Benznidazole
Benznidazole is a nitroimidazole antimicrobial (an antiparasitic medicine) used to treat Chagas disease in children 2 to 12 years old.
🧬 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 1 clinical label set 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 →
Benznidazole is an antiparasitic medicine that treats Chagas disease in children 2 to 12 years old, stopping the parasite from making DNA, RNA and proteins; it is generally the first-choice drug for Chagas, on the U.S. market since about 2018. Children usually tolerate the 60-day course better than adults, though stomach pain, nausea, poor appetite, weight loss and rash are common. Watch most for rash, which usually starts after about 10 days; stop the medicine and call right away for any rash, especially with fever, swollen glands or purple spots. It can also cause nerve problems (report numbness or tingling), low blood counts and harm to an unborn baby.
Clinical pearls
- Scored tablets can be split, or stirred into water as a slurry to drink right away, with or without food.
- Blood counts are checked before, during and after treatment, so keep every lab visit, including the one after the course ends.
- Mention any past reaction to metronidazole or another nitroimidazole drug, since that rules benznidazole out.
- If a girl could become pregnant, she needs a pregnancy test first and contraception until 5 days after the last dose.
Patient information guide A plain-language walkthrough of Benznidazole, written from its FDA label.
What Benznidazole is used for
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Benznidazole is used for one condition.
- Benznidazole Tablets treat Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi in children 2 to 12 years old.
- This is an accelerated approval based on antibody (IgG) negative results. Confirmatory trials are needed.
How Benznidazole works
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Benznidazole is a nitroimidazole antimicrobial. It stops the Chagas parasite from making DNA, RNA and proteins. The parasite's own enzyme activates the drug, which may then damage the parasite's DNA.
It is active against all three stages of the parasite. Strains from different regions may respond differently, and resistance is possible. The exact mechanism is not known.
Benznidazole dosage
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Benznidazole Tablets are taken by mouth, twice a day about 12 hours apart, for 60 days. Food does not matter. The dose depends on body weight.
- The 100 mg tablets are scored and can be split.
- Tablets can be mixed in water and drunk right away, then the cup is rinsed and the rinse is drunk.
Follow your prescriber's instructions and the label.
Dosing details from the FDA-approved label
From the Benznidazole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Pediatric patients 2 to 12 years of age
- Total daily dose is 5 mg/kg to 8 mg/kg orally administered in two divided doses separated by approximately 12 hours, for a duration of 60 days
- By body weight, twice daily approximately 12 hours apart for 60 days: less than 15 kg: 50 mg (4 x 12.5 mg tablets or ½ x 100 mg tablet)
- 15 kg to less than 20 kg: 62.5 mg (5 x 12.5 mg tablets)
- 20 kg to less than 30
- May be taken with or without food; dosed by body weight (kg); 100 mg tablets are scored and can be split into one-half (50 mg) or one-quarter (25 mg); tablets can be made into a slurry in water; obtain a pregnancy test in females of reproductive potential before therapy
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Pediatric patients 2 to 12 years of age: The total daily dose is 5 mg/kg to 8 mg/kg orally administered in two divided doses separated by approximately 12 hours for a duration of 60 days ( 2.2 ). See Full Prescribing Information for important administration instructions ( 2.1 , 2.3 , 2.4 ). 2.1 Important Administration Instructions Benznidazole Tablets (12.5 mg and 100 mg) are for oral use and may be taken with or without food [see Clinical Pharmacology ( 12.3 )] . Benznidazole Tablets are dosed by body weight (kg) [see Dosage and Administration ( 2.2 )] . Benznidazole Tablets 100 mg are functionally scored tablets which can be split into one-half (50 mg) or one-quarter (25 mg) at the scored lines to provide doses less than 100 mg [see Instructions for Use ] . Benznidazole Tablets 12.5 mg and 100 mg can be made into slurry as an alternative method of administration [see Dosage and Administration ( 2.4 )] . 2.2 Recommended Dosage in Pediatric Patients (2 to 12 Years of Age) The total daily dose for pediatric patients 2 to 12 years of age is 5 mg/kg to 8 mg/kg orally administered in two divided doses separated by approximately 12 hours, for a duration of 60 days (see Table 1 ). Table 1: Recommended Dosage of Benznidazole Tablets in Pediatric Patients (2 to 12 Years of Age) Body Weight Range (kg) Dose (mg) Number of Benznidazole Tablets 12.5 mg Number of Benznidazole Tablets 100mg Duration and Frequency of Therapy Less than 15 kg 50 mg 4 tablets ½ tablet Administered twice daily approximately 12 hours apart for 60 days. 15 kg to less than 20 kg 62.5 mg 5 tablets 20 kg to less than 30 kg 75 mg 6 tablets ¾ tablet 30 kg to less than 40 kg 100 mg 1 tablet 40 kg to less than 60 kg 150 mg 1 ½ tablets Greater than or equal to 60 kg 200 mg 2 tablets 2.3 Assessment Prior to Initiating Benznidazole Tablets Obtain a pregnancy test in females of reproductive potential prior to therapy with Benznidazole Tablets [see Use is Specific Populations ( 8.3 )] . 2.4 Preparation of Slurry as an Alternative Method of Administration A. Preparation of Slurry Using Benznidazole Tablets 12.5 mg for the Pediatric Population with Body Weight Less Than 30 kg Benznidazole Tablets 12.5 mg may be made into slurry in a specified volume of water for the pediatric population with body weight less than 30 kg (see Table 2 ).
