Fexinidazole Side Effects
Medically reviewed by Drugs.com. Last updated on May 10, 2023.
Applies to fexinidazole: oral tablet.
Serious side effects of Fexinidazole
Along with its needed effects, fexinidazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fexinidazole:
More common
- Black, tarry stools
- chest pain
- chills
- confusion
- cough
- fever
- lower back or side pain
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- painful or difficult urination
- pale skin
- shakiness in the legs, arms, hands, or feet
- sore throat
- stomach pain or cramps
- swelling of the feet or lower legs
- trembling or shaking of the hands or feet
- trouble breathing
- trouble sleeping
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Anxiety
- blurred vision
- deep or fast breathing with dizziness
- dizziness
- dry mouth
- fast, irregular, pounding, or racing heartbeat or pulse
- headache
- irritability
- nervousness
- numbness of the feet, hands, and around the mouth
- pounding in the ears
- restlessness
- shaking
Rare
- Change in personality
- changes in behavior
- discouragement
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- seeing, hearing, or feeling things that are not there
- thoughts of killing oneself
- trouble concentrating
Incidence not known
- Fainting
- nightmares
Other side effects of Fexinidazole
Some side effects of fexinidazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- back or neck pain
- belching
- feeling hot
- heartburn
- indigestion
- lack or loss of strength
- nausea
- stomach discomfort, upset, or pain
- vomiting
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
- burning feeling in the chest or stomach
- change in color vision
- constipation
- difficulty in speaking
- difficulty seeing at night
- drooling
- full or bloated feeling
- increased sensitivity of the eyes to sunlight
- increased sweating
- itching skin
- loss of balance control
- muscle spasm
- pressure in the stomach
- stiffness of the limbs
- swelling of the stomach area
- twisting movement of the body
- uncontrolled movement, especially of the face, neck, and back
For Healthcare Professionals
Applies to fexinidazole: oral tablet.
General
The most common side effects reported in human African trypanosomiasis patients treated with this drug in the comparative trial were headache, vomiting, insomnia, nausea, asthenia, tremor, decreased appetite, dizziness, hypocalcemia, dyspepsia, back pain, upper abdominal pain, and hyperkalemia.[Ref]
Nervous system
Very common (10% or more): Headache (up to 34.8%), tremor (up to 22%), dizziness (up to 18.9%)
Common (1% to 10%): Extrapyramidal disorder, paresthesia[Ref]
Gastrointestinal
Very common (10% or more): Vomiting (up to 28.4%), nausea (up to 25.8%), dyspepsia (up to 12.9%), upper abdominal pain (up to 10.2%)
Common (1% to 10%): Salivary hypersecretion, constipation, abdominal distension, gastritis[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 28%)
Common (1% to 10%): Agitation, anxiety, abnormal behavior
Frequency not reported: Hallucinations, psychotic disorder, depression, personality change, suicidal ideation, nightmares[Ref]
Other
Very common (10% or more): Asthenia (up to 22.7%)
Common (1% to 10%): Feeling hot, chest pain, hot flush, gait disturbance[Ref]
Metabolic
Very common (10% or more): Decreased appetite (up to 21.2%), hypocalcemia (up to 13.6%)
Common (1% to 10%): Hypoalbuminemia[Ref]
Musculoskeletal
Very common (10% or more): Back pain (up to 11.4%)
Common (1% to 10%): Neck pain, muscle spasms[Ref]
Hematologic
Common (1% to 10%): Neutropenia[Ref]
Neutropenia was defined as an absolute neutrophil count of less than 1000 cells/mm3 that occurred at any time after the first dose of study drug to the end of the study.[Ref]
Cardiovascular
Common (1% to 10%): Palpitations, hypertension
Frequency not reported: QT interval prolonged[Ref]
Respiratory
Common (1% to 10%): Cough, dyspnea[Ref]
Dermatologic
Common (1% to 10%): Pruritus, hyperhidrosis[Ref]
Ocular
Common (1% to 10%): Photophobia[Ref]
Hepatic
Frequency not reported: Elevated liver transaminases[Ref]
More about fexinidazole
- Check interactions
- Compare alternatives
- Imprints, shape & color data
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: amebicides
Patient resources
Professional resources
Related treatment guides
References
1. (2021) "Product Information. Fexinidazole (fexinidazole)." sanofi-aventis
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.