A Framework for Fitness-for-Purpose and Reuse in Computational Phenotyping
November 17, 2025
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Brand Name :
N/A
Synonyms :
fexinidazole
Class :
Antiparasitic Agents
Brand Name :
N/A
Synonyms :
fexinidazole
Class :
Antiparasitic Agents
Dosage Forms & StrengthsÂ
tabletÂ
600mgÂ
It is used for HAT hemolymphatic stage 1 and meningoencephalitic stage 2
10-Day treatment regimen
Days 1 to 4: 1800 mg (3 tab) orally every day, following
Days 5 to 10: 1200 mg (2 tab) orally every day
Dose Adjustments
Dosage Modifications
Hepatic impairment
pharmacokinetics not known; Contraindicated
Renal impairment
Mild-moderate (eGFR 30 to less than 89 mL/min/1.73 m2): dose adjustment is not required
Severe (eGFR less than 30 mL/min/1.73 m2): Pharmacokinetics are not known; avoid usage
Dosage Forms & StrengthsÂ
tabletÂ
600mgÂ
It is used for HAT hemolymphatic stage 1 and meningoencephalitic stage 2 in children aged above 6 years who weight 20 kg
Below 6 years: Safety & efficacy were not established
Above 6 years
10-Day treatment regimen
Above 20 to less than 35 kg
Days 1 to 4: 1200 mg (2 tab) orally every day, following
Days 5 to 10: 600 mg (1 tab) orally every day
More than 35 kg
Days 1 to 4: 1800 mg (3 tab) orally every day, following
Days 5 to 10: 1200 mg (2 tab) orally every day
Dose Adjustments
Dosage Modifications
Hepatic impairment
pharmacokinetics not known; Contraindicated
Renal impairment
Mild-moderate (eGFR 30 to less than 89 mL/min/1.73 m2): dose adjustment is not required
Severe (eGFR less than 30 mL/min/1.73 m2): Pharmacokinetics are not known; avoid usage
Refer to the adult dosing regimenÂ
may diminish the serum concentration when combined with CYP2D6 substrates
may diminish the serum concentration when combined with CYP2D6 substrates
may diminish the serum concentration when combined with CYP2D6 substrates
may diminish the serum concentration when combined with CYP2D6 substrates
may diminish the serum concentration when combined with CYP2D6 substrates
may have an increased QTc-prolonging effect when combined with citalopram
may diminish the concentration of serum when combined with fexinidazole
fexinidazole: they may diminish serum concentrations of CYP3A Inhibitors
fexinidazole: they may diminish serum concentrations of CYP3A Inhibitors
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
bunazosin (Not available in the United States)
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may enhance the CYP3A4 substrate serum concentration
may enhance the serum concentration of OAT1/3 substrates
may enhance the serum concentration of MATE1/2-K Substrates
ciprofloxacin inhaled (Pending FDA approval)Â
may enhance the serum concentration of OAT1/3 Substrates
may decrease the therapeutic effect when combined with anti-parkinson agents
may decrease the therapeutic effect when combined with anti-parkinson agents
may decrease the therapeutic effect when combined with anti-parkinson agents
may decrease the therapeutic effect when combined with anti-parkinson agents
may decrease the therapeutic effect when combined with anti-parkinson agents
may enhance the area under the curve when co-administered
may enhance the area under the curve when co-administered
may enhance the area under the curve when co-administered
may enhance the area under the curve when co-administered
may enhance the area under the curve when co-administered
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
bradycardia causing agents increase the arrhythmia-causing effect of fexinidazole
bradycardia causing agents increase the arrhythmia-causing effect of fexinidazole
bradycardia causing agents increase the arrhythmia-causing effect of fexinidazole
bradycardia causing agents increase the arrhythmia-causing effect of fexinidazole
bradycardia causing agents increase the arrhythmia-causing effect of fexinidazole
may enhance the serum concentration when combined with CYP3A4 substrates
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
it increases the concentration of CYP3A4 substrates in the serum
May enhance the serum concentration when combined with CYP3A4 Substrates
may have an increased myelosuppressive effect when combined with fexinidazole
may have an increased myelosuppressive effect when combined with fexinidazole
may have an increased myelosuppressive effect when combined with fexinidazole
may have an increased myelosuppressive effect when combined with fexinidazole
may have an increased myelosuppressive effect when combined with fexinidazole
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may decrease the therapeutic effect when combined with etofylline
may decrease the therapeutic effect when combined with etofylline
