Drug · FAERS side-effect profile with label screen
Midazolam side effects: what 25,056 FDA adverse event reports show
Brand names
Nayzilam
openFDA label
Who reports
25,056 reports · 93% serious · 4,706 with death outcome · 48% 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 40 strongest signals
Labeled (related wording) 3Likely indication confounding 3Reporting / coding artifact 1Lab value / disease marker 6Not in label — unassessed 27
What the badges mean
- 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). 1,148 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 129 | 615.0 489.8–772.2ROR 618.2 · calibrated p 1e-14 ✓ | 335.2 EB05 289.4 · IC025 +6.9 3/3 methods agree vs other Benzodiazepines: PRR 159.5 (132.6–191.9) | Not in label — unassessed | serious n=129 · ♀ 100% (drug 48%) | not reported in cached trials |
| Mitochondrial dna mutation | 36 | 605.9 394.1–931.6ROR 606.8 · calibrated p 9e-14 ✓ | 294.9 EB05 222.6 · IC025 +5.4 3/3 methods agree vs other Benzodiazepines: PRR 224.4 (151.6–332.2) | Not in label — unassessed | serious n=36 · ♀ 100% (drug 48%) | not reported in cached trials |
| New onset refractory status epilepticus | 35 | 412.4 274.9–618.6ROR 413.0 · calibrated p 3e-12 ✓ | 239.4 EB05 179.9 · IC025 +5.3 3/3 methods agree vs other Benzodiazepines: PRR 253.4 (168.7–380.6) | Likely indication confounding shares a disease stem with the indications wording | serious n=35 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Trigemino-cardiac reflex | 27 | 412.4 259.9–654.4ROR 412.8 · calibrated p 5e-12 ✓ | 230.5 EB05 166.3 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: PRR 448.9 (264.9–760.7) | Not in label — unassessed | serious n=27 · ♀ 0% (drug 48%) · 100% clinician | not reported in cached trials |
| Chest wall rigidity | 18 | 322.7 187.2–556.5ROR 323.0 · calibrated p 1e-10 ✓ | 186.6 EB05 124.9 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 404.0 (214.8–759.9) | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Negative pressure pulmonary oedema | 22 | 259.2 160.6–418.4ROR 259.4 · calibrated p 4e-10 ✓ | 168.8 EB05 117.5 · IC025 +4.5 3/3 methods agree vs other Benzodiazepines: PRR 448.9 (249.9–806.2) | Labeled (related wording) related wording | serious n=22 · 100% clinician | not reported in cached trials |
| Propofol infusion syndrome | 150 | 226.2 188.9–270.8ROR 227.5 · calibrated p 2e-10 ✓ | 173.8 EB05 151.7 · IC025 +6.5 3/3 methods agree vs other Benzodiazepines: PRR 331.7 (272.7–403.4) | Not in label — unassessed | serious n=150 · 95% clinician | not reported in cached trials |
| Csf oligoclonal band present | 24 | 204.1 130.6–319.0ROR 204.3 · calibrated p 2e-9 ✓ | 145.1 EB05 102.6 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: PRR 229.2 (141.1–372.4) | Lab value / disease marker | serious n=24 · ♀ 100% (drug 48%) | not reported in cached trials |
| Intra-abdominal pressure increased | 26 | 166.2 109.1–253.3ROR 166.4 · calibrated p 8e-9 ✓ | 125.9 EB05 90.3 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: PRR 333.4 (202.0–550.5) | Lab value / disease marker | serious n=26 · ♀ 100% (drug 48%) | not reported in cached trials |
| Burkholderia test positive | 20 | 160.1 99.2–258.5ROR 160.3 · calibrated p 2e-8 ✓ | 119.3 EB05 81.5 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 390.3 (215.5–707.0) | Lab value / disease marker | serious n=20 · 100% clinician | not reported in cached trials |
| Anal prolapse | 19 | 158.3 96.9–258.6ROR 158.4 · calibrated p 2e-8 ✓ | 117.5 EB05 79.5 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 448.9 (238.8–843.6) | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Intensive care unit acquired weakness | 54 | 137.9 103.4–183.9ROR 138.2 · calibrated p 2e-8 ✓ | 113.6 EB05 90.4 · IC025 +5.4 3/3 methods agree vs other Benzodiazepines: PRR 288.6 (206.9–402.4) | Not in label — unassessed | serious n=54 · ♀ 27% (drug 48%) · 100% clinician | not reported in cached trials |
| Airway peak pressure increased | 18 | 112.5 68.7–184.0ROR 112.5 · calibrated p 2e-7 ✓ | 89.9 EB05 60.2 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: PRR 351.3 (190.5–647.6) | Lab value / disease marker | serious n=18 | not reported in cached trials |
| Myoglobin urine present | 29 | 109.7 74.5–161.6ROR 109.8 · calibrated p 2e-7 ✓ | 91.3 EB05 66.7 · IC025 +4.6 3/3 methods agree vs other Benzodiazepines: PRR 103.3 (69.5–153.5) | Lab value / disease marker | serious n=28 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Unwanted awareness during anaesthesia | 37 | 106.3 75.5–149.7ROR 106.5 · calibrated p 2e-7 ✓ | 90.0 EB05 68.2 · IC025 +4.8 3/3 methods agree vs other Benzodiazepines: PRR 425.9 (273.5–663.1) | Not in label — unassessed | serious n=34 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Myocardial depression | 26 | 101.6 67.6–152.7ROR 101.7 · calibrated p 3e-7 ✓ | 85.1 EB05 61.0 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: PRR 176.8 (113.1–276.5) | Not in label — unassessed | serious n=26 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Anaesthetic complication neurological | 94 | 96.2 77.7–119.1ROR 96.5 · calibrated p 2e-7 ✓ | 84.8 EB05 71.4 · IC025 +5.6 3/3 methods agree vs other Benzodiazepines: PRR 444.1 (337.7–584.1) | Not in label — unassessed | serious n=94 · 100% clinician | not reported in cached trials |
| Necrosis ischaemic | 45 | 90.1 66.2–122.5ROR 90.2 · calibrated p 4e-7 ✓ | 78.7 EB05 61.2 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: PRR 336.7 (230.6–491.5) | Not in label — unassessed | serious n=45 | not reported in cached trials |
| Neuromuscular block prolonged | 36 | 89.7 63.6–126.5ROR 89.8 · calibrated p 5e-7 ✓ | 77.8 EB05 58.7 · IC025 +4.7 3/3 methods agree vs other Benzodiazepines: PRR 384.7 (248.3–596.3) | Not in label — unassessed | serious n=34 · 100% clinician | not reported in cached trials |
| Multiple-drug resistance | 292 | 87.2 77.3–98.3ROR 88.2 · calibrated p 3e-7 ✓ | 78.6 EB05 71.3 · IC025 +5.9 3/3 methods agree vs other Benzodiazepines: PRR 80.6 (73.2–88.7) | Reporting / coding artifact | serious n=228 · 98% clinician | not reported in cached trials |
| Hepatic ischaemia | 29 | 85.7 58.5–125.6ROR 85.8 · calibrated p 9e-7 ✓ | 74.1 EB05 54.1 · IC025 +4.5 3/3 methods agree vs other Benzodiazepines: PRR 406.8 (247.7–668.2) | Not in label — unassessed | serious n=29 · ♀ 100% (drug 48%) · 100% clinician | not reported in cached trials |
| Postoperative delirium | 17 | 83.0 50.4–136.6ROR 83.0 · calibrated p 2e-6 ✓ | 69.8 EB05 46.2 · IC025 +3.8 3/3 methods agree vs other Benzodiazepines: PRR 401.6 (209.8–769.0) | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Hyperthermia malignant | 131 | 81.4 68.1–97.4ROR 81.8 · calibrated p 6e-7 ✓ | 73.4 EB05 63.5 · IC025 +5.6 3/3 methods agree vs other Benzodiazepines: PRR 426.1 (340.0–534.0) | Not in label — unassessed | serious n=128 · ♀ 18% (drug 48%) · 97% clinician | not reported in cached trials |
