Applies to artemether / lumefantrine: oral tablet.

Serious side effects

Along with its needed effects, artemether / lumefantrine 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 immediately if any of the following side effects occur while taking artemether / lumefantrine:

More common

• Abdominal or stomach pain
• chills
• cough
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• headache
• muscle aches
• pale skin
• right upper abdominal or stomach pain and fullness
• sore throat
• stuffy or runny nose
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Accumulation of pus
• acid or sour stomach
• belching
• black, tarry stools
• bladder pain
• blood in the urine
• bloody or cloudy urine
• body aches or pain
• change in hearing
• chest pain
• cloudy urine
• convulsions
• cough producing mucus
• decreased urine
• diarrhea
• difficult, burning, or painful urination
• difficulty with breathing
• difficulty with swallowing
• dizziness
• dry mouth
• ear congestion
• ear drainage
• earache or pain in the ear
• frequent urge to urinate
• general feeling of discomfort or illness
• heartburn
• increased thirst
• indigestion
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• mood changes
• muscle pain or cramps
• nasal congestion
• nausea or vomiting
• noisy breathing
• numbness or tingling in the hands, feet, or lips
• red rash with watery, yellow-colored, or pus filled blisters
• shivering
• sneezing
• sores, ulcers, or white spots on the lips or in the mouth
• stomach discomfort, upset, or pain
• sweating
• swollen glands
• swollen, red, tender area of infection
• thick yellow to honey-colored crusts
• tightness in the chest
• troubled sleeping

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Other side effects

Some side effects of artemether / lumefantrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Difficulty with moving
• lack or loss of strength
• muscle aching or cramping
• muscle pain or stiffness
• weight loss

Less common

• Back pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty having a bowel movement (stool)
• discharge or excessive tearing
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• hearing loss
• hives or welts
• redness of the skin
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• sensation of spinning
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet
• uncontrolled eye movements
• unsteadiness, trembling, or other problems with muscle control or coordination

For Healthcare Professionals

Applies to artemether / lumefantrine: oral tablet.

General

The most common side effects were headache, anorexia, dizziness, asthenia, arthralgia, and myalgia during clinical studies. Most side effects were mild, did not lead to discontinuation of this drug, and resolved. The 6-dose regimen was discontinued due to side effects in 0.2% of adult patients.^[Ref]

Nervous system

Very common (10% or more): Headache (up to 56%), dizziness (up to 39%)

Common (1% to 10%): Vertigo, paresthesia, clonus

Uncommon (0.1% to 1%): Somnolence, involuntary muscle contractions, hypoesthesia, ataxia

Frequency not reported: Tinnitus, fine motor delay, hyperreflexia, nystagmus, tremor, ototoxicity (including decreased hearing)^[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 40%), decreased appetite

Frequency not reported: Hypokalemia^[Ref]

Other

Very common (10% or more): Asthenia (up to 38%), pyrexia/fever (up to 25%), chills (up to 23%), fatigue (up to 17%)

Common (1% to 10%): Malaise, rigors, parasitic infestation, viral infection, abscess

Uncommon (0.1% to 1%): Abnormal gait, gait disturbance

Frequency not reported: Ear infection

Postmarketing reports: Face edema, peripheral edema^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 34%), myalgia (up to 32%)

Common (1% to 10%): Back pain^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 26%), vomiting (up to 17%), abdominal pain (up to 17%)

Common (1% to 10%): Diarrhea, dyspepsia

Frequency not reported: Constipation, dysphagia, peptic ulcer, gastroenteritis, helminthic infection, hookworm infection, oral herpes^[Ref]

Psychiatric

Very common (10% or more): Sleep disorder (up to 22%)

Common (1% to 10%): Insomnia

Frequency not reported: Agitation, mood swings^[Ref]

Cardiovascular

Very common (10% or more): Palpitations (up to 18%)

Common (1% to 10%): QT interval prolongation on ECG

Frequency not reported: QTc prolongation (including asymptomatic)

Postmarketing reports: Hypertension^[Ref]

Hematologic

At least 1 case of autoimmune hemolytic anemia has been attributed to lumefantrine.

Cases of delayed hemolytic anemia have been reported after treatment with this drug, primarily when used for the treatment of severe malaria in patients initially treated with IV/parenteral artesunate.^[Ref]

Common (1% to 10%): Splenomegaly, anemia, malaria

Frequency not reported: Eosinophilia, abnormal lymphocyte morphology, decreased hematocrit, decreased platelet count, increased platelet count, decreased WBC count, increased WBC count, hemolytic anemia, Plasmodium falciparum infection, autoimmune hemolytic anemia

Postmarketing reports: Delayed hemolytic anemia, thrombocytopenia^[Ref]

Hepatic

Common (1% to 10%): Hepatomegaly, increased liver function tests

Frequency not reported: Increased ALT, increased AST, hepatitis

Postmarketing reports: Jaundice^[Ref]

During a study, jaundice was observed in 3 patients after treatment with this drug; however, each patient had elevated serum bilirubin at baseline. Resolution occurred on follow-up.^[Ref]

Respiratory

Common (1% to 10%): Cough/coughing, nasopharyngitis, pharyngitis

Frequency not reported: Asthma, pharyngolaryngeal pain, bronchitis, influenza, lower respiratory tract infection, pneumonia, respiratory tract infection, upper respiratory tract infection, rhinitis^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Urticaria

Frequency not reported: Acrodermatitis, impetigo, subcutaneous abscess

Postmarketing reports: Serious skin reactions (bullous eruption), urticaria, angioedema, erythematous rash^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including urticaria, angioedema), anaphylaxis^[Ref]

Genitourinary

Frequency not reported: Hematuria, proteinuria, urinary tract infection

Postmarketing reports: Chromaturia, hemoglobinuria^[Ref]

Ocular

Frequency not reported: Conjunctivitis^[Ref]