Drug · FAERS side-effect profile with label screen

Trimethobenzamide side effects: what 1,415 FDA adverse event reports show

Trimethobenzamide Hydrochloride · 46 reaction terms · 826 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Trimethobenzamide Hydrochloride (Trimethobenzamide Hydrochloride)

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

Who reports

1,415 reports · 35% serious · 61 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Trimethobenzamide hydrochloride capsules is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. Limitation of Use: Trimethobenzamide hydrochloride capsules is not recommended for us.

FDA label, Indications and Usage

Boxed warning

None in the current 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 17 strongest signals

Labeled (related wording) 1Likely indication confounding 1Lab value / disease marker 2Not in label — unassessed 13

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.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 29 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
Blood pressure decreased	101	22.6 18.7–27.3ROR 24.3 · χ² 2,069 / p <1e-300	22.5 EB05 19.1 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious PRR 5.6 · ♀ 38% (drug 58%) · 89% consumer	no trial data cached
Dyskinesia (involuntary movements)	52	19.0 14.6–24.9ROR 19.7 · χ² 871 / p 9e-192	18.9 EB05 14.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.0 · 85% consumer	no trial data cached
Somnolence (drowsiness)	228	16.8 14.9–19.0ROR 19.9 · χ² 3,409 / p <1e-300	16.8 EB05 15.0 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.6 · 93% consumer	no trial data cached
Blood pressure fluctuation	25	15.4 10.5–22.7ROR 15.7 · χ² 323 / p 2e-72	15.0 EB05 10.4 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 3.9 · 100% consumer	no trial data cached
Cold sweat	18	15.1 9.6–24.0ROR 15.3 · χ² 224 / p 7e-51	14.5 EB05 9.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Malnutrition	10	13.4 7.2–24.8ROR 13.4 · χ² 102 / p 2e-24	11.4 EB05 5.7 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 22.8	no trial data cached
Orthostatic hypotension (dizziness on standing)	14	11.9 7.1–20.1ROR 12.0 · χ² 129 / p 3e-30	10.5 EB05 6.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.2	no trial data cached
Retching	15	10.5 6.3–17.3ROR 10.6 · χ² 119 / p 5e-28	9.1 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
Pallor	14	7.6 4.5–12.8ROR 7.7 · χ² 74 / p 4e-18	6.3 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Rhinorrhoea (runny nose)	29	6.7 4.7–9.6ROR 6.8 · χ² 135 / p 2e-31	6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 1.8 · ♀ 31% (drug 58%) · 88% consumer	no trial data cached
Heart rate irregular	10	6.5 3.5–12.1ROR 6.6 · χ² 41 / p 6e-11	5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hyperhidrosis (excessive sweating)	55	6.3 4.9–8.2ROR 6.5 · χ² 243 / p 5e-55	6.0 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.9 · ♀ 35% (drug 58%) · 84% consumer	no trial data cached
Hallucination (hallucinations)	29	5.7 4.0–8.2ROR 5.8 · χ² 109 / p 8e-26	5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.5 · 75% consumer	no trial data cached
Tardive dyskinesia (persistent involuntary movements)	11	5.7 3.2–10.3ROR 5.8 · χ² 38 / p 3e-10	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Nervousness	17	4.8 3.0–7.7ROR 4.8 · χ² 48 / p 3e-12	4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 6.7	no trial data cached
Injection site pruritus	14	3.1 1.9–5.3ROR 3.1 · χ² 18 / p 1e-5	2.9 EB05 1.9 · IC025 +0.6	Not in label — unassessed	serious PRR 5.2	no trial data cached
Injection site bruising	16	3.0 1.8–4.9ROR 3.0 · χ² 20 / p 5e-6	2.8 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 3.8	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
Somnolence (drowsiness)	228	16.8 14.9–19.0ROR 19.9 · χ² 3,409 / p <1e-300	16.8 EB05 15.0 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.6 · 93% consumer	no trial data cached
Blood pressure decreased	101	22.6 18.7–27.3ROR 24.3 · χ² 2,069 / p <1e-300	22.5 EB05 19.1 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious PRR 5.6 · ♀ 38% (drug 58%) · 89% consumer	no trial data cached
Hyperhidrosis (excessive sweating)	55	6.3 4.9–8.2ROR 6.5 · χ² 243 / p 5e-55	6.0 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.9 · ♀ 35% (drug 58%) · 84% consumer	no trial data cached
Dyskinesia (involuntary movements)	52	19.0 14.6–24.9ROR 19.7 · χ² 871 / p 9e-192	18.9 EB05 14.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.0 · 85% consumer	no trial data cached
Hallucination (hallucinations)	29	5.7 4.0–8.2ROR 5.8 · χ² 109 / p 8e-26	5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.5 · 75% consumer	no trial data cached
Rhinorrhoea (runny nose)	29	6.7 4.7–9.6ROR 6.8 · χ² 135 / p 2e-31	6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 1.8 · ♀ 31% (drug 58%) · 88% consumer	no trial data cached
Blood pressure fluctuation	25	15.4 10.5–22.7ROR 15.7 · χ² 323 / p 2e-72	15.0 EB05 10.4 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 3.9 · 100% consumer	no trial data cached
Cold sweat	18	15.1 9.6–24.0ROR 15.3 · χ² 224 / p 7e-51	14.5 EB05 9.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Nervousness	17	4.8 3.0–7.7ROR 4.8 · χ² 48 / p 3e-12	4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 6.7	no trial data cached
Injection site bruising	16	3.0 1.8–4.9ROR 3.0 · χ² 20 / p 5e-6	2.8 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 3.8	no trial data cached
Retching	15	10.5 6.3–17.3ROR 10.6 · χ² 119 / p 5e-28	9.1 EB05 5.5 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
Injection site pruritus	14	3.1 1.9–5.3ROR 3.1 · χ² 18 / p 1e-5	2.9 EB05 1.9 · IC025 +0.6	Not in label — unassessed	serious PRR 5.2	no trial data cached
Pallor	14	7.6 4.5–12.8ROR 7.7 · χ² 74 / p 4e-18	6.3 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Orthostatic hypotension (dizziness on standing)	14	11.9 7.1–20.1ROR 12.0 · χ² 129 / p 3e-30	10.5 EB05 6.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.2	no trial data cached
Tardive dyskinesia (persistent involuntary movements)	11	5.7 3.2–10.3ROR 5.8 · χ² 38 / p 3e-10	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	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.

Dyskinesia — n=52, PRR 19.0
Rhinorrhoea — n=29, PRR 6.7
Hyperhidrosis — n=55, PRR 6.3
Hallucination — n=29, PRR 5.7

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 Trimethobenzamide?

In FDA FAERS, the most frequently co-reported reaction terms for Trimethobenzamide are somnolence, blood pressure decreased, hyperhidrosis, dyskinesia, hallucination, rhinorrhoea. 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 Trimethobenzamide have an FDA boxed warning?

No. The FDA label retrieved for Trimethobenzamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Trimethobenzamide 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 00ba5395-1455-4ea9-9278-e3749979526c, effective 20240404; matched on openfda.generic_name.exact:"TRIMETHOBENZAMIDE HYDROCHLORIDE")
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, 46 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.