ADVERSE REACTIONS
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, pruritis, 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 mcg/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.
Hypersensitivity reactions: erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, epidermal necrolysis (Lyell’s syndrome) with corneal damage, anaphylaxis, serum sickness syndrome, pneumonitis with or without eosinophilia, vasculitis, fibrosing alveolitis, pleuritis, pericarditis with or without tamponade, allergic myocarditis, polyarteritis nodosa, lupus erythematosus-like syndrome, hepatitis and hepatic necrosis with or without immune complexes, fulminant hepatitis, sometimes leading to liver transplantation, parapsoriasis varioliformis acuta (Mucha-Haberman syndrome), rhabdomyolysis, photosensitization, arthralgia, periorbital edema, conjunctival and scleral injection, and alopecia.
Gastrointestinal reactions: hepatitis, pancreatitis, bloody diarrhea, impaired folic acid absorption, impaired digoxin absorption, stomatitis, diarrhea, abdominal pains, and neutropenic enterocolitis.
Central nervous system reactions: transverse myelitis, convulsions, meningitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillian-Barre syndrome, peripheral neuropathy, mental depression, vertigo, hearing loss, insomnia, ataxia, hallucinations, tinnitus, and drowsiness.
Renal reactions: toxic nephrosis with oliguria and anuria, nephritis, nephrotic syndrome, urinary tract infections, hematuria, crystalluria, proteinuria, and hemolytic-uremic syndrome.
Other reactions: urine discoloration and skin discoloration.
The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides), and oral hypoglycemic agents. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides and long-term administration has produced thyroid malignancies in this species.
Postmarketing Reports
The following events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:
Gastrointestinal: Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin),jaundice,cholestatic jaundice,cirrhosis,and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported.
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REPORTS OF SUSPECTED SULFASALAZINE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Sulfasalazine. The information is not vetted and should not be considered as verified clinical evidence.
Possible Sulfasalazine side effects / adverse reactions in 43 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-04
Patient: 43 year old female
Reactions: Ankylosing Spondylitis, Cutaneous Lupus Erythematosus
Adverse event resulted in: hospitalization
Suspect drug(s):
Sulfasalazine
Dosage: 1500 mg (3 tablets daily in the 3rd week), 1x/day
Sulfasalazine
Dosage: 1000 mg (2 tablets daily in the 2nd week), 1x/day
Remicade
Dosage: unk
Start date: 2011-07-04
End date: 2011-08-09
Sulfasalazine
Dosage: 4 tablets daily, 2x/day
Sulfasalazine
Dosage: 500mg (1 tablet/day in the first week), 1x/day
Administration route: Oral
Indication: Ankylosing Spondylitis
Start date: 2004-11-08
Sulfasalazine
Dosage: 3000 mg (6 tablets daily), 1x/day
Start date: 2005-10-10
End date: 2011-06-20
Other drugs received by patient: Speciafoldine; Plaquenil; Novatrex ^lederle^
Possible Sulfasalazine side effects / adverse reactions in 28 year old female
Reported by a physician from United States on 2011-10-05
Patient: 28 year old female
Reactions: Eosinophilic Myocarditis, Cardiac Arrest, Drug Rash With Eosinophilia and Systemic Symptoms
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Sulfasalazine
Possible Sulfasalazine side effects / adverse reactions in 65 year old male
Reported by a physician from Sweden on 2011-10-06
Patient: 65 year old male
Reactions: Weight Decreased, Headache, Pyrexia, Pulmonary Fibrosis, Diplopia, Organising Pneumonia, Balance Disorder, Decreased Appetite
Adverse event resulted in: hospitalization
Suspect drug(s):
Sulfasalazine
Other drugs received by patient: Aspirin; Imdur; Omeprazole; Acetylcysteine; Ramipril; Combivent; Kalcipos-D; Simvastatin; Alendronate Sodium; Symbicort; Ezetimibe; Bisoprolol; Acetaminophen W/ Codeine; Furosemide; Escitalopram; Lactulose
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