Budesonide

Budesonide is a prescription medication used in a variety of inflammatory conditions. These include maintaining asthma control and preventing asthma attacks. Budesonide is also used to treat certain inflammatory bowel diseases, as well as symptoms of allergies. Budesonide belongs to a group of drugs called corticosteroids which help to decrease inflammation to relieve symptoms.

This medication comes in multiple forms. The capsule and extended-release tablet forms are usually taken once daily in the morning with or without food. The nasal spray may be used once per day, one to four sprays per nostril. The oral (by mouth) inhalation form is typically used twice daily.

Common side effects of budesonide tablets and capsules include headache, nausea, and stomach pain.

Oral:

• Budesonide tablets are used to treat ulcerative colitis (UC). UC is a disease that causes inflammation and sores, called ulcers, in the lining of the rectum and colon.
• Budesonide capsules is used to treat Crohn's disease. Crohn's is a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever).
• This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Topical:

• Budesonide is used to treat symptoms of stuffiness and runny nose due to allergies.
• This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Inhalational:

• Budesonide is used to prevent wheezing, shortness of breath, and troubled breathing caused by severe asthma and other lung diseases.
• This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Budesonide may be found in some form under the following brand names:

• Entocort

• Pulmicort

• Pulmicort Respules

• Pulmicort Turbuhaler

• Rhinocort

• Rhinocort Aqua

• Symbicort

• Uceris

Oral:

Common side effects include:

• headache
• nausea
• stomach pain
• fatigue
• flatulence
• abdominal problems
• acne
• urinary tract infection
• joint pain
• constipation

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Topical:

Common side effects of budesonide nasal spray include:

• nosebleeds
• soar throat
• bronchospasm (narrowing of air passageways)
• coughing
• nasal irritation

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Inhalation:

Common side effects reported by patients using budesonide inhalation include:

• sore nose and throat
• stuffy nose
• runny nose
• nausea
• hay fever
• viral infections of the upper respiratory tract
• viral irritation and inflammation of the stomach and intestine (gastroenteritis). Symptoms may include stomach area pain, diarrhea, nausea and vomiting, loss of appetite, headaches, and weakness.
• ear infections

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of budesonide inhalation. Ask your healthcare provider or pharmacist for more information.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using Pulmicort Flexhaler with certain other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

• a corticosteroid medicine
• anti-seizure medicine (anticonvulsants)
• medicines that suppress your immune system (immunosuppressant)
• ketoconazale (Nizoral)
• clarithromycin (Biaxin)
• erythromycin (Ery-C, Ery Gel, Ery-Tab, PCE)
• indinavir (Crixivan)
• itraconazole (Sporanox, Onmel)
• nefazodone
• nelfinavir (Viracept)
• ritonavir (Norvir, Kaletra)
• telithromycin (Ketek)

This is not a complete list of budesonide drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects of budesondie include the following:

Oral:

• Having too much corticosteroid medicine in your blood (hypercorticism). Long-time use can cause you to have too much glucocorticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism:
  • acne
  • bruise easily
  • rounding of your face (moon face)
  • ankle swelling
  • thicker or more hair on your body and face
  • a fatty pad or hump between your shoulders (buffalo hump)
  • pink or purple stretch marks on the skin of your abdomen, thighs, breasts and arms
• Adrenal suppression. When taken for a long period of time (chronic use), the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression:
  • tiredness
  • weakness
  • nausea
  • vomiting
  • low blood pressure
• Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to budesonide may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse.
• Do not take budesonide if you have had an allergic reaction to budesonide or to any of its ingredients.

Topical:

• hole in the cartilage inside the nose (nasal septal perforation). Tell your healthcare provider if you have a whistling sound from your nose when you breathe.

• slow wound healing. You should not use budesonide nasal spray until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured.
• fungal infection in your nose.
• allergic reactions. Tell your healthcare provider or get medical help right away if you have
• skin rash, redness or swelling
• severe itching
• swelling of the face, mouth and tongue
• immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while using budesonide nasal spray. Symptoms of infection may include fever, pain, aches, chills, feeling tired, nausea and vomiting.
• adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include tiredness, weakness, nausea, vomiting and low blood pressure.
• slowed or delayed growth in children. A child’s growth should be checked regularly while using budesonide nasal spray.
• eye problems, such as glaucoma and cataracts. Tell your healthcare provider if you have a change in vision or have a history of increased intraocular pressure, glaucoma, and/or cataracts.

Inhalation:

• thrush (candida), a fungal infection in your mouth and throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
• worsening of asthma or sudden asthma attacks.
• allergic reactions. Tell your healthcare provider or get medical help right away if you have:
  • skin rash, redness or swelling
  • severe itching
  • swelling of the face, mouth, and tongue
  • trouble breathing or swallowing
  • chest pain
  • anxiety (feeling of doom)

• Immune system effects and a higher chance of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using budesonide inhalation. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your healthcare provider about any signs of infection while you are using budesonide inhalation.
• Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency include: tiredness, weakness, nausea and vomiting and low blood pressure.
• Decrease in bone mineral density. Your healthcare provider should check you for this during treatment with budesonide inhalation.
• Slowed or delayed growth problems in children. A child’s growth should be checked regularly while using budesonide inhalation.
• Eye problems, including glaucoma and cataracts. You should have regular eye exams while using budesonide inhalation.
• Increased wheezing right after taking budesonide inhalation. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden wheezing. 
• Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.
• Do not use budesonide inhalation:
  • to treat sudden severe symptoms of asthma.
  • if you have a severe allergy to milk proteins. Budesonide inhalation contains a small amount of lactose (milk sugar). People with severe allergies to milk protein may have symptoms of an allergic reaction with budesonide inhalation including cough, wheezing, trouble breathing or feeling like your throat is closing.
• Fungal infection of the mouth and throat may occur with budesonide inhalation use. Rinse your mouth following inhalation.

Grapefruit and grapefruit juice may interact with budesonide and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using budesonide tell your healthcare provider if you:

• are allergic to any ingredients in budesonide
• have or had chicken pox or measles, or have recently been near anyone with chicken pox or measles. have or had tuberculosis of your respiratory tract. Have certain kinds of serious infections that have not been treated, including:
  • fungal infections
  • bacterial infections
  • viral infections
  • parasitic infections
• have recently had surgery or an injury to your nose
• herpes simplex infection of the eye (ocular herpes simplex)
• have eye problems such as increased pressure in the eye, glaucoma, or cataracts
• are planning to have surgery
• have liver problems
• have decreased bone mineral density

You are at risk for decreased bone mineral density if you:

• are inactive for a long period of time
• have a family history of osteoporosis
• are a woman going through menopause or are past menopause
• smoke or use tobacco
• do not eat well (poor nutrition)
• are elderly
• take bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Using budesonide with certain other medicines may affect each other causing side effects.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. Tell your doctor if you are pregnant or plan to become pregnant. It is not known if budesonide will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. The active ingredient in budesonide is excreted in human breast milk. It is not known if budesonide will harm your nursing baby.

Oral:

How should I take budesonide extended release tablets?

• Take budesonide extended release tablets exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how many budesonide extended release tablets to take.
• Take budesonide extended release tablets in the morning.
• Take budesonide extended release tablets capsules whole with water. Do not chew, crush, or break budesonide extended release tablets before swallowing.
• If you take too much of budesonide, call your healthcare provider right away or go to the nearest hospital emergency room.

How should I take budesonide capsules?

• Take budesonide capsules exactly as your healthcare provider tells you to take it.
• Take budesonide capsules in the morning. Swallow each budesonide capsule whole. Do not open, chew, or crush budesonide capsules.
• Your provider will tell you how long to take budesonide capsules.

Topical:

• Budesonide nasal spray is for use in your nose only. Do not spray it in your eyes or mouth.
• Use budesonide nasal spray exactly as your healthcare provider tells you to use it.
• It is very important that you use budesonide nasal spray regularly. Do not stop using budesonide nasal spray or change your dose without talking to your healthcare provider, even if you are feeling better.
• Talk to your healthcare provider if your symptoms do not improve after taking budesonide nasal spray for 2 weeks or if your symptoms get worse.
• An adult should help a young child use this medicine.

Inhalation:

• Use budesonide inhalation exactly as prescribed by your healthcare provider. 
• You must use budesonide inhalation regularly for it to work.
• Be sure you know the difference between budesonide inhalation and any other inhaled medicines that are prescribed for you, including what you use them for (prescribed use) and what they look like.
• Do not stop using budesonide inhalation, even if your symptoms get better. Your healthcare provider will change your medicines as needed.
• Do not change or stop any medicines used to control or treat your breathing problems, unless your healthcare provider tells you to.
• Rinse your mouth with water and spit the water out after each dose of budesonide inhalation. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth.
• If you miss a dose, just take your next regularly scheduled dose when it is due. Do not use budesonide inhalation more often or use more puffs than you have been prescribed.
• Make sure you always have a short-acting beta2-agonist medicine with you. Use your short acting beta2-agonist medicine if you have breathing problems between doses of budesonide inhalation or if a sudden asthma attack happens.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Oral:

• Store at room temperature.
• Dispense in a tight, light-resistant container using a child-resistant closure.
• Keep container tightly closed.
• Keep this and all medication out of the reach of children.

Topical:

• Store budesonide nasal spray at room temperature.
• Do not freeze budesonide nasal spray.
• Protect budesonide nasal spray from light.
• Do not use budesonide nasal spray after the labeled number of sprays have been used (does not include priming) or after the expiration date shown on the carton or bottle label.
• Keep the green protective cap on budesonide nasal spray when not in use.
• Keep budesonide nasal spray and all medications out of the reach of children.

Inhalational:

• Store at room temperature.
• Keep the budesonide inhaler dry.
• Keep your budesonide inhaler with the cover tightly in place when not in use.
• Keep budesonide and all medicines out of the reach of children.