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Coartem Side Effects

Generic name: artemether / lumefantrine

Medically reviewed by Drugs.com. Last updated on May 13, 2024.

Note: This document provides detailed information about Coartem.

Applies to artemether / lumefantrine: oral tablet Side Effects associated with artemether / lumefantrine. Some dosage forms listed on this page may not apply specifically to the brand name Coartem.

Applies to artemether / lumefantrine: oral tablet.

Precautions

It is important that your doctor check your or your child's progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

Tell your doctor if you or your child have used other medicines to treat your malaria infection. Using this medicine together with halofantrine (Halfan®), mefloquine (Lariam®), or quinine may increase the chance for more serious side effects.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Check with your doctor right away if you or your child have flu-like symptoms (such as chills, fever, headache, or muscle pains) again after treatment with this medicine.

This medicine may cause serious allergic reactions. Call your doctor right away if you or your child have a rash, itching, hives, hoarseness, trouble with breathing, trouble with swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in or will be traveling to an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

This medicine may decrease the effects of birth control pills or transdermal patches. To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills or patches (eg, condoms, a diaphragm, or a contraceptive foam or jelly) while using this medicine.

Grapefruits and grapefruit juice may increase the effects of artemether and lumefantrine combination by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you or your child are taking this medicine.

Do not take other medicines, including prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements, unless they have been discussed with your doctor. Artemether and lumefantrine combination should not be taken with certain other medicines, including carbamazepine (Tegretol®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), or St. John's wort.

Serious side effects of Coartem

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 side effects

  • 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 side effects

  • 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 of Coartem

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 side effects

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

Less common side effects

  • 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 adverse events

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

Metabolic

Other

Musculoskeletal

Gastrointestinal

Psychiatric

Cardiovascular

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]

Hepatic

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

Dermatologic

Hypersensitivity

Genitourinary

Ocular

See also:

References

1. (2009) "Product Information. Coartem (artemether-lumefantrine)." Novartis Pharmaceuticals

2. Lefevre G, Looareesuwan S, Treeprasertsuk S, et al. (2001) "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), p. 247-56

3. Bakshi R, Hermeling-Fritz I, Gathmann I, Alteri E (2000) "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, p. 419-24

4. (2009) "Artemether-lumefantrine (Coartem) for treatment of malaria." Med Lett Drugs Ther, 51, p. 75-6

5. Cerner Multum, Inc. "UK Summary of Product Characteristics."

6. Cerner Multum, Inc. "Australian Product Information."

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

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

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

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

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

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

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

Further information

Coartem side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.