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.

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

Budesonide comes as a capsule to take by mouth. It is usually taken once a day in the morning. Take budesonide at around the same time every day. Budesonide (Tarpeyo) should be taken at least one hour before a meal. Your doctor will tell you how long to take budesonide. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take budesonide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them. If you are unable to swallow the budesonide (Entocort EC) capsules whole, the capsules may be opened and sprinkled on a tablespoonful of apple sauce, mixed well and swallowed whole with no chewing within 30 minutes of mixing. The applesauce mixture should be followed by a full glass of water.

Budesonide may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well budesonide works for you. If your symptoms are controlled, your doctor may decrease your dose of budesonide. After your symptoms have been controlled for 3 months, your doctor may slowly decrease your dose and then stop treating you with this medication. It is important to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

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

Take Tarpeyo in the morning, at least 1 hour before a meal.

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.

Do not crush, break, or dissolve a tablet or capsule of Uceris, Tarpeyo, or Ortikos. Swallow it whole.

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 budesonide 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.

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

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.

Do not use budesonide in a child to treat any condition that has not been checked by your doctor.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not eat grapefruit or drink grapefruit juice while taking this medication.

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.

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

Budesonide may cause serious side effects. Call your doctor at once if you have:

• 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 budesonide.

Common side effects of budesonide 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.

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.

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking budesonide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.