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Benznidazole side effects
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The most common side effects in children were:
Common side effects
- Stomach pain
- Rash
- Weight loss
- Headache
- Nausea and vomiting
- Decreased appetite
- Itching or hives
- Low white blood cell counts (neutropenia)
When to get medical help
- Stop the medicine and call your doctor right away if a rash appears, especially with fever, swollen glands or purple spots on the skin.
- Call right away for any serious skin reaction, such as blistering or peeling skin.
- Call your doctor for numbness, tingling or other nerve symptoms. These can take months to clear.
- Tell your doctor about signs of low blood counts. Blood counts should be checked before, during and after treatment.
- Call your doctor for dizziness or ongoing headache.
Benznidazole warnings and precautions
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- Serious skin reactions, including TEN and DRESS, have been reported. Stop at the first sign, and especially if fever, swollen glands or purpura appear.
- Nerve effects such as tingling or neuropathy may take months to resolve. Stop treatment if they occur.
- Bone marrow depression (low blood counts) has been reported. Blood counts should be monitored.
- Genotoxicity: chromosome changes were seen in children. Cancer risk in humans is unknown.
- Fetal harm: it can harm an unborn baby.
Benznidazole interactions
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Few interactions are described.
- Disulfiram: do not use within 2 weeks of taking it, because of the risk of psychotic reactions.
- Alcohol: a disulfiram-like reaction is not expected.
Interactions listed in the FDA-approved label
From the Benznidazole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Disulfiram: Psychotic reactions have been reported in patients concurrently taking disulfiram and nitroimidazole agents (structurally related to benznidazole, but not with benznidazole). Benznidazole Tablets should not be given to patients who have taken disulfiram within the last two weeks.
- Alcohol and products containing propylene glycol: In vitro, benznidazole at concentrations from 0.03 μM to 100 μM does not inhibit the enzymatic activity of human alcohol dehydrogenase (ALDH); Benznidazole Tablets are not expected to cause alcohol aversion or a disulfiram-like reaction as a result of ethanol ingestion.
Read the label’s full interactions text
7 DRUG INTERACTIONS 7.1 Disulfiram Psychotic reactions have been reported in patients who are concurrently taking disulfiram and nitroimidazole agents (structurally related to benznidazole, but not with benznidazole). Benznidazole Tablets should not be given to patients who have taken disulfiram within the last two weeks [see Contraindications ( 4.2 )] . 7.2 Alcohol and Products Containing Propylene Glycol In vitro studies showed that benznidazole, at concentrations from 0.03 μM to 100 μM, does not inhibit the enzymatic activity of human alcohol dehydrogenase (ALDH). Benznidazole Tablets are not expected to cause alcohol aversion or a disulfiram-like reaction as a result of ethanol ingestion.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Benznidazole
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- Do not use with a past allergy to benznidazole or nitroimidazoles.
- Do not use with Cockayne syndrome.
- Do not use if you took disulfiram in the last 2 weeks.
- A pregnancy test is needed for females who could become pregnant. Use contraception during treatment and for 5 days after.
- Breastfeeding is not recommended.
- Not studied in children under 2 or over 12.
- Not studied in liver or kidney impairment.
What Benznidazole does in the body
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The way benznidazole affects the body is not known.
How your body processes Benznidazole
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Benznidazole peaks in the blood about 2 hours after a dose. A high-fat meal does not change how much is absorbed. Its half-life is about 13 hours. It is broken down by the body and cleared mostly in urine, with some in stool. Only about 6% of a dose leaves unchanged in urine.
How to store Benznidazole
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Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Benznidazole
44 supplements and herbal products have documented interactions with Benznidazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 33
- Minor · 10
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.
Nutrient depletion considerations
Benznidazole has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Benznidazole: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Benznidazole — the kind of thing our pharmacy team would talk through with you at the counter.
What is Benznidazole for?
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How do I give it?
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What side effects should I expect?
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Are there serious things to watch for?
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Can it be used in pregnancy?
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Does it interact with other medicines?
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Is Benznidazole available over the counter?
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When was Benznidazole first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Benznidazole on HelloPharmacist
Benznidazole forms and strengths (how it comes)
Benznidazole 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Benznidazole inactive ingredients by manufacturer.
Tablet
How this form is used
- Benznidazole Tablets treat Chagas disease caused by Trypanosoma cruzi in children 2 to 12 years old.
- Benznidazole Tablets are taken by mouth with or without food.
- Benznidazole 100 mg tablets are scored and can be split to give smaller doses.
- Benznidazole Tablets can be mixed into a water slurry and drunk right away.
- Benznidazole Tablets are dosed by body weight, about 12 hours apart, for 60 days.
Benznidazole on the U.S. market: products, makers and brands
How Benznidazole 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 company lists 2 Benznidazole product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2017.
Compare Benznidazole products
A representative set of FDA-listed product records for Benznidazole — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 12.5 mg | Oral | Exeltis USA, Inc. | NDA | View NDC → |
| 100 mg | Oral | Exeltis USA, Inc. | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Benznidazole NDCs →
Benznidazole side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Benznidazole — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Benznidazole in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Benznidazole FDA approval history
How Benznidazole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Benznidazole recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Benznidazole recalls since July 2021.
✅No Benznidazole recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
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.
RxCUI 18994 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 437846In current FDA listings
Look up RxCUI 18994 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.
Benznidazole supply and shortage status
Whether Benznidazole is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Who makes Benznidazole: manufacturers and labelers
One company lists Benznidazole products with the FDA. By number of product records, the largest are Exeltis USA, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Benznidazole drug class (RxNorm)
Benznidazole belongs to the Nitroimidazole derivatives class.
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.
Sources for this Benznidazole page
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.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Exeltis USA, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →