Pronunciation:

bue-DES-oh-nide

Brand Names:

• Entocort EC
• Ortikos
• Uceris
• Pulmicort
• Pulmicort Spacer

Dosage Forms:

• Capsule, Extended Release
• Capsule, Delayed Release
• Tablet, Extended Release

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Budesonide is used to treat mild to moderate active Crohn's disease, an inflammatory bowel disease. This medicine works inside the intestines (bowels) to reduce inflammation and symptoms of the disease. It also helps keep the symptoms of Crohn's disease from coming back. Budesonide is a steroid (cortisone-like) medicine.

Budesonide extended-release tablets are used to help get active mild to moderate ulcerative colitis under control (induce remission).

Budesonide delayed-release capsules are used to reduce levels of protein in the urine (proteinuria) in patients who have a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of progressing.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of budesonide extended-release capsules in children 8 to 17 years of age and weighing more than 25 kilograms (kg). However, safety and efficacy have not been established in children younger than 8 years of age, or in children 8 to 17 years of age and weighs 25 kg or less. Safety and efficacy have not been established to help keep the symptoms of Crohn's disease from coming back in children. Because budesonide may cause slowed growth in children, those who will be using it for a long time should have their weight and growth measured by the doctor regularly.

Appropriate studies have not been performed on the relationship of age to the effects of budesonide extended-release tablets in the pediatric population. Safety and efficacy have not been established. Because budesonide may cause slowed growth in children, those who will be using it for a long time should have their weight and growth measured by the doctor regularly.

Appropriate studies have not been performed on the relationship of age to the effects of budesonide delayed-release capsules in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving budesonide.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Levoketoconazole
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Adagrasib
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Balofloxacin
• Belzutifan
• Bemiparin
• Besifloxacin
• Boceprevir
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Ciprofloxacin
• Clarithromycin
• Clonixin
• Cobicistat
• Conivaptan
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Duvelisib
• Enoxacin
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Fosnetupitant
• Gatifloxacin
• Gemifloxacin
• Ibuprofen
• Idelalisib
• Indinavir
• Indomethacin
• Itraconazole
• Ivosidenib
• Ketoconazole
• Ketoprofen
• Ketorolac
• Larotrectinib
• Lefamulin
• Lenacapavir
• Levofloxacin
• Lomefloxacin
• Lopinavir
• Lorlatinib
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nirmatrelvir
• Norfloxacin
• Ofloxacin
• Olutasidenib
• Omaveloxolone
• Oxaprozin
• Oxyphenbutazone
• Pacritinib
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pirtobrutinib
• Posaconazole
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Ritlecitinib
• Ritonavir
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Saquinavir
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• Sulindac
• Telaprevir
• Telithromycin
• Tenoxicam
• Tiaprofenic Acid
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Trofinetide
• Valdecoxib
• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin
• Erythromycin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts (eye disease), or a family history of or
• Diabetes, or a family history of or
• Eczema (skin disease) or
• Glaucoma, or a family history of or
• Hypertension (high blood pressure) or
• Infection (eg, bacteria, virus, fungus) or
• Osteoporosis (thin bones) or
• Rhinitis (inflammation inside your nose) or
• Stomach ulcer, active or history of or
• Tuberculosis, active or history of or
• Weakened immune system—Use with caution. May make these conditions worse.

• Liver disease (including cirrhosis), moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Use of delayed-release capsules is not recommended in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop using this medicine without first checking with your doctor.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release capsule and extended-release tablet whole. Do not break, crush, chew, or open it.

If you cannot swallow the Entocort® EC extended-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.

Swallow the delayed-release capsule whole. Do not open, crush, or chew it. Take this medicine in the morning, at least 1 hour before a meal.

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.

Grapefruit and grapefruit juice may increase the effects of budesonide by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release capsules):
  • For proteinuria:
    • Adults—16 milligrams (mg) once a day in the morning for up to 9 months. Before stopping treatment, reduce your dose to 8 mg once a day in the morning for the last 2 weeks of treatment.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release capsules):
  • For mild to moderate active Crohn's disease:
    • Adults—9 milligrams (mg) once a day in the morning for up to 8 weeks. Your doctor may adjust your dose as needed.
    • Children 8 to 17 years of age and weighing more than 25 kilograms (kg)—At first, 9 mg once a day in the morning for up to 8 weeks, followed by 6 mg once a day in the morning for 2 weeks.
    • Children younger than 8 years of age or weighing 25 kg or less—Use and dose must be determined by your doctor.
  • For prevention of symptoms of Crohn's disease from coming back:
    • Adults—6 milligrams (mg) once a day in the morning for up to 3 months. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets):
  • For mild to moderate ulcerative colitis:
    • Adults—9 milligrams (mg) once a day in the morning for up to 8 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of the delayed-release capsule, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Throw away any unused applesauce mixture after 30 minutes.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If your condition does not improve or if it become worse, check with your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

If you are taking another steroid medicine and will switch to Entocort® EC, Ortikos™, Tarpeyo™, or Uceris™, check first with your doctor. This may increase your chance of having steroid withdrawal side effects, including headache, loss of appetite, blurred vision, change in the ability to see colors (especially blue or yellow), or vomiting.

You may get infections more easily while using this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bruising easily

chills

colds

cough

diarrhea

fever

general feeling of discomfort or illness

headache

hoarseness

joint pain

loss of appetite

muscle aches and pains

nausea

runny nose

shivering

sneezing

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Bladder pain

bleeding after defecation

blistering, crusting, irritation, itching, or reddening of the skin

bloody or cloudy urine

blurred vision

burning feeling while urinating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in vision

chest pain or tightness

cough producing mucus

decreased urine

diarrhea

difficult or labored breathing

difficult or painful urination

dizziness

dry mouth

eye pain

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

heartburn

increase in body movements

increased thirst

increased urge to urinate during the night

irregular heartbeat

lower back or side pain

mood changes

nervousness

pain or discomfort in the chest, upper stomach, or throat

pinpoint red or purple spots on the skin

pounding in the ears

rectal bleeding

redness of the face, neck, arms, and occasionally, upper chest

seizures

severe constipation

shakiness in the legs, arms, hands, or feet

shivering

skin rash, encrusted, scaly, and oozing

slow or fast heartbeat

stomach cramps or pain

sweating

swelling of the legs and feet

swelling or puffiness of the face

trouble sleeping

uncomfortable swelling around the anus

upper abdominal or stomach pain

waking to urinate at night

weight gain or loss

Incidence not known

Bulging soft spot on the head of an infant

change in the ability to see colors, especially blue or yellow

difficulty with swallowing

hives, itching, or skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

belching

blemishes on the skin

heartburn

indigestion

pain or tenderness around the eyes and cheekbones

pimples

rounded or moon face

stomach discomfort or upset

stuffy nose

Less common

Accumulation of pus

agitation

bloated or full feeling

change in hearing

cracked, dry, or scaly skin

cracks in the skin at the corners of mouth

difficulty having a bowel movement

difficulty with moving

dizziness or lightheadedness

ear drainage

earache or pain in the ear

excess air or gas in the stomach or bowels

fatty hump between the shoulders

feeling of constant movement of self or surroundings

increased appetite

increased hair growth, especially on the face

lack or loss of strength

loss of memory

loss or thinning of the hair

muscle stiffness

nervousness

pain, swelling, or redness in the joints

passing gas

pressure in the stomach

problems with memory

redness, swelling, or soreness of the tongue

sensation of spinning

sleepiness or unusual drowsiness

soreness or redness around the fingernails and toenails

swelling of the abdominal or stomach area

swollen joints

uterine bleeding between menstrual periods

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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