Uceris Tablets

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

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 20, 2024.

What is Uceris?

Uceris 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 or any of the ingredients in Uceris extended-release tablets.

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

• tuberculosis;

• any type of infection caused by bacteria, viruses (especially chickenpox or measles), fungi, or parasites such as threadworm (Strongyloides)

• high blood pressure;

• a weak immune system (caused by disease or by using certain medicines);

• osteoporosis or low bone mineral density;

• a stomach ulcer;

• cancer, including Kaposi's sarcoma;

• eczema;

• plan to have a surgery;

• any allergies;

• diabetes, cataracts, or glaucoma (in you or a family member); 

• have malaria of the brain (cerebral malaria)

• liver disease.

Steroids can weaken your immune system, making it easier to get an infection or worsen an infection you already have. Tell your doctor about any illness or infection you had within the last several weeks.

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

• May cause harm to an unborn baby. Talk to your doctor about the risks versus benefits of taking Uceris throughout pregnancy. Tell your healthcare provider if you inadvertently become pregnant while taking Uceris.
• Present in breastmilk. Talk to your healthcare provider about the best way to feed your baby.

How should I take Uceris?

Take Uceris exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Uceris in the morning with a full glass of water. You may take this medicine with or without food.

You should not stop using Uceris suddenly. Follow your doctor's instructions about tapering your dose.

Do not crush, break, or dissolve a Uceris extended-release tablet. Swallow the tablet whole.

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.

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

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

Store tightly closed at room temperature, away from moisture and heat.

Dosing information

Usual Adult Dose for Ulcerative Colitis:

Extended-release tablets:
Initial dose: 9 mg orally once a day in the morning
Duration of therapy: Up to 8 weeks

Comments:
-Avoid grapefruit juice for the duration of therapy.

Use: For the induction of remission in patients with active, mild to moderate ulcerative colitis.

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 should I avoid while taking Uceris?

Grapefruit may interact with budesonide and cause side effects. Avoid consuming 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

Common Uceris side effects may include:

• headache, dizziness;

• indigestion, nausea, vomiting, stomach pain, bloating, gas, constipation;

• feeling tired;

• high blood pressure;

• back pain, muscle cramps, joint pain;

• swelling of the face, lower legs, ankles, and feet;

• pain and burning when you urinate;

• acne;

• thicker or increased hair on your body and face;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• decreased adrenal gland hormones.

Serious side effects

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

Uceris may cause serious side effects. Call your doctor at once if you have any of the following. Note that 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.

Increased adrenal gland hormones (hypercorticism) leading to Cushing's Syndrome and Adrenal axis suppression

Symptoms include hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, and sexual changes. Your healthcare provider will monitor you for these changes and consider dose changes if necessary. People with moderate to severe liver disease are more at risk. The response of the hypothalamus-pituitary-adrenal (HPA) axis to
stress may also be compromised and supplementation with a systemic glucocorticosteroid may be necessary; 

Decreased adrenal gland hormones

Symptoms include nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods; or

Signs of an infection

Corticosteroids, including Uceris, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can:

• Reduce resistance to new infections
• Exacerbate existing infections
• Increase the risk of disseminated infections
• Increase the risk of reactivation or exacerbation of latent infections
• Mask some signs of infection.

These infections can be mild but can be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking Uceris. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking Uceris, including flu-like symptoms such as:

• fever
• chills
• stomach area (abdominal) pain
• cough
• pain
• feeling tired
• aches
• nausea and vomiting
• diarrhea.

Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking Uceris. Tell your healthcare provider if you develop a bad cough lasting longer than 2 weeks, night sweats, fever, weight loss, or unexplained fatigue. 

Chickenpox and measles: People taking corticosteroid medicines, including Uceris, who have not had chickenpox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chickenpox or measles.

Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking Uceris. Your healthcare provider will test you for HBV before you start treatment.

Amebiasis: Inactive (latent) amebiasis may become an active infection while taking Uceris. Your healthcare provider should check you for amebiasis before you start treatment if you have spent time in the tropics or have unexplained diarrhea.

Decreased growth rate in children

Uceris can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Kaposi’s sarcoma

Kaposi’s sarcoma has happened in people who received corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions.

What other drugs will affect Uceris?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Ask a doctor or pharmacist before using Uceris with any other medicines, especially:

• stomach acid reducers.

This list is not complete. Other drugs may interact with budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ingredients

Active Ingredient: budesonide
Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stea rate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.

Manufacturer

Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Uceris only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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