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Azulfidine EN-Tabs

Last reviewed on RxList: 1/9/2017
Azulfidine Side Effects Center

Last reviewed on RxList 01/05/2017

Azulfidine EN-tabs (sulfasalazine delayed release tablets) is an anti-inflammatory agent and immunomodulatory agent used to treat moderate to severe ulcerative colitis. Azulfidine is also used to treat rheumatoid arthritis in children and adults who have received other arthritis medications without successful treatment of symptoms. Azulfidine is available in generic form. Common side effects of Azulfidine include:

  • stomach upset,
  • nausea,
  • vomiting,
  • loss of appetite,
  • diarrhea,
  • headache,
  • ringing in your ears,
  • dizziness,
  • spinning sensation,
  • unusual tiredness,
  • white patches or sores inside your mouth or on your lips,
  • sleep problems (insomnia), or
  • itching or skin rash.

Azulfidine may cause temporary male infertility. This effect is reversible when Azulfidine is stopped. Tell your doctor if you have serious side effects of Azulfidine including:

  • sun sensitivity,
  • hearing changes,
  • mental/mood changes,
  • painful urination,
  • blood in the urine,
  • changes in the amount of urine,
  • new lump or growth in the neck (goiter),
  • numbness or tingling of the hands or feet,
  • signs of low blood sugar (e.g., hunger, cold sweat, blurred vision, weakness, fast heartbeat), or
  • swollen glands.

Adult doses of Azulfidine range from 1000 mg to 4000 mg daily, taken 2 to 4 times daily depending on the condition being treated. Pediatric doses are determined by weight. Azulfidine EN-tabs may interact with digoxin, folic acid, or vitamin or mineral supplements that contain folic acid. There may be other drugs that can interact with Azulfidine. Tell your doctor about all the prescription and over-the-counter medications and supplements you use. During pregnancy, Azulfidine EN-tabs should be used only when prescribed. Caution is advised if this medication is used near the expected delivery date because similar drugs may cause harm to a newborn. This medication may lower folic acid levels, increasing the risk of spinal cord defects. Consult your doctor about taking enough folic acid. This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

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.

Azulfidine Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sulfasalazine and call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, or other flu symptoms;
  • pale skin, easy bruising;
  • dark urine, jaundice (yellowing of the skin or eyes);
  • pain or burning when you urinate;
  • urinating less than usual or not at all;
  • the appearance of a whole tablet in your stool; or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, upset stomach;
  • loss of appetite;
  • headache, ringing in your ears;
  • dizziness, spinning sensation;
  • white patches or sores inside your mouth or on your lips;
  • sleep problems (insomnia); or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Azulfidine (Sulfasalazine Delayed Release Tablets)

Azulfidine Professional Information

SIDE EFFECTS

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

Drug Abuse And Dependence

None reported.

Read the entire FDA prescribing information for Azulfidine (Sulfasalazine Delayed Release Tablets)

Related Resources for Azulfidine

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