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Artemether and Lumefantrine

Artemether and lumefantrine is a two-drug antimalarial combination used to treat acute, uncomplicated malaria caused by Plasmodium falciparum.

Brand name Coartem
Drug class Antimalarial
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 9, 2026
Artemether and Lumefantrine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Artemether and lumefantrine (Coartem) treats acute, uncomplicated P. falciparum malaria, not severe malaria or prevention, by pairing a fast-acting drug with a longer-lasting partner that clears leftover parasites; it is a usual first choice, on the U.S. market since about 2009 with no generic version listed. Most people tolerate it well, noticing mainly headache, dizziness, poor appetite or tiredness, some of which malaria itself causes. The thing to watch is its effect on heart rhythm (QT prolongation), so tell your prescriber about any heart history and every medicine you take, including St. John’s wort and hormonal birth control. Take every dose with food and finish all 6 doses.

Clinical pearls

  • The second dose is due 8 hours after the first, not the next morning, so set an alarm.
  • If you vomit within 1 to 2 hours, repeat the dose; vomiting the repeat means you need a different antimalarial.
  • Rifampin, carbamazepine and phenytoin must not be combined with it, and skip grapefruit juice during treatment.
  • Report unusual tiredness or paleness after the course ends, since delayed breakdown of red blood cells has been reported.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2009
Companies listing it with the FDA1
FDA label last updatedMar 26, 2026
FDA’s strongest warning (boxed)None on the label

Patient Information Guide A plain-language walkthrough of Artemether and Lumefantrine, written from its FDA label.

What Artemether and Lumefantrine Is Used For

▾

Artemether and lumefantrine is used to treat one type of malaria.

  • Coartem tablets treat acute, uncomplicated malaria caused by Plasmodium falciparum in patients 2 months and older weighing at least 5 kg.
  • Coartem has been shown to work in regions where chloroquine resistance has been reported.
  • Coartem is not approved for severe or complicated malaria.
  • Coartem is not approved to prevent malaria.

How Artemether and Lumefantrine Works

▾

Coartem combines artemether and lumefantrine in a 1:6 ratio. Together they act as an antimalarial against the parasite.

Artemether and Lumefantrine Dosage

▾

Coartem tablets are taken by mouth over 3 days, for 6 doses in total. Take the first dose, the second 8 hours later, then morning and evening for 2 more days.

  • Always take it with food. Food greatly improves absorption.
  • The number of tablets depends on body weight.
  • Tablets may be crushed in 1 to 2 teaspoons of water for those who can't swallow them.
  • If you vomit within 1 to 2 hours, a repeat dose should be taken. If that is vomited too, a different antimalarial is needed.

Follow your prescriber and the label.

Dosing details from the FDA-approved label

From the Artemether and Lumefantrine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult patients (greater than 16 years of age) with bodyweight of 35 kg and above
    • Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice-daily (morning and evening) for the following 2 days (total course of 24 tablets)
    • 3-day schedule, total of 6 doses
    • Take with food; tablets may be crushed and mixed with 1 to 2 teaspoons of water
  • Pediatric patients 5 kg to less than 15 kg bodyweight
    • One tablet as an initial dose, 1 tablet again after 8 hours, and then 1 tablet twice daily (morning and evening) for the following 2 days (total course of 6 tablets)
    • Take with food; tablets may be crushed and mixed with 1 to 2 teaspoons of water
  • Pediatric patients 15 kg to less than 25 kg bodyweight
    • Two tablets as an initial dose, 2 tablets again after 8 hours, and then 2 tablets twice daily (morning and evening) for the following 2 days (total course of 12 tablets)
    • Take with food; tablets may be crushed and mixed with 1 to 2 teaspoons of water
  • Pediatric patients 25 kg to less than 35 kg bodyweight
    • Three tablets as an initial dose, 3 tablets again after 8 hours, and then 3 tablets twice daily (morning and evening) for the following 2 days (total course of 18 tablets)
    • Take with food; tablets may be crushed and mixed with 1 to 2 teaspoons of water
  • Pediatric patients 35 kg bodyweight and above
    • Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice daily (morning and evening) for the following 2 days (total course of 24 tablets)
    • Take with food; tablets may be crushed and mixed with 1 to 2 teaspoons of water
  • Patients with hepatic or renal impairment
    • No specific dose adjustments are needed for mild or moderate hepatic impairment
    • No dose adjustment is recommended for renal impairment, including severe
    • Caution should be exercised in patients with severe hepatic or renal impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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). In the event of vomiting within 1 to 2 hours after administration, a repeat dose should be taken. If the repeat dose is vomited, the patient should be given an alternative antimalarial for treatment. 2.2 Dosage in Adult Patients (greater than 16 years of age) A 3-day treatment schedule with a total of 6 doses is recommended for adult patients with a bodyweight of 35 kg and above: Four tablets as a single initial dose, 4 tablets again after 8 hours, and then 4 tablets twice-daily (morning and evening) for the following 2 days (total course of 24 tablets). For patients weighing less than 35 kg, [see Dosage and Administration (2.3)] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Artemether and Lumefantrine Side Effects

