Budesonide

Oral budesonide is used to treat the following conditions with inflammation as a symptom: Eosinophilic esophagitis (EoE) in adults and children 11 years and older for up to 12 weeks (Eohilia [ budesonide oral suspension 2 mg/10 mL ]) Active, mild to moderate Crohn's disease (CD) that involves the ileum and/or ascending colon in adults and children 8 years and older who weigh at least 55 pounds (25 kg). Also used in adults for up to 3 months to maintain clinical remission in CD (Entocort EC, generic, and Ortikos [ budesonide extended-release capsules 3 mg, 6 mg, 9 mg ]) Active, mild to moderate ulcerative colitis in adults, to help induce remission (Uceris and generic [ budesonide extended-release tablets 9 mg ]) Primary immunoglobulin A nephropathy (IgAN) to reduce the loss of kidney function in those who are at risk for disease progression (Tarpeyo [ budesonide delayed release capsules 4 mg ]) Budesonide works by preventing the activation of inflammatory cells (such as mast cells, eosinophils, and neutrophils) and blocking inflammatory mediators such as histamine and cytokines, which are involved in allergic responses. Exactly how it works for EoE is not fully understood, but inflammation plays a key role in EoE development. It belongs to the drug class called corticosteroids. Budesonide is a potent anti-inflammatory corticosteroid , 200 times stronger than cortisol and 15 times stronger than prednisolone. It has high glucocorticoid effects (strong effects on inflammation, immune system, wound healing, and intermediary metabolism) and weak mineralocorticoid effects (less effects on water, salt, and mineral metabolism). Budesonide oral FDA approvals are as follows: Eohilia (budesonide oral suspension 2 mg/10 mL; February 9, 2024). No generic. Entocort EC (budesonide extended-release capsule 3 mg; October 2, 2001). Generic available. Ortikos (budesonide extended-release capsule 6 mg, 9 mg; June 13, 2019 [discontinued]). Uceris (budesonide extended-release tablet 9 mg; January 14, 2013). Generic available . Tarpeyo (budesonide delayed-release capsule 4 mg; December 15, 2021). No generic.

Oral budesonide is used to treat the following conditions with inflammation as a symptom: Eosinophilic esophagitis (EoE) in adults and children 11 years and older for up to 12 weeks (Eohilia [ budesonide oral suspension 2 mg/10 mL ]) Active, mild to moderate Crohn's disease (CD) that involves the ileum and/or ascending colon in adults and children 8 years and older who weigh at least 55 pounds (25 kg). Also used in adults for up to 3 months to maintain clinical remission in CD (Entocort EC, generic, and Ortikos [ budesonide extended-release capsules 3 mg, 6 mg, 9 mg ]) Active, mild to moderate ulcerative colitis in adults, to help induce remission (Uceris and generic [ budesonide extended-release tablets 9 mg ]) Primary immunoglobulin A nephropathy (IgAN) to reduce the loss of kidney function in those who are at risk for disease progression (Tarpeyo [ budesonide delayed release capsules 4 mg ]) Budesonide works by preventing the activation of inflammatory cells (such as mast cells, eosinophils, and neutrophils) and blocking inflammatory mediators such as histamine and cytokines, which are involved in allergic responses. Exactly how it works for EoE is not fully understood, but inflammation plays a key role in EoE development. It belongs to the drug class called corticosteroids. Budesonide is a potent anti-inflammatory corticosteroid , 200 times stronger than cortisol and 15 times stronger than prednisolone. It has high glucocorticoid effects (strong effects on inflammation, immune system, wound healing, and intermediary metabolism) and weak mineralocorticoid effects (less effects on water, salt, and mineral metabolism). Budesonide oral FDA approvals are as follows: Eohilia (budesonide oral suspension 2 mg/10 mL; February 9, 2024). No generic. Entocort EC (budesonide extended-release capsule 3 mg; October 2, 2001). Generic available. Ortikos (budesonide extended-release capsule 6 mg, 9 mg; June 13, 2019 [discontinued]). Uceris (budesonide extended-release tablet 9 mg; January 14, 2013). Generic available . Tarpeyo (budesonide delayed-release capsule 4 mg; December 15, 2021). No generic.

You should not use budesonide if you are allergic to budesonide, Eohilia, Ortikos, Tarpeyo, Uceris, Entocort EC, or any of the excipients in oral budesonide products. Before you take budesonide tell your healthcare provider if you have any other medical conditions including if you: have liver problems are planning to have surgery have chicken pox or measles, or have recently been near anyone with chicken pox or measles have certain kinds of infections that have not been treated, including fungal infections, bacterial infections, and viral infections parasitic infections, including threadworm (Strongyloides) infections herpes simplex infection of the eye (ocular herpes simplex) have or had tuberculosis have malaria of the brain (cerebral malaria) have an infection of the mouth, throat, or esophagus have diabetes or glaucoma, or have a family history of diabetes or glaucoma have cataracts have high blood pressure (hypertension) have low bone mineral density or osteoporosis have stomach ulcers have a weak immune system have unexplained diarrhea are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed. Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially any type of infection caused by bacteria, virus, fungus, or parasites, including threadworm.

The most common side effects of budesonide oral suspension (Eohilia) are: respiratory tract infection sore throat fungal infections of the mouth, throat, and esophagus (thrush) adrenal suppression headache acid-related damage to the lining of the esophagus (erosive esophagitis) infection of the stomach and intestine (gastroenteritis). The most common side effects of budesonide extended-release capsules (Entocort EC, Ortikos, generic) are: headache infection in your air passages (respiratory infection) nausea back pain indigestion dizziness stomach area (abdominal) pain gas vomiting tiredness pain. The most common side effects of budesonide delayed-release capsules (Tarpeyo) are: swelling of the lower legs, ankles, and feet high blood pressure muscle spasms acne headache upper respiratory tract infection swelling of the face weight increase indigestion irritation or inflammation of the skin joint pain increased white blood cell count The most common side effects of budesonide extended release tablets (Uceris, generic) are: headache nausea decreased blood cortisol levels stomach-area pain tiredness stomach or intestinal gas bloating acne urinary tract infection joint pain constipation.

Budesonide (oral) may cause the following serious side effects: Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of budesonide may cause you to have elevated levels of corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms: acne thicker body hair and facial hair bruise easily a fatty pad or hump between your shoulders (buffalo hump) rounding of your face pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms ankle swelling. Adrenal suppression . Long-term use of budesonide can cause a condition in which the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or if you have any of the following signs or symptoms: tiredness nausea and vomiting weakness low blood pressure. Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including budesonide, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including budesonide, can also: make current infections worse increase the risk of infections spreading (disseminated) increase the risk of making infections active again or making infections worse that have not been active (latent) hide (mask) some signs of infection These infections can be mild, but can also be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking budesonide. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking budesonide, including flu-like symptoms such as: fever cough chills pain stomach area (abdominal) pain feeling tired aches nausea and vomiting diarrhea. Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking budesonide. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking budesonide. Chicken pox and measles: People taking corticosteroid medicines, including budesonide, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles. Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking budesonide. Your healthcare provider will test you for HBV before you start taking budesonide. Amebiasis: Inactive (latent) amebiasis may become an active infection while taking budesonide. Your healthcare provider should check you for amebiasis before you start taking budesonide if you have spent time in the tropics or have unexplained symptoms. Fungal infections of the mouth (thrush), throat, and esophagus in patients using budesonide may occur. Symptoms of infection include white spots in the mouth, a burning or painful sensation in your mouth, redness inside of your mouth, difficulty with eating or swallowing, loss of taste, and a feeling like cotton is in your mouth. Tell your healthcare provider if any of the above symptoms occur. Erosive esophagitis. Budesonide can cause acid-related damage to the lining of the esophagus. Tell your healthcare provider if you notice any new or worsening signs or symptoms such as: heartburn chest pain trouble swallowing. Effect on growth. Taking corticosteroids can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking budesonide. 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 a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking budesonide. Kaposi’s sarcoma: Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions. Get emergency medical help if you have signs of an allergic reaction : hives, difficulty breathing, swelling of your face, lips, tongue, or throat. 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 the FDA at 1-800-FDA-1088.

