Entocort EC Side Effects

Generic name: budesonide

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

Note: This document provides detailed information about Entocort EC Side Effects associated with budesonide. Some dosage forms listed on this page may not apply specifically to the brand name Entocort EC.

Applies to budesonide: oral capsule delayed release, oral capsule extended release, oral tablet extended release.

Other dosage forms:

• inhalation powder, inhalation suspension
• rectal foam

Serious side effects of Entocort EC

Along with its needed effects, budesonide (the active ingredient contained in Entocort EC) 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 while taking budesonide:

More common side effects

• 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 side effects

• 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

Other side effects of Entocort EC

Some side effects of budesonide 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 side effects

• 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 side effects

• 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

For healthcare professionals

Applies to budesonide: compounding powder, inhalation powder, inhalation suspension, oral capsule extended release, oral delayed release capsule, oral suspension, oral tablet extended release, rectal foam.

General adverse events

The most commonly reported adverse events with inhaled use have included nasopharyngitis, nasal congestion pharyngitis, rhinitis, and oral candidiasis. Headache, nausea, abdominal pain, and fatigue have been commonly reported with oral and rectal use. Due to the nature of its administration (inhalation, gastro-protective oral formulations, and rectal enema), it is less likely to cause systemic adverse effects associated with the use of corticosteroids.^[Ref]

Respiratory

• Very common (10% or more): Respiratory infection (up to 13%)
• Common (1% to 10%): Nasopharyngitis, nasal congestion, pharyngitis, allergic rhinitis, viral upper respiratory tract infection, epistaxis, cough, dysphonia, hoarseness
• Frequency not reported: Bronchitis, dyspnea, pharynx disorder, pneumonia
• Postmarketing reports: Throat irritation, sinusitis^[Ref]

Endocrine

• Common (1% to 10%): Decreased blood cortisol, moon face
• Uncommon (0.1% to 1%): Hirsutism, Cushingoid syndrome
• Frequency not reported: Intermenstrual bleeding, menstrual disorder, HPA axis suppression, deaths due to adrenal insufficiency
• Postmarketing reports: Hypocorticism^[Ref]

Immunologic

• Common (1% to 10%): Oral candidiasis
• Frequency not reported: Immunosuppression, abscess, bronchospasm in patients with severe milk protein hypersensitivity^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 13%); abdominal pain (21%)
• Common (1% to 10%): Viral gastroenteritis, gastrointestinal mucosal candidiasis, upper abdominal pain, flatulence, abdominal distension, constipation, dyspepsia, vomiting, diarrhea, sore/irritated throat, dry mouth, bad taste, rectal disorder, rectal hemorrhage, ulcerative colitis, burning in the rectum or pain
• Frequency not reported: Anus disorder, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder
• Postmarketing reports: Pancreatitis^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 28%)
• Common (1% to 10%): Dizziness
• Uncommon (0.1% to 1%): Disturbance of smell
• Very rare (less than 0.01%): Pseudotumor cerebri (including papilledema)
• Frequency not reported: Hyperkinesia, paresthesia, tremor, somnolence
• Postmarketing reports: Benign intracranial hypertension^[Ref]

Psychiatric

• Common (1% to 10%): Mood changes, sleep changes, insomnia,
• Frequency not reported: Amnesia
• Postmarketing reports: Psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, anxiety, mood swings^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, bronchospasm
• Postmarketing reports: Cough, wheezing, bronchospasm^[Ref]

Musculoskeletal

• Very common (10% or more): Muscle spasms (12%)
• Common (1% to 10%): Arthralgia, back pain
• Very rare (less than 0.01%): Osteoporosis, aseptic necrosis of bone (femur and head of the humerus)
• Frequency not reported: Bone mineral density reductions, arthritis, myalgia, growth suppression^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (12%), peripheral edema (17%)
• Common (1% to 10%): Fluid retention, palpitation

Uncommon (0.1% to 1%):

• Frequency not reported: Tachycardia, chest pain, flushing^[Ref]

Metabolic

• Frequency not reported: Weight gain, increased appetite, hypokalemia^[Ref]

Hematologic

• Common (1% to 10%): Leukocytosis
• Uncommon (0.1% to 1%): Anemia
• Rare (0.01% to 0.1%): Eosinophilic conditions, Churg-Strauss^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Frequency not reported: Eye abnormality, abnormal vision
• Postmarketing reports: Glaucoma, cataracts, increased intraocular pressure^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection, moniliasis
• Frequency not reported: Dysuria, micturition frequency, nocturia^[Ref]

Dermatologic

• Very common (10% or more): Acne (11%)
• Common (1% to 10%): Rash, contact dermatitis, eczema, pustular rash, pruritus, purpura
• Very rare (less than 0.01%): Allergic exanthema, red striae, petechiae, ecchymosis, delayed wound healing
• Frequency not reported: Face edema, alopecia, dermatitis, eczema, skin disorder, increased sweating, purpura
• Postmarketing reports: Skin bruising^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Increase in liver enzymes^[Ref]

Other

• Common (1% to 10%): Otitis media, fatigue, earache
• Frequency not reported: Asthenia, malaise, fever, flu-like disorder, vertigo^[Ref]

Frequently asked questions

• What are enteric-coated tablets?
• Can asthma inhalers cause a sore throat?

Further information

Entocort EC side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer