FDA-filed SPL labeling · retrieved through openFDA

Tinidazole

Tinidazole is an antiprotozoal and antibacterial antibiotic used to treat trichomoniasis, giardiasis, amebiasis, and bacterial vaginosis.

Brand name Tindamax
Drug class Nitroimidazole Antimicrobial
Rx Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 9 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveDec 1, 2025
Clinical labels in scope 9
AvailabilityRx
Earliest approval/marketing year 2004
FDA-listed product records 27
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Tinidazole at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Tinidazole is a short-course antibiotic and antiparasitic tablet used to treat trichomoniasis, giardiasis, amebiasis, and bacterial vaginosis. Always take it with food, strictly avoid alcohol during and for 3 days after treatment, and complete only the prescribed course. If you develop neurological symptoms like numbness or seizures, or signs of a severe allergic reaction, seek medical attention right away.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Important safety warning: possible cancer risk with long-term use. In animal studies, a closely related drug called metronidazole caused cancer in mice and rats when given in large amounts over a long time. Tinidazole has not been studied the same way, but it works similarly and has a similar chemical structure. Out of caution, tinidazole should only be used for its approved infections and should never be taken for longer than your prescription requires. Avoid using it repeatedly or for extended periods.

Read the full warning on DailyMed →

📖 Tinidazole: Patient Information Guide

A plain-language walkthrough of Tinidazole — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Tinidazole is an antiprotozoal and antibacterial antibiotic tablet approved to treat the following infections:

  • Trichomoniasis — a sexually transmitted infection caused by Trichomonas vaginalis; approved for both males and females, and sexual partners must be treated simultaneously
  • Giardiasis — a parasitic intestinal infection caused by Giardia duodenalis; approved for adults and children older than 3 years
  • Intestinal amebiasis and amebic liver abscess — infections caused by Entamoeba histolytica; approved for adults and children older than 3 years (not for symptom-free cyst carriers)
  • Bacterial vaginosis — a vaginal bacterial imbalance in adult women; Tindamax is specifically approved for non-pregnant adult women; other tinidazole tablet products are approved in adult women
⚙️How it works

Tinidazole belongs to a class of drugs called nitroimidazoles. Inside certain parasites such as Trichomonas, its nitro chemical group is converted into a free radical — an unstable molecule that damages the parasite's DNA, ultimately killing it. Against bacteria involved in bacterial vaginosis, it similarly disrupts DNA. The precise way it acts against Giardia and Entamoeba species is not fully established, but the result is clearance of the infection.

Tinidazole is active against the anaerobic bacteria (those that survive without oxygen) commonly associated with bacterial vaginosis, including Bacteroides spp., Gardnerella vaginalis, and Mobiluncus spp. As with all antibiotics and antiparasitic agents, using it only when needed helps prevent the development of resistant organisms.

💊How it's taken

Tinidazole tablets are taken by mouth with food. Depending on the infection, treatment may be a single dose or a once-daily course lasting several days — your prescriber will determine the right regimen for you. For patients who cannot swallow tablets, they can be crushed and mixed in artificial cherry syrup; this mixture stays stable for up to 7 days at room temperature and should be shaken well before each use.

  • Always take with food to minimize stomach side effects
  • Avoid alcohol during treatment and for at least 3 days after the last dose
  • For trichomoniasis, sexual partners must be treated at the same time
  • Follow your prescriber's schedule exactly — do not extend treatment beyond what is prescribed
🤒Side effects — in detail

The most common side effects of tinidazole are generally mild and often go away on their own:

  • Metallic or bitter taste in the mouth
  • Nausea
  • Stomach discomfort, cramps, or indigestion
  • Vomiting
  • Loss of appetite
  • Headache
  • Dizziness
  • Weakness or fatigue
  • Darkened urine (harmless but worth noting)
  • Vaginal yeast infection (Candida vaginitis) — more likely with longer courses

Serious reactions that need immediate medical attention include seizures, numbness or tingling in the limbs (peripheral neuropathy), and severe allergic reactions such as hives, skin blistering, or throat swelling. Stop taking tinidazole and seek care right away if any of these occur.

