Atovaquone Side Effects

Brand Names: Mepron

Please note - some side effects for Atovaquone 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 Atovaquone - for the Consumer

Atovaquone

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 Atovaquone:

Diarrhea; difficulty sleeping; dizziness; headache; increased cough; increased sweating; indigestion; loss of appetite; muscle pain; nausea; runny or stuffy nose; stomach pain; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); anxiety; change in the amount of urine produced; dark urine; depression; fever; flu-like symptoms; pale stools; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; shortness of breath; unusual bruising or bleeding; white patches in the mouth; yellowing of the eyes or skin.

Atovaquone/Proguanil

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 Atovaquone/Proguanil:

Cough; diarrhea; dizziness; headache; loss of appetite; mouth sores; nausea; stomach pain; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; fever, chills, or persistent sore throat; mood or mental changes; muscle or back pain; pale stools; red, blistered, swollen, or peeling skin; ringing in the ears; seizures; severe or persistent vomiting, diarrhea, or stomach pain; shortness of breath; unusual fatigue or weakness; weight loss; yellowing of the skin or eyes.

Side Effects by Body System

General

In PCP prevention studies comparing atovaquone to inhaled pentamidine, 16% to 25% of patients discontinued atovaquone and 7% discontinued pentamidine due to adverse events. Rash (6%), diarrhea (4%), and nausea (3%) were the most common reasons for discontinuing atovaquone, while bronchospasm (2%) was the most common reason for discontinuing pentamidine. In studies comparing atovaquone to dapsone, treatment-limiting hypersensitivity reactions were more frequent in the dapsone group (16.1%) and treatment-limiting gastrointestinal side effects were more common in the atovaquone group (up to 4.1%).

In PCP treatment studies, 9% of patients discontinued atovaquone due to side effects, compared to 24% of patients receiving sulfamethoxazole-trimethoprim. The most common reason for discontinuation in both treatment groups was rash (atovaquone, 4%; sulfamethoxazole-trimethoprim, 8%). In studies comparing intravenous pentamidine and atovaquone, 63% of patients in the atovaquone group and 72% of patients in the pentamidine group reported side effects. Treatment was discontinued in 7% of the atovaquone patients and 41% of the pentamidine patients due to adverse events; the most common reasons were rash (4%) in the atovaquone group and hypoglycemia (11%) and vomiting (9%) in the pentamidine group.

Gastrointestinal

Gastrointestinal side effects are among the most common and have included nausea (up to 40%), diarrhea (up to 42%), vomiting (up to 22%), abdominal pain (up to 21%), oral monilia (up to 10%), taste perversion (3%), and constipation (3%). The incidence of side effects was higher in patients in PCP treatment studies than in prevention studies. Seven percent of patients experience anorexia and 5% of patients experience dyspepsia, although these are difficult to attribute to the drug due to the serious underlying diseases in the patients who receive atovaquone. Hyperamylasemia has been reported in 8% of patients. Pancreatitis has also been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (up to 46%), pruritus (greater than or equal to 10%), exfoliative dermatitis, photosensitivity, and toxic epidermal necrolysis. Erythema multiforme, Stevens-Johnson syndrome, and skin desquamation have been reported during postmarketing experience in patients receiving multiple drug treatment including atovaquone.

Hepatic

Hepatic side effects have included elevated ALT (greater than 5 times ULN, 6%), elevated AST (greater than 5 times ULN, 4%), elevated alkaline phosphatase (greater than 2.5 times ULN, up to 8%), and increased amylase (greater than 1.5 times ULN, up to 8%) in patients being treated for PCP. Therapy was discontinued in 2% of patients receiving atovaquone due to ALT/AST elevations, compared to 7% of patients being treated with sulfamethoxazole-trimethoprim. Hepatomegaly has also been reported. Rarely, hepatitis and at least one case of fatal liver failure have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included anemia (up to 6%) and neutropenia (up to 5%), but may be due to underlying disease. Methemoglobinemia and thrombocytopenia have also been reported.

Metabolic

Metabolic side effects have included hyponatremia (up to 10%), hyperglycemia (9%), and hypoglycemia (1%).

Other

Other side effects have included fever (up to 40%), asthenia (up to 31%), flu syndrome (greater than or equal to 10%), pain (greater than or equal to 10%), infection (up to 22%), sweating (greater than or equal to 10%), and malaise, but some may be due to underlying disease. Fatigue, night sweats, and burning sensation of the tongue have also been reported.

Respiratory

Respiratory side effects have included dyspnea (up to 21%), increased cough (up to 25%), rhinitis (up to 24%), sinusitis (greater than or equal to 10%), bronchospasm (up to 4%), and pneumonia.

Nervous system

Nervous system side effects have included insomnia (up to 19%), dizziness (up to 8%), headache (up to 31%), anxiety (7%), and depression (greater than or equal to 10%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (greater than or equal to 10%).

Hypersensitivity

Hypersensitivity reactions have included rash, erythema multiforme, exfoliative dermatitis, and allergic reactions (unspecified, up to 1.1%).

Renal

Renal side effects have included elevated creatinine (1%) and elevated BUN (1%). Acute renal impairment has been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included hypotension (1%).

Ocular

Ocular side effects have included vortex keratopathy during postmarketing experience.

Immunologic

Immunologic side effects have included hypersensitivity reactions including angioedema, bronchospasm, throat tightness, and urticaria during postmarketing experience.

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