Drugs Details

Drugs Info of Daraprim
Drugs Details
  • Drugs Type  : FDA
  • Date : 2nd Apr 2015 01:12 am
  • Brand Name : Daraprim
  • Generic Name :  pyrimethamine (Pronunciation: PIR i METH a meen)
Descriptions

DARAPRIM (pyrimethamine) is an antiparasitic compound available in tablet form for oral administration. Each scored tablet contains 25 mg pyrimethamine and the inactive ingredients corn and potato starch, lactose, and magnesium stearate.

Pyrimethamine, known chemically as 5-(4-chlorophenyl)-6-ethyl-2,4-pyrimidinediamine, has the following structural formula:

 

DARAPRIM®(pyrimethamine) Structural Formula Illustration

C12H13ClN4
Mol. Wt 248.71

What are the possible side effects of pyrimethamine (Daraprim)?

Stop taking pyrimethamine and seek emergency medical attention if you experience an allergic reaction (swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; or hives) during treatment with pyrimethamine.

Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine.

Other, less serious side effects may be more likely to occur. Continue to take pyrimethamine and...

Read All Potential Side Effects and See Pictures of Daraprim »

What are the precautions when taking pyrimethamine (Daraprim)?

Before taking pyrimethamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, kidney problems, liver problems, a certain type of low red blood cell count (megaloblastic anemia due to low blood folate), low folic acid levels from other conditions (such as malnutrition, problems with absorption of food, alcoholism), low red/white blood cell counts, low blood-clotting cell (platelet) count.

Before having surgery, tell your doctor or dentist about all the products you use (including...

Read All Potential Precautions of Daraprim »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Treatment of Toxoplasmosis: DARAPRIM (pyrimethamine) is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

Treatment of Acute Malaria: DARAPRIM (pyrimethamine) is also indicated for the treatment of acute malaria. It should not be used alone to treat acute malaria. Fast-acting schizonticides such as chloroquine or quinine are indicated and preferable for the treatment of acute malaria. However, conjoint use of DARAPRIM (pyrimethamine) with a sulfonamide (e.g., sulfadoxine) will initiate transmission control and suppression of susceptible strains of plasmodia.

Chemoprophylaxis of Malaria: DARAPRIM (pyrimethamine) is indicated for the chemoprophylaxis of malaria due to susceptible strains of plasmodia. However, resistance to pyrimethamine is prevalent worldwide. It is not suitable as a prophylactic agent for travelers to most areas.

Dosage Administration

For Treatment of Toxoplasmosis: The dosage of DARAPRIM (pyrimethamine) 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 (pyrimethamine) 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 (pyrimethamine) .

For Treatment of Acute Malaria: DARAPRIM (pyrimethamine) is NOT recommended alone in the treatment of acute malaria. Fast-acting schizonticides, such as chloroquine or quinine, are indicated for treatment of acute malaria. However, DARAPRIM (pyrimethamine) at a dosage of 25 mg daily for 2 days with a sulfonamide will initiate transmission control and suppression of non-falciparum malaria. DARAPRIM (pyrimethamine) is only recommended for patients infected in areas where susceptible plasmodia exist. Should circumstances arise wherein DARAPRIM (pyrimethamine) must be used alone in semi-immune persons, the adult dosage for acute malaria is 50 mg for 2 days; children 4 through 10 years old may be given 25 mg daily for 2 days. In any event, clinical cure should be followed by the once-weekly regimen described below for chemoprophylaxis. Regimens which include suppression should be extended through any characteristic periods of early recrudescence and late relapse, i.e., for at least 10 weeks in each case.

For Chemoprophylaxis of Malaria:

Adults and pediatric patients over 10 years — 25 mg (1 tablet) once weekly

Children 4 through 10 years — 12.5 mg (1/2 tablet) once weekly

Infants and children under 4 years — 6.25 mg (1/4 tablet) once weekly

How Supplied

White, scored tablets containing 25 mg pyrimethamine, imprinted with “DARAPRIM (pyrimethamine) ” and “A3A” in bottles of 100 (NDC 0173-0201-55).

Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light.

Manufactured by: DSM Pharmaceuticals, Inc. Greenville, NC 27834 for GlaxoSmithKline, Research Triangle Park, NC 27709. March 2003. FDA Rev date: 11/18/2003


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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 (see PRECAUTIONS: General).

Pulmonary eosinophilia has been reported rarely.

Read the Daraprim (pyrimethamine) Side Effects Center for a complete guide to possible side effects

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.

Read the Daraprim Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

The dosage of pyrimethamine required for the treatment of toxoplasmosis is 10 to 20 times the recommended antimalaria dosage and approaches the toxic level. 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 (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.

Precautions

General

The recommended dosage for chemoprophylaxis of malaria should not be exceeded. A small “starting” dose for toxoplasmosis is recommended in patients with convulsive disorders to avoid the potential nervous system toxicity of pyrimethamine. DARAPRIM (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).

