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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Coartem:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Coartem Side Effects - for the Professional

Coartem

Serious Adverse Reactions

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

• Hypersensitivity Reactions [see Contraindications (4.1) and Postmarketing Experience (6.3)].

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

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Side Effects by Body System - for Healthcare Professionals

General

The most frequently reported side effects included headache, anorexia, dizziness, and asthenia during clinical studies. Most side effects were mild, did not lead to artemether-lumefantrine discontinuation, and resolved. The artemether-lumefantrine 6-dose regimen was discontinued in 0.2% of adult patients due to side effects.

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. Ototoxicity (including decreased hearing) and paresthesia have been reported.

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.

Hematologic

Hematologic side effects have included splenomegaly and anemia (3% or more). Eosinophilia, abnormal lymphocyte morphology, decreased hematocrit, increased and decreased platelet count, increased and decreased white blood cell count have been reported in less than 3% of patients. Hemolytic anemia (including at least one case of autoimmune hemolytic anemia attributed to lumefantrine) has been reported.

Hepatic

During a study, jaundice was observed in 3 patients following artemether-lumefantrine treatment; however, each patient had elevated serum bilirubin at baseline. Resolution occurred on follow-up.

Hepatic side effects have included hepatomegaly (3% or more). Increased alanine aminotransferase and aspartate aminotransferase have been reported in less than 3% of patients. Jaundice has been reported.

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.

Immunologic

Immunologic side effects have included malaria and nasopharyngitis (3% or more). Abscess, acrodermatitis, bronchitis, ear infection, gastroenteritis, helminthic infection, hookworm infection, impetigo, influenza, lower respiratory tract infection, oral herpes, pneumonia, respiratory tract infection, subcutaneous abscess, upper respiratory tract infection, and urinary tract infection have been reported in less than 3% of patients.

Metabolic

Metabolic side effects have included hypokalemia (less than 3%).

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.

Genitourinary

Genitourinary side effects have included hematuria and proteinuria (less than 3%).

Psychiatric

Psychiatric side effects have included sleep disorder and insomnia (3% or more). Agitation and mood swings have been reported in less than 3% of patients.

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