Prescription medicine
Pyrimethamine Brand names: Daraprim
Pyrimethamine (Daraprim) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $137.01 per pyrimethamine 25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the pyrimethamine FDA label on DailyMed (effective December 7, 2023, TILDE Sciences LLC); the NDA 8578 record on Drugs@FDA; every pyrimethamine label on DailyMed.
Highlights of the record
FDA label of December 7, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTreatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
Forms and strengths
- 25 mg
Tablet.
On the market
- Earliest approval on file
- January 23, 1953 Daraprim, Tilde Sciences; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first February 28, 2020; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 3 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $137.01 per tablet Pyrimethamine 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2015 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 1,262 through July 30, 2026
What is pyrimethamine used for?
From the label: indications and usageTreatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
FDA pharmacologic class: Dihydrofolate Reductase Inhibitor Antimalarial.
Source: FDA drug label (Daraprim), TILDE Sciences LLC, effective December 7, 2023 (SPL set f634f34b-0952-4dd3-9da3-f84b6ab823de), via openFDA; the full label on DailyMed
Is there a generic for pyrimethamine (Daraprim)?
The FDA approved the first generic pyrimethamine on February 28, 2020. 4 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists pyrimethamine from 3 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1953 earliest approval on file
- 2020 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pyrimethamine (Daraprim)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $137.01 per Pyrimethamine 25 mg tablet, down 10% from $152.23 on October 22, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Pyrimethamine 25 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pyrimethamine 25 mg tablet | Generic | $137.01 per tablet | $4,110.26 | -10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pyrimethamine been recalled?
The FDA's Enforcement Report lists 1 recall naming pyrimethamine since 2015: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of pyrimethamine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 12, 2015 | Class II | Health Innovations Pharmacy, Inc not a listed maker | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pyrimethamine label say about other medicines?
The pyrimethamine label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name pyrimethamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Leucovorin | drug interactions | Folinic acid (leucovorin) should be administered until normal hematopoiesis is restored (see WARNINGS ). |
| Lorazepam | drug interactions | Mild hepatotoxicity has been reported in some patients when lorazepam and pyrimethamine were administered concomitantly. |
| Methotrexate | drug interactions | 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 … |
| Quinine | drug interactions | Drug Interactions: Pyrimethamine may be used with sulfonamides, quinine and other antimalarials, and with other antibiotics. |
| Zidovudine | drug interactions | 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 … |
Other labels that name pyrimethamine
Source: FDA drug label (Daraprim), TILDE Sciences LLC, effective December 7, 2023 (SPL set f634f34b-0952-4dd3-9da3-f84b6ab823de), via openFDA; the full label on DailyMed
What do FAERS reports show for pyrimethamine?
The FDA Adverse Event Reporting System holds 1,262 reports that list pyrimethamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 220 are coded as a death and 533 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Pyrimethamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other