Artesunate Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 7, 2025.

Applies to artesunate: intravenous powder for solution.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed for 4 weeks after treatment with this medicine to check for unwanted effects (eg, delayed hemolysis).

Using this medicine while you are pregnant can harm your unborn baby. if you think you have become pregnant while using this medicine, tell your doctor right away.

Blood problems (eg, hemolytic anemia) may occur after you receive treatment with this medicine. Check with your doctor right away if you or your child have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellow eyes or skin.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening. Call your doctor right away if you or your child have blurred vision, chest tightness, confusion, cough, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, hoarseness, redness of the skin, skin rash, itching, hives or welts, sweating, swelling of your hands, face, or mouth, trouble breathing or swallowing, or unusual tiredness or weakness after you receive this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of artesunate

Along with its needed effects, artesunate 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 or nurse immediately if any of the following side effects occur while taking artesunate:

For healthcare professionals

Applies to artesunate: intravenous powder for injection.

Hematologic adverse events

• Very common (10% or more): Anemia (sometimes severe; up to 65%), delayed hemolysis (up to 27%), thrombocytopenia (up to 18%), leukocytosis (up to 10%), posttherapy hemolytic anemia in travelers, mild and transient decrease in reticulocyte count
• Common (1% to 10%): Lymphopenia, neutropenia (sometimes severe), disseminated intravascular coagulation, leukopenia, reduced reticulocyte count, posttherapy hemolytic anemia in endemic areas
• Uncommon (0.1% to 1%): Agranulocytosis, reticulocytopenia, erythroblastopenia
• Very rare (less than 0.01%): Pure red cell aplasia
• Frequency not reported: Posttherapy hemolytic anemia (including cases requiring transfusion), immune-mediated hemolysis
• Postmarketing reports: Delayed hemolysis, immune hemolytic anemia^[Ref]

Hepatic

• Very common (10% or more): Increased transaminase (up to 27%), hyperbilirubinemia (up to 14%)
• Common (1% to 10%): Jaundice, transient elevation in liver transaminases (AST, ALT)
• Uncommon (0.1% to 1%): Elevated liver enzymes
• Rare (0.01% to 0.1%): Hepatitis, calculous cholecystitis^[Ref]

Transient elevation in liver transaminases, nausea, vomiting, anorexia, and diarrhea have been reported commonly but it is unclear whether these events may have been symptoms of severe malaria.^[Ref]

Renal

• Very common (10% or more): Acute renal failure (up to 10%)
• Common (1% to 10%): Acute renal failure requiring dialysis (included dialysis, hemodialysis, peritoneal dialysis), elevated creatinine^[Ref]

Genitourinary

• Common (1% to 10%): Hemoglobinuria^[Ref]

Respiratory

• Common (1% to 10%): Acute respiratory distress syndrome, pneumonia, pulmonary edema, cough, nasal symptoms^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, abdominal pain/cramps, vomiting, nausea
• Uncommon (0.1% to 1%): Mild gastrointestinal disturbances
• Rare (0.01% to 0.1%): Elevated serum amylase, pancreatitis
• Postmarketing reports: Pancreatitis^[Ref]

Dermatologic

• Common (1% to 10%): Rash, alopecia
• Frequency not reported: Stevens-Johnson syndrome, urticaria^[Ref]

Nervous system

• Common (1% to 10%): Significant neurologic impairments, dysgeusia, tinnitus (with or without decreased auditory function), dizziness, headache, lightheadedness, altered taste (metallic/bitter taste)
• Very rare (less than 0.01%): Peripheral neuropathy, paresthesia
• Frequency not reported: Loss of balance, hemiplegia/paresis, ataxia, tremor^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia
• Frequency not reported: Neuropsychiatric symptoms, confusion, restlessness^[Ref]

Other

• Common (1% to 10%): Pyrexia/fever, fatigue, malaise
• Frequency not reported: Generalized weakness^[Ref]

Metabolic

• Common (1% to 10%): Anorexia^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, muscle disorders^[Ref]

Local

• Common (1% to 10%): Pain at injection site^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Rhythm disorders (bradycardia, sinus arrhythmia), conduction disorders (QTc lengthening, abnormal sinoatrial conduction)
• Rare (0.01% to 0.1%): Arterial ischemia, hypertensive retinopathy
• Frequency not reported: Cardiac arrest, atrioventricular block, possible QT prolongation^[Ref]

At least 1 case of cardiac arrest has been reported in a patient with severe malaria with multiorgan failure; causality by this drug has not been established.^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity (allergic) reactions
• Rare (0.01% to 0.1%): Severe allergic reaction (included urticarial rash, hypotension, pruritus, edema, dyspnea)
• Postmarketing reports: Hypersensitivity, anaphylaxis^[Ref]

See also:

Further information

Artesunate side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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