Artesunate Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 1, 2024.

Applies to artesunate: intravenous powder for solution.

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:

More common side effects

• agitation
• clay-colored stools
• coma
• confusion
• dark urine
• decreased urine output
• depression
• dizziness
• fever
• headache
• loss of appetite
• muscle twitching
• nausea or vomiting
• rapid weight gain
• seizures
• skin rash or itching
• stomach pain
• stupor
• swelling of the face, ankles, or hands
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Incidence not known

• back, leg, or stomach pains
• bleeding gums
• bloating
• blurred vision
• chest tightness
• chills
• constipation
• cough
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• general body swelling
• hives or welts
• hoarseness
• indigestion
• nosebleeds
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• sore throat
• sweating
• trouble breathing or swallowing

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]

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.

Medical Disclaimer