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Coartem

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Coartem

Coartem Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Coartem (artemether/lumefantrine) is used to treat non-severe malaria. It does not prevent malaria. It is an antimalarial medication. Common side effects include headache, dizziness, loss of appetite, weakness, fever, chills, tiredness, muscle/joint pain, nausea, vomiting, abdominal pain, cough, and trouble sleeping.

A 3-day treatment schedule of Coartem 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 two days (total course of 24 tablets). Pediatric dose is determined by the child's weight. Coartem may interact with ketoconazole, cold or allergy medicines, antibiotics, antidepressants, heart rhythm medication, HIV or AIDS medicine, medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicines, or narcotics. Tell your doctor all medications you use. During pregnancy, Coartem should be used only when prescribed. It is unknown if this medication passes into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Our Coartem (artemether/lumefantrine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Coartem in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • worsening malaria symptoms;
  • dizziness, fainting, fast or pounding heartbeat;
  • severe or uncontrolled vomiting or diarrhea; or
  • stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Call your doctor if you develop fever, chills, body aches, severe headache, or flu symptoms after you have finished taking all your doses of artemether and lumefantrine.

Less serious side effects may include:

  • weakness, mild headache;
  • nausea, vomiting, loss of appetite;
  • cough;
  • joint or muscle pain; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Coartem (Artemether Lumefantrine Tablets) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Coartem Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, dizziness, loss of appetite, weakness, fever, chills, tiredness, muscle/joint pain, nausea, vomiting, abdominal pain, cough, and trouble sleeping may occur. If any of these effects persist after stopping the medication or if these effects worsen while taking this medication, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Coartem (Artemether Lumefantrine Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Coartem FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Serious Adverse Reactions

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling:

Clinical Studies 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 1,979 patients including 647 adults (older than 16 years) and 1,332 children (16 years and younger). For the 6-dose regimen, Coartem Tablets was studied in active-controlled (366 patients) and non-controlled, open-label trials (1,613 patients). The 6-dose Coartem Tablets population was patients with malaria between ages 2 months and 71 years: 67% (1,332) were 16 years and younger and 33% (647) were older than 16 years. Males represented 73% and 53% of the adult and pediatric populations, respectively. The majority of adult patients were enrolled in studies in Thailand, while the majority of pediatric patients were enrolled in Africa.

Tables 1 and 2 show the most frequently reported adverse reactions ( ≥ 3%) in adults and children respectively who received the 6-dose regimen of Coartem Tablets. Adverse reactions collected in clinical trials included signs and symptoms at baseline but only treatment emergent adverse events, defined as events that appeared or worsened after the start of treatment, are presented below. In adults, the most frequently reported adverse reactions were headache, anorexia, dizziness, and asthenia. In children, the adverse reactions were pyrexia, cough, vomiting, anorexia, and headache. Most adverse reactions were mild, did not lead to discontinuation of study medication, and resolved.

In limited comparative studies, the adverse reaction profile of Coartem Tablets appeared similar to that of another antimalarial regimen.

Discontinuation of Coartem Tablets due to adverse drug reactions occurred in 1.1% of patients treated with the 6-dose regimen overall: 0.2% (1/647) in adults and 1.6% (21/1,332) in children.

Table 1: Adverse Reactions Occurring in 3% or More of Adult Patients Treated in Clinical Trials with the 6-dose Regimen of Coartem Tablets

System Organ Class Preferred Term Adults*
N=647 (%)
Nervous system disorders Headache 360 (56)
Dizziness 253 (39)
Metabolism and nutrition disorders Anorexia 260 (40)
General disorders and administration site conditions Asthenia 243 (38)
Pyrexia 159 (25)
Chills 147 (23)
Fatigue 111 (17)
Malaise 20 (3)
Musculoskeletal and connective tissue disorders Arthralgia 219 (34)
Myalgia 206 (32)
Gastrointestinal disorders Nausea 169 (26)
Vomiting 113 (17)
Abdominal pain 112 (17)
Diarrhea 46 (7)
Psychiatric disorders Sleep disorder 144 (22)
Insomnia 32(5)
Cardiac disorders Palpitations 115 (18)
Hepatobiliary disorders Hepatomegaly 59 (9)
Blood and lymphatic system disorders Splenomegaly 57(9)
Anemia 23 (4)
Respiratory, thoracic and mediastinal disorders Cough 37 (6)
Skin and subcutaneous tissue disorders Pruritus 24 (4)
Rash 21(3)
Ear and labyrinth disorders Vertigo 21 (3)
Infections and infestations Malaria 18(3)
Nasopharyngitis 17(3)
* Adult patients defined as > 16 years of age

Table 2: Adverse Reactions Occurring in 3% or More of Pediatric Patients Treated in Clinical Trials with the 6-dose Regimen of Coartem Tablets

System Organ Class Preferred Term Children*
N=1,332 (%)
General disorders and administration site conditions Pyrexia 381 (29)
Chills 72 (5)
Asthenia 63 (5)
Fatigue 46 (3)
Respiratory, thoracic and mediastinal disorders Cough 302 (23)
Gastrointestinal disorders Vomiting 242(18)
Abdominal pain 112 (8)
Diarrhea 100 (8)
Nausea 61 (5)
Infections and infestations Plasmodium falciparum infection 224 (17)
Rhinitis 51 (4)
Metabolism and nutrition disorders Anorexia 175 (13)
Nervous system disorders Headache 168 (13)
Dizziness 56(4)
Blood and lymphatic system disorders Splenomegaly 124 (9)
Anemia 115(9)
Hepatobiliary disorders Hepatomegaly 75 (6)
Investigations Aspartate aminotransferase increased 51 (4)
Musculoskeletal and connective tissue disorders Arthralgia 39(3)
Myalgia 39(3)
Skin and subcutaneous tissue disorders Rash 38 (3)
* Children defined as patients ≤ 16 years of age

Clinically significant adverse reactions reported in adults and/or children treated with the 6-dose regimen of Coartem Tablets which occurred in clinical studies at < 3% regardless of causality are listed below:

Blood and lymphatic system disorders: eosinophilia

Ear and labyrinth disorders: tinnitus

Eye disorders: conjunctivitis

Gastrointestinal disorders: constipation, dyspepsia, dysphagia, peptic ulcer

General disorders: gait disturbance

Infections and infestations: abscess, acrodermatitis, bronchitis, ear infection, gastroenteritis, helminthic infection, hookworm infection, impetigo, influenza, lower respiratory tract infection, malaria, nasopharyngitis, oral herpes, pneumonia, respiratory tract infection, subcutaneous abscess, upper respiratory tract infection, urinary tract infection

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, hematocrit decreased, lymphocyte morphology abnormal, platelet count decreased, platelet count increased, white blood cell count decreased, white blood cell count increased

Metabolism and nutrition disorders: hypokalemia

Musculoskeletal and connective tissue disorders: back pain

Nervous system disorders: ataxia, clonus, fine motor delay, hyperreflexia, hypoaesthesia, nystagmus, tremor

Psychiatric disorders: agitation, mood swings

Renal and urinary disorders: hematuria, proteinuria

Respiratory, thoracic and mediastinal disorders: asthma, pharyngo-laryngeal pain

Skin and subcutaneous tissue disorders: urticaria

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Coartem Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Hypersensitivity reactions including urticaria and angioedema. Serious skin reactions (bullous eruption) have been rarely reported.

Read the entire FDA prescribing information for Coartem (Artemether Lumefantrine Tablets) »

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Coartem - User Reviews

Coartem User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Coartem sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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