Drug · FAERS side-effect profile with label screen
Diazepam Oral side effects: what 88,498 FDA adverse event reports show
Who reports
88,498 reports · 85% serious · 20,478 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Diazepam is 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. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
FDA label, Indications and Usage
What it is
DESCRIPTION Diazepam is a benzodiazepine derivative.
FDA label, Description section
Boxed warning
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 1Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 3Not in label — unassessed 26
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). 1,187 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Rhesus incompatibility | 68 | 298.7 208.6–427.7ROR 298.9 · calibrated p 4e-11 ✓ | 126.8 EB05 103.4 · IC025 +5.7 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=68 | not reported in cached trials |
| Total lung capacity increased | 106 | 150.5 117.9–192.1ROR 150.6 · calibrated p 7e-9 ✓ | 90.3 EB05 76.8 · IC025 +5.7 3/3 methods agree vs other Benzodiazepines: PRR 10.1 (7.7–13.2) | Not in label — unassessed | serious n=106 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Congenital nystagmus | 79 | 141.5 107.0–187.1ROR 141.6 · calibrated p 1e-8 ✓ | 86.6 EB05 71.7 · IC025 +5.5 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=79 · 100% clinician | not reported in cached trials |
| Visceral congestion | 139 | 92.7 76.2–112.8ROR 92.9 · calibrated p 3e-7 ✓ | 66.0 EB05 57.3 · IC025 +5.5 3/3 methods agree vs other Benzodiazepines: PRR 6.3 (5.1–7.8) | Not in label — unassessed | serious n=139 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Myoglobin urine present | 64 | 81.4 61.3–108.2ROR 81.5 · calibrated p 8e-7 ✓ | 59.6 EB05 48.3 · IC025 +5.0 3/3 methods agree vs other Benzodiazepines: PRR 7.2 (5.2–9.9) | Lab value / disease marker | serious n=63 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Vital capacity decreased | 104 | 71.0 57.0–88.4ROR 71.1 · calibrated p 2e-6 ✓ | 54.1 EB05 45.9 · IC025 +5.1 3/3 methods agree vs other Benzodiazepines: PRR 10.0 (7.6–13.1) | Not in label — unassessed | serious n=104 · ♀ 100% (drug 56%) | not reported in cached trials |
| Substance use disorder | 664 | 65.2 59.8–71.0ROR 65.7 · calibrated p 2e-6 ✓ | 51.1 EB05 47.9 · IC025 +5.5 3/3 methods agree vs other Benzodiazepines: PRR 4.2 (3.8–4.6) | Labeled adverse reaction exact term | serious n=664 · ♀ 30% (drug 56%) · 100% clinician | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 108 | 61.9 50.1–76.6ROR 62.0 · calibrated p 4e-6 ✓ | 48.7 EB05 41.5 · IC025 +5.0 3/3 methods agree vs other Benzodiazepines: PRR 4.8 (3.8–6.0) | Not in label — unassessed | serious n=106 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Reversible airways obstruction | 104 | 59.9 48.3–74.3ROR 60.0 · calibrated p 5e-6 ✓ | 47.5 EB05 40.3 · IC025 +5.0 3/3 methods agree vs other Benzodiazepines: PRR 10.1 (7.7–13.2) | Not in label — unassessed | serious n=104 · ♀ 100% (drug 56%) | not reported in cached trials |
| Stiff person syndrome | 61 | 51.8 39.3–68.4ROR 51.9 · calibrated p 2e-5 ✓ | 42.1 EB05 33.9 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=59 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Bradypnoea | 376 | 38.5 34.5–42.9ROR 38.7 · calibrated p 7e-5 ✓ | 33.1 EB05 30.4 · IC025 +4.8 3/3 methods agree vs other Benzodiazepines: PRR 3.9 (3.5–4.4) | Not in label — unassessed | serious n=376 · 100% clinician | not reported in cached trials |
| Exposure via father | 185 | 38.5 32.9–44.9ROR 38.5 · calibrated p 7e-5 ✓ | 33.0 EB05 29.2 · IC025 +4.7 3/3 methods agree vs other Benzodiazepines: PRR 10.1 (8.3–12.4) | Reporting / coding artifact | serious n=185 · 100% clinician | not reported in cached trials |
