Budesonide (oral)
Pronunciation: bue-DES-oh-nide
Generic name: budesonide
Brand names: Eohilia, Entocort EC, Ortikos, Uceris, Tarpeyo
Dosage form: oral suspension (2 mg/10 mL), extended-release capsules (3 mg, 6 mg, 9 mg), extended-release tablets (9 mg), delayed-release capsules (4 mg)
Drug classes: Glucocorticoids, Inhaled corticosteroids
What is 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.
Budesonide side effects
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.
Serious side effects and warnings
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.
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Before taking this medicine
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.
Pregnancy
Budesonide may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take budesonide when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with budesonide.
Breastfeeding
It is not known if budesonide passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby if you take budesonide.
The Tarpeyo Prescribing information recommends routine monitoring of linear growth in infants with long-term use of budesonide in women who are breastfeeding.
How should I take budesonide?
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.
Budesonide oral suspension
Eohilia stick packs
See the detailed Instructions for Use that comes with Eohilia for information about how to prepare and take Eohilia and how to properly store and throw away (dispose of) used Eohilia stick packs. Take Eohilia exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Eohilia to take.
- Eohilia is taken 2 times a day (1 time in the morning and 1 time in the evening).
- Shake the stick pack for at least 10 seconds before opening. After opening the top, squeeze the stick pack from bottom to top to dispense contents directly into the mouth.
- Repeat this 2 to 3 times until the stick pack is empty. Swallow all of the suspension and avoid eating or drinking anything for 30 minutes.
- After 30 minutes, rinse your mouth with water and spit out the contents without swallowing.
Do not mix Eohilia with food or liquid.
Do not eat or drink at the same time as taking Eohilia. Wait to eat or drink at least 30 minutes after taking Eohilia.
Your healthcare provider may change your dose if needed. Do not change your dose or stop taking Eohilia unless your healthcare provider tells you.
Budesonide extended-release capsules
Entocort EC extended-release capsules and generic
Take Entocort EC exactly as your healthcare provider tells you. Your healthcare provider will tell you how many Entocort EC capsules to take. Your healthcare provider may change your dose if needed.
- Take Entocort EC 1 time each day in the morning.
- Swallow the capsules whole. Do not chew or crush the capsules before swallowing.
For patients unable to swallow a whole capsule, Entocort EC capsules can be opened and administered as follows:
- Place 1 tablespoonful of applesauce into a clean container, such as an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
- Open the capsule. You may need to use more than 1 Entocort EC capsule for the dose prescribed by your healthcare provider.
- Carefully empty all of the granules inside the capsule on the applesauce.
- Stir the granules with the applesauce.
- Swallow the applesauce and granules mixture within 30 minutes after preparing it. Follow the applesauce and granules immediately with a glass (8 ounces) of cool water to help with complete swallowing of the granules. Do not chew or crush the granules.
- Do not save the applesauce and granules for later use.
Ortikos extended-release capsules
Take Ortikos exactly as your healthcare provider tells you. Your healthcare provider will tell you how many capsules to take. Your healthcare provider may change your dose if needed.
- Take Ortikos 1 time each day, in the morning.
- Swallow the capsules whole. Do not chew or crush the capsules before swallowing.
Budesonide extended-release tablets
Uceris extended-release tablets and generic
Take Uceris extended-release tablets exactly as your healthcare provider tells you to take them.
- Take Uceris 1 time each day in the morning with or without food.
- Swallow the tablets whole with water. Do not chew, crush, or break the tablets before swallowing.
Budesonide delayed-release capsules
Tarpeyo delayed-release capsules
Take Tarpeyo exactly as your healthcare provider tells you. Your healthcare provider will decide how long you should take Tarpeyo. Do not stop taking Tarpeyo without first talking with your healthcare provider.
- Take Tarpeyo 1 time each day in the morning, at least 1 hour before a meal.
- Swallow Tarpeyo capsules whole. Do not open, chew, crush, or break Tarpeyo capsules before swallowing.
Dosing information
The dosage of budesonide depends on your condition and the formulation or brand you are prescribed.
Budesonide oral suspension 2 mg/10 mL
Dosage for EOS (Eohilia): 2 mg twice daily for 12 weeks.
- 2mg is contained in one Eohilia stick pack.
Budesonide extended-release capsules
Dosage for the treatment of Crohn’s disease (Entocort EC, Ortikos, generic):
- Adults: 9 mg once daily for up to 8 weeks
- Repeat 8-week courses with recurring episodes of active disease
- Children 8 through 17 years (weight > 25 kg): 9 mg once daily for up to 8 weeks followed by 6 mg once daily for 2 weeks.