may decrease the therapeutic effect when combined with etofylline
may decrease the therapeutic effect when combined with etofylline
may decrease the therapeutic effect when combined with etofylline
It may enhance the immunosuppressive effects when combined with idecabtagene vicleucel
may increase the QTc-prolonging action of QT-prolonging agents (Highest Risk)
may increase the QTc-prolonging action of QT-prolonging agents (Highest Risk)
may increase the QTc-prolonging action of QT-prolonging agents (Highest Risk)
may increase the QTc-prolonging action of QT-prolonging agents (Highest Risk)
may enhance the concentration of serum when combined with CYP3A4 substrates
it increases the concentration of ergot derivatives in serum
it increases the concentration of ergot derivatives in serum
it increases the concentration of ergot derivatives in serum
it increases the concentration of ergot derivatives in serum
it increases the concentration of ergot derivatives in serum
may have an increased arrhythmogenic effect when combined with fexinidazole
may have an increasingly adverse effect when combined with fexinidazole
may have an increasingly adverse effect when combined with disulfiram
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
may have an increased QTc-prolonging effect when combined with QT-prolonging agents
fexinidazole: they may increase the myelosuppressive effect of myelosuppressive agents
fexinidazole: they may enhance the serum concentration of CYP3A4 inhibitors
fexinidazole: they may enhance the serum concentration of CYP3A4 inhibitors
fexinidazole: they may enhance the serum concentration of CYP3A4 inhibitors
fexinidazole: they may enhance the serum concentration of CYP3A4 inhibitors
fexinidazole: they may enhance the serum concentration of CYP3A4 inhibitors
bradycardia-causing agents enhance arrhythmogenic effect of fexinidazole
fexinidazole: they may increase the bradycardic effect of Bradykinin receptor antagonists
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
nafcillin will increase the effect of action of fexinidazole by affecting enzyme CYP3A4 metabolism.
when both drugs combine fexinidazole will increase effect of ifosfamide by affecting the enzyme CYP3A4 metabolism.
cyclophosphamide effect of action decreased by affecting enzyme CYP3A4 metabolism.
when both drugs are combined, there may be a reduced excretion rate of topotecan and result in an elevated level of serum concentration 
when both drugs are combined, there may be a decreased metabolism of alpelisib   
may enhance the myelosuppressive effects of fexinidazole
the brentuximab on interacting with fexinidazole has its effect increased by altering the intestinal or hepatic CYP3A4 enzyme metabolism.
when both drugs are combined, there may be an increased risk or severity of adverse effects    
QTc interval increases on taking fexinidazole and lenvatinib together. Avoid or take an alternate drug
the effect of fexinidazole is decreased by lorlatinib, by altering intestinal or hepatic CYP3A4 enzyme metabolism
when both drugs are combined, both increase the QTC interval   
may increase bone marrow suppression
may increase bone marrow suppression
may increase bone marrow suppression
both lapatinib and fexinidazole increase the QTc interval
when both drugs are combined, there may be an increased QTC interval  
when both drugs are combined, there may be an increased QTC interval  
CYP3A enhancers may enhance plasma concentrations of the active metabolite(s) of fexinidazoleenzal
fexinidazole increases the effect of gefitinib by altering the intestinal/ hepatic CYP3A4 enzyme metabolism
when both drugs are combined, there may be an increase in the risk of the myelosuppressive effect of fexinidazole 
when both drugs are combined, there may be an increase in the risk of the myelosuppressive effect of fexinidazole 
it may increase the bone marrow suppression effects of fexinidazole
fexinidazole and gilteritinib, when used in combination, increase the QTc interval
it may increase the adverse effects such as bone marrow suppression activity
it will increase the impact or level of regorafenib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
myelosuppressive agents increase the therapeutic efficacy of fexinidazole
it increases the effect or level of ruxolitinib by altering the intestinal or hepatic CYP3A4 enzyme metabolism
it increases the concentration of CYP3A4 substrates in serum
it increases the concentration of CYP3A4 substrates in serum
bradycardia agents increase the arrhythmogenic impact of fexinidazole
it increases the concentration of CYP3A4 substrates in serum
it increases the effect or level of dronabinol by altering the intestinal or hepatic metabolism
it increases the concentration of CYP3A4 substrates in serum
May enhances the effects of the other by pharmacodynamic synergism
may increase the QTc interval when combined
may increase the level by affecting the hepatic enzyme CYP3A4 metabolism
may increase the level by affecting the hepatic enzyme CYP3A4 metabolism
it decreases by affecting the hepatic enzyme CYP2B6 metabolism
may increase the level of zonisamide by affecting the hepatic enzyme CYP3A4 metabolism
may increase the level by affecting the hepatic enzyme CYP3A4 metabolism
glycopyrrolate inhaled and formoterolÂ
may increase the QTc interval when combined
it increases by affecting the hepatic enzyme CYP3A4 metabolism
relugolix/​estradiol/​norethindroneÂ
it enhances by affecting the hepatic enzyme CYP3A4 metabolism
hydrocodone/​chlorpheniramine/​pseudoephedrineÂ
may enhance the serum concentration of CYP3A4 substrates
may enhance the serum concentration of vitamin D analogs
may increase the serum concentration of CYP3A4 substrates
azelastine/fluticasone intranasalÂ
may enhance the serum concentration
may increase the myelosuppressive effect of myelosuppressive agents
may increase the immunosuppressive effect of immunosuppressants
may enhance the arrhythmogenic effect of bradycardia-causing agents
may increase the arrhythmogenic effect of bradycardia-causing agents
may enhance the serum concentration of CYP3A4 substrates
may enhance the serum concentrations of CYP3A4 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may enhance the serum concentration of CYP3A4 inhibitors
may increase the toxic effect of myelosuppressive agents
may increase the myelosuppressive effect of myelosuppressive agents
may increase the myelosuppressive effect of myelosuppressive agents
may increase the toxic effect of myelosuppressive agents
may increase the arrhythmogenic effect of bradycardia-causing agents
may increase the serum concentration of CYP3A4 Substrates
may increase the adverse/toxic effect of Myelosuppressive Agents
may increase the serum concentration of CYP3A4 Substrates
may increase the myelosuppressive effect of Myelosuppressive Agents
may enhance the serum concentration of CYP3A4 Substrates
may have an increased QTc-prolonging effect when combined with dabrafenib
may have an increased myelosuppressive effect when combined with fexinidazole
may diminish the serum concentration of CYP3A4 substrates
fexinidazole may enhance the QTc-prolonging effect of QT-prolonging Agents
fexinidazole may enhance the QTc-prolonging effect of QT-prolonging Agents
fexinidazole may enhance the QTc-prolonging effect of QT-prolonging Agents
fexinidazole may enhance the QTc-prolonging effect of QT-prolonging Agents
fexinidazole may enhance the QTc-prolonging effect of QT-prolonging Agents
may have an increased QTc-prolonging effect when combined with escitalopram
may have an increased QTc-prolonging effect when combined with olanzapine
when bromazepam and fexinidazole are used together, there is a potential reduction in the bromazepam's metabolism
When alprazolam and fexinidazole is used together, this leads to reduction in the alprazolam’s metabolism
When dexrabeprazole and fexinidazole is used together, this leads to reduction in the dexrabeprazole’s metabolism
When fexinidazole is used together with somatotropin, this leads to a rise in fexinidazole metabolism
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
may increase the serum concentration of each other when it is combined
hepatic enzyme is affected i.e., CYP1A2 metabolism is affected when fexinidazole used combinely with lidocaine and raising its level
may enhance the serum levels of CYP3A4 substrates
may enhance the serum levels of CYP3A4 substrates
may enhance the serum levels of CYP3A4 substrates
may enhance the serum levels of CYP3A4 substrates
when both drugs are combined may enhance the bradycardia effect and raise blood pressureÂ
when both drugs are combined may enhance the bradycardia effect and raise blood pressure
May enhance the plasma concentration of CYP3A4 substrates
may increase the QTc prolonging effect of QT-prolonging agents
may have an increased QTc-prolonging effect when combined with clozapine
anagrelide: they may increase the antiplatelet effect of antiparasitic agents
zanubrutinib: they may increase the antiplatelet effect of antiparasitic agents
may have a decrease in excretion when combined with fexinidazole
When fexinidazole is used together with oliceridine, this leads to reduction in oliceridine’s metabolism
When fexinidazole is aided by hesperetin, it reduces hesperetin’s metabolism
Actions and spectrum:Â
fexinidazole is an antiprotozoal medication with a broad spectrum of activity against various parasites, including Trypanosoma brucei gambiense and Trypanosoma cruzi.