| Multiple drug therapy | 96 | 37.7 30.4–46.8ROR 37.7 · calibrated p 9e-5 ✓ | 32.4 EB05 27.3 · IC025 +4.5 3/3 methods agree vs other Benzodiazepines: PRR 5.5 (4.3–7.0) | Reporting / coding artifact | serious n=96 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Sputum culture positive | 111 | 36.8 30.1–44.9ROR 36.8 · calibrated p 1e-4 ✓ | 31.7 EB05 27.1 · IC025 +4.5 3/3 methods agree vs other Benzodiazepines: PRR 10.0 (7.7–13.0) | Lab value / disease marker | serious n=111 · ♀ 100% (drug 56%) | not reported in cached trials |
| Multiple drug overdose accidental | 61 | 35.8 27.3–46.8ROR 35.8 · calibrated p 1e-4 ✓ | 30.9 EB05 24.9 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: only this drug | Not in label — unassessed | serious n=61 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
| Victim of chemical submission | 71 | 32.5 25.4–41.7ROR 32.6 · calibrated p 2e-4 ✓ | 28.5 EB05 23.3 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 27.8 (17.8–43.6) | Not in label — unassessed | serious n=71 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Victim of crime | 133 | 29.9 25.0–35.8ROR 29.9 · calibrated p 3e-4 ✓ | 26.5 EB05 22.9 · IC025 +4.3 3/3 methods agree vs other Benzodiazepines: PRR 6.7 (5.4–8.3) | Not in label — unassessed | serious n=133 · ♀ 78% (drug 56%) · 100% clinician | not reported in cached trials |
| Drug use disorder | 917 | 29.4 27.5–31.5ROR 29.7 · calibrated p 3e-4 ✓ | 26.2 EB05 24.8 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: PRR 2.9 (2.7–3.1) | Labeled (related wording) related wording | serious PRR 18.4 · ♀ 32% (drug 56%) · 97% clinician | NCT00319501: 1/81 (1.2%) on Diazepam Oral |
| Miosis | 797 | 26.3 24.4–28.2ROR 26.5 · calibrated p 5e-4 ✓ | 23.7 EB05 22.3 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: PRR 2.9 (2.7–3.1) | Not in label — unassessed | serious PRR 16.9 · ♀ 31% (drug 56%) · 97% clinician | not reported in cached trials |
| Poisoning deliberate | 906 | 25.5 23.8–27.3ROR 25.7 · calibrated p 6e-4 ✓ | 23.1 EB05 21.8 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: PRR 2.4 (2.3–2.6) | Not in label — unassessed | serious PRR 15.6 · 97% clinician | not reported in cached trials |
| Accidental death | 173 | 24.3 20.8–28.4ROR 24.4 · calibrated p 8e-4 ✓ | 22.1 EB05 19.4 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 3.9 (3.3–4.7) | Not in label — unassessed | serious n=173 · 100% clinician | not reported in cached trials |
| Agoraphobia | 127 | 24.2 20.1–29.0ROR 24.2 · calibrated p 9e-4 ✓ | 21.9 EB05 18.9 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 4.0 (3.2–4.9) | Not in label — unassessed | serious n=124 | not reported in cached trials |
| Coma scale abnormal | 261 | 23.7 20.9–26.9ROR 23.8 · calibrated p 9e-4 ✓ | 21.6 EB05 19.5 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 4.4 (3.8–5.1) | Not in label — unassessed | serious n=261 | not reported in cached trials |
| Sedation complication | 223 | 23.1 20.2–26.5ROR 23.2 · calibrated p 0.001 ✓ | 21.1 EB05 18.9 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 1.8 (1.6–2.1) | Reporting / coding artifact | serious n=218 | not reported in cached trials |
| Poisoning | 1,079 | 22.1 20.8–23.5ROR 22.3 · calibrated p 0.001 ✓ | 20.3 EB05 19.3 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 2.3 (2.2–2.5) | Not in label — unassessed | serious PRR 13.9 · 97% clinician | not reported in cached trials |
| Bronchial secretion retention | 108 | 22.1 18.1–26.9ROR 22.1 · calibrated p 0.001 ✓ | 20.2 EB05 17.2 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: PRR 9.6 (7.4–12.6) | Not in label — unassessed | serious n=108 · ♀ 100% (drug 56%) | not reported in cached trials |