| Neuromuscular blockade | 20 | 80.5 50.8–127.3ROR 80.5 · calibrated p 2e-6 ✓ | 68.8 EB05 47.0 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: PRR 427.5 (232.9–784.6) | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Vagal nerve stimulator implantation | 25 | 76.9 51.1–115.9ROR 77.0 · calibrated p 2e-6 ✓ | 67.0 EB05 47.7 · IC025 +4.2 3/3 methods agree vs other Benzodiazepines: PRR 215.8 (134.8–345.4) | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Female genital tract fistula | 140 | 74.1 62.3–88.0ROR 74.5 · calibrated p 1e-6 ✓ | 67.4 EB05 58.6 · IC025 +5.5 3/3 methods agree vs other Benzodiazepines: PRR 155.9 (130.9–185.8) | Not in label — unassessed | serious n=140 · ♀ 100% (drug 48%) | NCT01296555: 1/20 (5.0%) on Midazolam (serious AE) |
| Airway complication of anaesthesia | 21 | 73.7 47.2–115.2ROR 73.8 · calibrated p 3e-6 ✓ | 64.0 EB05 44.1 · IC025 +4.0 3/3 methods agree vs other Benzodiazepines: PRR 409.8 (228.0–736.6) | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Seizure cluster | 65 | 73.5 57.1–94.7ROR 73.7 · calibrated p 1e-6 ✓ | 66.3 EB05 53.9 · IC025 +5.1 3/3 methods agree vs other Benzodiazepines: PRR 151.2 (115.4–198.0) | Likely indication confounding term in indications; also in warnings | serious n=65 | not reported in cached trials |
| Carcinoid crisis | 17 | 67.4 41.1–110.5ROR 67.5 · calibrated p 7e-6 ✓ | 58.5 EB05 38.7 · IC025 +3.7 3/3 methods agree vs other Benzodiazepines: PRR 448.9 (230.2–875.1) | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Delayed recovery from anaesthesia | 66 | 62.6 48.7–80.3ROR 62.7 · calibrated p 4e-6 ✓ | 57.3 EB05 46.6 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: PRR 361.3 (263.8–494.7) | Not in label — unassessed | serious n=65 · 100% clinician | not reported in cached trials |
| Local anaesthetic systemic toxicity | 63 | 54.1 42.0–69.8ROR 54.3 · calibrated p 1e-5 ✓ | 50.1 EB05 40.6 · IC025 +4.8 3/3 methods agree vs other Benzodiazepines: PRR 435.1 (310.5–609.6) | Not in label — unassessed | serious n=63 · 100% clinician | not reported in cached trials |
| Status epilepticus | 663 | 52.1 48.2–56.2ROR 53.4 · calibrated p 9e-6 ✓ | 49.0 EB05 45.9 · IC025 +5.4 3/3 methods agree vs other Benzodiazepines: PRR 78.9 (77.1–80.8) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 30.4 · 95% clinician | not reported in cached trials |
| Neonatal respiratory depression | 19 | 50.1 31.5–79.5ROR 50.1 · calibrated p 3e-5 ✓ | 45.3 EB05 30.6 · IC025 +3.7 3/3 methods agree vs other Benzodiazepines: PRR 448.9 (238.8–843.6) | Labeled (related wording) related wording | serious n=19 | not reported in cached trials |
| Pneumatosis | 24 | 47.7 31.6–72.0ROR 47.7 · calibrated p 4e-5 ✓ | 43.7 EB05 30.9 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: PRR 326.5 (194.1–549.0) | Not in label — unassessed | serious n=24 · ♀ 100% (drug 48%) | not reported in cached trials |
| Proctitis | 149 | 46.9 39.8–55.3ROR 47.2 · calibrated p 2e-5 ✓ | 44.2 EB05 38.6 · IC025 +5.0 3/3 methods agree vs other Benzodiazepines: PRR 158.1 (133.5–187.3) | Not in label — unassessed | serious n=149 · ♀ 100% (drug 48%) | NCT01296555: 1/10 (10.0%) on Midazolam |
| Upper airway obstruction | 47 | 46.6 34.8–62.6ROR 46.7 · calibrated p 3e-5 ✓ | 43.5 EB05 34.0 · IC025 +4.4 3/3 methods agree vs other Benzodiazepines: PRR 413.7 (280.5–610.0) | Labeled (related wording) related wording | serious n=47 · 100% clinician | not reported in cached trials |
