Budesonide, Oral

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KEY POINTS

• This medicine is taken by mouth to treat Crohn's disease or ulcerative colitis. Take it exactly as directed.
• You may get infections more easily when you are taking this medicine. Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: corticosteroid

Generic and brand names: budesonide, oral; Entocort EC; Uceris

What is this medicine used for?

Entocort EC is taken by mouth to treat Crohn's disease in the last part of the small intestine and the first part of the large intestine.

Uceris is taken by mouth to treat mild to moderate ulcerative colitis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis
• Blood clots
• Cataracts, glaucoma, or other eye problems or eye infection
• Diabetes
• Heart disease or a heart attack
• High blood pressure
• Liver or kidney disease
• Myasthenia gravis
• Osteoporosis
• Seizures
• Thyroid problems
• Tuberculosis (TB)
• Ulcers

Tell your provider if you currently have or have recently had any kind of infection, fever, serious illness or injury. Tell your provider if you have recently gotten a vaccine. Also tell your provider if you are scheduled to have surgery.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while taking this medicine. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. If you have taken it for over 2 weeks, you may have to gradually reduce your dosage to prevent serious side effects.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Take the medicine in the morning.

Swallow the tablets or capsules whole with a full glass of water. Do not open, chew, or crush them.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose or you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Contact your healthcare provider if your condition does not improve in a few days or if it gets worse.

This medicine may make you dizzy or confused. It may also affect your vision. Do not drive or operate machinery until you are fully alert and can see clearly. Talk to your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. Vaccines or skin tests may need to be postponed until after you have stopped taking this medicine. Talk with your healthcare provider about this.

If you have not had chickenpox, the measles, or tuberculosis (TB), and are exposed to them while taking this medicine, contact your healthcare provider right away.

If you take other steroid medicines to treat allergies, this medicine may cause your allergies to get worse. These allergies may include eczema (a skin disease) or a runny or stuffy nose. Tell your healthcare provider if your allergies get worse while taking this medicine.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you use this medicine for a long time, you will need to have checkups regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Signs of an infection (fever, sore throat, pain while urinating, muscle pain); unusual bruising, bleeding, or pinpoint red spots on the skin; warm, painful, or swollen ankles or calves, or any unexplained swelling; new or worsening depression; unexplained mood changes; confusion; chest pain; irregular heartbeat; vision changes; severe stomach pain; severe headache; bloody or black bowel movements; skin changes; fatty pad or hump between the shoulders; worsening acne; round face; increased hair growth; unusual tiredness or weakness; severe dizziness or fainting; severe or ongoing nausea or vomiting; bone or joint pain; changes in menstrual period; seizures.

Other: Mild nausea or stomach pain, dizziness, headache, back pain, gas, constipation, nervousness, shaking, trouble sleeping, increased appetite, gradual weight gain, increased sweating.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alzheimer’s disease medicines such as donepezil (Aricept), galantamine (Razadyne), and rivastigmine (Exelon)
• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as amphotericin b (Abelcet, AmBisome, Amphotec), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), and phenytoin (Dilantin, Phenytek)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Aprepitant (Emend)
• Aspirin and other salicylates
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as axitinib (Inlyta), brentuximab (Adcetris), ceritinib (Zykadia), dasatinib (Sprycel), enzalutamide (Xtandi), gefitinib (Iressa), idelalisib (Zydelig), ifosfamide (Ifex), imatinib (Gleevec), sorafenib (Nexavar), sunitinib (Sutent), teniposide, toremifene (Fareston), and vandetanib (Caprelsa)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), and colestipol (Colestid)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as acarbose (Precose), glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, linagliptin (Tradjenta), metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, eplerenone (Inspra), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Echinacea
• Ephedrine
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and estrogen hormones such as Cenestin, Estinyl, Estrace, Estraderm, Estratab, FemPatch, Premarin, and Vivelle
• Lumacaftor/ivacaftor (Orkambi)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), dexlansoprazole (Dexilant), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), omeprazole (Prilosec), rabeprazole (AcipHex), and ranitidine (Zantac)
• Mifepristone (Korlym, Mifeprex)
• Mitotane (Lysodren)
• Myasthenia gravis medicines such as neostigmine (Prostigmin) and pyridostigmine (Mestinon, Regonol)
• Natalizumab (Tysabri)
• Nefazodone
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other corticosteroids taken by mouth or inhaled
• Pimecrolimus (Elidel)
• Pimozide (Orap)
• Quetiapine (Seroquel)
• Somatropin (Genotropin, Humatrope, Nutropin, Serostim)
• Tacrolimus (Astagraf, Prograf, Protopic)
• Thalidomide (Thalomid)
• Tofacitinib (Xeljanz)
• Vaccines
• Warfarin (Coumadin)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.