Uceris (budesonide)

Generic name: budesonide (oral) (bue DES oh nide)
Brand name: Uceris
Drug class: Glucocorticoids

Uceris (budesonide) is an extended release corticosteroid tablet that reduces inflammation in the body.

Uceris extended release tablets are a prescription medicine used to help get active, mild to moderate ulcerative colitis (UC) under control (induce remission) in adults.

It is not known if Uceris extended release tablets are safe and effective in children.

Warnings

When taking Uceris avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Uceris.

Call your doctor if you have signs of too much corticosteroid in your body, such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Uceris if you are allergic to budesonide.

To make sure Uceris is safe for you, tell your doctor if you have ever had:

  • tuberculosis;
  • an infection, including chickenpox or measles;
  • high blood pressure;
  • a weak immune system (caused by disease or by using certain medicines);
  • osteoporosis or low bone mineral density;
  • a stomach ulcer;
  • liver disease;
  • eczema;
  • any allergy; or
  • (in you or a family member) diabetes, cataracts, or glaucoma.

Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether budesonide will harm an unborn baby. However, having untreated or uncontrolled ulcerative colitis during pregnancy can cause complications leading to preterm delivery or low birth weight. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

If you have taken Uceris during pregnancy, tell your doctor if you notice weakness, irritability, vomiting, or feeding problems in your newborn baby.

You should not breastfeed while using this medicine.

Uceris is not approved for use by anyone younger than 18 years old.

How should I take Uceris?

Take Uceris exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take this medicine in the morning with a full glass of water.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Swallow the tablet whole. Do not crush, chew, or break a tablet.

Your dosage needs may change if you have surgery, are ill, or are under stress. Do not change your doses or medication schedule without advice from your doctor.

Call your doctor if your symptoms do not improve, or if they get worse while using Uceris.

Uceris can weaken your immune system. Tell your doctor if you have signs of infection such as fever, chills, body aches, vomiting, or feeling tired.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

High doses or long-term use of steroid medicine can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What to avoid

Grapefruit may interact with budesonide and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using Uceris.

Uceris side effects

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

Call your doctor at once if you have:

  • thinning skin, easy bruising, increased acne or facial hair;
  • swelling in your ankles;
  • weakness, tiredness, or a light-headed feeling, like you might pass out;
  • nausea, vomiting, rectal bleeding;
  • pain or burning when you urinate;
  • menstrual problems (in women), impotence or loss of interest in sex (in men); or
  • signs of too much steroid medicine in your blood - acne, bruising, thinning skin, increased facial or body hair, stretch marks, increased body fat, or changes in the shape or location of body fat (especially in your face, neck, back, and waist).

Common Uceris side effects may include:

  • headache, dizziness;
  • indigestion, nausea, vomiting, stomach pain, bloating, gas, constipation;
  • feeling tired;
  • back pain, joint pain;
  • painful urination;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • pain anywhere in your body; or
  • signs of too much steroid medicine in your blood.

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.

What other drugs will affect Uceris?

Many drugs can interact with budesonide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.