Meprobamate side effects: what 1,268 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,268 reports · 94% serious · 838 with death outcome · 62% female
Used for
Meprobamate tablets 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 do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies.
What it is
DESCRIPTION Meprobamate is a white powder with a characteristic odor and a bitter taste. It is slightly soluble in water, freely soluble in acetone and alcohol, and sparingly soluble in ether.
Boxed warning
None in the current label
Causality screen of the 37 strongest signals
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.
- 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. 18 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 |
|---|---|---|---|---|---|---|
| Drug toxicity | 98 | 118.2 97.6–143.0ROR 128.0 · χ² 11,193 / p <1e-300 | 114.7 EB05 96.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 74.2 | no trial data cached |
| Accidental overdose | 105 | 47.6 39.7–57.2ROR 51.9 · χ² 4,742 / p <1e-300 | 47.1 EB05 40.0 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 48.0 | no trial data cached |
| Respiratory arrest | 79 | 47.1 38.0–58.3ROR 50.2 · χ² 3,513 / p <1e-300 | 46.5 EB05 38.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.6 · 96% clinician | no trial data cached |
| Pulmonary congestion | 35 | 43.8 31.6–60.8ROR 45.0 · χ² 1,419 / p <1e-300 | 42.8 EB05 32.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 31.3 · 90% clinician | no trial data cached |
| Hand deformity | 33 | 41.8 29.8–58.6ROR 42.9 · χ² 1,272 / p 9e-279 | 40.8 EB05 30.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · ♀ 100% (drug 62%) | no trial data cached |
| Sciatica | 38 | 39.7 29.0–54.3ROR 40.9 · χ² 1,393 / p <1e-300 | 38.9 EB05 29.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 · ♀ 100% (drug 62%) | no trial data cached |
| Impaired driving ability | 26 | 37.9 25.9–55.4ROR 38.6 · χ² 895 / p 6e-197 | 36.8 EB05 26.4 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 29.8 | no trial data cached |
| Toxicity to various agents | 323 | 31.9 29.0–35.0ROR 42.4 · χ² 9,691 / p <1e-300 | 31.8 EB05 29.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 | no trial data cached |
| Drug abuse | 160 | 31.7 27.4–36.6ROR 36.1 · χ² 4,734 / p <1e-300 | 31.5 EB05 27.6 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 19.5 | no trial data cached |
| Poisoning | 23 | 30.2 20.1–45.3ROR 30.7 · χ² 620 / p 5e-137 | 29.5 EB05 20.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · 100% clinician | no trial data cached |
| Arteriosclerosis | 15 | 26.4 15.9–43.6ROR 26.7 · χ² 341 / p 2e-76 | 25.5 EB05 16.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 | no trial data cached |
| Completed suicide (death by suicide) | 127 | 25.0 21.2–29.5ROR 27.7 · χ² 2,909 / p <1e-300 | 24.9 EB05 21.5 · IC025 +4.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 15.2 · 91% clinician | no trial data cached |
| Deformity | 14 | 24.7 14.7–41.7ROR 25.0 · χ² 295 / p 2e-66 | 23.9 EB05 15.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 | no trial data cached |
| Aspiration | 16 | 24.5 15.0–39.8ROR 24.8 · χ² 337 / p 2e-75 | 23.8 EB05 15.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 | no trial data cached |
| Unresponsive to stimuli | 32 | 20.6 14.6–29.0ROR 21.1 · χ² 577 / p 8e-128 | 20.3 EB05 15.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 88% (drug 62%) · 93% clinician | no trial data cached |
| Pulmonary oedema | 54 | 19.9 15.4–25.9ROR 20.8 · χ² 954 / p 1e-209 | 19.8 EB05 15.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 93% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 95 | 19.0 15.6–23.0ROR 20.4 · χ² 1,605 / p <1e-300 | 18.9 EB05 15.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 99% clinician | no trial data cached |
| Cardio-respiratory arrest | 46 | 18.1 13.6–24.0ROR 18.7 · χ² 726 / p 3e-160 | 17.9 EB05 14.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · 100% clinician | no trial data cached |
| Cardiomegaly | 13 | 17.3 10.1–29.8ROR 17.5 · χ² 184 / p 3e-42 | 16.4 EB05 9.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Contraindicated product administered | 30 | 16.5 11.6–23.4ROR 16.8 · χ² 421 / p 9e-94 | 16.2 EB05 11.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 · ♀ 100% (drug 62%) | no trial data cached |
| Cardiogenic shock | 14 | 16.2 9.6–27.3ROR 16.4 · χ² 185 / p 2e-42 | 15.4 EB05 9.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Dermatitis allergic | 12 | 15.9 9.1–28.0ROR 16.1 · χ² 153 / p 2e-35 | 14.8 EB05 8.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.5 | no trial data cached |
| Respiratory depression | 10 | 13.5 7.3–25.0ROR 13.6 · χ² 104 / p 1e-24 | 11.6 EB05 5.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Brain oedema | 10 | 13.1 7.1–24.3ROR 13.2 · χ² 100 / p 8e-24 | 11.2 EB05 5.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Drug level increased | 12 | 12.0 6.8–21.1ROR 12.1 · χ² 110 / p 5e-26 | 10.3 EB05 5.6 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 | no trial data cached |
| Road traffic accident | 27 | 10.7 7.3–15.5ROR 10.9 · χ² 227 / p 1e-51 | 10.0 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Coma | 29 | 10.1 7.0–14.4ROR 10.3 · χ² 228 / p 8e-52 | 9.4 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 96% clinician | no trial data cached |