| Cogwheel rigidity | 90 | 22.1 17.8–27.4ROR 22.1 · calibrated p 0.001 ✓ | 20.2 EB05 16.9 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: PRR 3.9 (3.1–5.0) | Not in label — unassessed | serious n=90 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Multiple drug overdose | 409 | 20.9 18.9–23.1ROR 21.0 · calibrated p 0.002 ✓ | 19.2 EB05 17.7 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 2.7 (2.4–3.0) | Not in label — unassessed | serious n=409 · 100% clinician | not reported in cached trials |
| Substance abuse | 653 | 20.6 19.0–22.3ROR 20.7 · calibrated p 0.002 ✓ | 19.0 EB05 17.8 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 2.3 (2.1–2.5) | Reporting / coding artifact | serious PRR 14.1 · ♀ 28% (drug 56%) | not reported in cached trials |
| Respiratory depression | 910 | 18.9 17.7–20.2ROR 19.1 · calibrated p 0.002 ✓ | 17.6 EB05 16.6 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: PRR 2.3 (2.2–2.5) | Labeled — boxed warning exact term | age-adj. PRR 13.8 · serious PRR 11.8 · 92% clinician | not reported in cached trials |
| Drug abuse | 6,138 | 18.7 18.2–19.2ROR 20.0 · calibrated p 0.002 ✓ | 17.4 EB05 17.0 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 2.2 (2.2–2.3) | Reporting / coding artifact | age-adj. PRR 13.8 · serious PRR 11.9 · 93% clinician | not reported in cached trials |
| Psychogenic seizure | 66 | 18.2 14.2–23.4ROR 18.2 · calibrated p 0.003 ✓ | 16.8 EB05 13.7 · IC025 +3.5 3/3 methods agree vs other Benzodiazepines: PRR 5.7 (4.2–7.7) | Not in label — unassessed | serious n=64 · ♀ 100% (drug 56%) | not reported in cached trials |
| Hypomania | 263 | 18.1 16.0–20.5ROR 18.2 · calibrated p 0.003 ✓ | 16.9 EB05 15.2 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: PRR 4.0 (3.4–4.6) | Not in label — unassessed | serious n=261 · ♀ 90% (drug 56%) | not reported in cached trials |
| Gastric ph decreased | 68 | 16.7 13.1–21.4ROR 16.7 · calibrated p 0.005 ✓ | 15.6 EB05 12.6 · IC025 +3.4 3/3 methods agree vs other Benzodiazepines: only this drug | Lab value / disease marker | serious n=67 · ♀ 100% (drug 56%) · 100% clinician | not reported in cached trials |
| Alcohol poisoning | 168 | 16.0 13.6–18.7ROR 16.0 · calibrated p 0.006 ✓ | 15.0 EB05 13.1 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: PRR 4.3 (3.6–5.2) | Likely indication confounding shares a disease stem with the indications wording | serious n=168 · ♀ 33% (drug 56%) | not reported in cached trials |
| Neuroleptic malignant syndrome | 728 | 15.4 14.3–16.6ROR 15.5 · calibrated p 0.006 ✓ | 14.5 EB05 13.6 · IC025 +3.7 3/3 methods agree vs other Benzodiazepines: PRR 2.0 (1.9–2.2) | Not in label — unassessed | age-adj. PRR 12.2 · serious PRR 9.8 · 92% clinician | not reported in cached trials |
| Drug withdrawal convulsions | 108 | 15.2 12.5–18.5ROR 15.2 · calibrated p 0.007 ✓ | 14.3 EB05 12.1 · IC025 +3.4 3/3 methods agree vs other Benzodiazepines: PRR 1.7 (1.4–2.1) | Likely indication confounding shares a disease stem with the indications wording | serious n=108 · 100% clinician | not reported in cached trials |
| Alcohol interaction | 113 | 14.5 12.0–17.6ROR 14.5 · calibrated p 0.008 ✓ | 13.7 EB05 11.6 · IC025 +3.4 3/3 methods agree vs other Benzodiazepines: PRR 9.1 (7.0–11.7) | Labeled (related wording) related wording | serious n=112 · ♀ 0% (drug 56%) | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 62 | 14.4 11.2–18.7ROR 14.4 · calibrated p 0.009 ✓ | 13.5 EB05 10.8 · IC025 +3.2 3/3 methods agree vs other Benzodiazepines: PRR 2.8 (2.1–3.8) | Not in label — unassessed | serious n=62 · ♀ 0% (drug 56%) | not reported in cached trials |
