Antiprotozoal (antimicrobial)
Fexinidazole is an oral antimicrobial medicine used to treat African trypanosomiasis (sleeping sickness) caused by Trypanoсоma brucei gambiense. It is intended for patients 6 years of age and older who weigh at least 20 kg.
How it worksFexinidazole works as an antiprotzoal drug to fight the parasites that cause sleeping sickness.
Brand names:FEXINIDAZOLE
How to take
Dosing is based on weight and includes a loading dose followed by a maintenance dose. For patients 35 kg or more, the loading dose is 1,800 mg daily for 4 days, followed by 1,200 mg daily for 6 days. For patients 20 kg to less than 35 kg, the loading dose is 1,200 mg daily for 4 days, followed by 600 mg daily for 6 days.
Take Fexinidazole tablets once daily with food at approximately the same time each day. Do not crush or break the tablets. If you vomit after taking a dose, do not take another dose immediately; wait until the next day. If you miss a dose, resume your normal schedule the next day until the 10-day course is finished.
Missed dose: If a dose is missed, resume the normal dosing schedule the following day until the full 10-day course is complete.
Key warnings
- ·Fexinidazole may cause changes in heart rhythm (QT prolongation).
- ·Mental health issues such as anxiety, depression, or hallucinations may occur.
- ·Low white blood cell counts (neutropenia) may occur; periodic monitoring may be needed.
- ·Fexinidazole can cause liver damage; liver tests should be checked at the start and during treatment.
- ·Avoid alcohol during treatment and for 48 hours after finishing, as it can cause a severe reaction.
Do not use if
- ·Known allergy to fexinidazole or other nitroimidazole drugs (like metronidazole).
- ·Severe liver problems.
- ·Cockayne syndrome.
Side effects
Common
Serious
- ·Heart rhythm changes (QT interval prolongation)
- ·Mental health changes (agitation, anxiety, depression, or suicidal thoughts)
- ·Low white blood cell count (neutropenia)
- ·Liver problems (hepatotoxicity)
- ·Disulfiram-like reactions if mixed with alcohol
Seek help if
- ·Agitation
- ·Anxiety
- ·Abnormal behavior
- ·Depression
- ·Suicidal ideation
- ·Hallucinations
Interactions
- ·Avoid herbal medicines and supplements.
- ·Avoid drugs that affect heart rhythm or cause slow heart rate (e.g., certain antiarrhythmics, neuroleptics, or certain antibiotics like fluoroquinolones).
- ·Avoid alcohol during treatment and for 48 hours after.
- ·Certain drugs metabolized by CYP3A4/5 (like simvastatin) may interact.
Special populations
PregnancyThere is a risk to both the mother and the baby if sleeping sickness is left untreated during pregnancy. There is not enough clinical data to know for sure if Fexinidazole causes major birth defects or miscarriage in humans.
PediatricFexinidazole is used in children 6 years and older who weigh at least 20 kg.
GeriatricThere is not enough information to know if Fexinidazole is safer or more effective in elderly patients compared to younger adults.
Talk to your doctor
Monitor
- ·Heart rhythm (QT interval)
- ·Liver function (laboratory tests)
- ·White blood cell count (neutropenia)
- ·Mental health/behavioral changes
Questions to ask
- ·Should I have my liver enzymes checked while taking Fexinidazole?
- ·Are my current heart medications safe to take with Fexinidazole?
- ·How will Fexinidazole affect my mental health?
- ·What should I do if I miss a dose?
Pharmacokinetics
Practical
OverdoseTaking too much can lead to increased liver enzymes, vomiting, and panic attacks. In children, it has caused vomiting and changes in potassium and calcium levels.
StorageStore below 30°C (86°F) in the original package to protect from light and moisture.
Ingredients
Allergens
Inactive
Educational summary derived from FDA labeling, AI-assisted. Not medical advice — consult a healthcare professional. Updated 2026-04-25.