Medical Editor: John P. Cunha, DO, FACOEP
- stomach pain,
- thinning of the skin,
- easy bruising,
- runny or stuffy nose,
- sore throat,
- muscle pain,
- skin rash, or
- changes in your menstrual periods.
Tell your doctor if you have rare but serious side effects of Entocort EC including:
- unusual tiredness,
- vision problems,
- easy bruising or bleeding,
- puffy face,
- unusual hair growth,
- mental/mood changes (such as depression, mood swings, agitation), or
- slow wound healing.
The recommended adult dosage of Entocort EC for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon is 9 mg orally taken once daily in the morning for up to 8 weeks. Following an 8 week course(s) of treatment and once the patient's symptoms are controlled 6 mg orally is recommended once daily for maintenance of clinical remission up to 3 months. Entocort EC may interact with ketoconazole (Nizoral). Other drugs may interact with Entocort EC. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Entocort EC should be used only when prescribed. Infants born to mothers who have used corticosteroids for a long time may have hormone problems. Tell your doctor if you notice persistent nausea/vomiting, severe diarrhea, or weakness. This drug passes into breast milk and may have undesirable effects in a nursing infant. Consult your doctor before breastfeeding.
Our Entocort EC (budesonide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
- increased blood pressure (severe headache, fast or uneven heart rate, blurred vision); or
- general ill feeling with headache, tiredness, nausea, and vomiting.
Less serious side effects may include:
- thinning of the skin, easy bruising;
- runny or stuffy nose, cough, sore throat;
- muscle pain;
- mild nausea, stomach pain, indigestion;
- mild skin rash; or
- changes in your menstrual periods.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Entocort (Budesonide)
The following clinically significant adverse reactions are described elsewhere in labeling:
- Hypercorticism and adrenal axis suppression [see WARNINGS AND PRECAUTIONS]
- Symptoms of steroid withdrawal in those patients transferred from other systemic corticosteroids [see WARNINGS AND PRECAUTIONS]
- Increased risk of infection [see WARNINGS AND PRECAUTIONS]
- Other corticosteroid effects [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to ENTOCORT EC in 520 patients with Crohn’s disease, including 520 exposed to 9 mg per day (total daily dose) for 8 weeks and 145 exposed to 6 mg per day for one year in placebo controlled clinical trials. Of the 520 patients, 38% were males and the age range was 17 to 74 years.
Treatment of Mild to Moderate Active Crohn’s Disease
The safety of ENTOCORT EC was evaluated in 651 adult patients in five clinical trials of 8 weeks duration in patients with active mild to moderate Crohn’s disease.
The most common adverse reactions, occurring in greater than or equal to 5% of the patients, are listed in Table 1.
Table 1 Common Adverse Reactions1 in 8-Week Treatment Clinical Trials
|Adverse Reaction||ENTOCORT EC 9 mg
|Prednisolone2 40 mg
|Headache||107 (21)||19 (18)||31 (21)||11 (13)|
|Respiratory Infection||55 (11)||7 (7)||20 (14)||5 (6)|
|Nausea||57 (11)||10 (9)||18 (12)||7 (8)|
|Back Pain||36 (7)||10 (9)||17 (12)||5 (6)|
|Dyspepsia||31 (6)||4 (4)||17 (12)||3 (3)|
|Dizziness||38 (7)||5 (5)||18 (12)||5 (6)|
|Abdominal Pain||32 (6)||18 (17)||6 (4)||10 (11)|
|Flatulence||30 (6)||6 (6)||12 (8)||5 (6)|
|Vomiting||29 (6)||6 (6)||6 (4)||6 (7)|
|Fatigue||25 (5)||8 (7)||11 (8)||0 (0)|
|Pain||24 (5)||8 (7)||17 (12)||2 (2)|
|1. Occurring in greater than or equal to 5% of the patients in any treated group.
2. Prednisolone tapering scheme: either 40 mg in week 1 to 2, thereafter tapering with 5 mg per week; or 40 mg in week 1 to 2, 30 mg in week 3 to 4, thereafter tapering with 5 mg per week.
3. This drug is not approved for the treatment of Crohn’s disease in the United States.
The incidence of signs and symptoms of hypercorticism reported by active questioning of patients in 4 of the 5 short-term clinical trials are displayed in Table 2.
