Budesonide (bue-DES-oh-nide)

Treats Crohn disease, ulcerative colitis, and eosinophilic esophagitis. Also reduces levels of proteinuria (protein in the urine). This medicine is a corticosteroid.

Brand Name(s):

Entocort EC, Eohilia, Tarpeyo, Uceris

When This Medicine Should Not Be Used:

How to Use This Medicine:

Delayed Release Capsule, Liquid, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. This medicine is usually taken in the morning.
• Swallow the delayed-release capsule or extended-release tablet whole. Do not break, crush, chew, or open it.
• Take Tarpeyo™ delayed-release capsule in the morning, at least 1 hour before a meal.
• If you cannot swallow the Entocort® EC delayed-release capsule, you may open it and mix the granules into a tablespoonful of applesauce (not hot). Swallow the mixture whole. Do not chew or crush the granules. Take the mixture within 30 minutes. Drink a glass (8 ounces) of water right after.
• Oral liquid:
  • Do not take this medicine with food or liquid. Do not use it if it is damaged or leaking.
  • Shake the stick pack for at least 10 seconds before opening. Using scissors, cut along the dotted line straight across the top of the stick pack.
  • Squeeze the stick pack from the bottom to the top directly into the mouth. Repeat 2 to 3 times until all the medicine is given. Swallow all the liquid.
  • Do not eat or drink for 30 minutes after taking the medicine. After 30 minutes, rinse your mouth and spit out the contents without swallowing.
• Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • Delayed-release capsule or extended-release tablet: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
  • Tarpeyo™ delayed-release capsule: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. You may store the oral liquid in the refrigerator or at room temperature. Do not freeze.
• Throw away any unused applesauce mixture after 30 minutes.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how budesonide works. Tell your doctor if you are using any of the following:
  • Cyclosporine, erythromycin, indinavir, itraconazole, ketoconazole, ritonavir, saquinavir
  • Medicine that weakens your immune system (including cancer medicines or other steroid medicines)
  • Stomach medicine (including cimetidine, famotidine, lansoprazole, omeprazole, pantoprazole, ranitidine)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease (including cirrhosis), diabetes, high blood pressure, osteoporosis, stomach ulcers, any type of infection (including tuberculosis), allergies, or a family history of cataracts, diabetes, or glaucoma.
• This medicine may cause the following problems:
  • Adrenal problems
  • Increased risk of infection
  • Erosive esophagitis (damage to the lining of the esophagus)
  • Slow growth in children
  • Increased risk for cancer (including Kaposi's sarcoma)
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark freckles, skin color changes, coldness, weakness, tiredness, nausea, vomiting, weight loss
• Diarrhea, loss of appetite
• Fever, chills, cough, sore throat, body aches
• Lightheadedness, dizziness, or fainting
• Round, puffy face
• Slow growth in children
• Thicker or more hair on your body and face

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Headache
• Runny or stuffy nose, sneezing
• Sores or white patches on your lips, mouth, or throat
• Stomach pain or upset, gas

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088