Budesonide belongs to the class of medications called corticosteroids. Budesonide capsules are used to treat mild-to-moderate ulcerative colitis, an inflammatory disease of the bowel. It works by decreasing inflammation in the large intestine and rectum.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended adult dose to treat a flare-up of ulcerative colitis is 9 mg taken once daily in the morning, preferably after breakfast, for up to 8 weeks.

Finish all this medication, even if you have started to feel better.

The tablets should be swallowed whole with water and not chewed, broken, or crushed. People who are taking this medication should avoid drinking grapefruit juice or eating grapefruit on a regular basis. Grapefruit may increase the amount of budesonide that stays in the body and increase the risk of side effects.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Each white-to-off-white, round, double-convex tablet with a film coating and "MX9" engraved on one side of the tablet contains 9 mg of budesonide. Nonmedicinal ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose monohydrate, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethylcitrate, and titanium dioxide.

Do not take this medication if you:

• are allergic to budesonide or any ingredients of the medication
• are allergic to soya or peanuts
• have a bacterial, fungal, or viral infection
• have active tuberculosis

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• back pain
• dizziness
• dry mouth
• fatigue
• headache
• feeling faint
• muscle cramps
• muscle pain
• nausea
• stomach bloating or gas
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• decreased bone strength (e.g., bone pain or fractures)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• mood swings
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• palpitations (fast or pounding heartbeat)
• signs of effects on the adrenal gland (decreased natural glucocorticoid production)
• acne
• fatty pad between the shoulders
• filling or rounding out of the face
• menstrual problems
• thinning skin
• unusual increase in hair growth
• swelling of the feet or lower legs
• symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
• wounds that will not heal

Stop taking the medication and seek immediate medical attention if any of the following occur:

• thoughts of self-harm or suicide
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Corticosteroids: Inform all of your doctors if you have recently taken or are taking corticosteroids.

Diabetes: Corticosteroids such as budesonide may cause an increase in blood sugar levels. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of high blood sugar, such as excessive thirst, a fruity odour to your breath, frequent urination, or increased infections, contact your doctor.

High blood pressure: Corticosteroids can cause buildup of fluid in the body, which can increase the work necessary for the heart to pump the blood around the body. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Illness and surgery: People who take this medication, or have taken other corticosteroids (e.g., prednisone) in the last several months, may need additional corticosteroids (e.g., prednisone) during times of any unusual stress, such as trauma, surgery, or infection.

Infections: When taken by mouth, this medication may mask some signs of infection and put people at increased risk for new infections. Viral infections such as chickenpox, measles, or herpes can be more serious and possibly fatal for people who are taking budesonide. Adults who have not had these diseases should try to avoid exposure to individuals with these infections.

Galactose intolerance: This medication is prepared with lactose. If you have lactose or galactose intolerance you should not take this medication.

Liver problems: Decreased liver function or liver disease can cause this medication to build up in the body, increasing the possibility of side effects. If you have decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mental health: Corticosteroids appear to make behavior and thought disturbances worse for people who have psychotic conditions. They may also cause symptoms of psychosis and mania to develop in people who have not had these symptoms before. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Myasthenia gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Corticosteroids such as budesonide can cause muscle wasting, decreasing muscle. If you have myasthenia gravis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Osteoporosis: Long-term use of corticosteroids may increase the risk of bone loss and osteoporosis. If your doctor recommends that you use this medication for a long period of time, talk to your doctor about supplements and strategies to slow down and reduce bone loss.

Steroid medication use: If you have recently taken or are still taking a different oral steroid medication (e.g., prednisone), consult your doctor before using this medication. If you experience symptoms such as tiredness, headache, nausea, or vomiting while taking this medication, contact your doctor. This may be a sign of withdrawal from the previous corticosteroid.

Stomach and intestinal problems: When taken by mouth, budesonide may cause heartburn or even stomach ulcers. Tell your doctor if you have had any stomach discomfort or signs of bleeding in the stomach (black, tarry stools). If you have certain stomach and intestinal problems (e.g., blockage, infection), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Vision problems: Budesonide can increase the risk of developing cataracts or glaucoma. If you have glaucoma or cataracts, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience changes in your vision while taking budesonide, contact your doctor.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Budesonide passes into breast milk. If you are a breast-feeding mother and are taking budesonide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between budesonide delayed release and any of the following:

• aldesleukin
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• BCG
• bicalutamide
• ceritinib
• cholestyramine
• colestipol
• conivaptan
• crizotinib
• dasatinib
• deferasirox
• denosumab
• diltiazem
• dronedarone
• echinacea
• fingolimod
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hyaluronidase
• imatinib
• leflunomide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• natalizumab
• nefazodone
• nilotinib
• nivolumab
• pimecrolimus
• roflumilast
• simeprevir
• tacrolimus
• tofacitinib
• trastuzumab
• vaccines
• verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.