It exerts its action by disrupting the energy metabolism of the parasites, leading to their death. fexinidazole is primarily used for the treatment of sleeping sickness (African trypanosomiasis) caused by Trypanosoma brucei gambiense.Â
Frequency definedÂ
1-10%Â
Above 15 yearsÂ
>10%Â
Above 15 yearsÂ
<2%Â
Laboratory investigations: increased liver transaminasesÂ
Psychiatric disorders: psychotic disorder, personality change, Hallucinations, depression, suicidal ideation Â
Post marketing ReportsÂ
Severe hepatotoxicity/acute hepatic failureÂ
Black Box Warning: Â
There is no specific black box warning associated with fexinidazoleÂ
Contraindication/Caution:Â
Contraindication:Â
Caution:Â
Comorbidities:Â
Pregnancy consideration: US FDA pregnancy category: Not assignedÂ
Lactation: Excreted into human milk: Unknown Â
Pregnancy category:Â
Pharmacology:Â
fexinidazole is an antiprotozoal medication with activity against the parasites causing African trypanosomiasis (sleeping sickness). Its pharmacology includes the following aspects:Â
Mechanism of Action:
fexinidazole is a nitroimidazole compound that is bioactivated within the parasites by nitroreduction. This leads to the production of reactive nitrogen species, which disrupts the DNA and other essential cellular components of the parasites, leading to their death. fexinidazole is administered orally and undergoes extensive metabolism in the liver. It is rapidly converted to its active metabolite, hydroxymethyl metabolite, which is responsible for its antiparasitic activity. The metabolites are mainly eliminated in the urine and feces.Â
Pharmacodynamics:Â
Pharmacokinetics:Â
AbsorptionÂ
fexinidazole is well absorbed after oral administration, and food does not significantly affect its absorption.Â
DistributionÂ
fexinidazole and its metabolites distribute extensively throughout the body, including into tissues where trypanosomes may reside.Â
MetabolismÂ
fexinidazole undergoes extensive metabolism in the liver by various enzymes, including cytochrome P450 enzymes. The primary metabolite, hydroxymethyl metabolite, has similar antiparasitic activity to the parent compound.Â
Elimination and excretionÂ
fexinidazole and its metabolites are eliminated mainly through the kidneys, with a small portion excreted in the feces.Â
Administration:Â
fexinidazole is an oral medication that is typically administered in the form of tablets. The specific administration instructions may vary depending on the prescribed dose and the specific product formulation.
Generally, fexinidazole should be taken with food to enhance its absorption and minimize the risk of gastrointestinal side effects. It is important to take the medication as directed at the recommended intervals, and for the full duration of the prescribed treatment course.Â
Patient information leafletÂ
Generic Name: fexinidazoleÂ
Pronounced: (feks-in-EYE-da-zole)Â Â
Why do we use fexinidazole?Â
fexinidazole is primarily used for the treatment of African sleeping sickness, also known as Human African Trypanosomiasis (HAT). It is effective against both the early-stage (hemolymphatic) and late-stage (meningoencephalitic) forms of the disease caused by Trypanosoma brucei parasites.
fexinidazole is an oral treatment option that offers advantages over traditional injectable therapies, as it is easier to administer and has a shorter treatment duration. It is an important tool in the fight against HAT, a neglected tropical disease that affects populations in sub-Saharan Africa.
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