| Accidental poisoning | 77 | 14.3 11.3–18.0ROR 14.3 · calibrated p 0.009 ✓ | 13.4 EB05 11.0 · IC025 +3.3 3/3 methods agree vs other Benzodiazepines: PRR 3.4 (2.6–4.4) | Not in label — unassessed | serious n=77 · ♀ 0% (drug 56%) · 100% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Suicidality | 8,053 | 8.07.8–8.2 | signal |
| Extrapyramidal | 1,821 | 4.14.0–4.3 | signal |
| Seizure | 3,040 | 3.73.6–3.8 | signal |
| Rhabdomyolysis / myopathy | 1,211 | 3.63.4–3.8 | signal |
| Dependence / withdrawal | 3,585 | 2.92.8–3.0 | signal |
| Depression | 2,972 | 2.52.4–2.6 | signal |
| Hyponatraemia | 811 | 2.42.2–2.6 | signal |
| Severe cutaneous reaction | 715 | 2.32.1–2.5 | signal |
| Arrhythmia / qt | 1,628 | 2.01.9–2.1 | raised |
| Fall / fracture | 2,994 | 1.91.8–1.9 | raised |
| Kidney injury | 3,472 | 1.81.7–1.9 | raised |
| Liver injury | 1,862 | 1.51.4–1.5 | raised |
| Serious infection | 4,649 | 1.41.4–1.5 | raised |
| Venous thromboembolism | 1,124 | 1.21.2–1.3 | raised |
| Hypoglycaemia | 487 | 1.21.1–1.3 | raised |
| Pancreatitis | 401 | 1.21.1–1.3 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Diazepam Oral 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 (1 of 40 signal terms matched).
- NCT00326612 — Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures (N=358, PHASE2; 1 AE terms posted; arms: Intranasal Midazolam; Rectal Diazepam)
- NCT00319501 — Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Inte (N=234, PHASE3; 181 AE terms posted; arms: Diazepam (Double-blind Period); Diazepam (Open-label Period); Diazepam (Open-label Extension); Placebo (Double-blind Period))
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 | 8,871 | 13.2 12.9–13.4ROR 14.5 · calibrated p 0.008 ✓ | 12.5 EB05 12.3 · IC025 +3.6 3/3 methods agree vs other Benzodiazepines: PRR 2.5 (2.5–2.6) | Not in label — unassessed | age-adj. PRR 10.8 · serious PRR 8.6 | NCT00319501: 1/33 (3.0%) on Diazepam Oral (serious AE) |
| Drug abuse | 6,138 | 18.7 18.2–19.2ROR 20.0 · calibrated p 0.002 ✓ | 17.4 EB05 17.0 · IC025 +4.1 3/3 methods agree vs other Benzodiazepines: PRR 2.2 (2.2–2.3) | Reporting / coding artifact | age-adj. PRR 13.8 · serious PRR 11.9 · 93% clinician | not reported in cached trials |
| Drug ineffective (drug did not work) | 4,966 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.235 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Benzodiazepines: PRR 0.8 (0.8–0.9) | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.2 | not reported in cached trials |
| Nausea | 4,145 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.479 | 1.2 EB05 1.2 · IC025 +0.3 vs other Benzodiazepines: PRR 0.9 (0.9–0.9) | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.3 | NCT00319501: 1/33 (3.0%) on Diazepam Oral (serious AE) |
| Completed suicide (death by suicide) | 3,839 | 11.3 10.9–11.6ROR 11.8 · calibrated p 0.018 ✓ | 10.8 EB05 10.5 · IC025 +3.4 3/3 methods agree vs other Benzodiazepines: PRR 1.7 (1.7–1.8) | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 7.8 · serious PRR 7.3 · 96% clinician | not reported in cached trials |
| Drug interaction | 3,775 | 5.8 5.6–5.9ROR 6.0 · calibrated p 0.152 | 5.6 EB05 5.5 · IC025 +2.4 3/3 methods agree vs other Benzodiazepines: PRR 1.6 (1.6–1.7) | Reporting / coding artifact | age-adj. PRR 4.9 · serious PRR 4.2 | not reported in cached trials |
| Fatigue (tiredness) | 3,769 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.411 | 1.1 EB05 1.1 · IC025 +0.1 vs other Benzodiazepines: PRR 0.8 (0.8–0.8) | Labeled adverse reaction exact term | age-adj. PRR 0.9 · serious PRR 1.1 | NCT00319501: 1/33 (3.0%) on Diazepam Oral |
