Daraprim Side Effects

Generic Name: pyrimethamine

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

Daraprim

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 Daraprim:

Loss of appetite; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; irregular heartbeat; pale skin; red, swollen, or blistered skin; severe or persistent vomiting; sore throat or fever; unusual bleeding or bruising.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Daraprim Side Effects - for the Professional

Daraprim

Hypersensitivity reactions, occasionally severe (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and anaphylaxis), and hyperphenylalaninemia, can occur particularly when pyrimethamine is administered concomitantly with a sulfonamide. Consult the complete prescribing information for the relevant sulfonamide for sulfonamide-associated adverse events. With doses of pyrimethamine used for the treatment of toxoplasmosis, anorexia and vomiting may occur. Vomiting may be minimized by giving the medication with meals; it usually disappears promptly upon reduction of dosage. Doses used in toxoplasmosis may produce megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm. Hematologic effects, however, may also occur at low doses in certain individuals.

Pulmonary eosinophilia has been reported rarely.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, glossitis, and atrophic glossitis, particularly with high doses. Gastrointestinal intolerance may be minimized by administering pyrimethamine with food.

Hypersensitivity

Hypersensitivity reactions have been reported when pyrimethamine is administered with a sulfonamide. These reactions may be severe and include erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, Lyell's syndrome, hepatitis, anaphylaxis, and pulmonary reactions. Fatal reactions have been estimated to occur in one of 11,000 to 25,000 patients treated. Hypersensitivity reactions have also been reported with pyrimethamine/clindamycin combinations and are usually limited to maculopapular rashes.

Hematologic

Hematologic side effects have occurred, especially when large doses of pyrimethamine are administered. Thrombocytopenia, megaloblastic anemia, leukopenia, pancytopenia, agranulocytosis, and fatalities have been reported.

Nervous system

Nervous system toxicity is problematic with higher dosages of pyrimethamine. Ataxia, tremors, and seizures may occur.

Respiratory

Respiratory side effects have rarely included pulmonary eosinophilia.

Cardiovascular

Cardiovascular side effects have included arrhythmias, particularly with high doses.

Metabolic

Metabolic side effects have included hyperphenylalaninemia, particularly when pyrimethamine is given in combination with a sulfonamide.

Oncologic

Oncologic side effects have included two reports of malignancy; both were associated with pyrimethamine treatment for toxoplasmosis: 1 patient developed chronic granulocytic leukemia after 2 years of therapy and 1 patient developed reticulum cell sarcoma after 14 months of therapy. Animal studies have revealed increased lung tumors with intraperitoneal administration.

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