Applies to artesunate: intravenous powder for injection.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• jaundice (yellowing of the skin or eyes);

• pale or yellowed skin, dark colored urine;

• fever, confusion or weakness; or

• kidney problems--swelling, urinating less, feeling tired or short of breath.

Common side effects may include:

• kidney problems;

• jaundice; or

• abnormal urine tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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]