Prescription medicine
Tinidazole Brand names: Tindamax
Tinidazole (Tindamax) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $2.35 per tinidazole 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the tinidazole FDA label on DailyMed (effective December 27, 2021, Mission Pharmacal Company); the NDA 21682 record on Drugs@FDA; every tinidazole label on DailyMed.
Highlights of the record
FDA label of December 27, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POTENTIAL RISK FOR CARCINOGENICITY.
Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1 ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE ( 1 ). WARNING: POTENTIAL RISK FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1 ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Use should be limited to approved indications only.
Used for
From the label: indications and usageINDICATIONS AND USAGE 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis.
Forms and strengths
- 250 mg
- 500 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- May 17, 2004 Tindamax, Mission Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first April 30, 2012; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.35 per tablet Tinidazole 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 438 through July 30, 2026
What is tinidazole used for?
From the label: indications and usageINDICATIONS AND USAGE 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. […]
FDA pharmacologic class: Nitroimidazole Antimicrobial.
Source: FDA drug label (Tindamax), Mission Pharmacal Company, effective December 27, 2021 (SPL set a0d01539-8413-4703-94cc-d221918630a1), via openFDA; the full label on DailyMed
Is there a generic for tinidazole (Tindamax)?
The FDA approved the first generic tinidazole on April 30, 2012. 4 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tinidazole from 5 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tinidazole (Tindamax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.35 per Tinidazole 500 mg tablet, down 4% from $2.44 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tinidazole 500 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tinidazole 250 mg tablet | Generic | $1.50 per tablet | $45.10 | +8% |
| Tinidazole 500 mg tablet | Generic | $2.35 per tablet | $70.63 | -4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the tinidazole label say about other medicines?
The tinidazole label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name tinidazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cholestyramine | drug interactions | Cholestyramine: Cholestyramine was shown to decrease the oral bioavailability of metronidazole by 21%. |
| Cimetidine | drug interactions | Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, i.e., CYP3A4 inhibitors such as cimetidine and ketoconazole, may prolong the half-life and decrease the plasma clearance of tinidazole, increasing the plasma concentrations of tinidazole. |
| Cyclosporine | drug interactions | Avoid during and up to 3 days after tinidazole therapy ( 7.1 ) Lithium: Monitor serum lithium concentrations ( 7.1 ) Cyclosporine, tacrolimus: |
| Disulfiram | drug interactions | Alcohols, Disulfiram: Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during tinidazole therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. |
| Fluorouracil | drug interactions | Monitor for toxicities of these immunosuppressive drugs ( 7.1 ) Fluorouracil: Monitor for fluorouracil-associated toxicities ( 7.1 ) Phenytoin, fosphenytoin: |
| Fosphenytoin | drug interactions | Monitor for toxicities of these immunosuppressive drugs ( 7.1 ) Fluorouracil: Monitor for fluorouracil-associated toxicities ( 7.1 ) Phenytoin, fosphenytoin: |
| Ketoconazole | drug interactions | Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, i.e., CYP3A4 inhibitors such as cimetidine and ketoconazole, may prolong the half-life and decrease the plasma clearance of tinidazole, increasing the plasma concentrations of tinidazole. |
| Lithium | drug interactions | Avoid during and up to 3 days after tinidazole therapy ( 7.1 ) Lithium: Monitor serum lithium concentrations ( 7.1 ) Cyclosporine, tacrolimus: |
| Metronidazole | boxed warning | POTENTIAL RISK FOR CARCINOGENICITY Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1 ). |
| Phenobarbital | drug interactions | Effects of Other Drugs on Tinidazole CYP3A4 Inducers and Inhibitors: Simultaneous administration of tinidazole with drugs that induce liver microsomal enzymes, i.e., CYP3A4 inducers such as phenobarbital, rifampin, phenytoin, and fosphenytoin (a pro-drug of phenytoin), may accelerate the elimination of tinidazole … |
| Phenytoin | drug interactions | Monitor for toxicities of these immunosuppressive drugs ( 7.1 ) Fluorouracil: Monitor for fluorouracil-associated toxicities ( 7.1 ) Phenytoin, fosphenytoin: |
| Rifampin | drug interactions | Effects of Other Drugs on Tinidazole CYP3A4 Inducers and Inhibitors: Simultaneous administration of tinidazole with drugs that induce liver microsomal enzymes, i.e., CYP3A4 inducers such as phenobarbital, rifampin, phenytoin, and fosphenytoin (a pro-drug of phenytoin), may accelerate the elimination of tinidazole … |
| Tacrolimus | drug interactions | Avoid during and up to 3 days after tinidazole therapy ( 7.1 ) Lithium: Monitor serum lithium concentrations ( 7.1 ) Cyclosporine, tacrolimus: |
| Warfarin | drug interactions | Warfarin and other oral coumarin anticoagulants: Anticoagulant dosage may need adjustment during and up to 8 days after tinidazole therapy ( 7.1 ) Alcohol-containing beverages/preparations: |
Other labels that name tinidazole
Source: FDA drug label (Tindamax), Mission Pharmacal Company, effective December 27, 2021 (SPL set a0d01539-8413-4703-94cc-d221918630a1), via openFDA; the full label on DailyMed
What do FAERS reports show for tinidazole?
The FDA Adverse Event Reporting System holds 438 reports that list tinidazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 129 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other nitroimidazole antimicrobials
- the pharmacologic class, with prices and generics
- Tinidazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other