Dosage for the maintenance of clinical remission of Crohn’s disease (Entocort EC, Ortikos, generic):
- Adults: 6 mg once daily for up to 3 months.
- Taper to complete cessation after 3 months.
- Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit.
- When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating Ortikos.
Budesonide delayed-release tablets
Dosage for ulcerative colitis (Uceris, generic)
- 9 mg once daily in the morning with or without food for up to 8 weeks.
Budesonide delayed-release capsules
Dosage for the treatment of IgAN in adults (Tarpeyo)
- 16 mg once daily
- Take in the morning at least 1 hour before food.
- The recommended duration of therapy is 9 months.
- When discontinuing, reduce the dosage to 8 mg once daily for the last 2 weeks.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
If you take budesonide for primary immunoglobulin A nephropathy, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I take too much budesonide?
If you take too much budesonide, call your healthcare provider right away or go to the nearest hospital emergency room.
What should I avoid while taking budesonide?
Grapefruit may interact with budesonide and cause side effects. Avoid consuming grapefruit products.
Avoid receiving a "live" vaccine and being near people who are sick or have infections. The vaccine may not work as well while you are using budesonide. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Also call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using budesonide.
What other drugs will affect budesonide?
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.
Storage
Eohilia: Store between 36°F to 77°F (2°C to 25°C). May be refrigerated. Do not freeze.
Entocort EC and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C).
Ortikos: Store at room temperature between 68° to 77°F (20° to 25°C). Keep in a tightly closed container.
Uceris and generic: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.
Tarpeyo: Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.
Keep all medicines out of the reach of children.
Ingredients
Eohilia ingredients
Active ingredient: budesonide
Inactive ingredients: acesulfame potassium, ascorbic acid, Avicel® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).
Entocort EC ingredients
Active ingredient: budesonide
Inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres.
The capsule shell contains: gelatin, iron oxide, and titanium dioxide.
Ortikos ingredients
Active ingredient: budesonide
Inactive ingredients: acetyl tributyl citrate, corn starch, ethylcellulose aqueous dispersion, methacrylic acid and ethyl acrylate copolymer dispersion, polysorbate 80, simethicone emulsion, sucrose, talc, and triethyl citrate.
Capsule shell contains gelatin, iron oxide black (for 6 mg), iron oxide red, iron oxide yellow, sodium lauryl sulphate, and titanium dioxide.
The imprinting ink contains black iron oxide, potassium hydroxide, and shellac.
Uceris ingredients
Active Ingredient: budesonide
Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.
Tarpeyo ingredients
Active ingredient: budesonide
Inactive ingredients: sugar spheres (sucrose and starch), hypromellose, polyethylene glycol, citric acid monohydrate, ethyl cellulose, medium chain triglycerides and oleic acid.
The capsules contain: hypromellose and titanium oxide (E171).
The printing ink on the capsules contains: shellac, propylene glycol and black iron oxide (E172).
The enteric coating on the capsules contains: methacrylic acid and methacrylate copolymer, talc and dibutyl sebacate.
Who makes budesonide?
Budesonide is made by various manufacturers.
Budesonide oral suspension (2 mg/10 mL, Eohilia) is made by Takeda Pharmaceuticals America, Inc., in Lexington, MA.
Budesonide extended-release oral capsules (3 mg, Entocort EC brand) are made by Perrigo. They acquired the rights to this medication from AstraZeneca in 2015. Perrigo is headquartered in Dublin, Ireland, with U.S. operations based in Michigan, USA.
- A generic Entocort 3mg delayed-release oral capsule 3 mg is available manufactured by Aurobindo Pharma USA, Zydus Pharma, Amneal Pharma, Dr Reddys Labs SA, and Rising.
Budesonide extended-release oral capsules (6 mg, 9 mg, Ortikos brand) were made by Sun Pharmaceutical Industries Ltd., in Gujarat, India.
Budesonide extended-release oral tablets (9 mg, Uceris brand) are made by Bausch Health Companies Inc. (formerly known as Valeant Pharmaceuticals). Salix Pharmaceuticals is the specific division or subsidiary of Bausch Health Companies that markets and distributes Uceris tablets.
- A generic Uceris extended-release oral tablet 9 mg is made by Actavis Labs FL Inc., and Mylan.
Budesonide delayed release capsules (4mg, Tarpeyo) are made by Calliditas Therapeutics AB, with headquarters in Stockholm, Sweden.
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.