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Fexinidazole Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 29, 2022.

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

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

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]

References

1. "Product Information. Fexinidazole (fexinidazole)." sanofi-aventis (2021):

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.