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What the label lists and what reports show

Sulfadiazine side effects

Sulfadiazine's FDA label lists its adverse reactions in its own words. FAERS holds 1,677 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug hypersensitivity (190 reports).

  • Generic listed

Check it at the source: the sulfadiazine FDA label on DailyMed (effective September 24, 2024, Chartwell RX, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Blood Dyscrasias Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia. Allergic Reactions Erythema multiforme (Stevens-Johnson syndrome), generalized skin eruptions, epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, drug fever and chills. Gastrointestinal Reactions Nausea, emesis, abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis. C.N.S. Reactions Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia. Renal Crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted. …

Source: FDA drug label, Chartwell RX, LLC, effective September 24, 2024 (SPL set 6032d6f7-cbce-4e5d-841c-a1e24b616f91), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,677 reports list sulfadiazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 264 are coded as a death and 701 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Hypersensitivity190
  • Condition Aggravated (a use or a product term, not a reaction)163
  • Dyspnoea154
  • Off Label Use (a use or a product term, not a reaction)146
  • Pain In Extremity132
  • Anxiety123
  • Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)122
  • Drug Ineffective (a use or a product term, not a reaction)120
  • Vomiting119
  • Lung Disorder116
  • Asthma115
  • Neurological Symptom114
  • Haemoptysis113
  • Pulmonary Fibrosis113
  • Pulmonary Alveolar Haemorrhage112
  • Neuritis (named in the label)111
  • Obstructive Airways Disorder111
  • Hypothyroidism109
  • Pulmonary Vasculitis109
  • Sleep Disorder Due To A General Medical Condition107
  • Wheezing107
  • Vasculitis106
  • Respiratory Symptom105
  • Nausea (named in the label)103
  • Full Blood Count Abnormal102

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sulfadiazine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions