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Daraprim

Generic: pyrimethamine

Verified·Apr 23, 2026
Manufacturer
Vyera
NDC
83649-330
RxCUI
198182
Route
ORAL
ICD-10 indication
B58.9

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About Daraprim

What is this medication? Daraprim, also known by its generic name pyrimethamine, is a prescription antiparasitic medication primarily used to treat toxoplasmosis. This condition is an infection caused by the Toxoplasma gondii parasite, which can lead to serious health complications in the brain, eyes, or other organs. It is particularly important for individuals with weakened immune systems, such as those living with HIV or AIDS, and for treating infants who were infected before birth. The medication works by inhibiting the parasite’s ability to use folic acid, which is necessary for it to reproduce and survive.

In addition to its use for toxoplasmosis, Daraprim is sometimes utilized to treat or prevent malaria, though it is less common for this purpose today due to drug resistance in many parts of the world. It is typically prescribed in combination with a sulfonamide antibiotic to maximize its effectiveness against the infection. Because the drug interferes with folic acid metabolism, healthcare providers often prescribe a specific form of vitamin B called leucovorin to help protect the patient's own blood cells and minimize potential side effects during the course of treatment.

Copay & patient assistance

  • Patient Copay Amount: As little as $0 out-of-pocket
  • Maximum Annual Benefit Limit: Not Publicly Available
  • Core Eligibility Restrictions: Must have commercial or private insurance or meet specific eligibility criteria if uninsured; subject to terms and conditions; available only through participating pharmacies.
  • RxBIN, PCN, and Group numbers: Not Publicly Available

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Prescribing information

From the FDA-approved label for Daraprim. Official source: DailyMed (NLM) · Label effective Dec 7, 2023

Indications and usage
INDICATIONS AND USAGE Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
Dosage and administration
DOSAGE AND ADMINISTRATION For Treatment of Toxoplasmosis: The dosage of DARAPRIM for the treatment of toxoplasmosis must be carefully adjusted so as to provide maximum therapeutic effect and a minimum of side effects. At the dosage required, there is a marked variation in the tolerance to the drug. Young patients may tolerate higher doses than older individuals. Concurrent administration of folinic acid is strongly recommended in all patients. The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a sulfonamide of the sulfapyrimidine type, e.g. sulfadoxine. This dosage is ordinarily continued for 1 to 3 weeks, depending on the response of the patient and tolerance to therapy. The dosage may then be reduced to about one half that previously given for each drug and continued for an additional 4 to 5 weeks. The pediatric dosage of DARAPRIM is 1 mg/kg/day divided into 2 equal daily doses; after 2 to 4 days this dose may be reduced to one half and continued for approximately 1 month. The usual pediatric sulfonamide dosage is used in conjunction with DARAPRIM.
Contraindications
CONTRAINDICATIONS Use of DARAPRIM is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation. Use of the drug is also contraindicated in patients with documented megaloblastic anemia due to folate deficiency.
Warnings
WARNINGS The dosage of pyrimethamine required for the treatment of toxoplasmosis has a narrow therapeutic window. If signs of folate deficiency develop (see ADVERSE REACTIONS ), reduce the dosage or discontinue the drug according to the response of the patient. Folinic acid (leucovorin) should be administered in a dosage of 5 to 15 mg daily (orally, IV, or IM) until normal hematopoiesis is restored. Data in 2 humans indicate that pyrimethamine may be carcinogenic; a 51-year-old female who developed chronic granulocytic leukemia after taking pyrimethamine for 2 years for toxoplasmosis 3 and a 56-year-old patient who developed reticulum cell sarcoma after 14 months of pyrimethamine for toxoplasmosis. 4 Pyrimethamine has been reported to produce a significant increase in the number of lung tumors in mice when given intraperitoneally at doses of 25 mg/kg. 5 DARAPRIM should be kept out of the reach of infants and children as they are extremely susceptible to adverse effects from an overdose. Deaths in pediatric patients have been reported after accidental ingestion.
Drug interactions
Drug Interactions: Pyrimethamine may be used with sulfonamides, quinine and other antimalarials, and with other antibiotics. However, the concomitant use of other antifolic drugs or agents associated with myelosuppression including sulfonamides or trimethoprim- sulfamethoxazole combinations, proguanil, zidovudine, or cytostatic agents (e.g., methotrexate), while the patient is receiving pyrimethamine, may increase the risk of bone marrow suppression. If signs of folate deficiency develop, pyrimethamine should be discontinued. Folinic acid (leucovorin) should be administered until normal hematopoiesis is restored (see WARNINGS ). Mild hepatotoxicity has been reported in some patients when lorazepam and pyrimethamine were administered concomitantly.
Adverse reactions
ADVERSE REACTIONS 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, neutropenia, atrophic glossitis, hematuria, and disorders of cardiac rhythm. Hematologic effects, however, may also occur at low doses in certain individuals (see PRECAUTIONS; General ). Pulmonary eosinophilia has been reported rarely.
Use in pregnancy
Pregnancy: Teratogenic Effects: Pregnancy Category C. Pyrimethamine has been shown to be teratogenic in rats when given in oral doses 2.5 times the human dose for treatment of toxoplasmosis. At these doses in rats, there was a significant increase in abnormalities such as cleft palate, brachygnathia, oligodactyly, and microphthalmia. Pyrimethamine has also been shown to produce terata such as meningocele in hamsters and cleft palate in miniature pigs when given in oral doses 5 times the human dose for the treatment of toxoplasmosis. There are no adequate and well-controlled studies in pregnant women. DARAPRIM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Concurrent administration of folinic acid is strongly recommended when used during pregnancy.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

Click a condition to see copay cards, grants, and PA rules specific to it. For the full list of FDA-approved indications, see Prescribing information above.

Medicare Part D coverage

How Daraprim appears across Medicare Part D plan formularies nationally. Source: CMS monthly Prescription Drug Plan file (2026-04-30).

Covered by plans

0%

2 of 5,509 plans

Most common tier

Tier 1

On 100% of covering formularies

Prior authorization required

100%

of covering formularies

TierFormularies on this tierShare
Tier 1 (preferred generic)1
100%

Step therapy: 0% of formularies

Quantity limits: 0% of formularies

Coverage breadth: 1 of 65 formularies

How to read this:plans on the same formulary share tier + PA rules. Your specific plan's copay depends on (a) the tier above, (b) your plan's cost-share for that tier, (c) whether you're in the initial coverage phase or past the 2026 $2,000 out-of-pocket cap. For your exact plan, check its Summary of Benefits or log in to your Medicare.gov account. Copay cards don't apply to Medicare (federal law).

Prior authorization & coverage

PayerPAStep therapyCopay tier

Medicare Part D

Related drugs

How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.