What the label lists and what reports show
Artemether and lumefantrine side effects
Artemether and lumefantrine's FDA label: “The most common adverse reactions in adults (greater than 30%) are headache, anorexia, dizziness, asthenia, arthralgia, and myalgia.” FAERS holds 196 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (22 reports).
- No generic listed
Check it at the source: the artemether and lumefantrine FDA label on DailyMed (effective March 26, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Coartem?Coartem can cause serious side effects, including: A heart problem called QT prolongation that can cause an abnormal heartbeat can happen in people who take Coartem. The chance of this happening is higher in people with a family history of prolonged QT interval, low potassium (hypokalemia) or low magnesium (hypomagnesemia), and in people who take certain medicines including medicine to control heartbeats. The most common side effects of Coartem in adults include: headache not wanting to eat dizziness fever weakness or lack of energy joint pain muscle pain, tenderness and weakness The most common side effects of Coartem in children include: fever cough vomiting not wanting to eat headache These are not all the possible side effects of Coartem. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective March 26, 2026 (SPL set 7866ec19-dfac-47d4-a53f-511a12643cbf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in adults (greater than 30%) are headache, anorexia, dizziness, asthenia, arthralgia, and myalgia.
Table 1: Adverse Reactions Occurring in 3% or More of Adult Patients Treated in Clinical Trials With the 6-dose Regimen of Coartem Tablets
| Preferred Term | *Adult patients defined as greater than 16 years of age. Adults* N = 647 (%) |
|---|---|
| Headache | 360 (56) |
| Anorexia | 260 (40) |
| Asthenia | 243 (38) |
| Arthralgia | 219 (34) |
| Nausea | 169 (26) |
| Sleep disorder | 144 (22) |
| Palpitations | 115 (18) |
| Hepatomegaly | 59 (9) |
| Splenomegaly | 57 (9) |
| Cough | 37 (6) |
| Pruritus | 24 (4) |
| Vertigo | 21 (3) |
| Malaria | 18 (3) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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). …
Source: FDA drug label, 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?
196 reports list artemether and lumefantrine among the medicines taken, 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. Of the 21 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Artemether and lumefantrine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions