Artesunate Side Effects
Medically reviewed by Drugs.com. Last updated on Mar 2, 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
- 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
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
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]
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]
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]
More about artesunate
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References
1. World Health Organization. WHO Public Assessment Reports (WHOPARs) https://extranet.who.int/pqweb/medicines/prequalification-reports/whopars 2020.
2. Product Information. Artesunate (artesunate). Amivas. 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.