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Pyrimethamine 25 mg Tablet, 100-count — NDC 59651-0590-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pyrimethamine 25 mg Tablet, 100-count — NDC 59651-590-01 (Billing 59651-0590-01)

by Aurobindo Pharma Limited · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Pyrimethamine 25 mg Tablet from Aurobindo Pharma Limited, marketed since Oct 2022 and currently FDA-listed; retail pharmacies pay about $137.01 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 59651-0590-01
🏷️ FDA NDC (as labeled) 59651-590-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$137.01 NADAC Per package$13,700.90 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $175.51/unit · Part D plans $284.05/unit — full pricing hub ↓
Main listing for product 59651-590 · Also comes in: 30 tablets 59651-590-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 59651-590-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
59651 labeler · 590 product · 01 package
Package marketed since
Oct 25, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
100 EA per package
Barcode (UPC)
0359651590300
Medicaid fills, this package
152 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59651-590-01
Product NDC 59651-590
11-digit billing NDC 59651059001
NCPDP billing unit EA — each (per item)
RxCUI 198182
UNII Z3614QOX8W
UPC 0359651590300
Application # ANDA216983
SPL Set ID 7aca002e-a538-4715-9121-a17bdb7f200c
Established class (EPC) Dihydrofolate Reductase Inhibitor Antimalarial
Mechanism of action Dihydrofolate Reductase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-10-25
Route ORAL
Dosage form TABLET
Substance PYRIMETHAMINE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 13000040000310
GCN Seq No 009579
GCN 42930
HICL code 004150
Ingredient (HICL) Pyrimethamine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4A
Therapeutic class — specific (HIC3) Antimalarial Drugs
AHFS code 08:30.08.00
AHFS class Antimalarials
FDB label name PYRIMETHAMINE 25 MG TABLET
FDB brand name Pyrimethamine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009579
  • GCN: 42930
  • GPI-14 (Medi-Span): 13000040000310
  • HICL (First Databank): 004150
  • AHFS class code: 08:30.08.00
  • RxCUI (RxNorm): 198182
Why two NDCs? The FDA registers this code as 59651-590-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 59651-0590-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Dihydrofolate Reductase Inhibitor Antimalarial class.

Pharmacologic class Dihydrofolate Reductase Inhibitor Antimalarial
Drug family (ATC) Diaminopyrimidines
How it works Dihydrofolate Reductase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PYRIMETHAMINE 25 MG TABLET Ingredient Pyrimethamine
4
Nutrient depletion considerations

Pyrimethamine may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Pyrimethamine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $137.009 $13,700.90 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $175.51 $17,551.20 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $284.05 $28,404.63 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Jan 2026 Mar 2026 May 2026 $149.197 $137.009
▼ Down 8% over the last 6 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
59651-0590-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE $137.01 / ea $13,700.90 2022-10-25 — Active
59651-0590-30 59651-590-30 30 TABLET in 1 BOTTLE — — 2022-10-25 — Active

You're viewing the largest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle.
How does this package differ from NDC 59651-0590-30?
Both are Pyrimethamine 25 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 59651-0590-30 is the 30 tablets package.
What NDC number is used to bill for this package of Pyrimethamine 25 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pyrimethamine 25 mg 00480-3720-01 Teva 100 tablets $137.009 AB Availability likely —
Pyrimethamine 25 mg 43598-0672-01 DR.REDDYS 100 tablets $137.009 AB Availability likely —
Pyrimethamine 25 mgthis 59651-0590-01 Aurobindo 100 tablets $137.009 AB Availability likely —
Pyrimethamine 25 mg 72603-0262-01 NorthStar 30 tablets $137.009 AB Discontinued —
Daraprim 25 mg 69413-0330-10 Vyera 100 tablets — AB FDA listed —
Pyrimethamine 25 mg 72647-0330-01 OAKRUM 100 tablets — AB FDA listed —
Daraprim 25 mg 83649-0330-01 TILDE 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Oct 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeRound
ImprintL;25
Size7 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA216983 (ANDA)
Labeler code59651
First marketedOct 2022
Product typeHuman Prescription Drug
Portfolio1,456 products on file

More NDCs from Aurobindo Pharma Limited labeler code 59651

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE Treatment of Toxoplasmosis: Pyrimethamine tablets are indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

⏱️ Dosage and Administration 190 words ▾

DOSAGE AND ADMINISTRATION For Treatment of Toxoplasmosis: The dosage of pyrimethamine tablets 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 pyrimethamine tablets 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 pyrimethamine tablets.

⛔ Contraindications 38 words ▾

CONTRAINDICATIONS Use of pyrimethamine tablets are 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 167 words ▾

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 Pyrimethamine 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.

🤒 Adverse Reactions 119 words ▾

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.

🔄 Drug Interactions 94 words ▾

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.

