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What is Azulfidine (sulfasalazine)?
Azulfidine (sulfasalazine) is an anti-inflammatory and immunomodulatory drug used to treat mild to severe ulcerative colitis and rheumatoid arthritis. It has also been used “off label” (not approved by the FDA) for Crohn's disease and ankylosing spondylitis.
Common side effects of Azulfidine include:
- gastrointestinal disturbances (nausea, vomiting, gastric distress, and loss of appetite),
- allergic reactions, and
- photosensitivity (development of a rash when exposed to sunlight), and
- changes in skin or urine color (orange-yellow discoloration of the urine is no cause for concern).
Serious side effects of Azulfidine include:
- a drop in white blood cell count or a type of anemia in which red blood cells are disrupted (hemolyzed).
- Liver failure, pancreatitis, and kidney failure also have been associated with sulfasalazine.
Conversely, methotrexate can increase the occurrence of the anemia caused by sulfonamides because methotrexate also causes folic acid deficiency.
Sulfonamides can increase the risk of kidney damage from cyclosporine. They also may increase the blood glucose lowering effect of oral anti-diabetic drugs and potentially cause excessive reductions in blood sugar (hypoglycemia) by decreasing elimination of anti-diabetic drugs by the liver and elevating the levels of the anti-diabetic drugs in the blood.
Combining Azulfidine with drugs that affect kidney function such as nonsteroidal anti-inflammatory drugs may increase the likelihood of kidney dysfunction.
In hundreds of pregnant women with ulcerative colitis or Crohn's disease treated with Azulfidine, there has been no increase in the risk of fetal malformations relative to other women with these illnesses who have not been treated with Azulfidine. Azulfidine may be used during pregnancy if the physician feels the benefit outweighs the possible risks.
Azulfidine and its constituents are secreted into breast milk. There is a small risk that sulfapyridine (a byproduct of sulfasalazine) may displace bilirubin from albumin in the blood of infants and cause jaundice. Caution should be exercised by breastfeeding women.
What are the important side effects of Azulfidine (sulfasalazine)?
Gastrointestinal disturbances frequently occur in patients taking sulfasalazine that may include:
Headache, allergic reactions, and photosensitivity (development of a rash when exposed to sunlight) may develop during sulfasalazine therapy and require medical attention. Some of the allergic reactions may progress from a rash to difficulty in swallowing, blistering, peeling, or loosening of the skin, aching joints and muscles, and unusual tiredness or weakness. It may be accompanied by fever. The more severe allergic reactions are rare.
Sulfasalazine may cause the skin or the urine to change color.
Development of an orange-yellow discoloration of the urine is no cause for concern.
Several potentially dangerous side effects have been reported rarely with sulfasalazine. A drop in white blood cell count or a type of anemia in which red blood cells are disrupted (hemolyzed) may occur. These effects are characterized by fever, pale skin, sore throat, fatigue, and unusual bleeding and bruising, and require discontinuation of the drug. Liver failure, pancreatitis, and kidney failure also have been associated with sulfasalazine.
Azulfidine (sulfasalazine) side effects list for healthcare professionals
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.
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.
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
Drug Abuse And Dependence
What drugs interact with Azulfidine (sulfasalazine)?
Reduced absorption of folic acid and digoxin have been reported when those agents were administered concomitantly with sulfasalazine.
Drug/Laboratory Test Interactions
Several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to sulfasalazine or its metabolite, mesalamine/mesalazine.
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Related Disease Conditions
Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body. Because it can affect multiple other organs of the body, rheumatoid arthritis is referred to as a systemic illness and is sometimes called rheumatoid disease. The 16 characteristic early RA signs and symptoms include the following. Anemia Both sides of the body affected (symmetric) Depression Fatigue Fever Joint deformity Joint pain Joint redness Joint stiffness Joint swelling Joint tenderness Joint warmth Limping Loss of joint function Loss of joint range of motion Many joints affected (polyarthritis)
16 Early Rheumatoid Arthritis (RA) Symptoms and Signs
Early RA symptoms and signs vary differently from person to person. The most common body parts that are initially affected by RA include the small joints of the hands, wrists, and feet, and the knees and hip joints. Joint inflammation causes stiffness. Warmth, redness, and pain may vary in degree.
