Artemether / Lumefantrine Side Effects

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

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:

• If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.
• Wear long-sleeved shirts and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply insect repellant, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• If possible, sleep in a screened or air-conditioned room or under mosquito netting sprayed with insecticide to avoid being bitten by malaria-carrying mosquitoes.
• Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

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

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:

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:

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

• 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

• 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]

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

• 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]

See also:

Further information

Artemether/lumefantrine 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.

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