Budesonide (oral) may cause the following serious side effects: Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of budesonide may cause you to have elevated levels of corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms: acne thicker body hair and facial hair bruise easily a fatty pad or hump between your shoulders (buffalo hump) rounding of your face pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms ankle swelling. Adrenal suppression . Long-term use of budesonide can cause a condition in which the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or if you have any of the following signs or symptoms: tiredness nausea and vomiting weakness low blood pressure. Decreased ability of your body to fight infections (immunosuppression) and increased risk of infection. Corticosteroid medicines, including budesonide, lower the ability of your immune system to fight infections and increase the risk of infections caused by viruses, bacteria, fungi, protozoans, or certain parasites. Corticosteroid medicines, including budesonide, can also: make current infections worse increase the risk of infections spreading (disseminated) increase the risk of making infections active again or making infections worse that have not been active (latent) hide (mask) some signs of infection These infections can be mild, but can also be severe and lead to death. Your healthcare provider should check you closely for signs and symptoms of an infection while taking budesonide. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking budesonide, including flu-like symptoms such as: fever cough chills pain stomach area (abdominal) pain feeling tired aches nausea and vomiting diarrhea. Tuberculosis: If you have inactive (latent) tuberculosis, your tuberculosis may become active again while taking budesonide. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking budesonide. Chicken pox and measles: People taking corticosteroid medicines, including budesonide, who have not had chicken pox or measles, should avoid contact with people who have these diseases. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles. Hepatitis B virus (HBV) reactivation: If you are a carrier of HBV, the virus can become an active infection again while taking budesonide. Your healthcare provider will test you for HBV before you start taking budesonide. Amebiasis: Inactive (latent) amebiasis may become an active infection while taking budesonide. Your healthcare provider should check you for amebiasis before you start taking budesonide if you have spent time in the tropics or have unexplained symptoms. Fungal infections of the mouth (thrush), throat, and esophagus in patients using budesonide may occur. Symptoms of infection include white spots in the mouth, a burning or painful sensation in your mouth, redness inside of your mouth, difficulty with eating or swallowing, loss of taste, and a feeling like cotton is in your mouth. Tell your healthcare provider if any of the above symptoms occur. Erosive esophagitis. Budesonide can cause acid-related damage to the lining of the esophagus. Tell your healthcare provider if you notice any new or worsening signs or symptoms such as: heartburn chest pain trouble swallowing. Effect on growth. Taking corticosteroids can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider may monitor the growth of your child while taking budesonide. 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 a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking budesonide. Kaposi’s sarcoma: Kaposi’s sarcoma has happened in people who receive corticosteroid therapy, most often for treatment of long-lasting (chronic) conditions. Get emergency medical help if you have signs of an allergic reaction : hives, difficulty breathing, swelling of your face, lips, tongue, or throat. 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 the FDA at 1-800-FDA-1088.

200 to 800 mcg (500 (500)) 12 hourly Inhalation — Scraped Dose — Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. How you take budesonide depends on your condition and the formulation or brand you are prescribed .

5 to 20 ug/kg (12 (12.5)) 12 hourly Inhalation — -

6.25 to 12.5 ug/kg (9.4 (9.375)) 12 hourly Inhalation —

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. Tell your doctor about all your other medicines, especially if you use stomach acid reducers. This list is not complete. Other drugs may affect budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products . Not all possible drug interactions are listed here.

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