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Artesunate Side Effects

Applies to artesunate: intravenous powder for injection

Hematologic

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]

References

1. "Product Information. Artesunate (artesunate)." Amivas, Frederick, MD.

2. World Health Organization "WHO Public Assessment Reports (WHOPARs) Available from: URL: https://extranet.who.int/prequal/key-resources/prequalification-reports/whopars." ([2020]):

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.