| Radiculopathy | 136 | 45.5 38.3–54.0ROR 45.7 · calibrated p 3e-5 ✓ | 42.9 EB05 37.2 · IC025 +4.9 3/3 methods agree vs other Benzodiazepines: PRR 119.5 (100.6–141.9) | Not in label — unassessed | serious n=136 · ♀ 100% (drug 48%) | not reported in cached trials |
| Tachyphylaxis | 18 | 45.3 28.2–72.7ROR 45.3 · calibrated p 6e-5 ✓ | 41.2 EB05 27.6 · IC025 +3.5 3/3 methods agree vs other Benzodiazepines: PRR 448.9 (234.7–858.6) | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Blood gases abnormal | 27 | 44.4 30.2–65.5ROR 44.5 · calibrated p 5e-5 ✓ | 41.1 EB05 29.7 · IC025 +3.9 3/3 methods agree vs other Benzodiazepines: PRR 216.4 (137.7–340.2) | Lab value / disease marker | serious n=27 · ♀ 100% (drug 48%) | not reported in cached trials |
| Diabetes insipidus | 120 | 43.6 36.3–52.4ROR 43.8 · calibrated p 3e-5 ✓ | 41.2 EB05 35.4 · IC025 +4.8 3/3 methods agree vs other Benzodiazepines: PRR 256.5 (207.9–316.4) | Not in label — unassessed | serious n=120 · 92% 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 Midazolam 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 (2 of 40 signal terms matched).
- NCT01296555 — A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanc (N=674, PHASE1; 637 AE terms posted; arms: Phase I, Stage 1: GDC-0032 3 Milligrams ; Phase I, Stage 1: GDC-0032 5 mg QD; Phase I, Stage 1: GDC-0032 8 mg QD; Phase I, Stage 1: GDC-0032 12 mg QD)
- NCT02937506 — Patient Satisfaction With Propofol for Out Patient Colonoscopy (N=600, PHASE4; 1 AE terms posted; arms: Propofol; Fentanyl Plus Midazolam Only)
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 3,133 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.984 | 2.0 EB05 1.9 · IC025 +0.9 vs other Benzodiazepines: PRR 22.7 (22.7–22.7) | Reporting / coding artifact | serious PRR 3.2 · 91% clinician | not reported in cached trials |
| Off label use (used outside approved label) | 2,412 | 2.3 2.2–2.4ROR 2.5 · calibrated p 0.826 | 2.3 EB05 2.2 · IC025 +1.2 3/3 methods agree vs other Benzodiazepines: PRR 26.2 (26.2–26.2) | Reporting / coding artifact | serious PRR 2.4 | not reported in cached trials |
| Seizure | 1,544 | 11.4 10.9–12.0ROR 12.1 · calibrated p 0.016 ✓ | 11.2 EB05 10.8 · IC025 +3.4 3/3 methods agree vs other Benzodiazepines: PRR 36.2 (36.2–36.2) | Likely indication confounding term in indications; also in warnings | serious PRR 7.1 | NCT01296555: 1/70 (1.4%) on Midazolam (serious AE) |
| Hypotension (low blood pressure) | 1,354 | 5.7 5.4–6.0ROR 6.0 · calibrated p 0.153 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree vs other Benzodiazepines: PRR 30.4 (30.4–30.4) | Labeled adverse reaction exact term | serious PRR 4.0 · 93% clinician | NCT01296555: 1/21 (4.8%) on Midazolam (serious AE) |
| Drug interaction | 1,139 | 6.0 5.7–6.4ROR 6.3 · calibrated p 0.133 | 6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree vs other Benzodiazepines: PRR 19.6 (19.6–19.6) | Reporting / coding artifact | serious PRR 4.0 · 94% clinician | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 877 | 4.8 4.5–5.2ROR 5.0 · calibrated p 0.237 | 4.8 EB05 4.5 · IC025 +2.2 3/3 methods agree vs other Benzodiazepines: PRR 27.7 (27.7–27.7) | Not in label — unassessed | serious PRR 3.0 · 95% clinician | NCT01296555: 1/21 (4.8%) on Midazolam (serious AE) |
| Toxicity to various agents | 866 | 4.3 4.1–4.6ROR 4.5 · calibrated p 0.303 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Benzodiazepines: PRR 8.9 (8.9–8.9) | Not in label — unassessed | serious PRR 2.8 · 94% clinician | not reported in cached trials |
| Pyrexia (fever) | 846 | 2.0 1.9–2.2ROR 2.1 · calibrated p 0.989 | 2.0 EB05 1.9 · IC025 +0.9 vs other Benzodiazepines: PRR 17.0 (17.0–17.0) | Not in label — unassessed | serious PRR 1.6 | NCT01296555: 1/20 (5.0%) on Midazolam (serious AE) |
| Cardiac arrest (heart stopping) | 840 | 8.6 8.0–9.2ROR 8.8 · calibrated p 0.049 ✓ | 8.5 EB05 8.0 · IC025 +3.0 3/3 methods agree vs other Benzodiazepines: PRR 29.3 (29.3–29.3) | Labeled adverse reaction exact term | serious PRR 5.3 | NCT01296555: 1/20 (5.0%) on Midazolam (serious AE) |
| Death | 708 | 0.7 0.6–0.7ROR 0.7 · calibrated p 0.120 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC vs other Benzodiazepines: PRR 10.9 (10.9–10.9) | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.4 | NCT01296555: 1/21 (4.8%) on Midazolam (serious AE) |
| Status epilepticus | 663 | 52.1 48.2–56.2ROR 53.4 · calibrated p 9e-6 ✓ | 49.0 EB05 45.9 · IC025 +5.4 3/3 methods agree vs other Benzodiazepines: PRR 78.9 (77.1–80.8) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 30.4 · 95% clinician | not reported in cached trials |
| Condition aggravated | 626 | 1.7 1.6–1.9ROR 1.8 · calibrated p 0.803 | 1.7 EB05 1.6 · IC025 +0.7 vs other Benzodiazepines: PRR 13.3 (13.2–13.4) | Reporting / coding artifact | serious PRR 1.6 · 91% clinician | not reported in cached trials |
| Respiratory failure | 622 | 7.2 6.6–7.8ROR 7.3 · calibrated p 0.086 | 7.1 EB05 6.6 · IC025 +2.7 3/3 methods agree vs other Benzodiazepines: PRR 41.4 (40.5–42.3) | Not in label — unassessed | serious PRR 4.4 · 91% clinician | NCT01296555: 1/35 (2.9%) on Midazolam (serious AE) |
| Tachycardia (fast heart rate) | 608 | 5.8 5.3–6.2ROR 5.9 · calibrated p 0.159 | 5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree vs other Benzodiazepines: PRR 25.3 (24.8–25.8) | Not in label — unassessed | serious PRR 3.9 | NCT01296555: 1/60 (1.7%) on Midazolam (serious AE) |
| Product use in unapproved indication | 591 | 2.0 1.9–2.2ROR 2.1 · calibrated p 0.972 | 2.0 EB05 1.9 · IC025 +0.9 vs other Benzodiazepines: PRR 22.6 (22.1–23.2) | Reporting / coding artifact | serious PRR 2.7 | 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.
- Vaginal flatulence — n=129, PRR 615.0
- Mitochondrial dna mutation — n=36, PRR 605.9
- Trigemino-cardiac reflex — n=27, PRR 412.4
- Propofol infusion syndrome — n=150, PRR 226.2
- Intensive care unit acquired weakness — n=54, PRR 137.9
- Unwanted awareness during anaesthesia — n=37, PRR 106.3
- Myocardial depression — n=26, PRR 101.6
- Anaesthetic complication neurological — n=94, PRR 96.2
- Necrosis ischaemic — n=45, PRR 90.1
- Neuromuscular block prolonged — n=36, PRR 89.7
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?
In FDA FAERS, the most frequently co-reported reaction terms for Midazolam are seizure, hypotension, acute kidney injury, toxicity to various agents, pyrexia, cardiac arrest. 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 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 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, fieldpatient.drug.openfda.generic_name.exact, 1,188 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
MIDAZOLAM, 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.