Drug · FAERS side-effect profile with label screen

Midazolam and 10 side effects: what 1,487 FDA adverse event reports show

Midazolam Injection, 10 Mg · 15 reaction terms · 873 drug–reaction co-reports · data 2026-09-14

Drug class

Benzodiazepine

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

Label matched

Midazolam (Nayzilam)

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

Who reports

1,487 reports · 94% serious · 391 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

NAYZILAM is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older.

FDA label, Indications and Usage

What it is

NAYZILAM contains midazolam, a compound of the benzodiazepine class. Midazolam is chemically designated as 8-Chloro-6-(ο-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine, and it has the following structure:

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 for 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 12 strongest signals

Labeled adverse reaction 1Reporting / coding artifact 7Outcome field, not a reaction 1Not in label — unassessed 3

What the badges mean

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.
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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 3 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
Therapy interrupted	158	32.4 27.9–37.5ROR 36.1 · χ² 4,776 / p <1e-300	32.2 EB05 28.2 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 43.6 · 97% clinician	no trial data cached
Therapy cessation	113	31.3 26.2–37.3ROR 33.7 · χ² 3,280 / p <1e-300	31.0 EB05 26.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 42.2	no trial data cached
Spinal operation	16	18.7 11.5–30.4ROR 18.9 · χ² 250 / p 1e-56	18.1 EB05 11.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 11.7	no trial data cached
Surgery	72	17.5 14.0–22.0ROR 18.4 · χ² 1,108 / p 3e-243	17.4 EB05 14.3 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 12.2 · 96% clinician	no trial data cached
Knee operation	9	13.1 6.8–25.1ROR 13.2 · χ² 89 / p 2e-21	10.8 EB05 5.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9	no trial data cached
Knee arthroplasty	15	10.2 6.1–16.8ROR 10.2 · χ² 115 / p 4e-27	8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Intentional dose omission	18	9.3 5.9–14.7ROR 9.4 · χ² 125 / p 3e-29	8.1 EB05 5.2 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 11.7	no trial data cached
Hospitalisation	95	8.8 7.2–10.7ROR 9.3 · χ² 653 / p 2e-144	8.6 EB05 7.2 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4	no trial data cached
Hip arthroplasty	7	6.5 3.1–13.6ROR 6.5 · χ² 27 / p 9e-8	4.8 EB05 2.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Pregnancy	9	6.3 3.3–12.0ROR 6.3 · χ² 35 / p 2e-9	4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.0	no trial data cached
Death	346	5.7 5.2–6.2ROR 7.1 · χ² 1,381 / p <1e-300	5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 3.5 · 96% clinician	no trial data cached
Dialysis	5	5.0 2.1–11.9ROR 5.0 · χ² 12 / p 3e-4	3.6 EB05 1.7 · IC025 +0.3	Not in label — unassessed	serious PRR 3.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Death	346	5.7 5.2–6.2ROR 7.1 · χ² 1,381 / p <1e-300	5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 3.5 · 96% clinician	no trial data cached
Therapy interrupted	158	32.4 27.9–37.5ROR 36.1 · χ² 4,776 / p <1e-300	32.2 EB05 28.2 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 43.6 · 97% clinician	no trial data cached
Therapy cessation	113	31.3 26.2–37.3ROR 33.7 · χ² 3,280 / p <1e-300	31.0 EB05 26.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 42.2	no trial data cached
Hospitalisation	95	8.8 7.2–10.7ROR 9.3 · χ² 653 / p 2e-144	8.6 EB05 7.2 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4	no trial data cached
Surgery	72	17.5 14.0–22.0ROR 18.4 · χ² 1,108 / p 3e-243	17.4 EB05 14.3 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 12.2 · 96% clinician	no trial data cached
Intentional dose omission	18	9.3 5.9–14.7ROR 9.4 · χ² 125 / p 3e-29	8.1 EB05 5.2 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 11.7	no trial data cached
Spinal operation	16	18.7 11.5–30.4ROR 18.9 · χ² 250 / p 1e-56	18.1 EB05 11.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 11.7	no trial data cached
Knee arthroplasty	15	10.2 6.1–16.8ROR 10.2 · χ² 115 / p 4e-27	8.8 EB05 5.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Pregnancy	9	6.3 3.3–12.0ROR 6.3 · χ² 35 / p 2e-9	4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.0	no trial data cached
Knee operation	9	13.1 6.8–25.1ROR 13.2 · χ² 89 / p 2e-21	10.8 EB05 5.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9	no trial data cached
Hip arthroplasty	7	6.5 3.1–13.6ROR 6.5 · χ² 27 / p 9e-8	4.8 EB05 2.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Dialysis	5	5.0 2.1–11.9ROR 5.0 · χ² 12 / p 3e-4	3.6 EB05 1.7 · IC025 +0.3	Not in label — unassessed	serious PRR 3.2	no trial data cached
Hospice care	4	5.7 2.2–15.2ROR 5.7 · χ² 11 / p 4e-4	3.8 EB05 1.6 · IC025 +0.1	Not in label — unassessed	serious PRR 5.1	no trial data cached
Wrong technique in device usage process	3	0.9 0.3–2.9ROR 0.9 · χ² 0 / p 0.443	1.0 EB05 0.4 · IC025 -2.2 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial data cached
Abortion induced	3	4.5 1.4–13.9ROR 4.5 · χ² 5 / p 0.013	3.0 EB05 1.2 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 1.9	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Midazolam and 10?

In FDA FAERS, the most frequently co-reported reaction terms for Midazolam and 10 are knee arthroplasty, pregnancy, hip arthroplasty, dialysis, hospice care, abortion induced. 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 Midazolam and 10 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 patients for whom alternative treatment options are inadequate.

Do FAERS signals prove that Midazolam and 10 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 2b29422e-54d5-4a49-8522-e9cf752368c3, effective 20230119; matched on openfda.generic_name.exact:"MIDAZOLAM")
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, 15 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.