9ROR 30.8 · calibrated p 3e-4 ✓ | 28.8 EB05 21.3 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: only this drug | Reporting / coding artifact | serious n=33 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Monoclonal immunoglobulin present | 38 | 29.2 21.1–40.5ROR 29.2 · calibrated p 4e-4 ✓ | 27.5 EB05 20.9 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=38 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Foetal death | 244 | 27.6 24.3–31.4ROR 27.8 · calibrated p 4e-4 ✓ | 26.3 EB05 23.6 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: PRR 6.1 (5.2–7.1) | Not in label — unassessed | serious n=244 · ♀ 100% (drug 60%) · 93% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 49 | 26.7 20.0–35.5ROR 26.7 · calibrated p 6e-4 ✓ | 25.3 EB05 19.9 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: PRR 2.1 (1.6–2.9) | Not in label — unassessed | serious n=49 | not reported in cached trials |
| Sternal fracture | 51 | 24.1 18.2–31.9ROR 24.1 · calibrated p 0.001 ✓ | 23.0 EB05 18.1 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=51 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Accidental poisoning | 55 | 23.7 18.1–31.1ROR 23.7 · calibrated p 0.001 ✓ | 22.6 EB05 18.0 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: PRR 2.2 (1.6–3.0) | Not in label — unassessed | serious n=55 · ♀ 0% (drug 60%) | not reported in cached trials |
| Coeliac disease | 392 | 23.2 21.0–25.7ROR 23.5 · calibrated p 9e-4 ✓ | 22.3 EB05 20.5 · IC025 +4.3 3/3 methods agree vs other Benzodiazepines: PRR 5.9 (5.2–6.6) | Not in label — unassessed | serious PRR 21.3 · ♀ 100% (drug 60%) | not reported in cached trials |
| Hyperparathyroidism secondary | 98 | 22.5 18.4–27.5ROR 22.5 · calibrated p 0.001 ✓ | 21.6 EB05 18.2 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: PRR 1.1 (0.9–1.4) | Not in label — unassessed | serious n=98 | not reported in cached trials |
| Rectal prolapse | 46 | 22.1 16.5–29.7ROR 22.2 · calibrated p 0.002 ✓ | 21.2 EB05 16.5 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=46 · ♀ 100% (drug 60%) | not reported in cached trials |
| Rectal polyp | 38 | 22.1 16.0–30.5ROR 22.1 · calibrated p 0.002 ✓ | 21.1 EB05 16.0 · IC025 +3.5 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=38 · ♀ 100% (drug 60%) | not reported in cached trials |
| Immunodeficiency | 539 | 21.2 19.5–23.1ROR 21.5 · calibrated p 0.001 ✓ | 20.5 EB05 19.0 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 6.5 (5.8–7.2) | Not in label — unassessed | serious PRR 17.1 · ♀ 100% (drug 60%) | not reported in cached trials |
| Bursitis | 429 | 20.6 18.7–22.7ROR 20.8 · calibrated p 0.002 ✓ | 19.9 EB05 18.3 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 2.3 (2.1–2.5) | Not in label — unassessed | serious PRR 17.9 · ♀ 95% (drug 60%) | not reported in cached trials |
| Kyphosis | 60 | 19.6 15.1–25.3ROR 19.6 · calibrated p 0.003 ✓ | 18.8 EB05 15.1 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=60 · ♀ 100% (drug 60%) | not reported in cached trials |
| Nephrogenic anaemia | 156 | 19.3 16.4–22.6ROR 19.4 · calibrated p 0.002 ✓ | 18.6 EB05 16.3 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: PRR 1.0 (0.8–1.1) | Not in label — unassessed | serious n=156 | not reported in cached trials |
| Psychotic behaviour | 32 | 18.0 12.7–25.6ROR 18.0 · calibrated p 0.004 ✓ | 17.3 EB05 12.7 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: PRR 14.8 (8.6–25.5) | Not in label — unassessed | serious n=31 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Judgement impaired | 41 | 16.1 11.8–21.9ROR 16.1 · calibrated p 0.006 ✓ | 15.5 EB05 11.8 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=41 · ♀ 100% (drug 60%) | not reported in cached trials |
| Arteriosclerosis coronary artery | 177 | 15.4 13.2–17.8ROR 15.4 · calibrated p 0.006 ✓ | 14.9 EB05 13.2 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: PRR 1.4 (1.2–1.6) | Not in label — unassessed | serious n=177 · ♀ 39% (drug 60%) | not reported in cached trials |
