Prescription medicine
Benznidazole
Benznidazole is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the benznidazole FDA label on DailyMed (effective August 27, 2026, Exeltis USA, Inc.); the NDA 209570 record on Drugs@FDA; every benznidazole label on DailyMed.
Highlights of the record
FDA label of August 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBenznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi.
Forms and strengths
- 12.5 mg
- 100 mg
Tablet.
On the market
- Earliest approval on file
- August 29, 2017 Benznidazole, Chemo Research Sl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 100 through July 30, 2026
What is benznidazole used for?
From the label: indications and usageBenznidazole Tablets are indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi. This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. […]
Source: FDA drug label (Benznidazole), NDA209570 (Chemo Research Sl), as published by Exeltis USA, Inc., effective August 27, 2026 (SPL set 8983d6a0-f63f-4f8e-bba4-38223f39e29b), via openFDA; the full label on DailyMed
Is there a generic for benznidazole?
No generic benznidazole is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the benznidazole label say about other medicines?
The benznidazole label names 2 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Disulfiram | contraindications | Tablets are contraindicated in patients who have taken disulfiram within the last two weeks. |
| Metronidazole | contraindications | Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to benznidazole in patients with Cockayne syndrome [see Adverse Reactions ( 6.2 )]. |
Source: FDA drug label (Benznidazole), NDA209570 (Chemo Research Sl), as published by Exeltis USA, Inc., effective August 27, 2026 (SPL set 8983d6a0-f63f-4f8e-bba4-38223f39e29b), via openFDA; the full label on DailyMed
What do FAERS reports show for benznidazole?
The FDA Adverse Event Reporting System holds 100 reports that list benznidazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 27 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?
- Benznidazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other