budesonide (oral)

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

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.

What is budesonide?

Budesonide is a steroid that reduces inflammation in the body.

Entocort and Ortikos are used to treat mild to moderate Crohn's disease in adults and children at least 8 years old. These medicines are also used in adults to keep symptoms from returning for up to 3 months.

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

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 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 UC during pregnancy can cause complications leading to preterm delivery or low birth weight. The benefit of treating UC may outweigh any risks to the baby.

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

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.

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

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away, or within 30 minutes after mixing. 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.

Budesonide 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.

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 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 budesonide.

What are the possible side effects of budesonide?

• 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 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 budesonide?

Many drugs can affect 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.

Where can I get more information?

Your pharmacist can provide more information about budesonide.