Azulfidine EN-tabs®

Class: Anti-inflammatory

Generic Name: sulfasalazine

Trade Name: Azulfidine®, Azulfidine EN-tabs®

For which conditions is this drug approved? Azulfidine is approved to treat or prolong the remission of ulcerative colitis (UC). It is also used for the treatment of rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA) in patients who have not responded well to certain other drugs.

What is the mechanism of action? After ingestion, Azulfidine is broken down by bacteria in the colon into its two components, 5-aminosalicylic acid (5-ASA) and sulfapyridine. It is thought that 5-ASA may reduce inflammation by blocking the activity of certain enzymes that produce the chemicals that cause inflammation.

How is Azulfidine administered?  Azulfidine is taken orally (by mouth). In RA patients, Azulfidine is recommended to be used in combination with NSAIDs or analgesics at least until the effects of Azulfidine EN-tabs is apparent. Sulfasalazine may produce an orange-yellow discoloration of the urine or skin.

How are patients typically monitored? During treatment with Azulfidine, your doctor will check your blood counts as well as liver function tests and urinalysis. These test will be performed before taking Azulfindine, and every second week for the first three months, then once monthly thereafter for the next three months, and then once every three months.

What are the most common side effects of Azulfidine for patients with RA?

  • Nausea
  • Stomach pain
  • Rash
  • Headache
  • Abdominal pain
  • Vomiting
  • Fever
  • Dizziness
  • Itching
  • Abnormal liver function tests
  • Low platelet counts
  • Low white blood cell counts

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What are the less common but potentially serious side effects of Azulfidine?

  • Blood disorders
  • Hypersensitivity reactions
  • Gastrointestinal problems
  • Central nervous system reactions
  • Kidney problems

The problems, disorders, and syndromes associated with these less common reactions are many and some may be potentially fatal. Those taking Azulfidine should see their doctor immediately with any new symptoms.

Are there any special precautions patients should be aware of before starting treatment?

  • Serious infections and deaths have occurred due to hypersensitivity reaction, blood disorders and kidney or liver problems, nervous systems disorders, and lung disorders.
  • Azulfidine EN-tabs is not indicted for patients with porphyria, intestinal or urinary obstructions, or hypersensitivity to sulfasalazine or any of its metabolites.
  • Infertility in men may occur, however, discontinuing the drug appears to reverse this effect.
  • Azulfidine should be given with caution to patients with severe allergy or asthma.
  • Reduced absorption of folic acid may occur when used with other drugs such as methotrexate.
  • Women who are breastfeeding may pass the drug to the child. Patients should discuss breastfeeding with their doctor.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines and all herbal supplements as other medicines may affect each other and cause serious side effects.

When should patients notify their physician?

Contact your healthcare professional immediately if you have signs of any of the following:

  • Serious blood disorder: Sore throat, fever, pallor, purpura, or jaundice.
  • Serious infection: Fever, chills; unusual tiredness; warm, red, or painful skin; or open sores on your body.
  • Serious skin reactions: Skin rash, mucosal lesions, or other indicators.
  • Severe hypersensitivity: Fever, swollen lymph nodes, severe fatigue.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 03/17.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.