Crohn's disease is a chronic inflammatory disease, primarily involving the small and large intestine, but which can affect other parts of the digestive system as well. Abdominal pain, diarrhea, vomiting, fever, and weight loss are common symptoms.
Crohn's Disease vs. Ulcerative Colitis (UC)
Crohn's disease and ulcerative colitis are diseases that cause inflammation of part of or the entire digestive tract (GI). Crohn's affects the entire GI tract (from the mouth to the anus), while ulcerative colitis or ulcerative colitis only affects the large and small intestine and ilium. Researchers do not know the exact cause of either disease. About 20% of people with Crohn's disease also have a family member with the disease. Researchers believe that certain factors may play a role in causing UC. Both Crohn's disease and ulcerative colitis are a type of inflammatory bowel disease, or IBD. Crohn's disease and ulcerative colitis both have similar symptoms and signs, for example, nausea, loss of appetite, fatigue, weight loss, episodic and/or persistent diarrhea, fever, abdominal pain and cramping, rectal bleeding, bloody stools, joint pain and soreness, eye redness, or pain. Symptoms unique to Crohn’s disease include anemia and skin changes. Symptoms of unique to ulcerative colitis include, certain rashes, an urgency to defecate (have a bowel movement). Doctors diagnose both diseases with similar tests and procedures. While there is no cure for either disease, doctors and other health care professionals can help you treat disease flares, and manage your Crohn's or ulcerative colitis with medication, diet, nutritional supplements, and/or surgery.
Rheumatoid Arthritis vs. Fibromyalgia
Though rheumatoid arthritis (RA) and fibromyalgia have similar symptoms, RA is an autoimmune disease and fibromyalgia is a chronic pain syndrome. RA symptoms include joint redness, swelling, and pain that lasts more than six weeks. Fibromyalgia symptoms include widespread pain, tingling feet or hands, depression, and bowel irritability. Home remedies for both include stress reduction, exercise, and getting enough sleep.
Pain Management and Rheumatoid Arthritis
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Rheumatoid Arthritis vs. Arthritis
Arthritis is a general term used to describe joint disease. Rheumatoid arthritis (RA) is a type of arthritis in which the body’s immune system mistakenly attacks the joints, causing chronic inflammation.
Juvenile Rheumatoid Arthritis (JRA)
Juvenile rheumatoid arthritis (JRA) annually affects one child in every thousand. There are six types of JRA. Treatment of juvenile arthritis depends upon the type the child has and should focus on treating the symptoms that manifest.
Is Crohn's Disease Contagious?
Crohn's disease, a form of inflammatory bowel disease (IBD), and is characterized by symptoms and signs that include diarrhea, fever, weight loss, vomiting, and abdominal pain. Though Crohn's disease is not contagious it can spread throughout a person's gastrointestinal tract. An increase in the above symptoms and signs warrants a visit to a doctor's office.
What Triggers Ankylosing Spondylitis?
Ankylosing spondylitis (AS), also called Bechterew disease, is a chronic inflammatory disease. Ankylosing spondylitis affects the joints of the body, especially the small joints of the spine and the pelvic (hip) bone. It can also affect multiple organ systems in rare conditions. Prolonged inflammation of the joints eventually leads to the fusion of the joints leading to deformities.
Osteoarthritis vs. Rheumatoid Arthritis
Osteoarthritis (OA) and rheumatoid arthritis (RA) are chronic joint disorders. RA is also an autoimmune disease. OA and RA symptoms and signs include joint pain, warmth, and tenderness. Over-the-counter pain relievers treat both diseases. There are several prescription medications that treat RA.
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.