Oxazepam side effects: what 21,381 FDA adverse event reports show
Who reports
21,381 reports · 98% serious · 4,840 with death outcome · 54% female
Used for
Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Anxiety associated with depression is also responsive to oxazepam therapy.
What it is
Description Oxazepam, USP is the first of a chemical series of compounds known as the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common.
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 for use 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.
- 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.
- 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). 1,112 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 | 34 | 632.3 410.4–974.0ROR 633.3 · calibrated p 6e-14 ✓ | 314.9 EB05 235.6 · IC025 +5.3 3/3 methods agree vs other Benzodiazepines: PRR 10.5 (6.5–16.9) | Not in label — unassessed | serious n=34 · ♀ 0% (drug 54%) | not reported in cached trials |
| Sedation complication | 540 | 270.8 246.4–297.7ROR 277.8 · calibrated p 2e-11 ✓ | 210.2 EB05 195.8 · IC025 +7.3 3/3 methods agree vs other Benzodiazepines: PRR 5.9 (5.3–6.5) | Reporting / coding artifact | serious n=540 · ♀ 100% (drug 54%) | not reported in cached trials |
| Wrong patient | 89 | 216.8 172.3–272.7ROR 217.7 · calibrated p 3e-10 ✓ | 170.8 EB05 143.1 · IC025 +6.1 3/3 methods agree vs other Benzodiazepines: PRR 60.4 (35.0–104.4) | Reporting / coding artifact | serious n=88 · 91% clinician | not reported in cached trials |
| Illicit prescription attainment | 18 | 200.1 120.5–332.3ROR 200.2 · calibrated p 4e-9 ✓ | 141.4 EB05 94.6 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Creatinine renal clearance decreased | 539 | 151.6 138.6–165.8ROR 155.5 · calibrated p 4e-9 ✓ | 130.6 EB05 121.6 · IC025 +6.7 3/3 methods agree vs other Benzodiazepines: PRR 21.4 (18.4–24.8) | Lab value / disease marker | serious n=538 · ♀ 100% (drug 54%) | not reported in cached trials |
| Asteatosis | 15 | 149.5 86.8–257.5ROR 149.6 · calibrated p 4e-8 ✓ | 111.6 EB05 71.8 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: PRR 7.6 (3.9–14.9) | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Hyper ige syndrome | 15 | 148.0 86.0–254.8ROR 148.1 · calibrated p 5e-8 ✓ | 110.8 EB05 71.2 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: only this drug | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Multiple drug therapy | 82 | 130.6 103.8–164.4ROR 131.1 · calibrated p 2e-8 ✓ | 112.3 EB05 93.3 · IC025 +5.7 3/3 methods agree vs other Benzodiazepines: PRR 4.4 (3.4–5.6) | Reporting / coding artifact | serious n=82 · ♀ 100% (drug 54%) | not reported in cached trials |
| Chemical submission | 28 | 125.4 84.6–185.8ROR 125.5 · calibrated p 6e-8 ✓ | 103.4 EB05 75.1 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=28 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Visceral congestion | 42 | 91.1 66.4–124.9ROR 91.2 · calibrated p 4e-7 ✓ | 80.4 EB05 62.0 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: PRR 1.3 (1.0–1.8) | Not in label — unassessed | serious n=42 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Creatinine renal clearance increased | 60 | 85.1 65.4–110.7ROR 85.3 · calibrated p 6e-7 ✓ | 76.4 EB05 61.5 · IC025 +5.1 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=60 · ♀ 100% (drug 54%) · 93% clinician | not reported in cached trials |
| Substance use disorder | 234 | 80.8 70.7–92.2ROR 81.6 · calibrated p 6e-7 ✓ | 74.2 EB05 66.5 · IC025 +5.8 3/3 methods agree vs other Benzodiazepines: PRR 1.2 (1.0–1.3) | Labeled adverse reaction exact term | serious n=234 · ♀ 18% (drug 54%) · 100% clinician | not reported in cached trials |
| Victim of sexual abuse | 36 | 73.3 52.2–102.8ROR 73.4 · calibrated p 2e-6 ✓ | 65.9 EB05 49.7 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: only this drug | Reporting / coding artifact | serious n=36 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Hyperdynamic left ventricle | 16 | 67.9 40.9–112.6ROR 67.9 · calibrated p 7e-6 ✓ | 59.2 EB05 38.6 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Poisoning deliberate | 599 | 67.5 62.2–73.2ROR 69.4 · calibrated p 2e-6 ✓ | 63.0 EB05 58.9 · IC025 +5.8 3/3 methods agree vs other Benzodiazepines: PRR 1.5 (1.4–1.6) | Not in label — unassessed | serious PRR 37.1 · 99% clinician | not reported in cached trials |
| Acetonaemia | 15 | 63.1 37.4–106.3ROR 63.1 · calibrated p 1e-5 ✓ | 55.3 EB05 35.6 · IC025 +3.5 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Patient uncooperative | 27 | 60.4 41.0–89.1ROR 60.5 · calibrated p 8e-6 ✓ | 54.9 EB05 39.6 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Faecal vomiting | 30 | 58.8 40.7–85.0ROR 58.9 · calibrated p 9e-6 ✓ | 53.7 EB05 39.5 · IC025 +4.3 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=30 · 100% clinician | not reported in cached trials |
| Reduced facial expression | 54 | 55.8 42.5–73.5ROR 56.0 · calibrated p 9e-6 ✓ | 51.9 EB05 41.3 · IC025 +4.7 3/3 methods agree vs other Benzodiazepines: PRR 27.5 (16.5–45.9) | Not in label — unassessed | serious n=54 · ♀ 74% (drug 54%) · 91% clinician | not reported in cached trials |
| Bezoar | 72 | 54.0 42.6–68.5ROR 54.2 · calibrated p 1e-5 ✓ | 50.6 EB05 41.5 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: PRR 11.6 (8.3–16.3) | Not in label — unassessed | serious n=72 · 100% clinician | not reported in cached trials |
| Blood calcium decreased | 546 | 49.9 45.8–54.3ROR 51.1 · calibrated p 1e-5 ✓ | 47.4 EB05 44.1 · IC025 +5.4 3/3 methods agree vs other Benzodiazepines: PRR 4.8 (4.4–5.3) | Lab value / disease marker | serious PRR 35.0 · ♀ 99% (drug 54%) | not reported in cached trials |
| Drug use disorder | 397 | 49.4 44.7–54.6ROR 50.3 · calibrated p 1e-5 ✓ | 46.9 EB05 43.2 · IC025 +5.3 3/3 methods agree vs other Benzodiazepines: PRR 1.1 (1.0–1.2) | Likely indication confounding term in indications; also in warnings | serious PRR 28.7 · ♀ 30% (drug 54%) · 98% clinician | not reported in cached trials |
| Bradypnoea | 122 | 46.7 38.9–55.9ROR 46.9 · calibrated p 2e-5 ✓ | 44.3 EB05 38.1 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: PRR 1.0 (0.8–1.2) | Not in label — unassessed | serious n=122 · ♀ 33% (drug 54%) · 100% clinician | not reported in cached trials |
| Pancreas infection | 18 | 46.3 28.9–74.3ROR 46.3 · calibrated p 5e-5 ✓ | 42.4 EB05 28.4 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: PRR 9.2 (4.8–17.3) | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Victim of chemical submission | 26 | 45.5 30.7–67.4ROR 45.5 · calibrated p 5e-5 ✓ | 42.2 EB05 30.3 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: PRR 3.7 (2.4–5.8) | Not in label — unassessed | serious n=26 · ♀ 100% (drug 54%) · 100% clinician | not reported in cached trials |
| Orthostatic hypotension (dizziness on standing) | 758 | 44.5 41.4–47.8ROR 46.1 · calibrated p 2e-5 ✓ | 42.6 EB05 40.1 · IC025 +5.3 3/3 methods agree vs other Benzodiazepines: PRR 4.0 (3.6–4.3) | Not in label — unassessed | serious PRR 28.6 · ♀ 92% (drug 54%) | not reported in cached trials |
| Wrong patient received product | 123 | 44.1 36.8–52.8ROR 44.3 · calibrated p 3e-5 ✓ | 41.9 EB05 36.1 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: PRR 34.8 (24.0–50.4) | Reporting / coding artifact | serious n=123 | not reported in cached trials |
| Pharmaceutical nomadism | 20 | 42.6 27.2–66.6ROR 42.6 · calibrated p 8e-5 ✓ | 39.4 EB05 27.0 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Victim of crime | 49 | 42.3 31.8–56.3ROR 42.4 · calibrated p 5e-5 ✓ | 40.0 EB05 31.4 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: PRR 1.7 (1.3–2.4) | Not in label — unassessed | serious n=49 · 100% clinician | not reported in cached trials |
| Miosis | 329 | 42.2 37.8–47.1ROR 42.9 · calibrated p 4e-5 ✓ | 40.4 EB05 36.9 · IC025 +5.1 3/3 methods agree vs other Benzodiazepines: PRR 1.0 (0.9–1.1) | Not in label — unassessed | serious PRR 25.1 · ♀ 31% (drug 54%) · 100% clinician | not reported in cached trials |
| Asphyxia | 329 | 41.1 36.8–45.9ROR 41.7 · calibrated p 4e-5 ✓ | 39.4 EB05 35.9 · IC025 +5.0 3/3 methods agree vs other Benzodiazepines: PRR 2.6 (2.3–2.9) | Not in label — unassessed | serious PRR 23.3 · ♀ 28% (drug 54%) · 96% clinician | not reported in cached trials |
| Monocytosis | 24 | 39.5 26.3–59.5ROR 39.6 · calibrated p 1e-4 ✓ | 37.0 EB05 26.2 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: PRR 12.9 (7.0–23.5) | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Neonatal respiratory distress | 30 | 35.1 24.4–50.5ROR 35.2 · calibrated p 2e-4 ✓ | 33.3 EB05 24.4 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: only this drug | Labeled (related wording) related wording | serious n=30 · ♀ 0% (drug 54%) | not reported in cached trials |
| Bladder dilatation | 36 | 33.5 24.0–46.7ROR 33.6 · calibrated p 2e-4 ✓ | 31.9 EB05 24.1 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=36 · ♀ 0% (drug 54%) · 100% clinician | not reported in cached trials |
| Housebound | 13 | 33.3 19.1–57.8ROR 33.3 · calibrated p 4e-4 ✓ | 30.9 EB05 19.2 · IC025 +3.0 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Opiates positive | 15 | 31.3 18.7–52.4ROR 31.3 · calibrated p 5e-4 ✓ | 29.4 EB05 18.9 · IC025 +3.1 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Accidental poisoning | 41 | 30.7 22.5–41.9ROR 30.7 · calibrated p 3e-4 ✓ | 29.4 EB05 22.6 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: PRR 1.6 (1.1–2.2) | Not in label — unassessed | serious n=41 · ♀ 0% (drug 54%) | not reported in cached trials |
| Sedation | 776 | 30.1 28.0–32.3ROR 31.2 · calibrated p 2e-4 ✓ | 29.2 EB05 27.5 · IC025 +4.7 3/3 methods agree vs other Benzodiazepines: PRR 1.2 (1.1–1.3) | Labeled — boxed warning exact term | serious PRR 23.7 · ♀ 83% (drug 54%) | not reported in cached trials |
| Poisoning | 366 | 29.3 26.4–32.5ROR 29.8 · calibrated p 3e-4 ✓ | 28.4 EB05 26.1 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: PRR 0.7 (0.6–0.8) | Not in label — unassessed | serious PRR 17.1 · ♀ 31% (drug 54%) · 97% clinician | not reported in cached trials |
| Substance abuse | 231 | 28.6 25.1–32.5ROR 28.9 · calibrated p 3e-4 ✓ | 27.7 EB05 24.9 · IC025 +4.5 3/3 methods agree vs other Benzodiazepines: PRR 0.7 (0.6–0.8) | Reporting / coding artifact | serious PRR 17.9 · ♀ 27% (drug 54%) · 97% clinician | 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 Oxazepam 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).
- NCT00567814 — A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction (N=45, NA; 75 AE terms posted; arms: Metyrapone 500 mg Oxazepam 20 mg; Metyrapone 1500 mg Oxazepam 20 mg; Placebo)
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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 2,858 | 17.0 16.4–17.6ROR 19.4 · calibrated p 0.002 ✓ | 16.7 EB05 16.2 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: PRR 0.7 (0.7–0.7) | Not in label — unassessed | serious PRR 10.0 · 90% clinician | not reported in cached trials |
| Drug abuse | 1,522 | 18.2 17.3–19.1ROR 19.5 · calibrated p 0.002 ✓ | 17.8 EB05 17.1 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 0.5 (0.4–0.5) | Reporting / coding artifact | serious PRR 10.6 · ♀ 32% (drug 54%) · 92% clinician | not reported in cached trials |
| Fall | 1,520 | 4.5 4.3–4.7ROR 4.8 · calibrated p 0.261 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Benzodiazepines: PRR 0.5 (0.5–0.5) | Not in label — unassessed | serious PRR 3.2 · ♀ 84% (drug 54%) | not reported in cached trials |
| Hypotension (low blood pressure) | 1,402 | 6.9 6.6–7.3ROR 7.3 · calibrated p 0.087 | 6.9 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other Benzodiazepines: PRR 0.7 (0.7–0.8) | Not in label — unassessed | serious PRR 4.7 · ♀ 78% (drug 54%) | not reported in cached trials |
| Drug interaction | 1,178 | 7.3 6.9–7.8ROR 7.7 · calibrated p 0.075 | 7.3 EB05 6.9 · IC025 +2.8 3/3 methods agree vs other Benzodiazepines: PRR 0.5 (0.4–0.5) | Reporting / coding artifact | serious PRR 4.8 · 90% clinician | not reported in cached trials |
| Coma | 1,109 | 23.3 22.0–24.7ROR 24.6 · calibrated p 7e-4 ✓ | 22.8 EB05 21.7 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: PRR 0.9 (0.8–0.9) | Labeled — boxed warning exact term | serious PRR 13.5 · 96% clinician | not reported in cached trials |
| Somnolence (drowsiness) | 997 | 4.9 4.6–5.2ROR 5.1 · calibrated p 0.227 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Benzodiazepines: PRR 0.3 (0.3–0.4) | Labeled — boxed warning synonym match | serious PRR 4.9 | NCT00567814: 2/15 (13.3%) on Oxazepam; 2/15 (13.3%) control |
| Depressed level of consciousness | 955 | 24.3 22.8–25.9ROR 25.4 · calibrated p 6e-4 ✓ | 23.7 EB05 22.5 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: PRR 1.2 (1.1–1.2) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.3 · ♀ 75% (drug 54%) | not reported in cached trials |
| Pain | 899 | 1.4 1.3–1.5ROR 1.5 · calibrated p 0.611 | 1.4 EB05 1.4 · IC025 +0.4 vs other Benzodiazepines: PRR 0.2 (0.2–0.2) | Not in label — unassessed | serious PRR 1.3 · ♀ 85% (drug 54%) | NCT00567814: 1/15 (6.7%) on Oxazepam; 3/15 (20.0%) control |
| Constipation | 868 | 3.9 3.7–4.2ROR 4.1 · calibrated p 0.365 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Benzodiazepines: PRR 0.5 (0.4–0.5) | Not in label — unassessed | serious PRR 4.1 · ♀ 87% (drug 54%) | NCT00567814: 1/15 (6.7%) on Oxazepam; 1/15 (6.7%) control |
| Overdose | 833 | 3.8 3.5–4.0ROR 3.9 · calibrated p 0.398 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Benzodiazepines: PRR 0.4 (0.4–0.4) | Reporting / coding artifact | serious PRR 2.8 | not reported in cached trials |
| Cognitive disorder | 832 | 17.8 16.7–19.1ROR 18.5 · calibrated p 0.003 ✓ | 17.5 EB05 16.6 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: PRR 1.5 (1.4–1.6) | Not in label — unassessed | serious PRR 14.5 · ♀ 87% (drug 54%) | not reported in cached trials |
| Death | 828 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.269 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Benzodiazepines: PRR 0.3 (0.3–0.3) | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.6 | not reported in cached trials |
| Sedation | 776 | 30.1 28.0–32.3ROR 31.2 · calibrated p 2e-4 ✓ | 29.2 EB05 27.5 · IC025 +4.7 3/3 methods agree vs other Benzodiazepines: PRR 1.2 (1.1–1.3) | Labeled — boxed warning exact term | serious PRR 23.7 · ♀ 83% (drug 54%) | not reported in cached trials |
| Dyspnoea (shortness of breath) | 773 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.545 | 1.3 EB05 1.3 · IC025 +0.3 vs other Benzodiazepines: PRR 0.2 (0.2–0.2) | Not in label — unassessed | serious PRR 1.1 | 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=34, PRR 632.3
- Chemical submission — n=28, PRR 125.4
- Visceral congestion — n=42, PRR 91.1
- Poisoning deliberate — n=599, PRR 67.5
- Patient uncooperative — n=27, PRR 60.4
- Faecal vomiting — n=30, PRR 58.8
- Reduced facial expression — n=54, PRR 55.8
- Bezoar — n=72, PRR 54.0
- Bradypnoea — n=122, PRR 46.7
- Victim of chemical submission — n=26, PRR 45.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Oxazepam ↔ 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 Oxazepam?
In FDA FAERS, the most frequently co-reported reaction terms for Oxazepam are toxicity to various agents, fall, hypotension, coma, somnolence, depressed level of consciousness. 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 Oxazepam 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 for use in patients for whom alternative treatment options are inadequate.
Do FAERS signals prove that Oxazepam 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 67f821fa-5663-4d69-82c9-5ee13a09f324, effective 20250711; matched on
openfda.generic_name.exact:"OXAZEPAM") - 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, 1,152 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
OXAZEPAM, 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.