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Does Entocort EC (budesonide) cause side effects?
Entocort EC (budesonide) is a synthetic steroid of the glucocorticoid family used to treat mild-to-moderately-active Crohn's disease involving the ileum (the second half of the small intestine) and/or ascending colon (the beginning of the large intestine).
It is approved for maintaining remissions for up to three months. Entocort EC also is used for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC).
Common side effects of Entocort EC include
- upper respiratory tract infection,
- abdominal pain,
- back pain,
- gas (flatulence),
- joint pain,
- abdominal distension,
- urinary tract infections (UTIs),
- viral infections,
- low potassium, and
Excessive corticosteroid use causes
Serious side effects of Entocort EC include
- adrenal suppression,
- suppression of the immune system,
- intracranial hypertension, and
- serious allergic reactions.
Drug interactions of Entocort EC include medicines that block the liver enzymes that break down Entocort EC, because the combination may lead to higher blood concentrations and more side effects of Entocort EC, such as
- indinavir, and
Grapefruit juice has a similar effect and should not be consumed by patients taking Entocort EC.
There are no adequate studies of Entocort EC in pregnant women. Entocort EC should only be used in pregnant women if the benefits outweigh the unknown risk. Use of Entocort EC during pregnancy may suppress the adrenal glands of the infant.
Entocort EC is secreted in human breast milk. Because of the potential for adverse reactions in nursing infants from any corticosteroid, a decision should be made whether to discontinue breastfeeding or discontinue the Entocort EC.
What are the important side effects of Entocort EC (budesonide)?
The most common side effects of budesonide are:
- Upper respiratory tract infection
- Abdominal pain
- Back pain
- Flatulence (intestinal gas, farting)
- Abdominal distension
- Urinary tract infections (UTIs)
- Viral infections
- Low potassium
Excessive corticosteroid use causes:
Serious side effects of budesonide include:
- Adrenal suppression
- Suppression of the immune system
- Intracranial hypertension
- Serious allergic reactions
Entocort EC (budesonide) side effects list for healthcare professionals
The following clinically significant adverse reactions are described elsewhere in labeling:
- Hypercorticism and adrenal axis suppression
- Symptoms of steroid withdrawal in those patients transferred from other systemic corticosteroids
- Increased risk of infection
- Other corticosteroid effects
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|
n=520 Number (%)
n=107 Number (%)
|Prednisolone2 40 mg|
n=145 Number (%)
n=88 Number (%)
|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)|
|1Occurring in greater than or equal to 5% of the patients in any treated group.|
2Prednisolone 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.
3This 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
|Signs/ Symptom||Entocort EC 9 mg|
n=427 Number (%)
n=107 Number (%)
|Prednisolone1 40 mg|
n=145 Number (%)
|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)|
|1Prednisolone 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.|
2Statistically significantly different from Entocort EC 9 mg
3including 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:
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
|Signs/ Symptom||Entocort EC 3 mg|
n=88 Number (%)
|Entocort EC 6 mg|
n=145 Number (%)
n=143 Number (%)
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
- General disorders and administration site conditions: asthenia, chest pain, dependent edema, face edema, flu-like disorder, malaise, fever
- Gastrointestinal disorders: anus disorder, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder
- Infections and infestations: Ear infection -not otherwise specified, bronchitis, abscess, rhinitis, urinary tract infection, thrush
- Investigations: weight increased
- Metabolism and nutrition disorders: appetite increased
- Musculoskeletal and connective tissue disorders: arthritis, cramps, myalgia
- Nervous system disorders: hyperkinesia, paresthesia, tremor, vertigo, somnolence, amnesia
- Psychiatric disorders: agitation, confusion, insomnia, nervousness, sleep disorder
- Renal and urinary disorders: dysuria, micturition frequency, nocturia
- Reproductive system and breast disorders: intermenstrual bleeding, menstrual disorder
- Respiratory, thoracic and mediastinal disorders: dyspnea, pharynx disorder
- Skin and subcutaneous tissue disorders: alopecia, dermatitis, eczema, skin disorder, sweating increased, purpura
- 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-naive 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:
- 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.
What drugs interact with Entocort EC (budesonide)?
- Budesonide is a substrate for CYP3A4. Avoid use with CYP3A4 inhibitors.
- Concomitant oral administration of a strong CYP3A4 inhibitor (ketoconazole) caused an eight-fold increase of the systemic exposure to oral budesonide.
- Inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine) can increase systemic budesonide concentrations.