🤰 Pregnancy 81 words ▾

Mutagenesis: Pyrimethamine has been shown to be nonmutagenic in the following in vitro assays: the Ames point mutation assay, the Rec assay, and the E. coli WP2 assay. It was positive in the L5178Y/TK +/- mouse lymphoma assay in the absence of exogenous metabolic activation. 6 Human blood lymphocytes cultured in vitro had structural chromosome aberrations induced by pyrimethamine.

In vivo, chromosomes analyzed from the bone marrow of rats dosed with pyrimethamine showed an increased number of structural and numerical aberrations.

🧒 Pediatric Use 7 words ▾

Pediatric Use: See DOSAGE AND ADMINISTRATION section.

🧓 Geriatric Use 82 words ▾

Geriatric Use: Clinical studies of pyrimethamine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage ~1 min read ▾

OVERDOSAGE Following the ingestion of 300 mg or more of pyrimethamine, gastrointestinal and/or central nervous system signs may be present, including convulsions. The initial symptoms are usually gastrointestinal and may include abdominal pain, nausea, severe and repeated vomiting, possibly including hematemesis. Central nervous system toxicity may be manifest by initial excitability, generalized and prolonged convulsions which may be followed by respiratory depression, circulatory collapse, and death within a few hours.

Neurological symptoms appear rapidly (30 minutes to 2 hours after drug ingestion), suggesting that in gross overdosage pyrimethamine has a direct toxic effect on the central nervous system. The fatal dose is variable, with the smallest reported fatal single dose being 375 mg. There are, however, reports of pediatric patients who have recovered after taking 375 to 625 mg.

There is no specific antidote to acute pyrimethamine poisoning. In the event of overdosage, symptomatic and supportive measures should be employed. Gastric lavage is recommended and is effective if carriedout very soon after drug ingestion.

Parenteral diazepam may be used to control convulsions. Folinic acid should be administered within 2 hours of drug ingestion to be most effective in counteracting the effects on the hematopoietic system (see WARNINGS). Due to the long half-life of pyrimethamine, daily monitoring of peripheral blood counts is recommended for up to several weeks after the overdose until normal hematologic values are restored.

🧬 Clinical Pharmacology 143 words ▾

CLINICAL PHARMACOLOGY Pyrimethamine is well absorbed with peak levels occurring between 2 to 6 hours following administration. It is eliminated slowly and has a plasma half-life of approximately 96 hours. Pyrimethamine is 87% bound to human plasma proteins.

Microbiology: Pyrimethamine is a folic acid antagonist and the rationale for its therapeutic action is based on the differential requirement between host and parasite for nucleic acid precursors involved in growth. This activity is highly selective against Toxoplasma gondii. The action of pyrimethamine against Toxoplasma gondii is greatly enhanced when used in conjunction with sulfonamides.

This was demonstrated by Eyles and Coleman 1 in the treatment of experimental toxoplasmosis in the mouse. Jacobs et al 2 demonstrated that combination of the 2 drugs effectively prevented the development of severe uveitis in most rabbits following the inoculation of the anterior chamber of the eye with toxoplasma.

📦 How Supplied / Storage and Handling 74 words ▾

HOW SUPPLIED: Pyrimethamine Tablets USP, 25 mg are white to off-white round shaped, biconvex, uncoated tablet, debossed with ‘L’ ‘25’ on one side and break line on other side. They are supplied as follows: Bottles of 30 NDC 59651-590-30 Bottles of 100 NDC 59651-590-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] in a dry place and protect from light.

📋 Description 50 words ▾

DESCRIPTION Pyrimethamine is an antiparasitic compound available in tablet form for oral administration. Each scored tablet contains 25 mg pyrimethamine USP and the inactive ingredients colloidal silicon dioxide, lactose monohydrate, magnesium stearate and pregelatinized starch (corn). Pyrimethamine USP, known chemically as 5-(4- chlorophenyl)-6-ethyl-2, 4-pyrimidinediamine, has the following structural formula: str

💬 Information for Patients 137 words ▾

Information for Patients: Patients should be warned that at the first appearance of a skin rash they should stop use of pyrimethamine and seek medical attention immediately. Patients should also be warned that the appearance of sore throat, pallor, purpura, or glossitis may be early indications of serious disorders which require treatment with pyrimethamine to be stopped and medical treatment to be sought. Women of childbearing potential who are taking pyrimethamine should be warned against becoming pregnant.

Patients should be warned to keep pyrimethamine out of the reach of children. Patients should be advised not to exceed recommended doses. Patients should be warned that if anorexia and vomiting occur, they may be minimized by taking the drug with meals.

Concurrent administration of folinic acid is strongly recommended when used for the treatment of toxoplasmosis in all patients.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: A small “starting” dose for toxoplasmosis is recommended in patients with convulsive disorders to avoid the potential nervous system toxicity of pyrimethamine. Pyrimethamine should be used with caution in patients with impaired renal or hepatic function or in patients with possible folate deficiency, such as individuals with malabsorption syndrome, alcoholism, or pregnancy, and those receiving therapy, such as phenytoin, affecting folate levels (see Pregnancy subsection). Information for Patients: Patients should be warned that at the first appearance of a skin rash they should stop use of pyrimethamine and seek medical attention immediately.

