Sulfasalazine (sul-fa-SAL-a-zeen)

Treats and prevents ulcerative colitis and rheumatoid arthritis.

Brand Name(s):

Azulfidine, Azulfidine Entabs, Sulfazine

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Coated Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine after meals, at evenly spaced times throughout the day and night. Try not to let more than 8 hours go by between doses, even at night.
• Coated tablet: Swallow the tablet whole. Do not crush, break, or chew it.
• Drink extra fluids so you will urinate more often and help prevent kidney problems.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses.
• If you are using this medicine for rheumatoid arthritis, it may take 4 to 12 weeks before you start feeling better.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sulfasalazine works. Tell your doctor if you are using digoxin or a folic acid supplement.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, trouble urinating, asthma, blood or bone marrow problems, or an enzyme problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• This medicine may decrease the amount of sperm a man makes and affect his ability to have children while using this medicine. If you are a man who plans to have children, talk with your doctor first.
• This medicine may cause the following problems.
  • Liver problems
  • Anemia or other blood problems
  • Serious infections
  • Heart problems, including myocarditis, pericarditis
  • Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)
• Your skin or urine may turn orange or yellow while you are using this medicine. This is normal and nothing to worry about.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody diarrhea, severe cramping, stomach pain, headache
• Change in how much or how often you urinate, difficult or painful urination, lower back or side pain
• Chest pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, sore throat, pale skin, body aches
• Swollen, painful, or tender lymph glands in your neck, armpit, or groin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Dizziness
• Mild diarrhea, nausea, vomiting, or stomach upset

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088