Coartem Side Effects

Please note - some side effects for Coartem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Coartem - for the Consumer

Coartem

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Coartem:

Cough; diarrhea; dizziness; fatigue; headache; joint and muscle pain and stiffness; loss of appetite; nausea; stomach pain; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; pale color; severe or persistent headache, muscle pain, or weakness; speech problems.

Coartem Side Effects - for the Professional

Coartem

The most common adverse reactions in adults (>30%) are headache, anorexia, dizziness, asthenia, arthralgia and myalgia. The most common adverse reactions in children (>12%) are pyrexia, cough, vomiting, anorexia and headache. (6.2)

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

Side Effects by Body System

Nervous system

Nervous system side effects have included headache, dizziness, and vertigo (3% or more). Tinnitus, ataxia, clonus, fine motor delay, hyperreflexia, hypoesthesia, nystagmus, and tremor have been reported in less than 3% of patients.

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, vomiting, abdominal pain, and diarrhea (3% or more). Constipation, dyspepsia, dysphagia, and peptic ulcer have been reported in less than 3% of patients.

Other

Other side effects have included asthenia, pyrexia, chills, fatigue, and malaise (3% or more).

Cardiovascular

Cardiovascular side effects have included palpitations (3% or more) and QT interval prolongation.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity reactions. Hypersensitivity including urticaria and angioedema has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included pruritus and rash (3% or more). Urticaria has been reported in less than 3% of patients. Serious skin reactions (bullous eruption) have been reported rarely during postmarketing experience.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia (3% or more). Gait disturbance and back pain have been reported in less than 3% of patients.

Respiratory

Respiratory side effects have included cough (3% or more). Asthma and pharyngolaryngeal pain have been reported in less than 3% of patients.

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