Artemether/Lumefantrine Side Effects

Please note - some side effects for Artemether/Lumefantrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Artemether/Lumefantrine - for the Consumer

Artemether/Lumefantrine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Artemether/Lumefantrine:

Cough; diarrhea; dizziness; fatigue; headache; joint and muscle pain and stiffness; loss of appetite; nausea; stomach pain; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; pale color; severe or persistent headache, muscle pain, or weakness; speech problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

The most frequently reported side effects included headache, anorexia, dizziness, and asthenia during clinical studies. Most side effects were mild, did not lead to artemether-lumefantrine discontinuation, and resolved. The artemether-lumefantrine 6-dose regimen was discontinued in 0.2% of adult patients due to side effects.

Nervous system

Nervous system side effects have included headache, dizziness, and vertigo (3% or more). Tinnitus, ataxia, clonus, fine motor delay, hyperreflexia, hypoesthesia, nystagmus, and tremor have been reported in less than 3% of patients. Ototoxicity (including decreased hearing) and paresthesia have been reported.

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, vomiting, abdominal pain, and diarrhea (3% or more). Constipation, dyspepsia, dysphagia, and peptic ulcer have been reported in less than 3% of patients.

Other

Other side effects have included asthenia, pyrexia, chills, fatigue, and malaise (3% or more).

Cardiovascular

Cardiovascular side effects have included palpitations (3% or more) and QT interval prolongation.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity reactions. Hypersensitivity including urticaria and angioedema has been reported during postmarketing experience.

Hematologic

Hematologic side effects have included splenomegaly and anemia (3% or more). Eosinophilia, abnormal lymphocyte morphology, decreased hematocrit, increased and decreased platelet count, increased and decreased white blood cell count have been reported in less than 3% of patients. Hemolytic anemia (including at least one case of autoimmune hemolytic anemia attributed to lumefantrine) has been reported.

Hepatic

During a study, jaundice was observed in 3 patients following artemether-lumefantrine treatment; however, each patient had elevated serum bilirubin at baseline. Resolution occurred on follow-up.

Hepatic side effects have included hepatomegaly (3% or more). Increased alanine aminotransferase and aspartate aminotransferase have been reported in less than 3% of patients. Jaundice has been reported.

Dermatologic

Dermatologic side effects have included pruritus and rash (3% or more). Urticaria has been reported in less than 3% of patients. Serious skin reactions (bullous eruption) have been reported rarely during postmarketing experience.

Immunologic

Immunologic side effects have included malaria and nasopharyngitis (3% or more). Abscess, acrodermatitis, bronchitis, ear infection, gastroenteritis, helminthic infection, hookworm infection, impetigo, influenza, lower respiratory tract infection, oral herpes, pneumonia, respiratory tract infection, subcutaneous abscess, upper respiratory tract infection, and urinary tract infection have been reported in less than 3% of patients.

Metabolic

Metabolic side effects have included hypokalemia (less than 3%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia (3% or more). Gait disturbance and back pain have been reported in less than 3% of patients.

Respiratory

Respiratory side effects have included cough (3% or more). Asthma and pharyngolaryngeal pain have been reported in less than 3% of patients.

Genitourinary

Genitourinary side effects have included hematuria and proteinuria (less than 3%).

Psychiatric

Psychiatric side effects have included sleep disorder and insomnia (3% or more). Agitation and mood swings have been reported in less than 3% of patients.

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