Pyrimethamine / sulfadoxine Side Effects

It is possible that some side effects of pyrimethamine / sulfadoxine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to pyrimethamine / sulfadoxine: oral tablet

As well as its needed effects, pyrimethamine / sulfadoxine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking pyrimethamine / sulfadoxine, check with your doctor immediately:

More common
  • Fever
  • increased sensitivity of skin to sunlight
  • irritation or soreness of tongue
  • skin rash
Less common
  • Black, tarry stools
  • bleeding or crusting sores on lips
  • blood in urine or stools
  • chest pain
  • chills
  • cough or hoarseness
  • loss of appetite
  • lower back or side pain
  • muscle cramps or pain
  • nausea
  • painful or difficult urination
  • pinpoint red spots on skin
  • redness, blistering, peeling, or loosening of skin
  • sore mouth
  • sore throat
  • sores, ulcers, and/or white spots in mouth
  • sores on lips
  • swelling in upper abdominal area
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin
Rare
  • Abdominal or stomach pain
  • changes in facial skin color
  • constipation
  • fast or irregular breathing
  • tenderness, itching, or burning of skin
  • puffiness or swelling of the eyelids or around the eyes
  • shortness of breath, troubled breathing, tightness in chest, and/or wheezing
  • swelling of front part of neck
Symptoms of overdose
  • Bleeding or bruising (severe)
  • clumsiness or unsteadiness
  • convulsions (seizures)
  • fever and sore throat
  • irritation or soreness of tongue
  • loss of appetite
  • unusual tiredness or weakness
  • trembling
  • vomiting (severe)

Some pyrimethamine / sulfadoxine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Anxiety
  • diarrhea
  • drowsiness
  • headache
  • nervousness
Less common
  • Pain in joints

For Healthcare Professionals

Applies to pyrimethamine / sulfadoxine: oral tablet

Hypersensitivity

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.

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.

Dermatologic

Dermatologic side effects have frequently included phototoxicity, rash, dermatitis, and hair loss.

Hematologic

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.

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.

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.

Hepatic

Hepatic side effects have included hepatitis (7%), hepatocellular necrosis, and liver enzyme elevations.

In many cases, the hepatitis has accompanied severe cutaneous reactions, fever, myalgias and arthralgias. Granulomas and necrosis have been seen on biopsy.

Renal

Renal side effects have included renal failure, interstitial nephritis, toxic nephrosis with oliguria and anuria, crystalluria, and increases in BUN and serum creatinine.

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.

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.

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).

Genitourinary

Genitourinary side effects have included crystalluria.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. 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 substances you are taking, check with your doctor, nurse, or pharmacist.

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