Budesonide is a steroid that reduces inflammation in the body.

Budesonide rectal is used to treat distal ulcerative colitis (extending from the part of the large intestine that is closest to the rectum).

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

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.

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

Do not take budesonide rectal by mouth. It is for use only in your rectum.

Budesonide rectal is generally used once in the morning and once in the evening for 2 weeks. Then you will use the medicine only once per day (at bedtime) for 4 more weeks. Follow your doctor's dosing instructions very carefully.

Try to empty your bowel and bladder just before using the rectal foam.

Wash your hands before and after using this medicine.

Warm the medicine canister in your hands and shake it for 10 to 15 seconds before each use.

After using budesonide rectal at bedtime, avoid using the bathroom until the next morning.

Budesonide rectal foam is flammable. Do not use near high heat or open flame, or while smoking.

If you plan to have a colonoscopy, tell your doctor ahead of time. You may need to stop using budesonide rectal while you are using laxative medicine to prepare for the colonoscopy. Follow your doctor's instructions about when to start using budesonide rectal foam again.

If you also use another steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely.

Store at room temperature away from moisture and heat. Do not refrigerate.

Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty rectal foam canister.

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

Tell your doctor if you have ever had:

• tuberculosis (now or in the past);

• a serious bacterial, viral, or fungal infection;

• herpes infection of the eyes;

• cirrhosis or other liver disease;

• diabetes;

• high blood pressure;

• osteoporosis;

• eczema;

• seasonal allergy;

• a stomach ulcer;

• glaucoma or cataracts;

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

• if you plan to have surgery.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using budesonide.

Budesonide rectal is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

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.

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 steroid medicine.

Grapefruit may interact with budesonide and lead to unwanted side effects. Avoid the use of grapefruit products.

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

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

• signs of infection--fever, chills, body aches, vomiting, flu symptoms;

• decreased adrenal gland hormones--muscle weakness, tiredness, nausea, vomiting, feeling light-headed; or

• increased adrenal gland hormones--weight gain in your face and shoulders, swelling in your ankles, slow wound healing, acne, skin discoloration, thinning skin, increased body hair, mood changes, menstrual changes, sexual changes.

Common side effects of budesonide may include:

• nausea; or

• low 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 medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.