Indication for UCERIS
UCERIS® extended release tablets are a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis (UC) under control (induce remission).
Important Safety Information about UCERIS
UCERIS® (budesonide) extended release tablets are not for everyone. Do not take UCERIS extended release tablets if you are allergic to budesonide or any of the ingredients in UCERIS.
UCERIS is a steroid. When UCERIS extended release 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 or have any of the following symptoms: tiredness, vomiting, weakness, low blood pressure, and nausea.
UCERIS 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 chicken pox or measles while taking UCERIS extended release tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter vitamins, and herbal supplements. UCERIS extended release tablets and other medicines may affect each other and cause side effects. If you take certain other steroid medicines to treat allergies, switching to UCERIS extended release 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 extended release tablets.
Before you take UCERIS extended release tablets tell your healthcare provider if you have liver problems, are planning to have surgery, 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), stomach ulcers, or any other medical condition. Do not eat grapefruit or drink grapefruit juice while taking UCERIS. Eating grapefruit or drinking grapefruit juice can increase the level of this medicine in your blood.
In clinical studies, the most common side effects (occurring in ≥ 2% of people) 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
Please see complete Prescribing Information for UCERIS extended release tablets.