Pronunciation: EN-toe-cort ee-cee
Generic name: budesonide (oral)
Dosage form: extended-release capsules (3 mg)
Drug class: Glucocorticoids

Medically reviewed by Carmen Pope, BPharm. Last updated on May 13, 2025.

What is Entocort EC?

Entocort EC extended-release capsules are used to treat mild to moderate Crohn's disease in adults and children at least 8 years old who weigh 55 pounds (25 kg) or more. This medicines is also used in adults for up to 3 months to keep symptoms from returning.

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. 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).

Entocort EC received FDA approval on October 2, 2001. Generic Entocort EC is available under the name budesonide extended-release capsules 3 mg.

Side effects

The most common side effects of Entocort EC are:

• headache
• infection in your air passages (respiratory infection)
• nausea
• back pain
• indigestion 
• dizziness
• stomach area (abdominal) pain
• gas
• vomiting
• tiredness
• pain.

Serious side effects and warnings

Entocort EC may cause the following serious side effects:

• Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-term use of Entocort EC 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 Entocort EC 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 Entocort EC, 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 Entocort EC, 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 Entocort EC. Tell your healthcare provider right away about any signs or symptoms of a new or worsening infection while taking Entocort EC, 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 Entocort EC. Your healthcare provider should check you closely for signs and symptoms of tuberculosis while taking Entocort EC.
• Chicken pox and measles: People taking corticosteroid medicines, including Entocort EC, 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 Entocort EC. Your healthcare provider will test you for HBV before you start taking Entocort EC.
• Amebiasis: Inactive (latent) amebiasis may become an active infection while taking Entocort EC. Your healthcare provider should check you for amebiasis before you start taking Entocort EC if you have spent time in the tropics or have unexplained symptoms.
• Fungal infections of the mouth (thrush), throat, and esophagus in patients using Entocort EC 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. Entocort EC 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 Entocort EC.
• Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to Entocort EC 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 Entocort EC.
• 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.

Related/similar drugs

Before taking this medicine

You should not use Entocort EC if you are allergic to budesonide, Eohilia, Ortikos, Tarpeyo, Uceris, Entocort EC, or any of the excipients in the extended-release capsules.

Before you take Entocort EC, 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

Entocort EC may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take Entocort EC when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with Entocort EC.

Breastfeeding

It is not known if Entocort EC 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 Entocort EC.

How should I take Entocort EC?

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.

Take Entocort EC 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 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:

1. 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.
2. Open the capsule. You may need to use more than 1 Entocort EC capsule for the dose prescribed by your healthcare provider.
3. Carefully empty all of the granules inside the capsule on the applesauce.
4. Stir the granules with the applesauce.
5. 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.
6. Do not save the applesauce and granules for later use.

Dosing information

Dosage for the treatment of Crohn’s disease (Entocort EC):

• 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):

• 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 Entocort EC.

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.

What happens if I take too much Entocort EC?

If you take too much Entocort EC, call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking Entocort EC?

Grapefruit may interact with Entocort EC 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 Entocort EC. 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 Entocort EC.

What other drugs will affect Entocort EC?

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 Entocort EC, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Entocort EC: Store at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of the reach of children.

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.

Who makes Entocort EC?

Entocort EC extended-release oral capsules (3 mg) 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.

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