Azulfidine Side Effects

Generic Name: sulfasalazine

Please note - some side effects for Azulfidine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Azulfidine - for the Consumer

Azulfidine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Azulfidine:

Headache; loss of appetite; mild stomach upset or pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Azulfidine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bluish discoloration of the skin or nails; chest pain; dark urine; decreased urination; fever, chills, or sore throat; hearing loss; mental or mood changes; muscle pain; numbness or tingling in the fingers or toes; pale stools; persistent loss of appetite; pinpoint bruises; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness, drowsiness, headache, or trouble sleeping; severe or persistent stomach pain; shortness of breath; trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; unusually pale skin; yellowing of the eyes; yellowing of the skin along with dark urine, pale stools, or persistent loss of appetite.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Azulfidine EN-tabs Delayed-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Azulfidine EN-tabs Delayed-Release Tablets:

Dizziness; headache; loss of appetite; mild stomach upset or pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Azulfidine EN-tabs Delayed-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bluish discoloration of the skin or nails; chest pain; dark urine; decreased urination; fever, chills, or sore throat; hearing loss; mental or mood changes; muscle pain; numbness or tingling in the fingers or toes; pale stools; persistent loss of appetite; pinpoint bruises; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness, drowsiness, headache, or trouble sleeping; severe or persistent stomach pain; shortness of breath; trouble walking; unusual bruising or bleeding; unusual tiredness or weakness; unusually pale skin; yellowing of the eyes; yellowing of the skin along with dark urine, pale stools, or persistent loss of appetite.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Azulfidine Side Effects - for the Professional

Azulfidine

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 µg/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 report7 showed a 10% rate of immunoglobulin suppression, which was slowly reversible and rarely accompanied by clinical findings.

In general, the adverse reactions in juvenile rheumatoid arthritis patients are similar to those seen in patients with adult rheumatoid arthritis except for a high frequency of serum sickness-like syndrome in systemic-course juvenile rheumatoid arthritis. One clinical trial showed an approximate 10% rate of immunoglobulin suppression.1

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 EN-tabs is administered.

Less common or rare adverse reactions include:

Blood dyscrasias: aplastic anemia, agranulocytosis, megaloblastic (macrocytic) anemia, purpura, 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, Guillain-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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Side Effects by Body System - for Healthcare Professionals

General

Gastrointestinal intolerance to sulfasalazine occurred frequently and resulted in drug withdrawal in 17% of treated patients. Hypersensitivity reactions accounted for therapy withdrawal in 13% of sulfasalazine-treated patients. Hypersensitivity adverse effects are generally attributed to the sulfapyridine moiety, which is common and is often the cause of serious complications in patients receiving sulfasalazine.

Hypersensitivity

The use of sulfonamides, including sulfasalazine, is associated with large increases in the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis, although these phenomena are rare as a whole.

Hypersensitivity side effects have included sulfasalazine-induced rash, erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome) with corneal damage, drug rash with eosinophilia and systemic symptoms (DRESS), 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, alopecia, and interstitial lung disease.

Gastrointestinal

Gastrointestinal side effects have included anorexia, nausea, vomiting, gastric distress, dyspepsia, stomatitis, abdominal pain, pancreatitis, altered taste, diarrhea (including bloody diarrhea), impaired folic acid absorption, impaired digoxin absorption, hemorrhagic colitis, and neutropenic enterocolitis. Pseudomembranous colitis has been reported in at least one patient, and necrotizing pancreatitis in at least two patients. The use of enteric-coated preparations may decrease gastrointestinal adverse effects.

Hepatic

Hepatitis associated with sulfasalazine often developed two to four weeks after therapy was initiated, although hypersensitivity hepatitis has been reported after longer periods of therapy. Associated rash usually progressed to desquamation. Liver biopsy has shown necrosis and infiltration with moderate number of inflammatory cells. Noncaseating granulomas have also been seen. Hepatitis generally resolved over several weeks after therapy discontinuation, although some patients progressed to fulminant hepatic failure.

Hepatic side effects have included abnormal liver function tests, hepatitis, and hepatic failure. Hepatitis has been reported in patients with sulfasalazine hypersensitivity. Hepatotoxicity, including elevated liver function tests, jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure have been reported during postmarketing experience with the use of products containing or metabolized to mesalamine. Some of these cases were fatal.

Hematologic

Hematologic side effects have included agranulocytosis, leukopenia, thrombocytopenia, hemolytic anemia and cyanosis, Heinz body anemia, aplastic anemia, purpura, hypoprothrombinemia, methemoglobinemia, congenital neutropenia, myelodysplastic syndrome, red cell aplasia, and megaloblastic (macrocytic) anemia.

Agranulocytosis has been reported to generally occur during the first one to three months of therapy. Patients often present with fever and sore throat. A few have also presented with a rash. Bone marrow hypoplasia or aplasia is usually confined to the myeloid series, but may be accompanied by erythroid hypoplasia and marrow plasmacytosis. In one review of 62 cases of sulfasalazine-induced agranulocytosis, 6.5% of patients died. Recovery of granulocytes is generally seen within one to two weeks after drug discontinuation, and leukocyte counts and differential return to normal in one to three weeks. Some cases of agranulocytosis have been treated with colony stimulating factor, which appears to increase the time to recovery.

Respiratory

Patients often presented after several weeks or months of therapy with fever, malaise, shortness of breath, and nonproductive cough. Eosinophilic infiltrates have been seen. Respiratory changes generally resolved over a few weeks, however, fatal reactions involving fibrosing alveolitis have been reported.

Respiratory side effects have included pulmonary infiltrates (frequently accompanied by eosinophilia), fibrosing alveolitis, and bronchiolitis obliterans. Sulfasalazine lung toxicity may mimic Wegener's granulomatosis and false positive c-ANCAs have been found in patients with ulcerative colitis.

Immunologic

Immunoglobulin suppression was slowly reversible and rarely accompanied by clinical findings.

In most cases of sulfasalazine-induced SLE, patients received the drug for greater than one year. Patients most commonly developed arthralgias and pleuritic chest pain. Generally, these patients had a positive ANA, anti-DNA antibody titer, and were slow acetylators of sulfonamides. Symptoms typically resolved over several weeks to several months.

Immunologic side effects have included a 10% rate of immunoglobulin suppression and drug-induced systemic lupus erythematosus (SLE).

Nervous system

Transverse myelitis developed in one patient after receiving sulfasalazine for two years. All symptoms resolved within two months after discontinuing sulfasalazine.

Nervous system side effects have included dizziness, headache, malaise, insomnia, meningitis (including aseptic meningitis), neurotoxicity, seizures, dysphasia, neuropathy (including peripheral neuropathy), acute encephalopathy, monoparesis, transverse myelitis, transient lesions of the posterior spinal column, cauda equina syndrome, Guillain-Barre syndrome, cerebrospinal fluid abnormalities, vertigo, hearing loss, ataxia, hallucinations, tinnitus, and drowsiness.

Renal

Renal side effects have included toxic nephrosis with oliguria and anuria, nephritis (including interstitial nephritis), nephrotic syndrome, and hemolytic uremic syndrome. At least one patient developed bilateral renal calculi composed of acetylsulfapyridine, a metabolite of sulfasalazine. Proteinase 3-ANCA positive necrotizing glomerulonephritis has been reported in at least one patient.

Cardiovascular

Cardiovascular side effects have included tachycardia.

Genitourinary

Infertility appears to be reversible upon drug discontinuation.

Genitourinary side effects have included reversible oligospermia, decreased motility, and abnormal sperm penetration sometimes resulting in infertility. Impotence (rare), urinary tract infections, hematuria, crystalluria, proteinuria, and urine discoloration have been reported.

Dermatologic

Dermatologic side effects have included rash, pruritus, urticaria, and skin discoloration. Rare cases of lichen planus and at least two cases of toxic epidermal necrolysis have been reported.

Psychiatric

Psychiatric side effects have included depression, confusion, and vivid dreams.

Musculoskeletal

Musculoskeletal side effects have included myopathy.

Other

Other side effects have included fever. At least one case of Kawasaki-like syndrome with hepatic function changes has been reported during postmarketing experience with the use of products containing or metabolized to mesalamine.

Ocular

Ocular side effects have included diplopia and blurred vision.

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