| Somnolence (drowsiness) | 3,560 | 4.3 4.1–4.4ROR 4.4 · calibrated p 0.312 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Benzodiazepines: PRR 1.3 (1.3–1.4) | Labeled — boxed warning synonym match | age-adj. PRR 3.9 · serious PRR 4.4 | NCT00319501: 2/33 (6.1%) on Diazepam Oral; 3/79 (3.8%) control |
| Off label use (used outside approved label) | 3,480 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.273 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC vs other Benzodiazepines: PRR 0.9 (0.9–0.9) | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.0 | not reported in cached trials |
| Anxiety | 3,361 | 2.8 2.7–2.9ROR 2.9 · calibrated p 0.665 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other Benzodiazepines: PRR 0.9 (0.9–1.0) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 2.4 · serious PRR 2.5 | NCT00319501: 1/128 (0.8%) on Diazepam Oral (serious AE) |
| Death | 3,334 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.251 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Benzodiazepines: PRR 1.3 (1.2–1.3) | Outcome field, not a reaction boxed warning mentions mortality | age-adj. PRR 1.3 · serious PRR 0.6 | not reported in cached trials |
| Headache | 3,235 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.463 | 1.2 EB05 1.2 · IC025 +0.2 vs other Benzodiazepines: PRR 0.9 (0.9–0.9) | Labeled adverse reaction exact term | age-adj. PRR 1.0 · serious PRR 1.3 | NCT00319501: 1/128 (0.8%) on Diazepam Oral (serious AE) |
| Pain | 3,209 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.471 | 1.2 EB05 1.2 · IC025 +0.2 vs other Benzodiazepines: PRR 0.9 (0.9–0.9) | Labeled adverse reaction exact term | age-adj. PRR 1.1 · serious PRR 1.1 | NCT00319501: 1/128 (0.8%) on Diazepam Oral (serious AE) |
| Overdose | 3,193 | 3.5 3.4–3.7ROR 3.6 · calibrated p 0.455 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other Benzodiazepines: PRR 1.6 (1.6–1.7) | Reporting / coding artifact | age-adj. PRR 4.3 · serious PRR 2.9 | not reported in cached trials |
| Vomiting | 3,069 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.690 | 1.6 EB05 1.5 · IC025 +0.6 vs other Benzodiazepines: PRR 1.0 (1.0–1.0) | Not in label — unassessed | age-adj. PRR 1.3 · serious PRR 1.4 | NCT00319501: 1/33 (3.0%) on Diazepam Oral (serious AE) |
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.
- Rhesus incompatibility — n=68, PRR 298.7
- Total lung capacity increased — n=106, PRR 150.5
- Congenital nystagmus — n=79, PRR 141.5
- Visceral congestion — n=139, PRR 92.7
- Vital capacity decreased — n=104, PRR 71.0
- Asthma-chronic obstructive pulmonary disease overlap syndrome — n=108, PRR 61.9
- Reversible airways obstruction — n=104, PRR 59.9
- Stiff person syndrome — n=61, PRR 51.8
- Bradypnoea — n=376, PRR 38.5
- Multiple drug overdose accidental — n=61, PRR 35.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Diazepam ↔ 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 Diazepam Oral?
In FDA FAERS, the most frequently co-reported reaction terms for Diazepam Oral are toxicity to various agents, nausea, fatigue, somnolence, anxiety, headache. 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 Diazepam Oral have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: 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 Diazepam Oral 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 1632f040-3b2c-43da-a42f-f2baf5ec778a, effective 20240429; matched on
openfda.generic_name.exact:"DIAZEPAM" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,227 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 - ClinicalTrials.gov API v2 (query
DIAZEPAM, 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.