Artemether and lumefantrine Side Effects
Please note - some side effects for Artemether and 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 by Body System - for Healthcare Professionals
Applies to: oral tablet
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 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 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 side effects have included asthenia, pyrexia, chills, fatigue, and malaise (3% or more).
Cardiovascular side effects have included palpitations (3% or more) and QT interval prolongation.
Hypersensitivity side effects have included hypersensitivity reactions. Hypersensitivity including urticaria and angioedema has been reported during postmarketing experience.
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.
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 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 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 side effects have included hypokalemia (less than 3%).
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 side effects have included cough (3% or more). Asthma and pharyngolaryngeal pain have been reported in less than 3% of patients.
Genitourinary side effects have included hematuria and proteinuria (less than 3%).
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.Top
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.