Artemether / lumefantrine Side Effects

Not all side effects for artemether / lumefantrine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to artemether / lumefantrine: oral tablet

In addition to its needed effects, some unwanted effects may be caused by artemether / lumefantrine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • shortness of breath
  • 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 with sleeping
Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some of the side effects that can occur with artemether / lumefantrine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Difficulty with moving
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pain or stiffness
  • sleeplessness
  • unable to sleep
  • 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 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.[Ref]

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.[Ref]

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.[Ref]

Other

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

Cardiovascular

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

Hypersensitivity

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

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Metabolic

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

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.[Ref]

Respiratory

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

Genitourinary

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

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.[Ref]

References

1. "Product Information. Coartem (artemether-lumefantrine)." Novartis Pharmaceuticals, East Hanover, NJ.

2. Bakshi R, Hermeling-Fritz I, Gathmann I, Alteri E "An integrated assessment of the clinical safety of artemether-lumefantrine: a new oral fixed-dose combination antimalarial drug." Trans R Soc Trop Med Hyg 94 (2000): 419-24

3. "Artemether-lumefantrine (Coartem) for treatment of malaria." Med Lett Drugs Ther 51 (2009): 75-6

4. Lefevre G, Looareesuwan S, Treeprasertsuk S, et al. "A clinical and pharmacokinetic trial of six doses of artemether-lumefantrine for multidrug-resistant Plasmodium falciparum malaria in Thailand." Am J Trop Med Hyg 64(5-6) (2001): 247-56

5. Toovey S "Effects of weight, age, and time on artemether-lumefantrine associated ototoxicity and evidence of irreversibility." Travel Med Infect Dis 4 (2006): 71-6

6. McCall MB, Beynon AJ, Mylanus EA, van der Ven AJ, Sauerwein RW "No hearing loss associated with the use of artemether-lumefantrine to treat experimental human malaria." Trans R Soc Trop Med Hyg 100 (2006): 1098-104

7. Stover KR, King ST, Robinson J "Artemether-lumefantrine: an option for malaria." Ann Pharmacother 46 (2012): 567-77

8. Toovey S "A case-control auditory evaluation of patients treated with artemether-lumefantrine." Am J Trop Med Hyg 74 (2006): 939-40; author reply 940

9. Gurkov R, Eshetu T, Miranda IB, et al. "Ototoxicity of artemether / lumefantrine in the treatment of falciparum malaria: a randomized trial." Malar J 7 (2008): 179

10. McGready R, Tan SO, Ashley EA, et al. "A randomised controlled trial of artemether-lumefantrine versus artesunate for uncomplicated plasmodium falciparum treatment in pregnancy." PLoS Med 5 (2008): e253

11. Merat S, Lambert E, Vincenti-Rouquette I, Gidenne S, Rousseau JM, Brinquin L "Case report: combination artemether-lumefantrine and haemolytic anaemia following a malarial attack." Trans R Soc Trop Med Hyg 97 (2003): 433-4

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