Entocort EC Side Effects

Generic Name: budesonide

Please note - some side effects for Entocort EC may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Entocort EC - for the Consumer

Entocort EC Sustained-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Entocort EC Sustained-Release Capsules:

Back pain; changes in menstrual cycle; dizziness; gas; headache; indigestion; nausea; nervousness; pain; respiratory tract infection; stomach pain; tiredness; tremor; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne; change in mood or behavior; chest pain; confusion; severe headache; sudden increase in weight; swelling of the ankles; unusual bruising; vision changes.

Entocort EC Side Effects - for the Professional

Entocort EC

The safety of Entocort EC was evaluated in 651 patients. They ranged in age from 17 to 74 (mean 35), 40% were male and 97% were white, 2.6% were ≥65 years of age. Five hundred and twenty patients were treated with Entocort EC 9 mg (total daily dose). In general, Entocort EC was well tolerated in these trials. The most common adverse events reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. Clinical studies have shown that the frequency of glucocorticosteroid-associated adverse events was substantially reduced with Entocort EC capsules compared with prednisolone at therapeutically equivalent doses. Adverse events occurring in ≥ 5% of the patients are listed in Table 2:

The safety of Entocort EC was evaluated in 233 patients in four long-term clinical trials (52 weeks). A total of 145 patients were treated with Entocort EC 6 mg. A total of 8% of Entocort EC patients discontinued treatment due to adverse events compared with 10% in the placebo group. The adverse event profile in long-term treatment of Crohn’s disease was similar to that of short-term treatment with Entocort EC 9 mg in active Crohn’s disease.

In the long-term clinical trials, the following adverse events occurred in ≥ 5% of the 6 mg Entocort EC patients and are not listed in Table 2 or by body system below: diarrhea (10%); sinusitis (8%); infection viral (6%); and arthralgia (5%).

Adverse events occurring in 520 patients treated with Entocort EC 9 mg (total daily dose), with an incidence <5% and greater than placebo (n=107), are listed below by body system:

Body as a Whole: asthenia, C-Reactive protein increased, chest pain, dependent edema, face edema, flu-like disorder, malaise; Cardiovascular:hypertension; Central and Peripheral Nervous System: hyperkinesia, paresthesia, tremor, vertigo; Gastrointestinal: anus disorder, Crohn’s disease aggravated, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder; Hearing and Vestibular: Ear infection-not otherwise specified; Heart Rate and Rhythm: palpitation, tachycardia; Metabolic and Nutritional: hypokalemia, weight increase; Musculoskeletal: arthritis aggravated, cramps, myalgia; Psychiatric: agitation, appetite increased, confusion, insomnia, nervousness, sleep disorder, somnolence; Resistance Mechanism:moniliasis; Reproductive, Female: intermenstrual bleeding, menstrual disorder; Respiratory: bronchitis, dyspnea; Skin and Appendages: acne, alopecia, dermatitis, eczema, skin disorder, sweating increased; Urinary: dysuria, micturition frequency, nocturia; Vascular: flushing; Vision: eye abnormality, vision abnormal; White Blood Cell: leukocytosis

For the 145 patients treated with Entocort EC 6 mg (total daily dose) in long-term studies, the following adverse events that are not included in the list above occurred with an incidence <5% but >2% and greater than for placebo: abscess, amnesia, dizziness, fever, pharynx disorder, purpura, rhinitis, and urinary tract infection.

Glucocorticosteroid Adverse Reactions

Table 3 displays the frequency and incidence of symptoms of hypercorticism by active questioning of patients in clinical trials.

In addition to the symptoms in Table 3, three cases of benign intracranial hypertension have been reported in patients treated with budesonide from post-marketing surveillance. A cause and effect relationship has not been established.

Table 4 displays the frequency and incidence of symptoms of hypercorticism by active questioning of patients in long-term clinical trials.

The incidence of symptoms of hypercorticism as described above in long-term clinical trials was similar to that seen in the short-term clinical trials.

A randomized, open, parallel-group multicenter safety study specifically compared the effect of Entocort EC (<9 mg/day) and prednisolone (<40 mg/day) on bone mineral density over 2 years when used at doses adjusted to disease severity. Bone mineral density decreased significantly less with Entocort EC than with prednisolone in steroid-naïve patients, whereas no difference could be detected between treatment groups for steroid-dependent patients and previous steroid users. The incidence of treatment-emergent symptoms of hypercorticism was significantly higher with prednisolone treatment.

Side Effects by Body System

General

Budesonide is generally well tolerated. Due to the nature of its administration (inhalation or enteric-coated capsules), it is not likely to cause the systemic adverse effects generally associated with the use of corticosteroids. General side effects of oral budesonide have included fatigue, flu-like disorder, viral infection, malaise, ear infection, fever, abscess, and pain .

Respiratory

Respiratory side effects of inhaled budesonide have included dysphonia and sore throat. Cough, rhinitis, and sinusitis have also been reported. Respiratory side effects of oral enteric-coated budesonide have included respiratory infection, bronchitis, dyspnea, pharynx disorder, rhinitis, and sinusitis.

Endocrine

Endocrine side effects have included suppression of the hypothalamic-pituitary-adrenal (HPA) axis. The risk of adrenal suppression from inhaled or enteric-coated budesonide is less than that associated with systemic corticosteroids and may occur less frequently with lower daily doses.

Immunologic

In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its decision regarding the relabeling of inhaled corticosteroids following concerns about the risk of their use during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.

The danger of infection from immune suppression associated with inhaled corticosteroids has been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled budesonide. There are no data concerning immune suppression form oral enteric-coated budesonide.

Gastrointestinal

Gastrointestinal side effects of inhaled budesonide have included oropharyngeal candidiasis, dry mouth, taste perversion, nausea, dyspepsia, and abdominal pain. Gastrointestinal side effects of oral enteric-coated budesonide have included nausea, diarrhea, dyspepsia, abdominal pain, flatulence, anus disorder, aggravation of Crohn's disease, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder, and vomiting.

Nervous system

Nervous system side effects of inhaled budesonide have included headache, asthenia, and pain. Nervous system side effects of oral enteric-coated budesonide have included headache, dizziness, hyperkinesia, paresthesia, tremor, vertigo, asthenia, and pain. Benign intracranial hypertension has been reported with oral budesonide.

Psychiatric

Psychiatric side effects of inhaled budesonide have included rare reports of depression, aggression, irritability, anxiety, and psychosis. Psychiatric side effects of oral budesonide have included agitation, increased appetite, confusion, insomnia, nervousness, sleep disorder, amnesia, and somnolence.

Hypersensitivity

Hypersensitivity side effects of inhaled budesonide have included immediate and delayed reactions including rash, contact dermatitis, urticaria, angioedema, and bronchospasm. Postmarketing experience has included very reports of cough, wheezing, or bronchospasm in patients with severe milk protein hypersensitivity. Anaphylactic reactions have been reported with oral budesonide.

Musculoskeletal

Musculoskeletal side effects of inhaled budesonide have included a reduction in bone density. This effect may be dose-related and has been reported with high dosages and prolonged use (over 1 year). Musculoskeletal side effects of oral enteric-coated budesonide have included back pain and arthralgia.

Cardiovascular

Cardiovascular side effects of oral budesonide have included chest pain, palpitations, tachycardia, dependent edema, face edema, hypertension, flushing, and increased C-reactive protein.

Metabolic

Metabolic side effects of oral budesonide have included hypokalemia and weight increase.

Hematologic

Hematologic side effects of oral budesonide have included leukocytosis and purpura.

Ocular

Ocular side effects of oral budesonide have included conjunctivitis, eye abnormality, and abnormal vision. Glaucoma and cataracts have also been reported.

Genitourinary

Genitourinary side effects of oral budesonide have included dysuria, increased micturition frequency, nocturia, urinary tract infection, intermenstrual bleeding, and menstrual disorder.

Dermatologic

Dermatologic side effects of oral budesonide have included acne, alopecia, dermatitis, eczema, increased sweating and skin disorder.

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