budesonide (oral)

What is the most important information I should know about budesonide?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is budesonide?

Entocort and Ortikos are used to treat mild to moderate Crohn's disease in adults and children at least 8 years old who weigh 55 pounds (25 kg) or more. These medicines are also used in adults for up to 3 months to keep symptoms from returning.

Uceris is used to treat mild to moderate ulcerative colitis (UC) in adults.

Tarpeyo is used to lower levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy.

Budesonide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking budesonide?

Tell your doctor if you have or ever had:

• tuberculosis;
• any type of infection caused by bacteria, virus, fungus, or parasites especially 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;
• eczema;
• plan to have a surgery;
• any allergies;
• diabetes, cataracts, or glaucoma (in you or a family member); or
• liver disease.

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

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

How should I take budesonide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Do not stop using Tarpeyo without your doctor's advice. Tell your doctor if your medicine seems to stop working.

If you cannot swallow an Entocort capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing, then drink a full glass of water.

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.

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?

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 budesonide?

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 budesonide.

What are the possible side effects of budesonide?

• increased adrenal gland hormones --hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes;
• decreased adrenal gland hormones --nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods; or
• signs of infection --fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

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

Common 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.

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 budesonide?

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 budesonide with any other medicines, especially:

• stomach acid reducers.

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

Where can I get more information?

Your doctor or pharmacist can provide more information about budesonide.

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

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 7.01. Revision date: 3/29/2023.