pharmacopeia
GET
/api/v1/drug/sulfasalazine
2D structure
2-hydroxy-5-[[4-(pyridin-2-ylsulfamoyl)phenyl]diazenyl]benzoic acid
SMILES C1=CC=NC(=C1)NS(=O)(=O)C2=CC=C(C=C2)N=NC3=CC(=C(C=C3)O)C(=O)O
InChIKey NCEXYHBECQHGNR-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cyclooxygenase Inhibitors; Lipoxygenase Inhibitors.

CyclooxygenaseLipoxygenase

Indications

Sourced from openFDA
  • Sulfasalazine Tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis.ICD-10: K51.90

Contraindications

Sourced from openFDA
  • Sulfasalazine Tablets are contraindicated in: Patients with intestinal or urinary obstruction, Patients with porphyria as sulfonamides have been reported to precipitate an acute attack, Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.contraindicated

Dosage & administration

Sourced from openFDA

The dosage of Sulfasalazine Tablets should be adjusted to each individual’s response and tolerance. Initial Therapy: Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. In some cases, it is advisable to initiate therapy with a smaller dosage, e.g., 1 to 2 g daily, to reduce possible gastrointestinal intolerance. If daily doses exceeding 4 g are required to achieve desired effects, the increased risk of toxicity should be kept in mind. Children, six years of age and older: 40 to 60 mg/kg body weight in each 24-hour period, divided into 3 to 6 doses. Maintenance Therapy: Adults: 2 g daily. Children, six years of age and older: 30 mg/kg body weight in each 24-hour period, divided into 4 doses. The response of acute ulcerative colitis to Sulfasalazine Tablets can be evaluated by clinical criteria, including the presence of fever, weight changes, and degree and frequency of diarrhea and bleeding, as well as by sigmoidoscopy and the evaluation of biopsy samples. It is often necessary to continue medication even when clinical symptoms, including diarrhea, have been controlled. When endoscopic examination confirms satisfactory improvement, the dosage of sulfasalazine should be reduced to a maintenance level. If diarrhea recurs, the dosage should be increased to previously effective levels.

Warnings & precautions

Sourced from openFDA

Hepatic, Renal, and Hematologic Toxicity or Other Conditions Only after critical appraisal should Sulfasalazine Tablets be given to patients with hepatic or renal damage or blood dyscrasias. Deaths associated with the administration of sulfasalazine have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia, other blood dyscrasias, renal and liver damage, irreversible neuromuscular and central nervous system changes, and fibrosing alveolitis. The presence of clinical signs such as sore throat, fever, pallor, purpura, or jaundice may be indications of serious blood disorders or hepatotoxicity. Complete blood counts, as well as urinalysis with careful microscopic examination, should be done frequently in patients receiving sulfasalazine (see PRECAUTIONS, Laboratory Tests). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Oligospermia and Infertility Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reverse these effects. Serious Infections Serious infections, including fatal sepsis and pneumonia, have been reported. Some infections were associated with agranulocytosis, neutropenia, or myelosuppression. Discontinue sulfasalazine if a patient develops a serious infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with sulfasalazine.

Adverse reactions

Sourced from openFDA

The most common adverse reactions associated with sulfasalazine are anorexia, headache, nausea, vomiting, gastric distress, and apparently reversible oligospermia. These occur in about one-third of the patients. Less frequent adverse reactions are skin rash, pruritus, urticaria, fever, Heinz body anemia, hemolytic anemia, and cyanosis, which may occur at a frequency of one in every thirty patients or less. Experience suggests that with a daily dosage of 4 g or more, or total serum sulfapyridine levels above 50 μg/mL, the incidence of adverse reactions tends to increase. Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the sulfonamides require that each of these reactions be considered when Sulfasalazine Tablets are administered. Less common or rare adverse reactions include: Blood dyscrasias: aplastic anemia, agranulocytosis, leukopenia, megaloblastic (macrocytic) anemia, purpura, thrombocytopenia, hypoprothrombinemia, methemoglobinemia, congenital neutropenia, and myelodysplastic syndrome.

Overdosage

Sourced from openFDA

There is evidence that the incidence and severity of toxicity following overdosage are directly related to the total serum sulfapyridine concentration. Symptoms of overdosage may include nausea, vomiting, gastric distress, and abdominal pains. In more advanced cases, central nervous system symptoms such as drowsiness, convulsions, etc., may be observed. Serum sulfapyridine concentrations may be used to monitor the progress of recovery from overdosage. There are no documented reports of deaths due to ingestion of large single doses of sulfasalazine. Doses of Sulfasalazine tablets of 16 g per day have been given to patients without mortality. A single oral dose of 12 g/kg was not lethal to mice. Instructions for Overdosage: Gastric lavage or emesis plus catharsis as indicated. Alkalinize urine. If kidney function is normal, force fluids. If anuria is present, restrict fluids and salt, and treat appropriately. Catheterization of the ureters may be indicated for complete renal blockage by crystals. The low molecular weight of sulfasalazine and its metabolites may facilitate their removal by dialysis.

Approval history

Sourced from openFDA
  • Jun 20, 1950NDANDA007073Pfizer
  • Nov 12, 1973ANDAANDA080197Chartwell
  • Oct 21, 1977ANDAANDA085828Watson Labs
  • Jan 11, 2002ANDAANDA075339Nuvo Pharms Inc
  • Jan 11, 2002ANDAANDA040349Nuvo Pharms Inc
  • Nov 4, 2025ANDAANDA219046Rising

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
76,997 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective29,16038%
  2. 2Rheumatoid Arthritis19,33125%
  3. 3Pain15,78821%
  4. 4Drug Intolerance13,63718%
  5. 5Arthralgia13,30317%
  6. 6Fatigue13,15517%
  7. 7Joint Swelling12,59916%
  8. 8Off Label Use10,93214%
  9. 9Rash10,80914%
  10. 10Abdominal Discomfort9,91213%
  11. 11Contraindicated Product Administered9,54612%
  12. 12Condition Aggravated9,47712%
  13. 13Alopecia9,38312%
  14. 14Arthropathy9,10712%
  15. 15Synovitis9,05112%

Literature

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Recent PubMed references pinned to Sulfasalazine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 119 ClinicalTrials.gov registrations naming Sulfasalazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Sulfasalazine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • G6PDCPIC CClinPGx 3FDA label: Actionable PGx
    G6PD
  • NAT2CPIC B/C (provisional)FDA label: Informative PGx

Frequently asked questions

How does Sulfasalazine work?
Mechanism-of-action classes: Cyclooxygenase Inhibitors; Lipoxygenase Inhibitors.
What is Sulfasalazine used for?
According to FDA labeling, Sulfasalazine carries indications including: Sulfasalazine Tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sulfasalazine?
Sulfasalazine is classified as Aminosalicylic acid and similar agents, Aminosalicylate, Cyclooxygenase Inhibitors, Lipoxygenase Inhibitors, Decreased Platelet Aggregation, Decreased Prostaglandin Production, Decreased Thromboxane Production.
What are the brand names for Sulfasalazine?
Sulfasalazine is marketed under brand names including Azulfidine.
What are the contraindications for Sulfasalazine?
Sulfasalazine labeling lists contraindications including: Sulfasalazine Tablets are contraindicated in: Patients with intestinal or urinary obstruction, Patients with porphyria as sulfonamides have been reported to precipitate an acute attack, Patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates.. Always consult the full prescribing information and a clinician.
Note. Data for sulfasalazine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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