Artemether

Coartem Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent [see Microbiology (12.4)] .

• Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above.ICD-10: B54

• Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions (6.2)] . Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St.contraindicated

Coartem Tablets should be taken with food. ( 2.1 , 5.2 ) Tablets may be crushed and mixed with 1 to 2 teaspoons of water immediately prior to administration to patients, including children. ( 2.1 ) Coartem Tablets should be administered over 3 days for a total of 6 doses: an initial dose, second dose after 8 hours, and then twice-daily (morning and evening) for the following 2 days. ( 2.2 , 2.3 ) The adult dosage for patients with bodyweight of 35 kg and above is 4 tablets per dose for a total of 6 doses. ( 2.2 ) The number of tablets per dose for children is determined by bodyweight, as shown in the chart below. ( 2.3 ) Tablets per dose by bodyweight; total of 6 doses over 3 days 5 to < 15 kg 1 tablet 15 to < 25 kg 2 tablets 25 to < 35 kg 3 tablets 35 kg and over 4 tablets 2.1 Administration Instructions Coartem Tablets should be taken with food. Patients with acute malaria are frequently averse to food. Patients should be encouraged to resume normal eating as soon as food can be tolerated since this improves absorption of artemether and lumefantrine. For patients who are unable to swallow the tablets such as infants and children, Coartem Tablets may be crushed and mixed with a small amount of water (1 to 2 teaspoons) in a clean container for administration immediately prior to use. The container can be rinsed with more water and the contents swallowed by the patient. The crushed tablet preparation should be followed whenever possible by food/drink (e.g., milk, formula, pudding, broth, and porridge).

Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval. ( 5.1 , 12.6 ) Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval. ( 5.1 , 5.2 , 12.3 ) Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data. ( 5.2 ) QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets. ( 5.1 , 5.2 , 7.7 , 12.3 ) Substrates, inhibitors, or inducers of CYP3A4, including antiretroviral medications, should be used cautiously with Coartem Tablets, due to a potential loss of efficacy of the concomitant drug or additive QT prolongation. ( 5.3 , 7.2 , 7.3 ) 5.1 Prolongation of the QT Interval Some antimalarials (e.g., halofantrine, quinine, quinidine) including Coartem Tablets have been associated with prolongation of the QT interval on the electrocardiogram (ECG). Coartem Tablets should be avoided in patients: With congenital prolongation of the QT interval (e.g., long QT syndrome) or any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease. With a family history of congenital prolongation of the QT interval or sudden death. With known disturbances of electrolyte balance, e.g., hypokalemia or hypomagnesemia.

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4)] Prolongation of the QT Interval [see Warnings and Precautions (5.1)] Use of QT Prolonging Drugs and Other Antimalarials [see Warnings and Precautions (5.2)] Drug Interactions with CYP3A4 [see Warnings and Precautions (5.3)] Drug Interactions with CYP2D6 [see Warnings and Precautions (5.4)] The most common adverse reactions in adults (greater than 30%) are headache, anorexia, dizziness, asthenia, arthralgia, and myalgia. The most common adverse reactions in children (greater than 12%) are pyrexia, cough, vomiting, anorexia, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in practice. The data described below reflect exposure to a 6-dose regimen of Coartem Tablets in 1979 patients including 647 adults (older than 16 years) and 1332 children (16 years and younger). For the 6-dose regimen, Coartem Tablets was studied in active-controlled (366 patients) and noncontrolled, open-label trials (1613 patients).

8.1 Pregnancy Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Malaria during and after pregnancy increases the risk for adverse pregnancy and neonatal outcomes, including maternal anemia, severe malaria, spontaneous abortion, stillbirths, preterm delivery, low birth weight, intrauterine growth restriction, congenital malaria, and maternal and neonatal mortality.

Metabolism

Absorption Following administration of Coartem Tablets to healthy volunteers and patients with malaria, artemether is absorbed with peak plasma concentrations reached about 2 hours after dosing. Absorption of lumefantrine, a highly lipophilic compound, starts after a lag-time of up to 2 hours, with peak plasma concentrations about 6 to 8 hours after administration.

There is no information on overdoses of Coartem Tablets higher than the doses recommended for treatment. In cases of suspected overdosage, symptomatic and supportive therapy, which would include ECG and blood electrolyte monitoring, should be given as appropriate.

