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.

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.

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