Quick answers
- What is Fexinidazole used for?
- The FDA-approved label (Fexinidazole, Sanofi-Aventis U.S. LLC, May 2, 2025) says: “Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fexinidazole have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fexinidazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fexinidazole been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fexinidazole?
- 1 company lists prescription products of Fexinidazole in the FDA NDC Directory, including Sanofi-Aventis U.S. LLC.
What Fexinidazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. …
— FDA label: Fexinidazole, Sanofi-Aventis U.S. LLC, effective May 2, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Sanofi-Aventis U.S. LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA214429 FEXINIDAZOLE | Sanofi | July 16, 2021 | 3, latest September 20, 2024 2024: Labeling · 2024: Labeling · 2021: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2564151, 2564152, 2564153 |
|---|---|
| SPL set ID of the quoted label | 74a611bc-9977-46bb-b626-0370b3031628 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA214429 |
| Active ingredients (FDA) | FEXINIDAZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fexinidazole, Sanofi-Aventis U.S. LLC, effective May 2, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →