Artemether and Lumefantrine
Artemether and lumefantrine is a combination antimalarial used to treat acute, uncomplicated malaria caused by Plasmodium falciparum.
🧬 Where this information comes from Click to expand
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 →
📖 Artemether and Lumefantrine: Patient Information Guide
A plain-language walkthrough of Artemether and Lumefantrine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Artemether and lumefantrine is a combination antimalarial indicated for the following use:
- Coartem Tablets are approved to treat acute, uncomplicated malaria infections caused by Plasmodium falciparum in patients 2 months of age and older weighing at least 5 kg (about 11 lbs)
- Coartem Tablets have been shown to be effective in regions where the malaria parasite has developed resistance to chloroquine
- Coartem Tablets are not approved for severe or complicated P. falciparum malaria
- Coartem Tablets are not approved for the prevention of malaria
⚙️How it works▾
Coartem Tablets combine two antimalarial medicines, artemether and lumefantrine, in a fixed ratio. Together they attack the Plasmodium falciparum parasite through different mechanisms, clearing the parasite from the bloodstream more completely than either drug alone. Artemether is rapidly absorbed and converted in the body to an active form called dihydroartemisinin (DHA), which acts quickly against the parasite. Lumefantrine is absorbed more slowly and stays in the body longer, helping to eliminate any remaining parasites and reduce the chance of the infection returning.
The combination approach is also designed to help prevent antimalarial drug resistance, since a parasite is less likely to survive attacks from two different agents at once.
💊How it's taken▾
Coartem Tablets are taken by mouth over 3 days for a total of 6 doses. The first dose is taken as soon as possible, a second dose is taken 8 hours later, and then one dose is taken in the morning and one in the evening for the next 2 days. Taking Coartem with food is essential — food dramatically increases how much medicine your body absorbs, especially lumefantrine. The number of tablets per dose depends on body weight and is determined by your prescriber.
- Tablets may be crushed and mixed with a small amount of water for patients who cannot swallow them whole
- If vomiting occurs within 1–2 hours of a dose, that dose should be repeated; if vomiting continues, contact your doctor
- Do not miss doses — completing the full 3-day course is important to clear the infection
🤒Side effects — in detail▾
Most side effects of Coartem are mild and resolve after treatment is finished. Common ones include:
- Headache and dizziness
- Loss of appetite (anorexia)
- Weakness (asthenia) and fatigue
- Joint pain (arthralgia) and muscle aches (myalgia)
- Fever, chills, and general feeling of illness
- Nausea, vomiting, and stomach pain
- Palpitations (awareness of heartbeat)
- Sleep disturbances or insomnia
Serious reactions are less common but require prompt attention: signs of a dangerous heart rhythm change (irregular, fast, or pounding heartbeat), severe allergic reactions (facial swelling, hives, difficulty breathing), or malaria symptoms that return after finishing treatment all warrant immediate medical care.
⚠️Warnings & precautions▾
- Heart rhythm (QT prolongation): Coartem can lengthen the QT interval — an electrical measurement of the heart — which can trigger life-threatening arrhythmias. Avoid Coartem if you have long QT syndrome, a family history of sudden cardiac death, symptomatic arrhythmias, low potassium or magnesium, or if you take other QT-prolonging drugs.
- Drug interactions with heart consequences: Many common medicines — including certain antibiotics, antidepressants, antifungals, and antiarrhythmics — can add to Coartem's QT effect. Sharing your full medication list with your doctor before starting is critical.
- Halofantrine: Do not take halofantrine within one month of Coartem due to combined QT risk.
- Food and treatment failure: Taking Coartem without food reduces absorption significantly, raising the risk of the infection returning (recrudescence). If the infection comes back, a different antimalarial drug must be used.
- Hormonal contraceptives: Coartem may reduce the effectiveness of hormonal birth control. Use an additional barrier method during treatment.
- Severe liver or kidney impairment: Coartem has not been well-studied in patients with severe liver or kidney disease; use with caution in these patients.
