Prescription medicine
Artemether and lumefantrine Brand names: Coartem
Artemether and lumefantrine (Coartem) is a prescription medicine with an FDA approval on record since 2009. No generic is listed; pharmacies paid $5.36 per Coartem tablets in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the artemether and lumefantrine FDA label on DailyMed (effective March 26, 2026, Novartis Pharmaceuticals Corporation); the NDA 22268 record on Drugs@FDA; every artemether and lumefantrine label on DailyMed.
Highlights of the record
FDA label of March 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCoartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P.
Forms and strengths
- 20 mg / 120 mg
Tablet.
On the market
- Earliest approval on file
- April 7, 2009 Coartem, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $5.36 per tablet Coartem tablets
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 196 through July 30, 2026
What is artemether and lumefantrine used for?
From the label: indications and usageCoartem 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. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)]. Limitations of Use: Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria. Coartem Tablets are not approved for the prevention of malaria. […]
FDA pharmacologic class: Antimalarial.
Source: FDA drug label (COARTEM), Novartis Pharmaceuticals Corporation, effective March 26, 2026 (SPL set 7866ec19-dfac-47d4-a53f-511a12643cbf), via openFDA; the full label on DailyMed
Is there a generic for artemether and lumefantrine (Coartem)?
No generic artemether and lumefantrine is approved (Drugs@FDA, October 8, 2026).
- 2009 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for artemether and lumefantrine (Coartem)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $5.36 per Coartem tablets, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Coartem tablets (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Coartem tablets | Brand | $5.36 per tablet | $160.89 | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the artemether and lumefantrine label say about other medicines?
The artemether and lumefantrine label names 18 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name artemether and lumefantrine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | Receiving other medications that prolong the QT interval, such as Class IA (quinidine, procainamide, disopyramide), or Class III (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; … |
| Amitriptyline | drug interactions | Many of the drugs metabolized by CYP2D6 can prolong the QT interval and should not be administered with Coartem Tablets due to the potential additive effect on the QT interval (e.g., flecainide, imipramine, amitriptyline, clomipramine) [see Warnings and Precautions (5.1, 5.4) and Clinical Pharmacology (12.3)]. |
| Carbamazepine | contraindications | Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy [see Warnings and Precautions (5.3), Drug Interactions … |
| Clomipramine | drug interactions | Many of the drugs metabolized by CYP2D6 can prolong the QT interval and should not be administered with Coartem Tablets due to the potential additive effect on the QT interval (e.g., flecainide, imipramine, amitriptyline, clomipramine) [see Warnings and Precautions (5.1, 5.4) and Clinical Pharmacology (12.3)]. |
| Disopyramide | warnings and precautions | Receiving other medications that prolong the QT interval, such as Class IA (quinidine, procainamide, disopyramide), or Class III (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; … |
| Flecainide | drug interactions | Many of the drugs metabolized by CYP2D6 can prolong the QT interval and should not be administered with Coartem Tablets due to the potential additive effect on the QT interval (e.g., flecainide, imipramine, amitriptyline, clomipramine) [see Warnings and Precautions (5.1, 5.4) and Clinical Pharmacology (12.3)]. |
| Imipramine | drug interactions | Many of the drugs metabolized by CYP2D6 can prolong the QT interval and should not be administered with Coartem Tablets due to the potential additive effect on the QT interval (e.g., flecainide, imipramine, amitriptyline, clomipramine) [see Warnings and Precautions (5.1, 5.4) and Clinical Pharmacology (12.3)]. |
| Ketoconazole | drug interactions | Concurrent oral administration of ketoconazole, a potent CYP3A4 inhibitor, with a single dose of Coartem Tablets resulted in a moderate increase in exposure to artemether, DHA, and lumefantrine in a study of 15 healthy subjects. |
| Levonorgestrel | drug interactions | In vitro, the metabolism of ethinyl estradiol and levonorgestrel was not induced by artemether, DHA, or lumefantrine. |
| Mefloquine | drug interactions | Use of Mefloquine Administration of 3 doses of mefloquine followed 12 hours later by a 6-dose regimen of Coartem Tablets in 14 healthy volunteers demonstrated no effect of mefloquine on plasma concentrations of artemether or the artemether/DHA ratio. |
| Phenytoin | contraindications | Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy [see Warnings and Precautions (5.3), Drug Interactions … |
| Pimozide | warnings and precautions | Receiving other medications that prolong the QT interval, such as Class IA (quinidine, procainamide, disopyramide), or Class III (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; … |
| Procainamide | warnings and precautions | Receiving other medications that prolong the QT interval, such as Class IA (quinidine, procainamide, disopyramide), or Class III (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; … |
| Quinidine | warnings and precautions | … 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 … |
Every other medicine the artemether and lumefantrine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Quinine | drug interactions | Use of Quinine A single dose of intravenous quinine (10 mg/kg bodyweight) concurrent with the final dose of a 6-dose regimen of Coartem Tablets demonstrated no effect of intravenous quinine on the … |
| Rifampin | contraindications | Strong CYP3A4 Inducers Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets can result in decreased concentrations of … |
| Sotalol | warnings and precautions | Receiving other medications that prolong the QT interval, such as Class IA (quinidine, procainamide, disopyramide), or Class III (amiodarone, sotalol) antiarrhythmic agents; … |
| Ziprasidone | warnings and precautions | … (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; certain antibiotics (macrolide antibiotics, fluoroquinolone antibiotics, imidazole, and triazole … |
Other labels that name artemether and lumefantrine
Source: FDA drug label (COARTEM), Novartis Pharmaceuticals Corporation, effective March 26, 2026 (SPL set 7866ec19-dfac-47d4-a53f-511a12643cbf), via openFDA; the full label on DailyMed
What do FAERS reports show for artemether and lumefantrine?
The FDA Adverse Event Reporting System holds 196 reports that list artemether and lumefantrine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 61 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antimalarials
- the pharmacologic class, with prices and generics
- Artemether and lumefantrine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other