Artemether / lumefantrine Side Effects
Some side effects of 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.
For the Consumer
Applies to artemether / lumefantrine: oral tablet
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
- fast, irregular, pounding, or racing heartbeat or pulse
- 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
- Accumulation of pus
- acid or sour stomach
- black, tarry stools
- bladder pain
- blood in the urine
- bloody or cloudy urine
- body aches or pain
- change in hearing
- chest pain
- cloudy urine
- cough producing mucus
- decreased urine
- difficult, burning, or painful urination
- difficulty with breathing
- difficulty with swallowing
- dry mouth
- ear congestion
- ear drainage
- earache or pain in the ear
- frequent urge to urinate
- general feeling of discomfort or illness
- increased thirst
- 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
- shortness of breath
- sores, ulcers, or white spots on the lips or in the mouth
- stomach discomfort, upset, or pain
- swollen glands
- swollen, red, tender area of infection
- thick yellow to honey-colored crusts
- tightness in the chest
- troubled with sleeping
- Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
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
- unable to sleep
- weight loss
- 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
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.
More artemether/lumefantrine resources
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