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Daraprim Side Effects

Generic Name: pyrimethamine

Note: This document contains side effect information about pyrimethamine. Some of the dosage forms listed on this page may not apply to the brand name Daraprim.

For the Consumer

Applies to pyrimethamine: oral tablet

Side effects requiring immediate medical attention

Along with its needed effects, pyrimethamine (the active ingredient contained in Daraprim) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pyrimethamine:

Less common

  • Black, tarry stools
  • blood in urine or stools
  • cough or hoarseness
  • fever or chills
  • irritation or soreness of tongue
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on skin
  • unusual bleeding or bruising

Rare

  • Bleeding or crusting sores on lips
  • chest pain or discomfort
  • muscle cramps or pain
  • redness, blistering, peeling, or loosening of skin
  • skin rash
  • sores, ulcers, and/or white spots in mouth
  • sore throat
  • unusual tiredness or weakness

Frequency not known

  • Blood in urine
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fainting spells
  • fast, slow, or irregular heartbeat
  • hives
  • itching
  • joint or muscle pain
  • lightheadedness
  • pale skin
  • pounding or rapid pulse
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • rapid breathing
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • shortness of breath
  • swollen glands
  • tightness in chest
  • unexplained bleeding or bruising
  • wheezing

Symptoms of overdose

  • Abdominal or stomach pain
  • convulsions (seizures)
  • increased excitability
  • vomiting (severe and continuing)

Side effects not requiring immediate medical attention

Some side effects of pyrimethamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Diarrhea
  • loss of appetite
  • nausea
  • vomiting

For Healthcare Professionals

Applies to pyrimethamine: compounding powder, oral tablet

General

Since this drug is coadministered with a sulfonamide, the manufacturer product information for the relevant sulfonamide should be consulted for sulfonamide-related side effects.[Ref]

Gastrointestinal

Very common (10% or more): Nausea, vomiting, diarrhea, colic

Uncommon (0.1% to 1%): Dry mouth, dry throat

Very rare (less than 0.01%): Buccal ulceration

Frequency not reported: Glossitis, atrophic glossitis[Ref]

Nervous system

Precipitation of a grand mal attack in a patient predisposed to epilepsy was reported; clinical significance was not established.[Ref]

Very common (10% or more): Headache

Common (1% to 10%): Dizziness

Very rare (less than 0.01%): Convulsions/seizures

Frequency not reported: Ataxia, tremors, precipitation of grand mal attack[Ref]

Hematologic

Very common (10% or more): Anemia

Common (1% to 10%): Thrombocytopenia, leukopenia

Very rare (less than 0.01%): Pancytopenia

Frequency not reported: Megaloblastic anemia, neutropenia, agranulocytosis[Ref]

Dermatologic

Very common (10% or more): Rash

Uncommon (0.1% to 1%): Abnormal skin pigmentation, dermatitis

Other

Uncommon (0.1% to 1%): Fever, malaise

Psychiatric

Insomnia was reported when this drug was given weekly at higher than recommended doses.

Uncommon (0.1% to 1%): Depression

Very rare (less than 0.01%): Insomnia

Respiratory

Rare (0.01% to 0.1%): Pulmonary eosinophilia

Very rare (less than 0.01%): Pneumonia with cellular and eosinophilic pulmonary infiltration[Ref]

Pneumonia with cellular and eosinophilic pulmonary infiltration was observed when this drug was administered once a week with sulfadoxine.[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (included erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, Lyell's syndrome, hepatitis, anaphylaxis, pulmonary reactions, maculopapular rashes)[Ref]

Cardiovascular

Circulatory collapse was reported in patients treated with higher than recommended doses.[Ref]

Very rare (less than 0.01%): Circulatory collapse

Frequency not reported: Disorders of cardiac rhythm, arrhythmias[Ref]

Metabolic

Hyperphenylalaninemia was reported in neonates treated for congenital toxoplasmosis.[Ref]

Very rare (less than 0.01%): Hyperphenylalaninemia

Frequency not reported: Anorexia[Ref]

Genitourinary

Very rare (less than 0.01%): Hematuria

Oncologic

A 51-year-old female developed chronic granulocytic leukemia after taking this drug for 2 years for toxoplasmosis and a 56-year-old patient developed reticulum cell sarcoma after taking this drug for 14 months for toxoplasmosis.[Ref]

Frequency not reported: Chronic granulocytic leukemia, reticulum cell sarcoma[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Daraprim (pyrimethamine)." Glaxo Wellcome, Research Triangle Park, NC.

4. Bowcock SJ, Linch DC, Machin SJ, Stewart JW "Pyrimethamine in the myeloproliferative disorders: a forgotten treatment?" Clin Lab Haematol 9 (1987): 129-36

5. Iaccheri B, Fiore T, Papadaki T, et al. "Adverse drug reactions to treatments for ocular toxoplasmosis: A retrospective chart review." Clin Ther 30 (2008): 2069-74

6. Booth F, Barker LC, Barton CJ, Naik RB "Agranulocytosis during malaria prophylaxis with Maloprim (pyrimethamine and dapsone)." Postgrad Med J 60 (1984): 566-7

7. Nicholls MD, Concannon AJ "Maloprim-induced agranulocytosis and red-cell aplasia." Med J Aust 2 (1982): 564-6

8. Olsen VV, Loft S, Christensen KD "Serious reactions during malaria prophylaxis with pyrimethamine- sulfadoxine." Lancet 2 (1982): 994

9. Ree GH "Chemoprophylaxis of malaria in Africa." Br Med J (Clin Res Ed) 286 (1983): 562

10. Phillips-Howard PA, West LJ "Serious adverse drug reactions to pyrimethamine-sulphadoxine pyrimethamine-dapsone and to amodiaquine in Britain." J R Soc Med 83 (1990): 82-5

11. Whitehead S "Agranulocytosis associated with maloprim." Br Med J (Clin Res Ed) 286 (1983): 1515

12. Davidson AC, Bateman C, Shovlin C, Marrinan M, Burton GH, Cameron IR "Pulmonary toxicity of malaria prophylaxis." BMJ 297 (1988): 1240-1

13. Hornstein OP, Ruprecht KW "Fansidar-induced Stevens-Johnson Syndrome." N Engl J Med 307 (1982): 1529-30

14. "Fansidar-associated fatal reaction in an HIV-infected man." MMWR Morb Mortal Wkly Rep 37 (1988): 571-2

15. Ortel B, Sivayathorn A, Honigsmann H "An unusual combination of phototoxicity and Stevens-Johnson syndrome due to antimalarial therapy." Dermatologica 178 (1989): 39-42

16. Phillips-Howard PA, Behrens RH, Dunlop J "Stevens-Johnson syndrome due to pyrimethamine/sulfadoxine during presumptive self-therapy of malaria." Lancet 2 (1989): 803-4

17. Whitfield D "Presumptive fatality due to pyrimethamine-sulfadoxine." Lancet 2 (1982): 1272

18. Zitelli BJ, Alexander J, Taylor S, Miller KD, Howrie DL, Kuritsky JN, Perez TH, Van Thiel DH "Fatal hepatic necrosis due to pyrimethamine-sulfadoxine (Fansidar)." Ann Intern Med 106 (1987): 393-5

19. Pang JA "Non-cardiogenic pulmonary oedema associated with pyrimethamine." Respir Med 83 (1989): 247-8

20. Ward DJ, Krzeminska EC, Tanner NS "Treatment of toxic epidermal necrolysis and a review of six cases." Burns 16 (1990): 97-104

21. Svanbom M, Rombo L, Gustafsson L "Unusual pulmonary reaction during short term prophylaxis with pyrimethamine-sulfadoxine (Fansidar)." Br Med J (Clin Res Ed) 288 (1984): 1876

22. Selby CD, Ladusans EJ, Smith PG "Fatal multisystemic toxicity associated with prophylaxis with pyrimethamine and sulfadoxine (Fansidar)." Br Med J (Clin Res Ed) 290 (1985): 113-4

23. Bamber MG, Elder AT, Gray JA, Minns RA "Fatal Stevens-Johnson syndrome associated with Fansidar and chloroquine." J Infect 13 (1986): 31-3

24. Adams SJ, Broadbent J, Clayden LM, Ridley CM "Erythema multiforme (Stevens-Johnson) precipitated by Fansidar." Postgrad Med J 61 (1985): 263-4

25. McCormack D, Morgan WK "Fansidar hypersensitivity pneumonitis." Br J Dis Chest 81 (1987): 194-6

26. Jeffrey RF "Transient lupus anticoagulant and fansidar therapy." Postgrad Med J 62 (1986): 893-4

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.