🔀What it interacts with▾
Coartem interacts with a wide range of medications, mainly through liver enzymes (CYP3A4 and CYP2D6). Key interactions include:
- Rifampin, carbamazepine, phenytoin, St. John's wort — contraindicated; these strong CYP3A4 inducers sharply reduce Coartem blood levels and can cause treatment failure
- Ketoconazole and other CYP3A4 inhibitors (including grapefruit juice) — increase levels of artemether and lumefantrine, raising the risk of QT prolongation; use with caution
- HIV antiretroviral drugs — have variable effects on Coartem levels and QT interval; use cautiously and monitor for both antimalarial efficacy and heart effects
- Halofantrine — do not use within one month of Coartem; combined QT risk is significant
- Quinine and quinidine — avoid or use with extreme caution after Coartem; additive QT prolongation risk; ECG monitoring is recommended
- CYP2D6 substrates (e.g., flecainide, amitriptyline, imipramine, clomipramine) — Coartem can increase their blood levels, raising the risk of side effects and QT prolongation; generally should not be combined
- Antiarrhythmics (Class IA and III), antipsychotics, antidepressants, macrolide/fluoroquinolone antibiotics, imidazole/triazole antifungals — all increase QT prolongation risk when combined with Coartem
- Hormonal contraceptives — Coartem may reduce their effectiveness; use an additional non-hormonal method during treatment
- Mefloquine (used just before Coartem) — may reduce lumefantrine absorption; eating with doses and monitoring for reduced efficacy is important
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor if you have any heart rhythm disorders, long QT syndrome, or a family history of sudden cardiac death
- Tell your doctor if you have low potassium (hypokalemia) or low magnesium (hypomagnesemia) levels
- Tell your doctor about every medication, supplement, and herbal product you take — especially heart medicines, antidepressants, antibiotics, antifungals, and HIV drugs
- Tell your doctor if you are pregnant: malaria in pregnancy is dangerous, and the risks and benefits of Coartem should be discussed carefully with your healthcare provider
- Tell your doctor if you are breastfeeding: it is not known whether artemether or lumefantrine passes into human breast milk
- Coartem is not established as safe or effective in children under 2 months of age or weighing less than 5 kg
- If you use hormonal birth control (pill, patch, ring, or implant), use an additional barrier method during Coartem treatment, as the medicine may reduce its effectiveness
- Tell your doctor if you have severe liver or kidney disease; caution is needed in these situations
- Older adults should use Coartem with care, as age-related changes in liver, kidney, or heart function may affect how the drug works
🚑If you take too much▾
There is no specific information available on what happens if more than the recommended amount of Coartem is taken. If an overdose is suspected, seek medical attention right away. Treatment would focus on monitoring heart rhythm (ECG) and blood electrolyte levels, along with supportive care as needed.
🔬Pharmacokinetics — how your body processes it▾
After you take Coartem Tablets, artemether is absorbed quickly — reaching peak levels in about 2 hours. Lumefantrine takes longer to be absorbed, peaking around 6 to 8 hours after dosing. Eating with the tablets is critical: food increases artemether absorption 2- to 3-fold and lumefantrine absorption up to 16-fold compared to taking the tablets on an empty stomach.
Artemether is converted in the liver mainly by the enzyme CYP3A4 into an active form called dihydroartemisinin (DHA). Both artemether and DHA leave the body relatively quickly, with a half-life of about 2 hours. Lumefantrine stays in the body much longer — with a half-life of 3 to 6 days — which helps clear any remaining parasites after the faster-acting artemether component has worn off. Neither lumefantrine, artemether, nor DHA is significantly eliminated through the kidneys.
📦How to store it▾
Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) . Dispense in tight container (USP).
📄 Written from Artemether and Lumefantrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
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 Coartem actually for — can it prevent malaria if I'm traveling? ▾
Why does it matter so much whether I eat when I take this medicine? ▾
What side effects should I actually expect, and which ones should make me call the doctor? ▾
Are there medicines I need to stop or avoid while I'm taking Coartem? ▾
Is it safe to take Coartem if I'm pregnant or breastfeeding? ▾
My child needs to take this — is it safe for kids, and how do I give it to a young child who can't swallow tablets? ▾
Is Artemether and Lumefantrine available over the counter? ▾
When was Artemether and Lumefantrine first available? ▾
💬 Answers drafted from Artemether and Lumefantrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Artemether and Lumefantrine 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.
Tablet
How this form is used
- Coartem Tablets are used to treat acute, uncomplicated malaria caused by Plasmodium falciparum in patients 2 months of age and older weighing at least 5 kg
- Coartem Tablets are effective in areas where chloroquine-resistant Plasmodium falciparum has been reported
- Coartem Tablets are not approved for severe or complicated malaria, or for malaria prevention
- Coartem Tablets must be taken with food to maximize absorption of both artemether and lumefantrine
- Coartem Tablets are taken over 3 days: an initial dose, a second dose 8 hours later, then one dose in the morning and one in the evening for the next 2 days (6 doses total)
- Coartem Tablets may be crushed and mixed with 1–2 teaspoons of water for patients who cannot swallow tablets, such as infants or young children; give food or drink right after if possible
- If vomiting occurs within 1–2 hours of a Coartem dose, repeat the dose; if the repeat dose is also vomited, seek an alternative antimalarial
📊 Artemether and Lumefantrine across the U.S. market
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.
📈 How widely Artemether and Lumefantrine is used
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.
How commonly is Artemether and Lumefantrine prescribed? Of the 1,596 medications we measure, Artemether and Lumefantrine ranks #1,578 by Medicaid prescriptions — more than 1% of them.
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 → |
| 20; 120 mg/1; mg | Oral | Novartis Pharmaceuticals Corporation × 2 listings | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Artemether and Lumefantrine NDCs →
📈 What people report — real-world data (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.
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.
🏛️ The road to your pharmacy
How Artemether and Lumefantrine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 282448 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 847730In current FDA listingsClinical drug / strength (SCD) artemether 20 MG / lumefantrine 120 MGRxCUI 847731
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.
📦 Supply & shortage status
Whether Artemether and Lumefantrine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Artemether and Lumefantrine belongs to the Antimalarial class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.