⚠️Warnings & precautions
  • Neurological risks: Tinidazole has caused seizures and peripheral neuropathy (nerve damage with numbness or tingling in the hands or feet). Stop the medicine and call your doctor immediately if you notice any abnormal neurological symptoms.
  • Possible cancer risk with long-term use: A related drug caused cancer in animals given high doses over a long time. Tinidazole should only be used for approved indications and never taken chronically or beyond the prescribed course.
  • Vaginal yeast infection: Tinidazole can disrupt normal vaginal flora and trigger a Candida (yeast) infection. This can be treated with an antifungal if it occurs.
  • Low white blood cell count: Tinidazole can temporarily reduce white blood cells (leukopenia and neutropenia). People with pre-existing blood disorders should use it with caution and may need monitoring.
  • Cockayne syndrome: Tinidazole is contraindicated in people with Cockayne syndrome — a structurally related drug caused fatal liver failure in this group.
  • Alcohol reaction: Combining tinidazole with alcohol or alcohol-containing products can cause severe nausea, vomiting, cramping, flushing, and headache. Avoid all alcohol during treatment and for 3 full days after finishing.
🔀What it interacts with

Tinidazole can interact with several medications and substances. Let your doctor and pharmacist know about everything you take:

  • Alcohol and disulfiram: Alcohol causes a severe reaction (nausea, vomiting, flushing) — avoid completely during treatment and for 3 days after. Do not take tinidazole if you have used disulfiram (Antabuse) in the past 2 weeks.
  • Warfarin and blood thinners: Tinidazole can amplify the blood-thinning effect of warfarin; your dose may need adjustment for up to 8 days after finishing tinidazole.
  • Lithium: May raise lithium blood levels, increasing the risk of lithium toxicity; monitoring may be needed.
  • Phenytoin / fosphenytoin (seizure medications): Tinidazole can slow the clearance of phenytoin, raising its levels; dose adjustments may be required.
  • Cyclosporine and tacrolimus (immune suppressants): Tinidazole may increase their blood levels, raising the risk of toxicity.
  • Fluorouracil (cancer treatment): Tinidazole may slow its clearance, increasing fluorouracil side effects without added benefit.
  • CYP3A4 enzyme inducers (e.g., rifampin, phenobarbital): Can speed up tinidazole breakdown, reducing its effectiveness.
  • CYP3A4 enzyme inhibitors (e.g., ketoconazole, cimetidine): Can slow tinidazole breakdown, raising its levels and the risk of side effects.
  • Cholestyramine: May reduce tinidazole absorption; separate doses to minimize this effect.
  • Oxytetracycline: May reduce tinidazole's effectiveness against certain infections.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Allergy to nitroimidazoles: Do not take tinidazole if you have had a reaction to tinidazole, metronidazole, or any other nitroimidazole drug — reactions can range from hives to life-threatening skin conditions like Stevens-Johnson syndrome.
  • Cockayne syndrome: Tinidazole is contraindicated — do not use it if you have this condition.
  • Pregnancy: Available data are limited; discuss the risks and benefits with your doctor. There are risks associated with untreated infections during pregnancy as well.
  • Breastfeeding: Tinidazole passes into breast milk. Breastfeeding is not recommended during treatment or for 72 hours after the last dose. You may choose to pump and discard milk during this window.
  • Male fertility: Animal studies suggest tinidazole may affect male fertility; whether this applies to humans or is reversible is unknown — discuss with your doctor if relevant.
  • Children: Approved only for giardiasis and amebiasis in children older than 3 years. Safety for other uses in children has not been established.
  • Older adults: Use with extra care; age-related declines in liver, kidney, or heart function can affect how tinidazole is processed.
  • Liver problems: There are no formal studies in this group, but a related drug is cleared more slowly in people with liver disease. Use cautiously and follow your doctor's guidance.
  • Hemodialysis: Dialysis removes a significant portion of tinidazole from the body; if a dose is given before dialysis, an additional partial dose may be needed afterward — your doctor will advise.
  • Blood disorders: Use with caution if you have a history of blood dyscrasia (abnormal blood counts); tinidazole can temporarily lower white blood cell counts.
🚑If you take too much

There are no reported cases of tinidazole overdose in humans. There is no specific antidote, so treatment would focus on managing symptoms and providing supportive care. Gastric lavage (stomach pumping) may be considered, and hemodialysis can help remove tinidazole from the body if needed — roughly 43% of the drug present can be cleared during a 6-hour dialysis session.

📡Pharmacodynamics — effects in the body

The exact relationship between tinidazole blood levels and its clinical effect is not established. Its measurable action is the killing of susceptible protozoa and anaerobic bacteria by disrupting their DNA.

🔬Pharmacokinetics — how your body processes it

Tinidazole is rapidly and completely absorbed after oral administration, reaching peak blood levels within about 1.6 hours under fasted conditions; taking it with food delays peak levels by roughly 2 hours but does not meaningfully change the total amount absorbed. It distributes widely throughout the body — including across the blood-brain barrier and the placenta — and is also secreted into breast milk. The drug is broken down mainly by liver enzymes (CYP3A4) and has a half-life of approximately 12–14 hours, meaning it takes about that long for blood levels to fall by half; steady levels are reached after about 2.5–3 days of daily dosing. About 20–25% is excreted unchanged in the urine and approximately 12% in the stool; hemodialysis significantly increases its removal from the body.

📦How to store it

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

📄 Written from Tinidazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

140

Supplements & herbs that interact with Tinidazole

140 supplements and herbal products have documented interactions with Tinidazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 96
  • Minor · 41
Every supplement checked against Tinidazole — ranked by severity The full interaction hub: 3 major · 96 moderate · 41 minor · every one linked to its full report. Check Tinidazole against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Tinidazole — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to take this with food — does it really matter?
Yes, it really does help. Taking tinidazole with food doesn't change how much medicine gets into your system — it absorbs just as well either way — but it significantly reduces the chance of stomach upset, cramps, and nausea. Think of it as protecting your stomach, not the drug. So eat something, even if it's just a light snack, before or with each dose.
Why can't I have any alcohol while I'm taking this?
Tinidazole reacts with alcohol in a way that can make you feel really unwell — we're talking nausea, vomiting, stomach cramps, flushing, and headache. This isn't just a mild warning; the reaction can be quite severe. You need to avoid all alcoholic drinks AND any products that contain ethanol or propylene glycol (some mouthwashes, cough syrups, or sauces, for example) during your treatment AND for 3 full days after your last dose.
I was prescribed this for trichomoniasis. Why does my partner need to take it too?
Trichomoniasis is a sexually transmitted infection — it passes between partners. If only you get treated and your partner doesn't, you can very easily get re-infected after finishing your course. That's why it's important for both of you to take the medication at the same time, even if your partner has no symptoms. It's the only way to fully clear the infection between you.
What side effects should I just ride out versus call my doctor about?
Mild things like a metallic taste, some nausea, a bit of stomach upset, or feeling a little tired are common and usually settle on their own — taking it with food helps a lot. What you should NOT ignore: seizures, numbness or tingling in your hands or feet, signs of a severe allergic reaction (hives, swelling, skin blistering), or a vaginal yeast infection developing. Any of those warrant a call to your doctor right away.
Is it safe to take this if I'm pregnant or breastfeeding?
If you're pregnant, talk to your doctor before taking tinidazole — the available data in humans are limited, and your doctor will weigh the risk of the infection against any potential concerns. If you're breastfeeding, the recommendation is to hold off on nursing during treatment and for 72 hours (about 3 days) after your last dose, since tinidazole does pass into breast milk. You can pump and discard your milk during that window to keep up your supply if you wish.
Can my child take this medication?
Tinidazole is approved for children older than 3 years of age, but only for giardiasis (a parasitic gut infection) and amebiasis. It has not been established as safe or effective for other uses in children. If your child can't swallow tablets, they can be crushed and mixed into artificial cherry syrup — your pharmacist can prepare this, and it stays stable for 7 days. Always follow your child's doctor's instructions on the dose and duration.
Is Tinidazole available over the counter?
Tinidazole is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Tinidazole first available?
Tinidazole has been available in the United States since at least 2004, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Tinidazole?
Tinidazole is supplied by 13 manufacturers listed in the FDA NDC Directory, including Edenbridge Pharmaceuticals LLC., Lupin Pharmaceuticals,Inc., Rising Pharma Holdings, Inc..

💬 Answers drafted from Tinidazole’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Tinidazole comes

Tinidazole is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Tindamax
How this form is used
What it may be used for
  • Tindamax tablets are indicated for trichomoniasis, giardiasis (ages 3+), amebiasis (ages 3+), and bacterial vaginosis in non-pregnant adult women
  • Tindazole tablets are indicated for trichomoniasis, giardiasis (ages 3+), amebiasis (ages 3+), and bacterial vaginosis in adult women
  • Tinidazole tablets are indicated for trichomoniasis, giardiasis (ages 3+), amebiasis (ages 3+), and bacterial vaginosis in adult women
Important instructions
  • Take tablets with food to reduce stomach upset — food does not reduce the medicine's effectiveness
  • Tindamax tablets may be crushed and mixed into artificial cherry syrup for patients who cannot swallow tablets; shake the mixture well before each dose and use within 7 days
  • Avoid alcohol and products containing ethanol or propylene glycol during treatment and for 3 full days after the last dose
  • For trichomoniasis, sexual partners should be treated at the same time to prevent re-infection
Available strengths 2 strengths
25 FDA-listed product records

📊 Tinidazole across the U.S. market

How Tinidazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
13
Manufacturers
3
Brand names
27
FDA-listed product records
2004
First marketed

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Edenbridge Pharmaceuticals LLC.15%
Lupin Pharmaceuticals,Inc.15%
Rising Pharma Holdings, Inc.15%
Chartwell RX, LLC7%
Mission Pharmacal Company7%
RedPharm Drug, Inc.7%
Other makers33%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Tinidazole is used

A general measure of how commonly Tinidazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Tinidazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

15,770
Medicaid prescriptions filled (Q1–Q4 2025)
$491,328 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Tinidazole prescribed? Of the 1,596 medications we measure, Tinidazole ranks #845 by Medicaid prescriptions — more than 47% of them.

Where Tinidazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Tinidazole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 500 mg oral tablet is the most-dispensed Tinidazole product — about 100% of these Medicaid prescriptions.

tinidazole 500 MG Oral Tablet Most dispensed

15,699 Medicaid prescriptions (Q1–Q4 2025) 100% of Tinidazole prescriptions shown $488,697 gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 2 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199519

tinidazole 250 MG Oral Tablet

71 Medicaid prescriptions (Q1–Q4 2025) <1% of Tinidazole prescriptions shown $2,630 gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 477234

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tinidazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 22 listed Tinidazole NDCs with Medicaid activity.

🔍 Compare Tinidazole products

A representative set of FDA-listed product records for Tinidazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 27 of 27 products — FDA National Drug Code Directory. See every product, package size and price: browse all 27 Tinidazole NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Tinidazole RxCUI 10612 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 374138 In current FDA listings
    Clinical drug / strength (SCD) 250 MG RxCUI 477234 500 MG RxCUI 199519

Look up RxCUI 10612 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Tindamax

🏭 Manufacturers & labelers

Edenbridge Pharmaceuticals LLC. 4 Lupin Pharmaceuticals,Inc. 4 Rising Pharma Holdings, Inc. 4 Chartwell RX, LLC 2 Mission Pharmacal Company 2 RedPharm Drug, Inc. 2 Remedyrepack Inc. 2 Rising Pharmaceuticals, Inc. 2 BioComp Pharma, Inc. 1 Bryant Ranch Prepack 1 Medisca Inc. 1 RPK Pharmaceuticals, Inc. 1 Zhejiang Supor Pharmaceuticals Co., Ltd 1

RxNorm drug class

Tinidazole belongs to the Nitroimidazole Antimicrobial class.

Pharmacologic class Nitroimidazole Antimicrobial
Drug family (ATC) Imidazole derivatives, Imidazole derivatives, Nitroimidazole derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 1, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Tinidazole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Tinidazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
9
NDC products indexed
27
Distinct labelers/manufacturers represented
13
Linked representative label
BioComp Pharma, Inc.
Linked label effective
Dec 1, 2025
Composite sections available
25
Linked SPL Set ID
f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c
Linked SPL Document ID
44ecbffa-e4aa-9dd3-e063-6394a90a4d48
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 9 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. BioComp Pharma, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.