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Molecule

Tinidazole

Nitroimidazole Antimicrobial
Available on requestOrphanAntibiotics
Presentations
6
Brands
2
Manufacturers
2
Available from stock
0

Tinidazole is a nitroimidazole antimicrobial indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Tinidazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Nitroimidazole Antimicrobial
ATC classification
J01XD02 Tinidazole · Antibiotics for systemic use, subgroup J01X, subgroup J01XDP01AB02 Tinidazole · Antiprotozoals, including antimalarials, subgroup P01A, subgroup P01AB
US FDA first approval
17 May 2004
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 033KF7V46HRxCUI 10612CAS 19387-91-8DrugBank DB00911Q1321320

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection.

Source: US FDA prescribing information

Dosing overview

2 DOSAGE AND ADMINISTRATION Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time. Giardiasis: Adults: a single 2 g dose taken with food. Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food. Amebiasis, Intestinal: Adults: 2 g per day for 3 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3 days with food. Amebic liver abscess: Adults: 2 g per day for 3-5 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3-5 days with food. Bacterial vaginosis: Adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food

Source: US FDA prescribing information

Contraindications

The use of tinidazole is contraindicated: In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome. In patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to tinidazole, in patients with Cockayne syndrome Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives. Patients with Cockayne syndrome

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (potential risk for carcinogenicity warning: potential risk for carcinogenicity): Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of TINIDAZOLE to approved indications only. Avoid chronic use. Avoid chronic use. Seizures and neuropathy have been reported. Discontinue tinidazole if abnormal neurologic signs develop. Vaginal candidiasis may develop with tinidazole and require treatment with an antifungal agent. Use tinidazole with caution in patients with blood dyscrasias. Tinidazole may produce transient leukopenia and neutropenia

Source: US FDA prescribing information

Side effects

Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation

Source: US FDA prescribing information

Interactions

Although not specifically identified in studies with tinidazole, the following drug interactions were reported for metronidazole, a chemically-related nitroimidazole. Therefore, these drug interactions may occur with tinidazole. The following drug interactions were reported for metronidazole, a chemically-related nitroimidazole and may therefore occur with tinidazole: Warfarin and other oral coumarin anticoagulants: Anticoagulant dosage may need adjustment during and up to 8 days after tinidazole therapy. Alcohol-containing beverages/preparations: Avoid during and up to 3 days after tinidazole therapy. Lithium: Monitor serum lithium concentrations. Cyclosporine, tacrolimus: Monitor for toxicities of these immunosuppressive drugs. Fluorouracil: Monitor for fluorouracil-associated toxicities. Phenytoin, fosphenytoin: Adjustment of anticonvulsant and/or tinidazole dose(s) may be needed.

Source: US FDA prescribing information

Storage

Store at controlled room temperature 20-25° C (68-77° F), excursions permitted to 15-30° C (59-86° F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

6 presentations of Tinidazole, sorted by availability.

MedicineManufacturerRegisterAvailability
Tinidazole 500 mg tabletOralGeneric name—US FDAAvailable on request
Tinidazole 250 mg tabletOralGeneric name—US FDAAvailable on request
Tindazole 500 mg tabletOralRising Pharma HoldingsUS FDAAvailable on request
Tindamax 500 mg tabletOralMission PharmacalUS FDAAvailable on request
Tindamax 250 mg tabletOralMission PharmacalUS FDAAvailable on request
Tindazole 250 mg tabletOralRising Pharma HoldingsUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 17 May 2004Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Tinidazole in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Tinidazole available for export from India?

Yes, on request. MedsAcross lists 6 presentations of Tinidazole and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Tinidazole have?

The catalogue lists 2 brand names for Tinidazole, including Tindamax, Tindazole.

Is Tinidazole approved by the US FDA?

Yes. The US FDA first approved Tinidazole on 17 May 2004, according to Drugs@FDA.

Does Tinidazole need cold chain shipping?

No listed presentation of Tinidazole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Tinidazole in?

Tinidazole is classified under ATC code J01XD02 (Tinidazole).

References

  1. Tinidazole prescribing information (BioComp Pharma). U.S. National Library of Medicine, DailyMed. Retrieved 1 December 2025

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