Drug · FAERS side-effect profile with label screen

Diazepam (Concentrate) side effects: what 88,496 FDA adverse event reports show

Diazepam Oral Solution (Concentrate) · 1,227 reaction terms · 368,677 drug–reaction co-reports · data 2026-09-14

Drug class

Benzodiazepine

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Diazepam Oral (Diazepam)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

88,496 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 Each 5 mL of Diazepam Oral Solution contains: diazepam USP ....................................................... 5 mg

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. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.

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 2Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 3Not 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.
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: 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
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	Not in label — unassessed	serious n=68	no trial arm names this drug
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	Not in label — unassessed	serious n=106 · ♀ 100% (drug 56%) · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=79 · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=139 · ♀ 0% (drug 56%) · 100% clinician	no trial arm names this drug
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	Lab value / disease marker	serious n=63 · ♀ 100% (drug 56%) · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=104 · ♀ 100% (drug 56%)	no trial arm names this drug
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	Labeled adverse reaction exact term	serious n=664 · ♀ 30% (drug 56%) · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=106 · ♀ 100% (drug 56%) · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=104 · ♀ 100% (drug 56%)	no trial arm names this drug
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	Not in label — unassessed	serious n=59 · ♀ 100% (drug 56%) · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=376 · 100% clinician	no trial arm names this drug
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	Reporting / coding artifact	serious n=185 · 100% clinician	no trial arm names this drug
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	Reporting / coding artifact	serious n=96 · ♀ 100% (drug 56%) · 100% clinician	no trial arm names this drug
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	Lab value / disease marker	serious n=111 · ♀ 100% (drug 56%)	no trial arm names this drug
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	Not in label — unassessed	serious n=61 · ♀ 0% (drug 56%) · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=71 · ♀ 100% (drug 56%) · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=133 · ♀ 78% (drug 56%) · 100% clinician	no trial arm names this drug
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	Likely indication confounding term in indications; also in warnings	serious PRR 18.4 · ♀ 32% (drug 56%) · 97% clinician	no trial arm names this drug
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	Not in label — unassessed	serious PRR 16.9 · ♀ 31% (drug 56%) · 97% clinician	no trial arm names this drug
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	Not in label — unassessed	serious PRR 15.6 · 97% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=173 · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=124	no trial arm names this drug
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	Not in label — unassessed	serious n=261	no trial arm names this drug
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	Reporting / coding artifact	serious n=218	no trial arm names this drug
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	Labeled adverse reaction exact term	serious PRR 13.9 · 97% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=108 · ♀ 100% (drug 56%)	no trial arm names this drug
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	Not in label — unassessed	serious n=90 · ♀ 100% (drug 56%) · 100% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=409 · 100% clinician	no trial arm names this drug
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	Reporting / coding artifact	serious PRR 14.1 · ♀ 28% (drug 56%)	no trial arm names this drug
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	Labeled — boxed warning exact term	age-adj. PRR 13.8 · serious PRR 11.8 · 92% clinician	no trial arm names this drug
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	Reporting / coding artifact	age-adj. PRR 13.8 · serious PRR 11.9 · 93% clinician	no trial arm names this drug
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	Not in label — unassessed	serious n=64 · ♀ 100% (drug 56%)	no trial arm names this drug
Hypomania	263	18.1 16.0–20.6ROR 18.2 · calibrated p 0.003 ✓	16.9 EB05 15.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=261 · ♀ 90% (drug 56%)	no trial arm names this drug
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	Lab value / disease marker	serious n=67 · ♀ 100% (drug 56%) · 100% clinician	no trial arm names this drug
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	Labeled (related wording) related wording	serious n=168 · ♀ 33% (drug 56%)	no trial arm names this drug
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	Not in label — unassessed	age-adj. PRR 12.2 · serious PRR 9.8 · 92% clinician	no trial arm names this drug
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	Likely indication confounding shares a disease stem with the indications wording	serious n=108 · 100% clinician	no trial arm names this drug
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	Labeled (related wording) related wording	serious n=112 · ♀ 0% (drug 56%)	no trial arm names this drug
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	Not in label — unassessed	serious n=62 · ♀ 0% (drug 56%)	no trial arm names this drug
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	Not in label — unassessed	serious n=77 · ♀ 0% (drug 56%) · 100% clinician	no trial arm names this drug

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	8,052	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	2,971	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	1,627	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)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Diazepam (Concentrate) (searched DIAZEPAM (CONCENTRATE).

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	Not in label — unassessed	age-adj. PRR 10.8 · serious PRR 8.6	no trial arm names this drug
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	Reporting / coding artifact	age-adj. PRR 13.8 · serious PRR 11.9 · 93% clinician	no trial arm names this drug
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	Reporting / coding artifact	age-adj. PRR 0.9 · serious PRR 1.2	no trial arm names this drug
Nausea	4,145	1.2 1.2–1.3ROR 1.3 · calibrated p 0.479	1.2 EB05 1.2 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 1.3	no trial arm names this drug
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	Outcome field, not a reaction boxed warning mentions mortality	age-adj. PRR 7.8 · serious PRR 7.3 · 96% clinician	no trial arm names this drug
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	Reporting / coding artifact	age-adj. PRR 4.9 · serious PRR 4.2	no trial arm names this drug
Fatigue (tiredness)	3,769	1.2 1.1–1.2ROR 1.2 · calibrated p 0.411	1.1 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	age-adj. PRR 0.9 · serious PRR 1.1	no trial arm names this drug
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	Labeled — boxed warning synonym match	age-adj. PRR 3.9 · serious PRR 4.4	no trial arm names this drug
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	Reporting / coding artifact	age-adj. PRR 0.9 · serious PRR 1.0	no trial arm names this drug
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	Likely indication confounding term in indications; also in warnings	age-adj. PRR 2.4 · serious PRR 2.5	no trial arm names this drug
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	Outcome field, not a reaction boxed warning mentions mortality	age-adj. PRR 1.3 · serious PRR 0.6	no trial arm names this drug
Headache	3,235	1.2 1.2–1.3ROR 1.2 · calibrated p 0.463	1.2 EB05 1.2 · IC025 +0.2	Labeled adverse reaction exact term	age-adj. PRR 1.0 · serious PRR 1.3	no trial arm names this drug
Pain	3,207	1.2 1.2–1.3ROR 1.2 · calibrated p 0.471	1.2 EB05 1.2 · IC025 +0.2	Not in label — unassessed	age-adj. PRR 1.1 · serious PRR 1.1	no trial arm names this drug
Overdose	3,192	3.5 3.4–3.7ROR 3.6 · calibrated p 0.455	3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 4.3 · serious PRR 2.9	no trial arm names this drug
Vomiting	3,069	1.6 1.5–1.6ROR 1.6 · calibrated p 0.690	1.6 EB05 1.5 · IC025 +0.6	Not in label — unassessed	age-adj. PRR 1.3 · serious PRR 1.4	no trial arm names this drug

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 (Concentrate)?

In FDA FAERS, the most frequently co-reported reaction terms for Diazepam (Concentrate) 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 (Concentrate) 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 Diazepam (Concentrate) 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 cdb839fb-27e5-4a11-aed6-da0a7ab6e996, effective 20251203; matched on openfda.generic_name.exact:"DIAZEPAM ORAL SOLUTION (CONCENTRATE)")
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, 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 (CONCENTRATE, 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.