| Multiple drug overdose | 128 | 14.6 12.2–17.4ROR 14.6 · calibrated p 0.008 ✓ | 14.2 EB05 12.2 · IC025 +3.5 3/3 methods agree vs other Benzodiazepines: PRR 0.7 (0.6–0.8) | Not in label — unassessed | serious n=128 · 100% clinician | not reported in cached trials |
| Libido increased | 51 | 14.4 10.9–19.0ROR 14.4 · calibrated p 0.009 ✓ | 13.9 EB05 10.9 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: PRR 37.1 (20.5–67.0) | Not in label — unassessed | serious n=48 · ♀ 100% (drug 60%) | not reported in cached trials |
| Accidental death | 45 | 13.9 10.3–18.7ROR 13.9 · calibrated p 0.011 ✓ | 13.4 EB05 10.3 · IC025 +3.1 3/3 methods agree vs other Benzodiazepines: PRR 0.8 (0.6–1.1) | Not in label — unassessed | serious n=45 · 100% clinician | not reported in cached trials |
| Hypothalamo-pituitary disorder | 35 | 13.9 9.9–19.4ROR 13.9 · calibrated p 0.012 ✓ | 13.2 EB05 9.7 · IC025 +3.0 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=35 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Change of bowel habit | 49 | 13.7 10.3–18.2ROR 13.7 · calibrated p 0.012 ✓ | 13.2 EB05 10.2 · IC025 +3.1 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=49 · ♀ 100% (drug 60%) | not reported in cached trials |
| Prescribed overdose | 456 | 13.5 12.3–14.8ROR 13.6 · calibrated p 0.010 ✓ | 13.2 EB05 12.2 · IC025 +3.5 3/3 methods agree vs other Benzodiazepines: PRR 1.8 (1.6–2.0) | Not in label — unassessed | serious PRR 16.7 · ♀ 91% (drug 60%) | not reported in cached trials |
| Personality disorder | 62 | 13.5 10.5–17.3ROR 13.5 · calibrated p 0.012 ✓ | 13.0 EB05 10.4 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: PRR 1.5 (1.2–2.0) | Not in label — unassessed | serious n=61 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Rebound acid hypersecretion | 70 | 13.0 10.3–16.5ROR 13.1 · calibrated p 0.013 ✓ | 12.6 EB05 10.2 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: PRR 0.8 (0.7–1.1) | Not in label — unassessed | serious n=70 | not reported in cached trials |
| Osteosclerosis | 36 | 13.0 9.4–18.1ROR 13.1 · calibrated p 0.015 ✓ | 12.4 EB05 9.2 · IC025 +2.9 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=36 · 100% consumer | not reported in cached trials |
| Logorrhoea | 80 | 13.0 10.4–16.2ROR 13.0 · calibrated p 0.013 ✓ | 12.5 EB05 10.3 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: PRR 1.0 (0.8–1.3) | Not in label — unassessed | serious n=74 · ♀ 0% (drug 60%) | not reported in cached trials |
| Dyslipidaemia | 113 | 12.7 10.5–15.3ROR 12.7 · calibrated p 0.014 ✓ | 12.3 EB05 10.5 · IC025 +3.3 3/3 methods agree vs other Benzodiazepines: PRR 4.8 (3.8–6.0) | Not in label — unassessed | serious n=112 · ♀ 81% (drug 60%) | not reported in cached trials |
| Hostility | 57 | 12.7 9.8–16.5ROR 12.7 · calibrated p 0.015 ✓ | 12.2 EB05 9.7 · IC025 +3.1 3/3 methods agree vs other Benzodiazepines: PRR 2.0 (1.5–2.7) | Not in label — unassessed | serious n=53 · ♀ 100% (drug 60%) | not reported in cached trials |
| Fibrosis | 68 | 12.6 9.9–16.1ROR 12.6 · calibrated p 0.015 ✓ | 12.2 EB05 9.9 · IC025 +3.1 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=68 · ♀ 83% (drug 60%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Temazepam as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT02153788 — Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia (N=44, PHASE4; 2 AE terms posted; arms: Temazepam; Placebo)
- NCT00465972 — The Treatment of Insomnia in Patients With HIV Disease (N=44, PHASE4; 2 AE terms posted; arms: Placebo; Temazepam)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 2,831 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.988 | 2.0 EB05 2.0 · IC025 +1.0 vs other Benzodiazepines: PRR 0.6 (0.6–0.6) | Labeled adverse reaction exact term | serious PRR 2.1 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,455 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.337 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Benzodiazepines: PRR 0.4 (0.4–0.4) | Reporting / coding artifact | serious PRR 1.3 | not reported in cached trials |
| Nausea | 2,441 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.821 | 1.7 EB05 1.7 · IC025 +0.7 vs other Benzodiazepines: PRR 0.5 (0.5–0.5) | Labeled adverse reaction exact term | serious PRR 1.8 | not reported in cached trials |
