{
 "query": "sulfasalazine",
 "ingredient": "sulfasalazine",
 "slug": "sulfasalazine",
 "rxcui": "9524",
 "brands": [
  "Azulfidine"
 ],
 "names": [
  "sulfasalazine"
 ],
 "classes": [
  {
   "id": "A07EC",
   "name": "Aminosalicylic acid and similar agents"
  }
 ],
 "alternatives": [
  "balsalazide",
  "mesalamine",
  "olsalazine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 13
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Sulfasalazine delayed release tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; b) for the prolongation of the remission period between acute attacks of ulcerative colitis; c) in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and d) in the treatment of pediatric patients with polyarticular-course 1 juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs. Sulfasalazine delayed release tablets are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, ...",
  "contraindications": "CONTRAINDICATIONS Sulfasalazine delayed release tablets are contraindicated in: Hypersensitivity to sulfasalazine, its metabolites, sulfonamides or salicylates, Patients with intestinal or urinary obstruction, Patients with porphyria, as the sulfonamides have been reported to precipitate an acute attack.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Hepatic, Renal, and Hematologic Toxicity or Other Conditions Only after critical appraisal should sulfasalazine delayed release 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 delayed release tablets (see PRECAUTIONS, Laboratory Tests ). Discontinue treatment with sulfasalazine while awaiting the results of blood tests. Discontinue sulfasalazine delayed release tablets if renal function deteriorates while on therapy. Oligospermia and Infertility Oligospermia and infertility have been observed in men treated with sulfasalazine; however, withdrawal of the drug appears to reve...",
  "adverse_reactions": "ADVERSE REACTIONS The most common adverse reactions associated with sulfasalazine in ulcerative colitis 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 pruritus, urticaria, rash, fever, Heinz body anemia, hemolytic anemia, and cyanosis, which may occur at a frequency of 1 in 30 patients or less. Experience suggests that with a daily dose of 4 g or more, or total serum sulfapyridine levels above 50 \u00b5g/mL, the incidence of adverse reactions tends to increase. Similar adverse reactions are associated with sulfasalazine use in adult rheumatoid arthritis, although there was a greater incidence of some reactions. In rheumatoid arthritis studies, the following common adverse reactions were noted: nausea (19%), dyspepsia (13%), rash (13%), headache (9%), abdominal pain (8%), vomiting (8%), fever (5%), dizziness (4%), stomatitis (4%), pruritis (4%), abnormal liver function tests (4%), leukopenia (3%), and thrombocytopenia (1%). One report 7 showed a 10% rate of immunoglobulin suppression, which was slowly reversible and rarely accompanied by clinical findin...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE None reported.",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information For Patients: Patients should be informed of the possibility of adverse effects and of the need for careful medical supervision. The occurrence of sore throat, fever, pallor, purpura, or jaundice may indicate a serious blood disorder. Should any of these occur, the patient should seek medical advice. Patients should be instructed to take sulfasalazine delayed release tablets in evenly divided doses, preferably after meals, and to swallow the tablets whole. Additionally, patients should be advised that sulfasalazine may produce an orange-yellow discoloration of the urine or skin. Ulcerative Colitis: Patients with ulcerative colitis should be made aware that ulcerative colitis rarely remits completely, and that the risk of relapse can be substantially reduced by continued administration of sulfasalazine delayed release tablets at a maintenance dosage. Rheumatoid Arthritis: Rheumatoid arthritis rarely remits. Therefore, continued administration of sulfasalazine delayed release tablets is indicated. Patients requiring sulfasalazine should follow up with their physicians to determine the need for continued administration.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Sulfasalazine",
  "manufacturer": "Mylan Pharmaceuticals Inc.",
  "application_number": "NDA007073",
  "pharm_class_epc": [
   "Aminosalicylate [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260825",
  "set_id": "257cee60-b68f-4c2b-b57d-8e4d73d17e09",
  "has_boxed_warning": false,
  "boxed_labels": "0 of 13",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 73709,
  "serious": 63488,
  "death": 6894,
  "hospitalization": 20126,
  "primary_suspect": 73646,
  "top_reactions": [
   [
    "Drug Ineffective",
    29492
   ],
   [
    "Rheumatoid Arthritis",
    19455
   ],
   [
    "Pain",
    15918
   ],
   [
    "Drug Intolerance",
    13870
   ],
   [
    "Arthralgia",
    13280
   ],
   [
    "Fatigue",
    13217
   ],
   [
    "Joint Swelling",
    12737
   ],
   [
    "Off Label Use",
    11356
   ],
   [
    "Rash",
    10857
   ],
   [
    "Abdominal Discomfort",
    10099
   ],
   [
    "Contraindicated Product Administered",
    9718
   ],
   [
    "Condition Aggravated",
    9618
   ],
   [
    "Alopecia",
    9477
   ],
   [
    "Synovitis",
    9285
   ],
   [
    "Arthropathy",
    9257
   ]
  ],
  "by_year": {
   "2019": 8098,
   "2020": 11986,
   "2021": 7608,
   "2022": 7303,
   "2023": 5241,
   "2024": 5848,
   "2025": 4660,
   "2026": 1469
  },
  "by_year_primary": {
   "2019": 8098,
   "2020": 11981,
   "2021": 7600,
   "2022": 7286,
   "2023": 5230,
   "2024": 5842,
   "2025": 4655,
   "2026": 1463
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 16,
  "nda": 4,
  "anda": 10,
  "first_approval": "19500620",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 36,
  "labeling_recent": 4,
  "sponsors": [
   "CHARTWELL",
   "EPIC PHARMA LLC",
   "NUVO PHARMS INC",
   "PFIZER",
   "PHARMACIA AND UPJOHN",
   "PHARMACIA UPJOHN",
   "RISING",
   "SOLVAY"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/20/1950"
 },
 "trials": {
  "total": 123,
  "completed": 68,
  "terminated": 9,
  "with_results": 37,
  "industry": 45,
  "phase3": 33,
  "results_share": 0.5441176470588235,
  "terminated_share": 0.07317073170731707
 },
 "pubmed": {
  "rct": 95,
  "meta": 20,
  "recent_rct": 1,
  "cochrane": [
   {
    "pmid": "25427435",
    "title": "Sulfasalazine for ankylosing spondylitis",
    "year": "2014"
   },
   {
    "pmid": "15846731",
    "title": "Sulfasalazine for ankylosing spondylitis",
    "year": "2005"
   },
   {
    "pmid": "10796400",
    "title": "Sulfasalazine for rheumatoid arthritis",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "sulfasalazine",
   "Azulfidine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 583061,
  "beneficiaries": 149055,
  "spend": 18590772.2,
  "by_brand": [
   {
    "brand": "Sulfasalazine",
    "claims": 451008,
    "per_claim": 27.536520616,
    "is_generic": true
   },
   {
    "brand": "Sulfasalazine Dr",
    "claims": 131521,
    "per_claim": 45.159018712,
    "is_generic": false
   },
   {
    "brand": "Azulfidine",
    "claims": 532,
    "per_claim": 436.50716165,
    "is_generic": false
   }
  ],
  "per_claim": 31.884780837682506
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "sulfasalazine",
  "matched": "sulfasalazine",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 11960,
  "fills": 583061,
  "per_million": 20512.43351896285,
  "ratio": 7.408019409121885,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "20,512 FDA reports naming it as the suspect drug per million Medicare fills, 7.4x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "95 randomized trials and 20 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "3 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "4 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (10 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are rheumatoid arthritis, pain, drug intolerance. How would we recognize and handle those?",
  "Why this one over balsalazide, mesalamine, olsalazine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}