| Overdose | 121 | 9.2 7.8–10.9ROR 10.1 · χ² 890 / p 8e-196 | 9.1 EB05 7.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Injection site reaction | 33 | 8.0 5.7–11.1ROR 8.1 · χ² 194 / p 2e-44 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 100% (drug 62%) | no trial data cached |
| Breast cancer female | 12 | 7.4 4.2–13.0ROR 7.4 · χ² 60 / p 5e-15 | 6.0 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Suicide attempt | 26 | 7.1 4.8–10.4ROR 7.2 · χ² 130 / p 2e-30 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Intentional overdose | 23 | 6.0 4.0–8.9ROR 6.1 · χ² 90 / p 9e-22 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · 90% clinician | no trial data cached |
| Wrong technique in drug usage process | 13 | 5.8 3.4–10.0ROR 5.9 · χ² 47 / p 3e-12 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.0 | no trial data cached |
| Femur fracture | 10 | 5.3 2.9–9.9ROR 5.4 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Drug exposure during pregnancy | 11 | 5.3 2.9–9.5ROR 5.3 · χ² 34 / p 3e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Rheumatoid arthritis | 31 | 4.5 3.2–6.4ROR 4.6 · χ² 82 / p 6e-20 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · ♀ 100% (drug 62%) | no trial data cached |
| Drug dependence | 38 | 3.9 2.8–5.3ROR 4.0 · χ² 78 / p 4e-19 | 3.7 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 323 | 31.9 29.0–35.0ROR 42.4 · χ² 9,691 / p <1e-300 | 31.8 EB05 29.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 | no trial data cached |
| Drug abuse | 160 | 31.7 27.4–36.6ROR 36.1 · χ² 4,734 / p <1e-300 | 31.5 EB05 27.6 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 19.5 | no trial data cached |
| Completed suicide (death by suicide) | 127 | 25.0 21.2–29.5ROR 27.7 · χ² 2,909 / p <1e-300 | 24.9 EB05 21.5 · IC025 +4.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 15.2 · 91% clinician | no trial data cached |
| Overdose | 121 | 9.2 7.8–10.9ROR 10.1 · χ² 890 / p 8e-196 | 9.1 EB05 7.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Accidental overdose | 105 | 47.6 39.7–57.2ROR 51.9 · χ² 4,742 / p <1e-300 | 47.1 EB05 40.0 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 48.0 | no trial data cached |
| Drug toxicity | 98 | 118.2 97.6–143.0ROR 128.0 · χ² 11,193 / p <1e-300 | 114.7 EB05 96.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 74.2 | no trial data cached |
| Cardiac arrest (heart stopping) | 95 | 19.0 15.6–23.0ROR 20.4 · χ² 1,605 / p <1e-300 | 18.9 EB05 15.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 99% clinician | no trial data cached |
| Respiratory arrest | 79 | 47.1 38.0–58.3ROR 50.2 · χ² 3,513 / p <1e-300 | 46.5 EB05 38.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.6 · 96% clinician | no trial data cached |
| Pulmonary oedema | 54 | 19.9 15.4–25.9ROR 20.8 · χ² 954 / p 1e-209 | 19.8 EB05 15.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 93% clinician | no trial data cached |
| Cardio-respiratory arrest | 46 | 18.1 13.6–24.0ROR 18.7 · χ² 726 / p 3e-160 | 17.9 EB05 14.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · 100% clinician | no trial data cached |
| Drug dependence | 38 | 3.9 2.8–5.3ROR 4.0 · χ² 78 / p 4e-19 | 3.7 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Sciatica | 38 | 39.7 29.0–54.3ROR 40.9 · χ² 1,393 / p <1e-300 | 38.9 EB05 29.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 · ♀ 100% (drug 62%) | no trial data cached |
| Pulmonary congestion | 35 | 43.8 31.6–60.8ROR 45.0 · χ² 1,419 / p <1e-300 | 42.8 EB05 32.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 31.3 · 90% clinician | no trial data cached |
| Injection site reaction | 33 | 8.0 5.7–11.1ROR 8.1 · χ² 194 / p 2e-44 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 100% (drug 62%) | no trial data cached |
| Hand deformity | 33 | 41.8 29.8–58.6ROR 42.9 · χ² 1,272 / p 9e-279 | 40.8 EB05 30.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · ♀ 100% (drug 62%) | no trial data cached |
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.
- Drug toxicity — n=98, PRR 118.2
- Respiratory arrest — n=79, PRR 47.1
- Pulmonary congestion — n=35, PRR 43.8
- Hand deformity — n=33, PRR 41.8
- Sciatica — n=38, PRR 39.7
- Toxicity to various agents — n=323, PRR 31.9
- Poisoning — n=23, PRR 30.2
- Unresponsive to stimuli — n=32, PRR 20.6
- Pulmonary oedema — n=54, PRR 19.9
- Cardiac arrest — n=95, PRR 19.0
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 Meprobamate?
In FDA FAERS, the most frequently co-reported reaction terms for Meprobamate are toxicity to various agents, drug toxicity, cardiac arrest, respiratory arrest, pulmonary oedema, cardio-respiratory 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 Meprobamate have an FDA boxed warning?
No. The FDA label retrieved for Meprobamate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Meprobamate 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 3b255bcd-0218-44f8-830b-971f5ec45276, effective 20211001; matched on
openfda.generic_name.exact:"MEPROBAMATE") - 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, 55 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.