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These highlights do not include all the information needed to use FEXINIDAZOLE TABLETS safely and effectively. See full prescribing information for FEXINIDAZOLE TABLETS. FEXINIDAZOLE tablets, for oral use Initial U.S. Approval: 2021
Medication labelWhy this: Advisory · dailymed-prescription
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. Limitations of Use Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/µL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options [see Warnings and Precautions (5.1)].
- generic_name
- fexinidazole
- product_names
- Fexinidazole
- ndc
- 0024-4512, 0024-4512-14, 0024-4512-24
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en