Azulfidine EN-tabs

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/9/2021
Azulfidine EN-tabs Side Effects Center

What Are Azulfidine EN-Tabs?

Azulfidine EN-tabs (sulfasalazine delayed release tablets) are indicated in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; for the prolongation of the remission period between acute attacks of ulcerative colitis; in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs) (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 in the treatment of pediatric patients with polyarticular-course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.

What Are Side Effects of Azulfidine EN-Tabs?

Common side effects of Azulfidine EN-tabs include:

Dosage for Azulfidine EN-Tabs

The initial adult dose of Azulfidine EN-tabs is 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding eight hours. The adult maintenance dose is 2 g daily. The initial dose of Azulfidine EN-tabs for children six years of age and older is 40 to 60 mg/kg of body weight in each 24-hour period, divided into 3 to 6 doses. The maintenance dose for children is 30 mg/kg of body weight in each 24-hour period, divided into 4 doses.

What Drugs, Substances, or Supplements Interact with Azulfidine EN-Tabs?

Azulfidine EN-tabs may interact with folic acid, digoxin, and methotrexate. Tell your doctor all medications and supplements you use.

Azulfidine EN-Tabs During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Azulfidine EN-tabs; it is unknown how it would affect a fetus. Azulfidine EN-tabs pass into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Azulfidine EN-tabs (sulfasalazine delayed release tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer
Azulfidine EN-tabs Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, sore throat;
  • mouth sores, red or swollen gums;
  • pale skin, easy bruising, unusual bleeding; or
  • chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

  • fever with headache, rash, and vomiting;
  • a skin rash, no matter how mild;
  • severe nausea or vomiting when you first start taking sulfasalazine;
  • little or no urination, urine that looks foamy;
  • puffy eyes, swelling in your ankles or feet, weight gain; or
  • liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, upset stomach, loss of appetite;
  • headache;
  • rash; or
  • low sperm count in men.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Azulfidine EN-tabs (sulfasalazine Delayed Release Tablets)

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Inflammatory Bowel Disease (IBD) Causes, Symptoms, Treatment See Slideshow
Azulfidine EN-tabs Professional Information

SIDE EFFECTS

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 (see PRECAUTIONS, Pediatric Use). 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:

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

None reported.

Read the entire FDA prescribing information for Azulfidine EN-tabs (sulfasalazine Delayed Release Tablets)

© Azulfidine EN-tabs Patient Information is supplied by Cerner Multum, Inc. and Azulfidine EN-tabs Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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