Trimethobenzamide

FDA label, Par Health USA, LLC, intramuscular, effective 2026-03-10. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

DOSAGE AND ADMINISTRATION (See WARNINGS and PRECAUTIONS .) Dosage should be adjusted according to the indication for therapy, severity of symptoms and the response of the patient. Geriatric Patients Dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered in elderly patients with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m 2 ).

Final dose adjustment should be based upon integration of clinical efficacy and safety considerations. (See CLINICAL PHARMACOLOGY and PRECAUTIONS ). Patients with Renal Impairment In subjects with renal impairment (creatinine clearance ≤ 70 mL/min/1.73m 2 ), dose adjustment such as reducing the total dose administered at each dosing or increasing the dosing interval should be considered. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ).

Preparation and administration

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Basis

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Such effects may be minimized by deep injection into the upper outer quadrant of the gluteal region, and by avoiding the escape of solution along the route.

Contraindications

The injectable form of Tigan ® is contraindicated in pediatric patients and in patients with known hypersensitivity to trimethobenzamide.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

D

Likelihood score D: Possible rare cause of clinically apparent liver injury.

Trimethobenzamide is an orally available, antiemetic agent used in the therapy of nausea and vomiting associated with medications and gastrointestinal, viral and other illnesses. Trimethobenzamide has not been linked convincingly to elevations in serum enzymes during therapy and despite widescale use for almost 50 years, it has rarely been linked to instances of clinically apparent liver injury with jaundice.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Trimethobenzamide (NIDDK, public domain)Chapter updated Sep 3, 2020

Pregnancy and lactation

Pregnancy

Usage in Pregnancy: Trimethobenzamide hydrochloride was studied in reproduction experiments in rats and rabbits and no teratogenicity was suggested. The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg and 100 mg/kg and increased resorptions in rabbits receiving 100 mg/kg. In each study these adverse effects were attributed to one or two dams. The relevance to humans is not known. Since there is no adequate experience in pregnant or lactating women who have received this drug, safety in pregnancy or in nursing mothers has not been established.

Breastfeeding (LactMed)

Because no information is available on the continuous use of trimethobenzamide during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. Occasional, short-term use of trimethobenzamide for the treatment of nausea and vomiting appears to be acceptable.

Alternatives LactMed suggests considering:
Source: LactMed: Trimethobenzamide (NICHD, public domain)Revised Jun 15, 2024

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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