This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Coartem (Artemether / Lumefantrine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (8)
Reports by Reaction Type
Wrong Drug Administered (5),
Acute Respiratory Distress Syndrome (5),
Acidosis (3),
Malaria (3),
Drug Ineffective (2),
Thrombocytopenia (2),
Condition Aggravated (2),
Blood Bilirubin Increased (1),
Abortion Spontaneous (1),
Protein Total Increased (1),
Haptoglobin Decreased (1),
Maternal Exposure During Pregnancy (1)
Possible Coartem side effects in female
Reported by a health professional (non-physician/pharmacist) from Senegal on 2012-07-30
Patient: female
Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Coartem
Possible Coartem side effects in 28 year old male
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: 28 year old male, weighing 83.9 kg (184.6 pounds)
Reactions: Blood Bilirubin Increased, Haptoglobin Decreased, Blood Lactate Dehydrogenase Increased, Protein Total Increased, Toxicity To Various Agents, Haemolytic Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coartem
Possible Coartem side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: male, weighing 43.6 kg (95.9 pounds)
Reactions: Wrong Drug Administered, Acute Respiratory Distress Syndrome, Acidosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coartem
Other drugs received by patient: Acetaminophen; Doxycycline Hyclate; Quinine Sulfate; Ceftriaxone; Lasix; Zofran; Quinidine HCL
Possible Coartem side effects in
Reported by a physician from United States on 2012-04-05
Patient:
Reactions: NO Adverse Event
Drug(s) suspected as cause:
Coartem
Possible Coartem side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-16
Patient: female, weighing 68.4 kg (150.5 pounds)
Reactions: Malaria, Drug Ineffective, Wrong Drug Administered, Condition Aggravated, Acute Respiratory Distress Syndrome, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coartem
Other drugs received by patient: Vitamin D; Promethazine; Multi-Vitamins; Artesunate; Iron; Fish OIL; Calcium
Possible Coartem side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-06
Patient: male, weighing 43.6 kg (95.9 pounds)
Reactions: Wrong Drug Administered, Acute Respiratory Distress Syndrome, Acidosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coartem
Other drugs received by patient: Quinidine HCL; Ceftriaxone; Acetaminophen; Doxycycline; Quinine Sulfate; Lasix; Zofran
Possible Coartem side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: female, weighing 68.4 kg (150.5 pounds)
Reactions: Malaria, Drug Ineffective, Wrong Drug Administered, Acute Respiratory Distress Syndrome, Condition Aggravated, Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coartem
Other drugs received by patient: Vitamin D; Fish OIL; Calcium; Promethazine; Artesunate; Multi-Vitamins; Iron
Possible Coartem side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-27
Patient: male, weighing 43.6 kg (95.9 pounds)
Reactions: Malaria, Wrong Drug Administered, Acute Respiratory Distress Syndrome, Acidosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coartem
Other drugs received by patient: Doxycycline; Quinidine HCL; Acetaminophen; Ceftriaxone; Zofran; Quinine Sulfate; Lasix
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