Prescription medicine
Fexinidazole
Fexinidazole is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the fexinidazole FDA label on DailyMed (effective May 2, 2025, Sanofi-Aventis U.S. LLC); the NDA 214429 record on Drugs@FDA; every fexinidazole label on DailyMed.
Highlights of the record
FDA label of May 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFexinidazole 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.
Forms and strengths
- 600 mg
Tablet.
On the market
- Earliest approval on file
- July 16, 2021 Fexinidazole, Sanofi; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- 11 through July 30, 2026
What is fexinidazole used for?
From the label: indications and usageFexinidazole 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. Fexinidazole Tablets is a nitroimidazole antimicrobial, indicated for the treatment of both 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 pharmacologic class: Nitroimidazole Antimicrobial.
Source: FDA drug label (Fexinidazole), Sanofi-Aventis U.S. LLC, effective May 2, 2025 (SPL set 74a611bc-9977-46bb-b626-0370b3031628), via openFDA; the full label on DailyMed
Is there a generic for fexinidazole?
No generic fexinidazole is approved (Drugs@FDA, October 8, 2026).
- 2021 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the fexinidazole label say about other medicines?
The fexinidazole label names 37 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 |
|---|---|---|
| Bexagliflozin | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
| Bupropion | drug interactions | Examples (not fully inclusive):; Bupropion, efavirenz |
| Cabotegravir | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
| Canagliflozin | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
| Carbamazepine | drug interactions | Effect of other Drugs on Fexinidazole CYP450 Inducers Examples (not fully inclusive): Rifampin, phenytoin, St. John's wort, carbamazepine Clinical Impact Increased risk for adverse reactions associated with increased systemic exposure to the M1 and M2 metabolites of fexinidazole. … |
| Cefaclor | drug interactions | Examples (not fully inclusive):; Metformin, dofetilide, adefovir, cefaclor, furosemide |
| Clarithromycin | drug interactions | Examples (not fully inclusive):; Clarithromycin, itraconazole, voriconazole, erythromycin, fluconazole |
| Deferasirox | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
| Diazepam | drug interactions | Examples (not fully inclusive):; CYP1A2: duloxetine, tacrine, tizanidine, theophylline CYP2C19: lansoprazole, mephenytoin, diazepam |
| Disulfiram | warnings and precautions | Advise patients to avoid consumption of alcohol during treatment with and for at least 48 hours after completing therapy. ( 2.1 , 5.6 ) Risk of Psychotic Reactions Due to Concomitant Use with Disulfiram: |
| Dofetilide | drug interactions | Examples (not fully inclusive):; Metformin, dofetilide, adefovir, cefaclor, furosemide |
| Dolutegravir | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
| Duloxetine | drug interactions | Examples (not fully inclusive):; CYP1A2: duloxetine, tacrine, tizanidine, theophylline CYP2C19: lansoprazole, mephenytoin, diazepam |
| Efavirenz | drug interactions | Examples (not fully inclusive):; Bupropion, efavirenz |
Every other medicine the fexinidazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Eflornithine | warnings and precautions | … psychiatric-related adverse reactions than those treated with nifurtimox eflornithine combination therapy (NECT) in a clinical trial [see Adverse Reactions (6.1) ]. |
| Erythromycin | drug interactions | Examples (not fully inclusive):; Clarithromycin, itraconazole, voriconazole, erythromycin, fluconazole |
| Fluconazole | drug interactions | Examples (not fully inclusive):; Clarithromycin, itraconazole, voriconazole, erythromycin, fluconazole |
| Furosemide | drug interactions | Examples (not fully inclusive):; Metformin, dofetilide, adefovir, cefaclor, furosemide |
| Itraconazole | drug interactions | Examples (not fully inclusive):; Clarithromycin, itraconazole, voriconazole, erythromycin, fluconazole |
| Lamotrigine | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
| Lansoprazole | drug interactions | Examples (not fully inclusive):; CYP1A2: duloxetine, tacrine, tizanidine, theophylline CYP2C19: lansoprazole, mephenytoin, diazepam |
| Lovastatin | drug interactions | Examples (not fully inclusive):; Lovastatin, simvastatin, nisoldipine, saquinavir, midazolam, certain hormonal contraceptives (e.g., birth control pills, skin patches, implant) |
| Metformin | drug interactions | Examples (not fully inclusive):; Metformin, dofetilide, adefovir, cefaclor, furosemide |
| Metronidazole | contraindications | CONTRAINDICATIONS Fexinidazole Tablets are contraindicated in: Patients with known hypersensitivity to Fexinidazole Tablets and/or any nitroimidazole-class drugs (e.g., metronidazole, tinidazole). |
| Midazolam | drug interactions | Examples (not fully inclusive):; Lovastatin, simvastatin, nisoldipine, saquinavir, midazolam, certain hormonal contraceptives (e.g., birth control pills, skin patches, implant) |
| Nifurtimox | warnings and precautions | … and psychiatric-related adverse reactions than those treated with nifurtimox eflornithine combination therapy (NECT) in a clinical trial [see Adverse Reactions (6.1) ]. |
| Nisoldipine | drug interactions | Examples (not fully inclusive):; Lovastatin, simvastatin, nisoldipine, saquinavir, midazolam, certain hormonal contraceptives (e.g., birth control pills, skin patches, implant) |
| Phenytoin | drug interactions | Effect of other Drugs on Fexinidazole CYP450 Inducers Examples (not fully inclusive): Rifampin, phenytoin, St. John's wort, carbamazepine Clinical Impact Increased risk for adverse reactions … |
| Rifampin | drug interactions | Effect of other Drugs on Fexinidazole CYP450 Inducers Examples (not fully inclusive): Rifampin, phenytoin, St. John's wort, carbamazepine Clinical Impact Increased risk for adverse reactions … |
| Selexipag | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
| Simvastatin | drug interactions | Examples (not fully inclusive):; Lovastatin, simvastatin, nisoldipine, saquinavir, midazolam, certain hormonal contraceptives (e.g., birth control pills, skin patches, implant) |
| Sotagliflozin | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
| Theophylline | drug interactions | Examples (not fully inclusive):; CYP1A2: duloxetine, tacrine, tizanidine, theophylline CYP2C19: lansoprazole, mephenytoin, diazepam |
| Tinidazole | contraindications | CONTRAINDICATIONS Fexinidazole Tablets are contraindicated in: Patients with known hypersensitivity to Fexinidazole Tablets and/or any nitroimidazole-class drugs (e.g., metronidazole, tinidazole). |
| Tizanidine | drug interactions | Examples (not fully inclusive):; CYP1A2: duloxetine, tacrine, tizanidine, theophylline CYP2C19: lansoprazole, mephenytoin, diazepam |
| Voriconazole | drug interactions | Examples (not fully inclusive):; Clarithromycin, itraconazole, voriconazole, erythromycin, fluconazole |
| Zidovudine | drug interactions | Examples (not fully inclusive):; Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag |
Source: FDA drug label (Fexinidazole), Sanofi-Aventis U.S. LLC, effective May 2, 2025 (SPL set 74a611bc-9977-46bb-b626-0370b3031628), via openFDA; the full label on DailyMed
What do FAERS reports show for fexinidazole?
The FDA Adverse Event Reporting System holds 11 reports that list fexinidazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 3 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
- Fexinidazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other