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Most side effects are mild and settle on their own.

Common side effects

  • Headache
  • Dizziness
  • Loss of appetite
  • Weakness or tiredness (asthenia)
  • Joint and muscle pain
  • In children: fever, cough and vomiting
  • Nausea and vomiting

When to get medical help

  • Get medical help right away for signs of a serious allergic reaction, such as swelling, hives, trouble breathing or a severe skin reaction.
  • Call your doctor if you have palpitations, fainting or a very irregular heartbeat, since this medicine can affect heart rhythm (QT prolongation).
  • Call your doctor if you vomit your dose again after a repeat dose, because you may need a different antimalarial.
  • Call your doctor if your malaria symptoms return or do not improve after treatment.
  • Tell your doctor about unusual tiredness or paleness after treatment, since delayed hemolytic anemia (destruction of red blood cells) has been reported.

Artemether and Lumefantrine Warnings and Precautions

▾
  • QT prolongation: Coartem can affect heart rhythm. Avoid it with known QT problems, low potassium or magnesium, or other QT-prolonging drugs.
  • Food matters: If you can't eat, the infection may be more likely to return.
  • Not for severe malaria: Delayed hemolytic anemia has been reported in people treated for severe malaria.
  • Other antimalarials: Don't combine them unless there is no other option. Halofantrine must be separated by one month.
  • P. vivax: Extra treatment is needed to clear parasites dormant in the liver.
  • Recurrence: If the infection returns, a different antimalarial is needed.

Artemether and Lumefantrine Interactions

▾

Many medicines can change how Coartem works or add to heart rhythm risk.

  • Rifampin, carbamazepine, phenytoin, St. John’s wort: must not be used, as they lower Coartem levels and cause loss of effect.
  • QT-prolonging drugs (some antiarrhythmics, antipsychotics, antidepressants, macrolide and fluoroquinolone antibiotics, azole antifungals): added heart rhythm risk.
  • CYP3A4 inhibitors, including grapefruit juice: may raise levels and QT risk.
  • HIV medicines: effects vary and may reduce effectiveness or raise QT risk.
  • Hormonal birth control: may be less effective, so add a non-hormonal or barrier method.
  • CYP2D6 drugs (flecainide, imipramine, amitriptyline, clomipramine): should not be used together.
  • Mefloquine just before Coartem: may lower lumefantrine levels, so eat well and be monitored.
  • Quinine and quinidine after Coartem: use with caution, with ECG monitoring if needed.

Interactions listed in the FDA-approved label

From the Artemether and Lumefantrine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St. John's wort): Rifampin decreased exposure to artemether, DHA, and lumefantrine by 89%, 85%, and 68%, respectively, with potential loss of antimalarial efficacy. Concomitant use is contraindicated.
  • CYP3A4 inhibitors (e.g., ketoconazole): Ketoconazole moderately increased exposure to artemether, DHA, and lumefantrine; increased lumefantrine could lead to QT prolongation. No dose adjustment necessary, but use cautiously with drugs that inhibit CYP3A4.
  • Antiretroviral drugs (protease inhibitors, non-nucleoside reverse transcriptase inhibitors): Variable effects on artemether, DHA, and lumefantrine exposure; decreased concentrations may reduce antimalarial efficacy and increased lumefantrine may cause QT prolongation. Use cautiously.
  • Mefloquine (prior use): Exposure to lumefantrine was reduced; no effect on artemether concentrations or artemether/DHA ratio. Monitor for decreased efficacy and encourage food consumption.
  • Hormonal contraceptives: Coartem may potentially reduce the effectiveness of hormonal contraceptives. Use an alternative non-hormonal contraceptive method or add a barrier method during treatment.
  • CYP2D6 substrates (e.g., flecainide, imipramine, amitriptyline, clomipramine): Lumefantrine inhibits CYP2D6 in vitro; may significantly increase plasma concentrations of the coadministered drug and increase risk of adverse effects, including additive QT effect. Many QT-prolonging CYP2D6 substrates should not be administered with Coartem Tablets.
  • Quinine (sequential use): No effect on DHA, lumefantrine or quinine exposure; artemether exposure decreased, not thought clinically significant; additive QT effects possible. Use quinine and other QT-prolonging drugs cautiously after Coartem; ECG monitoring is advised if medically required.
  • Drugs that prolong the QT interval (Class IA and III antiarrhythmics, neuroleptics, antidepressants, macrolides, fluoroquinolones, imidazole and triazole antifungals): May cause prolonged QT interval when coadministered with Coartem. Use with caution.
Read the label’s full interactions text

7 DRUG INTERACTIONS CYP3A4 Inducers: Potential for loss of antimalarial efficacy. ( 4 , 5.3 , 7.1 , 12.3 ) CYP3A4 Inhibitors: Use cautiously due to potential for QT prolongation. ( 5.3 , 7.2 , 12.3 ) Antiretrovirals: Use cautiously due to potential for QT prolongation, loss of antiviral efficacy, or loss of antimalarial efficacy of Coartem Tablets. ( 5.3 , 7.3 , 12.3 ) Mefloquine: If used immediately before treatment, monitor for decreased efficacy of Coartem Tablets and encourage food consumption. ( 2.1 , 7.4 , 12.3 ) Hormonal Contraceptives: Effectiveness may be reduced; use an additional method of birth control. ( 5.3 , 7.5 , 12.3 ) CYP2D6 Substrates: Monitor for adverse reactions and potential QT prolongation. ( 5.1 , 5.4 , 7.6 ) 7.1 Rifampin Oral administration of rifampin, a strong CYP3A4 inducer, with Coartem Tablets resulted in significant decreases in exposure to artemether, DHA (metabolite of artemether), and lumefantrine by 89%, 85%, and 68%, respectively, when compared to exposure values after Coartem Tablets alone. Concomitant use of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort is contraindicated with Coartem Tablets [see Contraindications (4) and Clinical Pharmacology (12.3)] . 7.2 Ketoconazole 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. No dose adjustment of Coartem Tablets is necessary when administered with ketoconazole or other potent CYP3A4 inhibitors. However, due to the potential for increased concentrations of lumefantrine which could lead to QT prolongation, Coartem Tablets should be used cautiously with drugs that inhibit CYP3A4 [see Warnings and Precautions (5.1, 5.3) and Clinical Pharmacology (12.3)] . 7.3 Antiretroviral Drugs Both artemether and lumefantrine are metabolized by CYP3A4.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Artemether and Lumefantrine against a supplement or herb →

Before Taking Artemether and Lumefantrine

▾
  • Do not use if allergic to artemether, lumefantrine or any ingredient.
  • Tell your doctor about heart rhythm problems, slow heartbeat, severe heart disease, or a family history of long QT or sudden death.
  • Tell your doctor about low potassium or magnesium.
  • Pregnancy: studies haven't shown increased birth defects or miscarriage, and malaria itself is risky in pregnancy.
  • Breastfeeding: no human data. Weigh benefits and risks with your doctor.
  • Children: not established under 2 months or 5 kg.
  • Older adults: limited study data, so consider reduced liver, kidney or heart function.
  • Severe liver or kidney disease: not studied, so use caution.

Artemether and Lumefantrine Overdose

▾

There is no information on overdoses above the recommended treatment doses. If an overdose is suspected, treatment is symptom-based and supportive, including ECG and blood electrolyte monitoring.

How Your Body Processes Artemether and Lumefantrine

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Food greatly increases absorption: artemether rose 2- to 3-fold and lumefantrine 16-fold after a high-fat meal. Artemether peaks in about 2 hours, while lumefantrine peaks at about 6 to 8 hours.

Both are broken down mainly by the liver enzyme CYP3A4. Artemether and its active form DHA clear in about 2 hours. Lumefantrine clears slowly, with a half-life of 3 to 6 days. Neither drug was found in urine.

How to Store Artemether and Lumefantrine

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Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) . Dispense in tight container (USP).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Artemether and Lumefantrine: Pharmacist Answers to Common Questions

Quick, plain-English answers to the questions patients ask most about Artemether and Lumefantrine — the kind of thing our pharmacy team would talk through with you at the counter.

What is this medicine for?

▾
It treats acute, uncomplicated malaria caused by Plasmodium falciparum. It is not for severe malaria and won't prevent malaria. Coartem tablets are approved for patients 2 months and older who weigh at least 5 kg.

How should I take it?

▾
Take it by mouth with food, for 6 doses over 3 days. The first two doses are 8 hours apart, then you take one in the morning and one in the evening for 2 days. Follow the tablet count your prescriber gives you.

What if I can't eat or I vomit?

▾
Try to eat as soon as you can tolerate food, since food helps your body absorb the medicine. If you vomit within 1 to 2 hours of a dose, take a repeat dose. If you vomit that one too, contact your doctor, because you will need a different antimalarial.

What side effects should I expect?

▾
Headache, dizziness, loss of appetite, weakness, and joint or muscle aches are common. Children often have fever, cough or vomiting. Call right away if you notice allergic reactions, a racing or irregular heartbeat, or fainting.

Can I take my other medicines with it?

▾
Tell me everything you take first. Rifampin, carbamazepine, phenytoin and St. John’s wort must not be used with it, and some heart, antibiotic, antifungal and HIV medicines need caution. Avoid grapefruit juice too.

Does it affect birth control or pregnancy?

▾
It may make hormonal birth control less effective, so use a non-hormonal or barrier method during treatment. Studies haven't shown an increased risk of birth defects or miscarriage, but talk with your doctor if you are pregnant or breastfeeding.

Is Artemether and Lumefantrine available over the counter?

▾
No. Artemether and Lumefantrine is a prescription medicine: every Artemether and Lumefantrine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Artemether and Lumefantrine first available?

▾
The earliest FDA record we hold for Artemether and Lumefantrine is from 2009: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Artemether and Lumefantrine was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Artemether and Lumefantrine on HelloPharmacist

🌿Drug & Supplement CheckerArtemether and Lumefantrine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Artemether and Lumefantrine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed Data & References for Artemether and Lumefantrine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Artemether and Lumefantrine Forms and Strengths (How It Comes)

Artemether and Lumefantrine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Artemether and Lumefantrine inactive ingredients by manufacturer.

Tablet

By mouth
Brands Coartem
How this form is used
What it may be used for
  • Coartem tablets treat acute, uncomplicated P. falciparum malaria in patients 2 months and older weighing 5 kg or more.
  • Coartem is not approved for severe or complicated malaria or for malaria prevention.
Important instructions
  • Coartem tablets are taken with food over 3 days for a total of 6 doses.
  • Coartem tablets may be crushed and mixed with 1 to 2 teaspoons of water for those who can't swallow them, followed by food or drink.
  • If vomiting occurs within 1 to 2 hours of a Coartem dose, a repeat dose should be taken.
  • The number of Coartem tablets per dose depends on body weight.
Available strengths 1 strength
20 mg / 120 mg
3 FDA-listed product records ⓘ

Artemether and Lumefantrine on the U.S. Market: Products, Makers and Brands

How Artemether and Lumefantrine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 1 Artemether and Lumefantrine product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2009. Brand names on the directory include Coartem; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2009
Earliest FDA record ⓘ

How Widely Artemether and Lumefantrine Is Used (Medicaid Data)

A general measure of how commonly Artemether and Lumefantrine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q2 2025 – Q1 2026, summed across every form and brand of the drug.