Laboratory Tests

In patients receiving high dosage, as for the treatment of toxoplasmosis, semiweekly blood counts, including platelet counts, should be performed.

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: Pregnancy Category C. Pyrimethamine has been shown to be teratogenic in rats when given in oral doses 7 times the human dose for chemoprophylaxis of malaria or 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 170 and 5 times the human dose, respectively, for chemoprophylaxis of malaria or for treatment of toxoplasmosis.

There are no adequate and well-controlled studies in pregnant women. DARAPRIM (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 for the treatment of toxoplasmosis 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 DARAPRIM (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 ).

Pediatric Use

See DOSAGE AND ADMINISTRATION section.

Geriatric Use

Clinical studies of DARAPRIM (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.

REFERENCES

3. Jim RTS, Elizaga FV. Development of chronic granulocytic leukemia in a patient treated with pyrimethamine. Hawaii Med J. 1977;36:173-176.

4. Sadoff L. Antimalarial drugs and Burkitt's lymphoma. Lancet. 1973;2:1262-1263.

5. Bahna L. Pyrimethamine. LARC Monogr Eval Carcinog Risk Chem. 1977;13:233-242.

6. 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.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

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 carried out very soon after drug ingestion. Parenteral diazepam may be used to control convulsions. Folinic acid should also 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.

 

ContrainDications

Use of DARAPRIM (pyrimethamine) 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.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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 plasmodia and Toxoplasma gondii.

Pyrimethamine possesses blood schizonticidal and some tissue schizonticidal activity against malaria parasites of humans. However, the 4-amino-quinoline compounds are more effective against the erythrocytic schizonts. It does not destroy gametocytes, but arrests sporogony in the mosquito.

The action of pyrimethamine against Toxoplasma gondii is greatly enhanced when used in conjunction with sulfonamides. This was demonstrated by Eyles and Coleman1 in the treatment of experimental toxoplasmosis in the mouse. Jacobs et al2 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.

REFERENCES

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

2. Jacobs L, Melton ML, Kaufman HE. Treatment of experimental ocular toxoplasmosis. Arch Ophthalmol. 1964;71:111-118.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients should be warned that at the first appearance of a skin rash they should stop use of DARAPRIM (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 DARAPRIM (pyrimethamine) to be stopped and medical treatment to be sought.

Women of childbearing potential who are taking DARAPRIM (pyrimethamine) should be warned against becoming pregnant. Patients should be warned to keep DARAPRIM (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.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

PYRIMETHAMINE - ORAL

 

(pir-ih-METH-uh-meen)

 

COMMON BRAND NAME(S): Daraprim

 

USES: This medication is used with other medication (such as a sulfonamide) to treat a serious parasite infection (toxoplasmosis) of the body, brain, or eye or to prevent toxoplasmosis infection in people with HIV infection. Rarely, pyrimethamine is used with sulfadoxine to treat malaria. The CDC no longer recommends using pyrimethamine alone to prevent or treat malaria. Pyrimethamine belongs to a class of drugs known as antiparasitics. It works by killing parasites.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used with other medications (such as dapsone) for the prevention and treatment of pneumocystis pneumonia in AIDS patients.

 

HOW TO USE: Take this medication by mouth usually once or twice daily or as directed by your doctor. Take this medication with food to decrease nausea and vomiting. If vomiting is severe or continues, your doctor may lower your dose or direct you to stop taking this medication. Your doctor will prescribe another medication (folic/folinic acid) to prevent blood problems caused by pyrimethamine. Follow your doctor's directions carefully. Drink plenty of fluids to prevent kidney problems if you are taking a "sulfa" medication with pyrimethamine.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug and other antiparasitic drugs regularly, exactly as prescribed by your doctor. To help you remember, take it at the same time(s) each day.

Dosage is based on the type of infection, your medical condition, age, and response to treatment. The length of time you will take this medication depends on your infection. Your dose must be carefully adjusted by your doctor to treat your infection and prevent serious side effects. Follow your doctor's directions carefully.

Do not take more or less of this drug than prescribed. Do not stop taking it before completing this prescription unless directed to do so by your doctor, even if you feel better. Skipping or changing your dose without approval from your doctor may cause the amount of parasites to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Tell your doctor if your condition persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: See also How to Use section.

Nausea, vomiting, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Some people using this medication may develop serious side effects including blood problems, especially at higher doses. This risk can be reduced with the use of folic/folinic acid and regular blood tests. Tell your doctor immediately if any of these symptoms occur: easy bruising/bleeding, signs of serious infection (such as high fever, severe chills, persistent sore throat), signs of low red blood cell count (such as severe tiredness, pale lips/nails/skin, fast heartbeat/breathing with usual activities), swollen/painful tongue.

Seek immediate medical attention if any of these rare but very serious side effects occur: bloody/pink urine, chest pain, slow/fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, stop this medication immediately and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Daraprim (pyrimethamine) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking pyrimethamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, kidney problems, liver problems, a certain type of low red blood cell count (megaloblastic anemia due to low blood folate), low folic acid levels from other conditions (such as malnutrition, problems with absorption of food, alcoholism), low red/white blood cell counts, low blood-clotting cell (platelet) count.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Folic acid is very important during pregnancy. Your doctor will prescribe folic/folinic acid to prevent low folate levels.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: lorazepam, penicillamine, sulfa drugs (such as sulfamethoxazole), drugs that can lower folate levels (such as phenytoin, trimethoprim), drugs that can lower blood counts (such as proguanil, zidovudine, chemotherapy including methotrexate, daunorubicin, cytosine).

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: abdominal pain, severe/repeated vomiting, vomiting blood, seizures, slow/shallow breathing, inability to wake up.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, liver blood tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Daraprim

Generic Name: pyrimethamine (Pronunciation: PIR i METH a meen)

  • What is pyrimethamine (Daraprim)?
  • What are the possible side effects of pyrimethamine (Daraprim)?
  • What is the most important information I should know about pyrimethamine (Daraprim)?
  • What should I discuss with my healthcare provider before taking pyrimethamine (Daraprim)?
  • How should I take pyrimethamine (Daraprim)?
  • What happens if I miss a dose (Daraprim)?
  • What happens if I overdose (Daraprim)?
  • What should I avoid while taking pyrimethamine (Daraprim)?
  • What other drugs will affect pyrimethamine (Daraprim)?
  • Where can I get more information?

What is pyrimethamine (Daraprim)?

Pyrimethamine is an antiparasitic drug. It prevents the growth and reproduction of parasites.

Pyrimethamine is used to treat and prevent malaria. Pyrimethamine is also used in the treatment of toxoplasmosis.

Pyrimethamine may also be used for purposes other than those listed in this medication guide.

Daraprim 25 mg

round, white, imprinted with DARAPRIM A3A

What are the possible side effects of pyrimethamine (Daraprim)?

Stop taking pyrimethamine and seek emergency medical attention if you experience an allergic reaction (swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; or hives) during treatment with pyrimethamine.

Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine.

Other, less serious side effects may be more likely to occur. Continue to take pyrimethamine and talk to your doctor if you experience

  • nausea, vomiting, or loss of appetite;
  • insomnia;
  • headache;
  • lightheadedness; or
  • dryness of the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Daraprim (pyrimethamine) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about pyrimethamine (Daraprim)?

Stop taking pyrimethamine and seek medical attention at the first sign of a skin rash, sore throat, paleness of the skin, unusual bruising under the skin, or swelling of the tongue. These may be early symptoms of serious side effects of pyrimethamine.

Pyrimethamine may cause stomach upset or vomiting. Take each dose with food to lessen this side effect.

Side Effects Centers
  • Daraprim

Patient Detailed How Take

What should I discuss with my healthcare provider before taking pyrimethamine (Daraprim)?

Before taking pyrimethamine, tell your doctor if you have

  • had an allergic reaction to previous treatment with pyrimethamine,
  • megaloblastic anemia due to folate deficiency,
  • seizures or epilepsy,
  • kidney disease, or
  • liver disease.

You may not be able to take pyrimethamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pyrimethamine is in the FDA pregnancy category C. This means that it is not known whether pyrimethamine will be harmful to an unborn baby. Do not take pyrimethamine without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Pyrimethamine passes into breast milk and may be harmful to a nursing infant. Do not take pyrimethamine without first talking to your doctor if you are breast-feeding a baby.

How should I take pyrimethamine (Daraprim)?

Take pyrimethamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Take pyrimethamine with food to lessen stomach upset.

Store pyrimethamine at room temperature away from moisture and heat.

Side Effects Centers
  • Daraprim

Patient Detailed Avoid Taking

What happens if I miss a dose (Daraprim)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of the medication.

What happens if I overdose (Daraprim)?

Seek emergency medical attention.

Symptoms of a pyrimethamine overdose may include abdominal pain, nausea, severe vomiting (possibly with blood in the vomit), anxiety or excitability, and seizures.

What should I avoid while taking pyrimethamine (Daraprim)?

There are no restrictions on foods, beverages, or activities during treatment with pyrimethamine unless otherwise directed by your doctor.

What other drugs will affect pyrimethamine (Daraprim)?

Before taking pyrimethamine, tell your doctor if you are taking any of the following medicines:

  • auranofin (Ridaura);
  • aurothioglucose (Solganal); or
  • or gold sodium thiomalate (Aurolate, Myochrysine).

You may not be able to take pyrimethamine, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with pyrimethamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist can provide more information about pyrimethamine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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