| Pain | 2,314 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.961 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Benzodiazepines: PRR 0.6 (0.6–0.6) | Not in label — unassessed | serious PRR 2.1 | not reported in cached trials |
| Headache | 2,294 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.991 | 2.0 EB05 2.0 · IC025 +1.0 vs other Benzodiazepines: PRR 0.6 (0.6–0.6) | Labeled adverse reaction exact term | serious PRR 2.4 | not reported in cached trials |
| Toxicity to various agents | 2,176 | 7.3 7.0–7.6ROR 7.7 · calibrated p 0.074 | 7.2 EB05 7.0 · IC025 +2.8 3/3 methods agree vs other Benzodiazepines: PRR 0.5 (0.5–0.5) | Not in label — unassessed | serious PRR 5.6 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,823 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.717 | 1.6 EB05 1.5 · IC025 +0.6 vs other Benzodiazepines: PRR 0.5 (0.5–0.5) | Labeled adverse reaction exact term | serious PRR 1.5 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,779 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.830 | 1.8 EB05 1.7 · IC025 +0.7 vs other Benzodiazepines: PRR 0.5 (0.5–0.5) | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Death | 1,696 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.377 | 1.1 EB05 1.1 · IC025 +0.1 vs other Benzodiazepines: PRR 0.6 (0.6–0.6) | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.8 | not reported in cached trials |
| Insomnia (trouble sleeping) | 1,692 | 3.6 3.4–3.7ROR 3.7 · calibrated p 0.441 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other Benzodiazepines: PRR 0.6 (0.6–0.6) | Likely indication confounding term in indications; also in warnings | serious PRR 3.4 | not reported in cached trials |
| Dizziness | 1,680 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.907 | 1.9 EB05 1.8 · IC025 +0.8 vs other Benzodiazepines: PRR 0.5 (0.5–0.5) | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
| Fall | 1,657 | 2.8 2.7–2.9ROR 2.9 · calibrated p 0.666 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Benzodiazepines: PRR 0.6 (0.5–0.6) | Labeled adverse reaction exact term | serious PRR 2.3 | not reported in cached trials |
| Off label use (used outside approved label) | 1,651 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.351 | 1.1 EB05 1.0 · IC025 +0.0 vs other Benzodiazepines: PRR 0.4 (0.4–0.4) | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Anxiety | 1,521 | 3.0 2.8–3.1ROR 3.1 · calibrated p 0.602 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Benzodiazepines: PRR 0.4 (0.4–0.4) | Labeled adverse reaction exact term | serious PRR 2.8 | not reported in cached trials |
| Asthenia (weakness) | 1,453 | 2.2 2.1–2.3ROR 2.2 · calibrated p 0.945 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Benzodiazepines: PRR 0.6 (0.5–0.6) | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
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.
- Dystonic tremor — n=33, PRR 343.1
- Temperature regulation disorder — n=420, PRR 133.3
- Carbuncle — n=47, PRR 111.6
- Myocardial depression — n=38, PRR 105.2
- Visceral congestion — n=38, PRR 46.5
- Food allergy — n=517, PRR 41.1
- Soft tissue injury — n=43, PRR 33.6
- Post-traumatic neck syndrome — n=46, PRR 33.5
- Wrist deformity — n=35, PRR 33.4
- Sensitisation — n=43, PRR 33.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Temazepam ↔ Drug Abuse.
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 Temazepam?
In FDA FAERS, the most frequently co-reported reaction terms for Temazepam are fatigue, nausea, pain, headache, toxicity to various agents, diarrhoea. 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 Temazepam 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 Temazepam 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 066e25b2-8a1b-4b08-b585-ce36753bf104, effective 20241211; matched on
openfda.generic_name.exact:"TEMAZEPAM") - 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, 1,194 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 - ClinicalTrials.gov API v2 (query
TEMAZEPAM, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.