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.

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 Side Effects associated with budesonide. Some dosage forms listed on this page may not apply specifically to the brand name Entocort EC.

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

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?

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