Sulfadiazine Side Effects

Some side effects of sulfadiazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sulfadiazine: oral tablet

If you experience any of the following serious side effects, stop taking sulfadiazine and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);

• blood in the urine;

• difficult or painful urination;

• yellowing of the skin or eyes;

• ringing in the ears;

• difficulty breathing, sore throat, or chills;

• a skin rash;

• unusual tiredness or weakness;

• severe watery diarrhea and abdominal cramps; or

• unusual bleeding or bruising.

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

• headache, fatigue, or dizziness;

• nausea, vomiting, decreased appetite, or diarrhea; or

• increased skin sensitivity to the sun.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to sulfadiazine: compounding powder, oral tablet

Hypersensitivity

Hypersensitivity side effects have included urticarial rash (most common), allergic myocarditis, anaphylactoid reactions, anaphylaxis, arthralgia, conjunctival and scleral injection, drug fever and chills, epidermal necrolysis, erythema multiforme, exfoliative dermatitis, generalized skin eruptions, periorbital edema, photosensitization, serum sickness, Stevens-Johnson syndrome, and urticaria.

The use of sulfonamide antibiotics, including sulfadiazine, is associated with large increases in the risk of Stevens-Johnson syndrome and toxic epidermal necrolysis, although these phenomena are rare as a whole.

Hematologic

Hematologic side effects have included agranulocytosis (0.1%), aplastic anemia, hemolytic anemia (0.05%), hypoprothrombinemia, leukopenia, methemoglobinemia, and purpura.

Hemolytic anemia occurs less often with sulfadiazine than with other sulfonamides. Aplastic anemia may be more likely in patients with poor bone marrow reserves.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal pain, diarrhea, anorexia, pancreatitis, and stomatitis.

Hepatic

Hepatic side effects are rare but can be serious. Isolated cases of hepatitis and jaundice due to cholestasis have been associated with sulfadiazine. Elevated liver function tests (with a negative hepatitis panel) have been reported in at least one case associated with psychosis.

Psychiatric

Psychosis associated with sulfadiazine and pyrimethamine therapy in patients with AIDS and CNS toxoplasmosis has been described in two separate case reports. In each case, tremulousness and disorientation developed within three days to two weeks after starting therapy, despite partial resolution of the size of the intracranial T gondii lesions. No other obvious cause for mental status changes was found. The delirium resolved upon discontinuation of therapy in each case, and was reproducible upon rechallenge. In one case, the patient had elevated liver function tests (hepatitis panel was negative), which were reversible upon discontinuation of therapy.

Psychiatric side effects have rarely included frank psychosis in patients with AIDS and CNS toxoplasmosis. Tremulousness, disorientation, and delirium have been reported.

Nervous system

Nervous system side effects have included ataxia, convulsions, hallucinations, headache, insomnia, mental depression, peripheral neuritis, tinnitus, and vertigo.

Renal

Renal side effects have included crystalluria, lupus erythematosus, periarteritis nodosa, toxic nephrosis with oliguria and anuria, and acute renal failure secondary to crystalluria or tubulointerstitial nephritis.

Genitourinary

In one case, analysis of the stone fragments showed a composition of 100% acetylated 2-sulfanilamidopyrimidine, a metabolite of sulfadiazine.

Genitourinary side effects have included urolithiasis.

Metabolic

Metabolic side effects have included hypoglycemia.

Endocrine

Endocrine side effects associated with sulfonamides have rarely included diuresis, goiter production, and sialadenitis.

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