Table 2: Summary and Incidence of Signs/Symptoms of Hypercorticism in 8-Week Treatment Clinical Trials
|Total||145 (34%)||29 (27%)||69 (48%)|
|Acne||63 (15)||14 (13)||33 (23)2|
|Bruising Easily||63 (15)||12 (11)||13 (9)|
|Moon Face||46 (11)||4 (4)||53 (37) 2|
|Swollen Ankles||32 (7)||6 (6)||13 (9)|
|Hirsutism3||22 (5)||2 (2)||5 (3)|
|Buffalo Hump||6 (1)||2 (2)||5 (3)|
|Skin Striae||4 (1)||2 (2)||0 (0)|
|1. Prednisolone tapering scheme: either 40 mg in week 1-2, thereafter tapering with 5 mg/week; or 40 mg in week 1 to 2, 30 mg in week 3 to 4, thereafter tapering with 5 mg/week.
2. Statistically significantly different from ENTOCORT EC 9 mg
3. including hair growth increased, local and hair growth increased, general
Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease
The safety of ENTOCORT EC was evaluated in 233 adult patients in four long-term clinical trials (52 weeks) of maintenance of clinical remission in patients with mild to moderate Crohn’s disease. A total of 145 patients were treated with ENTOCORT EC 6 mg once daily.
The adverse reaction profile of ENTOCORT EC 6 mg once daily in maintenance of Crohn’s disease was similar to that of short-term treatment with ENTOCORT EC 9 mg once daily in active Crohn’s disease. In the long-term clinical trials, the following adverse reactions occurred in greater than or equal to 5% and are not listed in Table 1: diarrhea (10%); sinusitis (8%); infection viral (6%); and arthralgia (5%).
Signs/symptoms of hypercorticism reported by active questioning of patients in the long-term maintenance clinical trials are displayed in Table 3.
Table 3: Summary and Incidence of Signs/Symptoms of Hypercorticism in Long-Term Clinical Trials
|Skin Striae||6 (1)||0||0|
The incidence of signs/symptoms of hypercorticism as described above in long-term maintenance clinical trials was similar to that seen in the short-term treatment clinical trials.
Less Common Adverse Reactions in Treatment and Maintenance Clinical Trials
Less common adverse reactions (less than 5%), occurring in adult patients treated with ENTOCORT EC 9 mg (total daily dose) in short-term treatment clinical studies and/or ENTOCORT EC 6 mg (total daily dose) in long-term maintenance clinical trials, with an incidence are listed below by system organ class:
Cardiac disorders: palpitation, tachycardia
Eye disorders: eye abnormality, vision abnormal
Investigations: weight increased
Metabolism and nutrition disorders: appetite increased
Psychiatric disorders: agitation, confusion, insomnia, nervousness, sleep disorder
Reproductive system and breast disorders: intermenstrual bleeding, menstrual disorder
Vascular disorders: flushing, hypertension
Bone Mineral Density
A randomized, open, parallel-group multicenter safety clinical trial specifically compared the effect of ENTOCORT EC (less than 9 mg per day) and prednisolone (less than 40 mg per 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 symptoms associated with hypercorticism was significantly higher with prednisolone treatment.
Clinical Laboratory Test Findings
The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to ENTOCORT EC, were reported in greater than or equal to 1% of patients: hypokalemia, leukocytosis, anemia, hematuria, pyuria, erythrocyte sedimentation rate increased, alkaline phosphatase increased, atypical neutrophils, c-reactive protein increased and adrenal insufficiency.
Pediatrics --Treatment Of Mild To Moderate Active Crohn’s Disease
Adverse reactions reported in pediatric patients 8 to 17 years of age, who weigh more than 25 kg, were similar to those reactions described above in adult patients.
The following adverse reactions have been reported during post-approval use of ENTOCORT EC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: Anaphylactic reactions
Nervous System Disorders: Benign intracranial hypertension
Psychiatric Disorders: Mood swings
Read the entire FDA prescribing information for Entocort (Budesonide)
© Entocort Patient Information is supplied by Cerner Multum, Inc. and Entocort Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.