Think of this as a proxy for how widely Artemether and Lumefantrine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

14
Medicaid prescriptions filled (Q2 2025 – Q1 2026)
$1,810 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Artemether and Lumefantrine prescribed? Of the 1,603 medications we measure, Artemether and Lumefantrine ranks #1,584 by Medicaid prescriptions — more than 1% of them.

Where Artemether and Lumefantrine ranks among the drugs we measure · Q2 2025 – Q1 2026 · neighbors ±5
Total prescriptions — #1,584 of 1,603
#1,579 Capsaicin Transdermal... 22 Rx #1,580 Piperacillin / Sodium... 17 Rx #1,581 Mosunetuzumab-axgb Inj... 15 Rx #1,582 Acetaminophen / Ibupro... 15 Rx #1,583 Hyaluronidase / Ocreli... 15 Rx #1,584 Artemether and Lumefan... 14 Rx #1,585 Phenoxybenzamine 14 Rx #1,586 Siltuximab Injection 13 Rx #1,587 Phenytoin Injection 13 Rx #1,588 Dactinomycin 13 Rx #1,589 Tetrahydrozoline Ophth... 13 Rx

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Artemether and Lumefantrine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Artemether and Lumefantrine NDCs with Medicaid activity.

Compare Artemether and Lumefantrine Products

A representative set of FDA-listed product records for Artemether and Lumefantrine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
ARTEMETHER 20 mg/1; LUMEFANTRINE 120 mg Oral Novartis Pharmaceuticals Corporation NDA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Artemether and Lumefantrine NDCs →

Artemether and Lumefantrine Side Effects Reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Artemether and Lumefantrine — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Artemether and Lumefantrine are pyrexia, vomiting, dyspnoea; about 88% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

196
Reports mentioning it
88%
Reported as serious
12
Distinct effects shown
Most reported effects
Pyrexia
22
Vomiting
18
Dyspnoea
17
Asthenia
16
Malaise
13
Malaria
13
Headache
10
Anaemia
9
Dizziness
9
Pain
9
Age groups
Adult · 2Child · 1Elderly · 1

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Artemether and Lumefantrine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Artemether and Lumefantrine Recall History

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Artemether and Lumefantrine recalls since July 2021.

✅No Artemether and Lumefantrine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Artemether and Lumefantrine RxCUI 282448 1 dose form · 1 strength

Look up RxCUI 282448 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Artemether and Lumefantrine Costs Pharmacies (NADAC Benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Oct 7, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 20; 120 mg/1; mg $5.36 per tablet NDC details & price history
Tablet · Oral ARTEMETHER 20 mg/1; LUMEFANTRINE 120 mg $5.36 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Artemether and Lumefantrine Brand Names

Artemether and Lumefantrine is sold under one brand name in the FDA directory — Coartem. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Coartem

Who Makes Artemether and Lumefantrine: Manufacturers and Labelers

One company lists Artemether and Lumefantrine products with the FDA. By number of product records, the largest are Novartis Pharmaceuticals Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Novartis Pharmaceuticals Corporation 1

Artemether and Lumefantrine Drug Class (RxNorm)

Artemether and Lumefantrine belongs to the Antimalarial class.

Pharmacologic class Antimalarial
Drug family (ATC) Artemisinin and derivatives, plain

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for This Artemether and Lumefantrine Page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 26, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Artemether and Lumefantrine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Artemether and Lumefantrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Novartis Pharmaceuticals Corporation
Linked label effective
Mar 26, 2026
Composite sections available
20
Linked SPL Set ID
7866ec19-dfac-47d4-a53f-511a12643cbf
Linked SPL Document ID
d8b344bc-882f-4f60-8593-8c6ed1a11919
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

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HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →