Fansidar Side Effects
Generic name: pyrimethamine / sulfadoxine
Medically reviewed by Drugs.com. Last updated on Nov 12, 2024.
Note: This document provides detailed information about Fansidar Side Effects associated with pyrimethamine / sulfadoxine. Some dosage forms listed on this page may not apply specifically to the brand name Fansidar.
Applies to pyrimethamine / sulfadoxine: oral tablet.
Important warnings
This medicine can cause some serious health issues
Do not use this medication if you have ever had a serious allergic reaction to pyrimethamine or sulfadoxine. Stop taking the medicine and call your doctor at once if you have any signs of skin rash, no matter how mild.
You should not use this medication if you are allergic to sulfa drugs, or if you have liver or kidney disease (if using the medication long-term), a blood cell disorder (such as anemia), if you are in late pregnancy, or if you are breast-feeding a baby.
Take the pyrimethamine and sulfadoxine tablet after a meal, with plenty of water or other fluid. Swallow the tablet whole, do not break or chew it.
Drink plenty of water to keep your kidneys working and prevent kidney stones while taking this medication.
You should not take pyrimethamine and sulfadoxine for longer than 2 years without a doctor's advice.
In addition to taking pyrimethamine and sulfadoxine, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.
No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.
Get emergency medical help if you have any of these signs of an allergic reaction while taking pyrimethamine / sulfadoxine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using pyrimethamine and sulfadoxine and call your doctor at once if you have any of these serious side effects:
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the first sign of any skin rash, no matter how mild;
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a severe blistering, peeling, and red skin rash;
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pale skin, easy bruising or bleeding;
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feeling tired, weak, or dizzy;
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hallucinations, seizure (convulsions);
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urinating less than usual or not at all;
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jaundice (yellowing of the skin or eyes); or
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fever, chills, sore throat, swollen tongue, joint pain, cough, feeling short of breath.
Less serious side effects of pyrimethamine / sulfadoxine may include:
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mild stomach pain, feeling full;
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slight hair loss;
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headache;
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muscle weakness;
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depression, nervousness;
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ringing in your ears; or
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sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
For healthcare professionals
Applies to pyrimethamine / sulfadoxine: oral tablet.
Hypersensitivity adverse events
Hypersensitivity reactions have included erythema multiforme, Stevens-Johnson syndrome, generalized skin eruptions, toxic epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, and allergic pericarditis. Fatalities due to severe hypersensitivity reactions have been reported.[Ref]
Severe cutaneous reactions have occurred in patients who have taken as few as two doses of pyrimethamine-sulfadoxine. The risk of fatal cutaneous reactions in patients receiving pyrimethamine-sulfadoxine has been estimated to range from 1 in 11,000 to 1 in 25,000. In general, the use of sulfonamide antibiotics is associated with large increases in the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis, although these phenomena are rare as a whole.[Ref]
Dermatologic
Dermatologic side effects have frequently included phototoxicity, rash, dermatitis, and hair loss.[Ref]
Hematologic
Hematologic side effects have included leucopenia (7%), agranulocytosis, aplastic anemia, megaloblastic anemia, thrombocytopenia, hemolytic anemia, purpura, hypoprothrombinemia, methemoglobinemia, and eosinophilia. Macrocytic anemia has also been reported. Fatalities have been reported.[Ref]
Hematologic toxicity is more common with higher doses of pyrimethamine.
Many cases of agranulocytosis have occurred during therapy with pyrimethamine-dapsone, although it has been reported in patients receiving pyrimethamine-sulfadoxine as well.[Ref]
Gastrointestinal
Gastrointestinal side effects have included anorexia (5.5%), digestive intolerance (3%), diarrhea (2.74%), abdominal pain (2.74%), vomiting (2.74%), nausea, glossitis, stomatitis, and pancreatitis.[Ref]
Hepatic
Hepatic side effects have included hepatitis (7%), hepatocellular necrosis, and liver enzyme elevations.[Ref]
In many cases, the hepatitis has accompanied severe cutaneous reactions, fever, myalgias and arthralgias. Granulomas and necrosis have been seen on biopsy.[Ref]
Renal
Renal side effects have included renal failure, interstitial nephritis, toxic nephrosis with oliguria and anuria, crystalluria, and increases in BUN and serum creatinine.[Ref]
Respiratory
Respiratory side effects have included cough (9.6%), pulmonary infiltrates and shortness of breath which may be due to pulmonary hypersensitivity reactions. Frequently, the pulmonary reactions have accompanied other systemic symptoms.[Ref]
Nervous system
Nervous system side effects have included headache (4.1%), peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo, insomnia, apathy, fatigue, muscle weakness, nervousness, and polyneuritis.[Ref]
Metabolic
Metabolic side effects associated with sulfonamides have included diuresis and hypoglycemia. Sulfonamides are chemically similar to goitrogenic agents (i.e., diuretics and oral hypoglycemic agents).[Ref]
Genitourinary
Genitourinary side effects have included crystalluria.[Ref]
Endocrine
Endocrine side effects including weight gain (1 kg or greater) have been reported in 53% of patients.
