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Azulfidine (Sulfasalazine) - Side Effects and 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, 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 AZULFIDINE 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, drug rash with eosinophilia and systemic symptoms (DRESS), anaphylaxis, serum sickness syndrome, interstitial lung disease, 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, hepatic failure, 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:

Blood dyscrasias: pseudomononucleosis

Cardiac disorders: myocarditis

Hepatobiliary disorders: reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, hepatitis cholestatic, cholestasis 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.

Immune system disorders: anaphylaxis

Metabolism and nutrition system disorders: folate deficiency

Renal and urinary disorders: nephrolithiasis

Respiratory, thoracic and mediastinal disorders: oropharyngeal pain

Skin and subcutaneous tissue disorders: angioedema, purpura

Vascular disorders: pallor


Below is a sample of reports where side effects / adverse reactions may be related to Azulfidine. The information is not vetted and should not be considered as verified clinical evidence.

Possible Azulfidine side effects / adverse reactions in 53 year old male

Reported by a physician from Japan on 2011-10-04

Patient: 53 year old male

Reactions: Angioedema, Neck Pain, Hand-Foot-and-Mouth Disease, Headache, Drug Rash With Eosinophilia and Systemic Symptoms, Infection

Adverse event resulted in: hospitalization

Suspect drug(s):
    Dosage: 2 g per day
    Administration route: Oral
    Indication: Rheumatoid Arthritis

    Dosage: 1 g per day
    Administration route: Oral

Possible Azulfidine side effects / adverse reactions in 62 year old male

Reported by a physician from Japan on 2011-10-05

Patient: 62 year old male

Reactions: General Physical Condition Abnormal, Vomiting, Pyrexia, Erythema, Drug Rash With Eosinophilia and Systemic Symptoms, Skin Irritation, Multi-Organ Failure, Haematochezia, Renal Failure, Diarrhoea

Adverse event resulted in: death, hospitalization

Suspect drug(s):

Possible Azulfidine side effects / adverse reactions in 74 year old male

Reported by a physician from Japan on 2011-10-10

Patient: 74 year old male weighing 63.5 kg (139.7 pounds)

Reactions: Acute Tonsillitis, Pneumonia, Granulocytopenia, Blood Albumin Decreased, Duodenal Ulcer

Adverse event resulted in: hospitalization

Suspect drug(s):
    Dosage: 6 mg/weekly
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2009-06-01

    Dosage: 1000 mg, 1x/day
    Start date: 2011-02-09
    End date: 2011-03-21

    Dosage: 8 mg/weekly
    Administration route: Oral
    Start date: 2010-03-01

    Dosage: 4 mg/week
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-03-21

    Dosage: 500 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-01-12
    End date: 2011-02-08

Other drugs received by patient: Prednisolone; Etodolac

See index of all Azulfidine side effect reports >>

Drug label data at the top of this Page last updated: 2014-05-14

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