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INDICATION

UCERIS® (budesonide) extended release tablets are a prescription corticosteroid medicine used to help get active, mild to moderate ulcerative colitis (UC) under control (induce remission).

IMPORTANT SAFETY INFORMATION—UCERIS extended release tablets

  • UCERIS extended release tablets are not for everyone. Do not take UCERIS tablets if you are allergic to budesonide or any of the ingredients in UCERIS tablets
  • Before you take UCERIS tablets, tell your healthcare provider if you have liver problems; are planning to have surgery; have chickenpox or measles or have recently been near anyone with chickenpox or measles; have an infection; have or had a family history of diabetes, cataracts, or glaucoma; have or had tuberculosis; have high blood pressure (hypertension); have decreased bone mineral density (osteoporosis); have stomach ulcers; or have any other medical condition
  • Before you take UCERIS tablets, tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if UCERIS tablets will harm your unborn baby
  • Tell your healthcare provider if you are breastfeeding or plan to breastfeed. UCERIS tablets can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take UCERIS tablets or breastfeed. You should not do both
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter vitamins and herbal supplements. UCERIS tablets and other medicines may affect each other and cause side effects
  • Do not eat grapefruit or drink grapefruit juice while taking UCERIS tablets. Eating grapefruit or drinking grapefruit juice can increase the level of this medicine in your blood
  • UCERIS is a steroid. Long-time use of UCERIS tablets can cause you to have too much glucocorticosteroid medicine in your blood (hypercorticism). Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism: acne; bruise easily; rounding of your face (moon face); ankle swelling; thicker or more hair on your body and face; a fatty pad or hump between your shoulders (buffalo hump); or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms
  • When UCERIS tablets are taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your healthcare provider if you are under stress, have a persistent fever, or have any of the following symptoms: tiredness, weakness, nausea, vomiting, and/or low blood pressure
  • UCERIS tablets may weaken your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles while taking UCERIS tablets
  • If you take certain other steroid medicines to treat allergies, switching to UCERIS tablets may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse while taking UCERIS tablets
  • In clinical studies, the most common side effects of UCERIS tablets were headache, nausea, decreased blood cortisol (a hormone made by the adrenal glands), stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-321-4576
Email: salixmc@dlss.com

Please click here for full Prescribing Information for UCERIS extended release tablets.