Other
Other side effects have included drug fever, chills, periarteritis nodosa, and lupus erythematosus phenomenon.[Ref]
References
1. (2022) "Product Information. Fansidar (pyrimethamine-sulfadoxine)." Roche Laboratories
2. Roujeau JC, Kelly JP, Naldi L, et al. (1995) "Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis." N Engl J Med, 333, p. 1600-7
3. Zitelli BJ, Alexander J, Taylor S, Miller KD, Howrie DL, Kuritsky JN, Perez TH, Van Thiel DH (1987) "Fatal hepatic necrosis due to pyrimethamine-sulfadoxine (Fansidar)." Ann Intern Med, 106, p. 393-5
4. Selby CD, Ladusans EJ, Smith PG (1985) "Fatal multisystemic toxicity associated with prophylaxis with pyrimethamine and sulfadoxine (Fansidar)." Br Med J (Clin Res Ed), 290, p. 113-4
5. Murphy RL, Phair JP (1986) "Systemic reaction to pyrimethamine-sulfadoxine." J Fam Pract, 22, p. 375-6
6. Phillips-Howard PA, West LJ (1990) "Serious adverse drug reactions to pyrimethamine-sulphadoxine pyrimethamine-dapsone and to amodiaquine in Britain." J R Soc Med, 83, p. 82-5
7. Whitfield D (1982) "Presumptive fatality due to pyrimethamine-sulfadoxine." Lancet, 2, p. 1272
8. Olsen VV, Loft S, Christensen KD (1982) "Serious reactions during malaria prophylaxis with pyrimethamine- sulfadoxine." Lancet, 2, p. 994
9. Phillips-Howard PA, Behrens RH, Dunlop J (1989) "Stevens-Johnson syndrome due to pyrimethamine / sulfadoxine during presumptive self-therapy of malaria." Lancet, 2, p. 803-4
10. (1988) "Fansidar-associated fatal reaction in an HIV-infected man." MMWR Morb Mortal Wkly Rep, 37, p. 571-2
11. Hornstein OP, Ruprecht KW (1982) "Fansidar-induced Stevens-Johnson Syndrome." N Engl J Med, 307, p. 1529-30
12. Jeffrey RF (1986) "Transient lupus anticoagulant and fansidar therapy." Postgrad Med J, 62, p. 893-4
13. Adams SJ, Broadbent J, Clayden LM, Ridley CM (1985) "Erythema multiforme (Stevens-Johnson) precipitated by Fansidar." Postgrad Med J, 61, p. 263-4
14. Ward DJ, Krzeminska EC, Tanner NS (1990) "Treatment of toxic epidermal necrolysis and a review of six cases." Burns, 16, p. 97-104
15. Ortel B, Sivayathorn A, Honigsmann H (1989) "An unusual combination of phototoxicity and Stevens-Johnson syndrome due to antimalarial therapy." Dermatologica, 178, p. 39-42
16. Bamber MG, Elder AT, Gray JA, Minns RA (1986) "Fatal Stevens-Johnson syndrome associated with Fansidar and chloroquine." J Infect, 13, p. 31-3
17. Ree GH (1983) "Chemoprophylaxis of malaria in Africa." Br Med J (Clin Res Ed), 286, p. 562
18. Nicholls MD, Concannon AJ (1982) "Maloprim-induced agranulocytosis and red-cell aplasia." Med J Aust, 2, p. 564-6
19. Booth F, Barker LC, Barton CJ, Naik RB (1984) "Agranulocytosis during malaria prophylaxis with Maloprim (pyrimethamine and dapsone)." Postgrad Med J, 60, p. 566-7
20. Bowcock SJ, Linch DC, Machin SJ, Stewart JW (1987) "Pyrimethamine in the myeloproliferative disorders: a forgotten treatment?" Clin Lab Haematol, 9, p. 129-36
21. Whitehead S (1983) "Agranulocytosis associated with maloprim." Br Med J (Clin Res Ed), 286, p. 1515
22. Winstanley P (1998) "Malaria: treatment." J R Coll Physicians Lond, 32, p. 203-7
23. Lazar HP, Murphy RL, Phair JP (1985) "Fansidar and hepatic granulomas." Ann Intern Med, 102, p. 722
24. Davidson AC, Bateman C, Shovlin C, Marrinan M, Burton GH, Cameron IR (1988) "Pulmonary toxicity of malaria prophylaxis." BMJ, 297, p. 1240-1
25. Svanbom M, Rombo L, Gustafsson L (1984) "Unusual pulmonary reaction during short term prophylaxis with pyrimethamine-sulfadoxine (Fansidar)." Br Med J (Clin Res Ed), 288, p. 1876
26. McCormack D, Morgan WK (1987) "Fansidar hypersensitivity pneumonitis." Br J Dis Chest, 81, p. 194-6
27. Pang JA (1989) "Non-cardiogenic pulmonary oedema associated with pyrimethamine." Respir Med, 83, p. 247-8
28. Fish DR, Espir ML (1988) "Convulsions associated with prophylactic antimalarial drugs: implications for people with epilepsy." BMJ, 297, p. 526-7
More about Fansidar (pyrimethamine / sulfadoxine)
- Check interactions
- Compare alternatives
- Reviews (1)
- Drug images
- Dosage information
- During pregnancy
- Drug class: antimalarial combinations
Patient resources
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Further information
Fansidar side effects can vary depending on the individual. 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.