Patients should also be warned that the appearance of sore throat, pallor, purpura, or glossitis may be early indications of serious disorders which require treatment with pyrimethamine to be stopped and medical treatment to be sought. Women of childbearing potential who are taking pyrimethamine should be warned against becoming pregnant. Patients should be warned to keep pyrimethamine out of the reach of children.

Patients should be advised not to exceed recommended doses. Patients should be warned that if anorexia and vomiting occur, they may be minimized by taking the drug with meals. Concurrent administration of folinic acid is strongly recommended when used for the treatment of toxoplasmosis in all patients.

Laboratory Tests: In patients receiving high dosage, semiweekly blood counts, including platelet counts, should be performed. 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility: See WARNINGS section for information on carcinogenesis. Mutagenesis: Pyrimethamine has been shown to be nonmutagenic in the following in vitro assays: the Ames point mutation assay, the Rec assay, and the E. coli WP2 assay. It was positive in the L5178Y/TK +/- mouse lymphoma assay in the absence of exogenous metabolic activation.

6 Human blood lymphocytes cultured in vitro had structural chromosome aberrations induced by pyrimethamine. In vivo, chromosomes analyzed from the bone marrow of rats dosed with pyrimethamine showed an increased number of structural and numerical aberrations. Pregnancy: Teratogenic Effects: 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.

Pyrimethamine 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. Nursing Mothers: Pyrimethamine is excreted in human milk.

Because of the potential for serious adverse reactions in nursing infants from pyrimethamine and from concurrent use of a sulfonamide with pyrimethamine for treatment of some patients with toxoplasmosis, a decision shou… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 68 words ▾

Nursing Mothers: Pyrimethamine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pyrimethamine and from concurrent use of a sulfonamide with pyrimethamine for treatment of some patients with toxoplasmosis, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS and PRECAUTIONS : Pregnancy).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 12 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: See WARNINGS section for information on carcinogenesis.

📚 References 119 words ▾

REFERENCES Eyles DE, Coleman N. Synergistic effect of sulfadiazine and Daraprim against experimental toxoplasmosis in the mouse. Antibiot Chemother 1953;3:483-490.

Jacobs L, Melton ML, Kaufman HE. Treatment of experimental ocular toxoplasmosis. Arch Ophthalmol.

1964;71:111-118. Jim RTS, Elizaga FV. Development of chronic granulocytic leukemia in a patient treated with pyrimethamine.

Hawaii Med J. 1977;36:173-176. Sadoff L.

Antimalarial drugs and Burkitt’s lymphoma. Lancet. 1973;2:1262-1263.

Bahna L. Pyrimethamine. LARC Monogr Eval Carcinog Risk Chem.

1977;13:233-242. Clive D, Johnson KO, Spector JKS, et al. Validation and characterization of the L5178Y/TK +/- mouse lymphoma mutagen assay system.

Mut Res. 1979;59:61-108. Distributed by: Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: July 2022

📄 Package Label / Principal Display Panel 32 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 25 mg (30 Tablets Bottle) NDC 59651-590-30 Rx only Pyrimethamine Tablets, USP 25 mg Warning: Potent Drug - do not exceed recommended dosage. AUROBINDO 30 Tablets fig

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
152
Units reimbursed last 4 qtrs
7K
Gross reimbursed last 4 qtrs
$1.22M
Avg / prescription
$8,048.15
Avg / unit
$175.51
Latest quarter Q1 2026
80Rx
Medicaid pays / ea
$175.51
gross reimbursed
vs
NADAC / ea
$137.01
acquisition cost
=
Spread
+$38.5030
+28% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 152 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 6,430 units · 32.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 540 units · 16.9 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
16.932.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 32.9 /100k
2 Nevada 16.9 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page59651-0590-01 152 Rx · $1,223,319
30 tablets59651-0590-30 No Medicaid data
Drug total (last 4 qtrs): 152 Rx · 6,970 units · $1,223,319 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Pyrimethamine — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Pyrimethamine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.91M
Claims incl. refills
205
Beneficiaries
95
Spend / beneficiary
$30,591.94
Spend / claim
$14,176.75
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Pyrimethamine — the ingredient across all brands.

Top reported reactions

Nausea134
Vomiting101
Pancytopenia87
Neutropenia72
Pyrexia64
Headache63
Dizziness50

Age at onset

Neonate9
Infant3
Child16
Adolescent1
Adult92
Elderly26

Reporter sex

1,262 reports
Male · 55%
Female · 45%
Unknown · 0%

Serious outcomes

Hospitalization533
Death220
Life-threatening86
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 136 39
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 59651-0589-01 · Aurobindo 59651-0591-30 · Aurobindo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.