• Apr 7, 2009NDANDA022268Novartis

1. 1Pyrexia2211%
2. 2Vomiting189.2%
3. 3Dyspnoea178.7%
4. 4Asthenia168.2%
5. 5Malaise136.6%
6. 6Malaria136.6%
7. 7Drug Ineffective126.1%
8. 8Maternal Exposure During Pregnancy115.6%
9. 9Headache105.1%
10. 10Anaemia94.6%
11. 11Dizziness94.6%
12. 12Pain94.6%
13. 13Condition Aggravated84.1%
14. 14Fatigue84.1%
15. 15Swelling Face84.1%

Recent PubMed references pinned to Artemether as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Research Progress on Anti-Inflammatory and Antioxidant Mechanism of Artemether Based on MAPK/NF-κB Signaling Pathway.
  International journal of molecular sciences · 2026 · Yang M, Feng K, Li Y, et al.
  PMID 42196584DOI 10.3390/ijms27104607
• Artemether ameliorates type 1 diabetic liver injury alongside the associated defects in mitochondrial ultrastructure and central carbon metabolism.
  PloS one · 2026 · Fu Q, Li J, Gu X, et al.
  PMID 42054402DOI 10.1371/journal.pone.0348214
• Therapeutic efficacy of artemether-lumefantrine and molecular markers of antimalarial drug resistance in Benin, 2022.
  Malaria journal · 2026 · Cavros I, Kpemasse A, Maye ASY, et al.
  PMID 42032728DOI 10.1186/s12936-026-05857-5
• Socioeconomic Impact of Artemether-Lumefantrine in Malaria Treatment across Sub-Saharan Africa: A Model-Based Historical Analysis with 2022 as Reference Year.
  The American journal of tropical medicine and hygiene · 2026 · Atitallah A, Peristeris P, Lovera D, et al.
  PMID 42013819DOI 10.4269/ajtmh.25-0570
• Gaps in knowledge and use of artemether-lumefantrine among university students in Southwestern Nigeria: A cross-sectional study.
  PloS one · 2026 · Orok E, Olumoko O, Ekada I, et al.
  PMID 42008437DOI 10.1371/journal.pone.0347554
• Efficacy and safety of artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ) for the treatment of uncomplicated Plasmodium falciparum malaria among children 6-59 months in three sentinel sites of Sierra Leone, 2021-2022.
  Malaria journal · 2026 · Cavros I, Abanyie F, Kamara ARY, et al.
  PMID 41957831DOI 10.1186/s12936-026-05850-y
• Artemether and Euphorbia factor L9 suppress kynurenine production through distinct effects on tryptophan metabolism.
  The Biochemical journal · 2026 · Capatina AL, Czechowski T, Plunkett-Jones C, et al.
  PMID 41823303DOI 10.1042/BCJ20253246
• Artemether as a modulator of EMT in colorectal cancer: enhancing radiosensitivity and reversing chemo-radiation resistance.
  BMC gastroenterology · 2026 · Ge L, Liu S, Yu S, et al.
  PMID 41634588DOI 10.1186/s12876-026-04653-4

The 10 most recently updated of 248 ClinicalTrials.gov registrations naming Artemether as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• First-in-Human PfSPZ-LARC2 Vaccination/CHMI
  Active not recruiting · Phase 1 · Interventional · 22 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06735209updated 2026-06-12
• Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)
  Completed · Phase 2 · Interventional · 60 enrolled · Novartis Pharmaceuticals
  NCT07235033updated 2026-05-07
• Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
  Completed · Phase 2 · Interventional · 295 enrolled · Novartis Pharmaceuticals
  NCT04546633updated 2026-05-07
• Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
  Active not recruiting · Phase 4 · Interventional · 2,174 enrolled · Duke University
  NCT05757167updated 2026-05-07
• Pharmacokinetics of Antimalarials in Breastfeeding Ugandan Mother-infant Pairs
  Active not recruiting · Observational · 30 enrolled · University of Liverpool
  NCT05676645updated 2026-05-06
• Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria
  Recruiting · Phase 2 · Interventional · 1,116 enrolled · Victoria Biomedical Research Institute
  NCT07559370updated 2026-04-30
• Targeting High Risk Populations With Enhanced Reactive Case Detection in Southern Lao Peoples Democratic Republic
  Withdrawn · Interventional · 0 enrolled · University of California, San Francisco
  NCT04416945updated 2026-04-29
• Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax
  Not yet recruiting · Interventional · 300 enrolled · Walter Reed Army Institute of Research (WRAIR)
  NCT07533136updated 2026-04-16
• Artemisinin Partial Resistance in Ethiopian Plasmodium Falciparum: A Multisite Clinical, Molecular and In Vitro Study
  Completed · Interventional · 277 enrolled · Didier Menard
  NCT07527182updated 2026-04-14
• To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria
  Completed · Phase 2 · Interventional · 254 enrolled · Novartis Pharmaceuticals
  NCT04675931updated 2026-04-09

Frequently asked questions

How does Artemether work?

Coartem Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent [see Microbiology (12.4)] .

What is Artemether used for?

According to FDA labeling, Artemether carries indications including: Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 kg and above.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Artemether?

Artemether is classified as Artemisinin and derivatives, plain, Antimalarial, Nucleic Acid Synthesis Inhibitors, Protein Synthesis Inhibitors.

What are the brand names for Artemether?

Artemether is marketed under brand names including Coartem.

What are the contraindications for Artemether?

Artemether labeling lists contraindications including: Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions (6.2)] . Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St.. Always consult the full prescribing information and a clinician.