- Avoid ingestion of grapefruit juice with budesonide.
- Intake of grapefruit juice which inhibits CYP3A4 activity with budesonide can increase the systemic exposure for budesonide.
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Related Disease Conditions
Ulcerative Colitis Diet Plan
An ulcerative colitis diet plan can help a person with the disease avoid foods and drinks that trigger flares. There also are foods that can soothe ulcerative colitis symptoms during a flare. Types of ulcerative colitis plans include a high-calorie diet, a lactose-free diet, a low-fat diet, a low-fiber diet (low-residue diet), or a low-salt diet. Self-management of ulcerative colitis using healthy lifestyle habits and a nutrient rich diet can be effective in management of the disease. Learn what foods to avoid that aggravate, and what foods help symptoms of the disease and increase bowel inflammation.
Crohn's disease is a chronic inflammatory disease, primarily involving the small and large intestine, but which can affect other parts of the digestive system as well. Abdominal pain, diarrhea, vomiting, fever, and weight loss are common symptoms.
Ulcerative colitis is a chronic inflammation of the colon. Symptoms include abdominal pain, diarrhea, and rectal bleeding. Ulcerative colitis is closely related to Crohn's disease, and together they are referred to as inflammatory bowel disease. Treatment depends upon the type of ulcerative colitis diagnosed.
What Is the Life Expectancy of Someone with Crohn's Disease?
Crohn’s disease is a chronic condition that causes inflammation in the gut (digestive tract).Crohn’s disease belongs to a group of conditions known as inflammatory bowel disease (IBD). With appropriate management, patients with Crohn’s disease may expect a normal life expectancy and a good quality of life.
Crohn's Disease vs. Ulcerative Colitis (UC)
Crohn's disease and ulcerative colitis are diseases that cause inflammation of part of or the entire digestive tract (GI). Crohn's affects the entire GI tract (from the mouth to the anus), while ulcerative colitis or ulcerative colitis only affects the large and small intestine and ilium. Researchers do not know the exact cause of either disease. About 20% of people with Crohn's disease also have a family member with the disease. Researchers believe that certain factors may play a role in causing UC. Both Crohn's disease and ulcerative colitis are a type of inflammatory bowel disease, or IBD. Crohn's disease and ulcerative colitis both have similar symptoms and signs, for example, nausea, loss of appetite, fatigue, weight loss, episodic and/or persistent diarrhea, fever, abdominal pain and cramping, rectal bleeding, bloody stools, joint pain and soreness, eye redness, or pain. Symptoms unique to Crohn’s disease include anemia and skin changes. Symptoms of unique to ulcerative colitis include, certain rashes, an urgency to defecate (have a bowel movement). Doctors diagnose both diseases with similar tests and procedures. While there is no cure for either disease, doctors and other health care professionals can help you treat disease flares, and manage your Crohn's or ulcerative colitis with medication, diet, nutritional supplements, and/or surgery.
Second Source WebMD Medical Reference
Second Source article from Government
What Is the Life Expectancy of Someone With Ulcerative Colitis?
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel) leading to erosion and ulcers. It is a lifelong illness with no specific cause or cure.
Is Crohn's Disease Contagious?
Crohn's disease, a form of inflammatory bowel disease (IBD), and is characterized by symptoms and signs that include diarrhea, fever, weight loss, vomiting, and abdominal pain. Though Crohn's disease is not contagious it can spread throughout a person's gastrointestinal tract. An increase in the above symptoms and signs warrants a visit to a doctor's office.
Is Ulcerative Colitis Curable?
Ulcerative colitis is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel or colon) leading to erosion and ulcers. It is also associated with various manifestations outside of the colon, such as inflammation of the eyes, joints, skin, and lungs. Ulcerative colitis is a lifelong illness with no specific cause or cure. Patients have repeated cycles of flare-ups and disappearance of the disease.
How Serious Is Ulcerative Colitis?
Ulcerative colitis (UC) is a lifelong disease with constant periods of flare-ups and remissions (periods without symptoms, which may last for weeks or years). Presently, there is no permanent medical cure for it, but there are various medications that can provide symptomatic relief, reduce inflammation and manage flare-ups.
What Is the Best Treatment for Ulcerative Colitis?
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel) leading to erosion and ulcers. It is a lifelong illness with no specific cause or cure. Patients have repeated cycles of flare-ups and remission with potential extraintestinal (beyond the bowel) manifestations, such as joint pain, eye pain, and skin rashes.
What Are the Five Types of Crohn's Disease?
The five types of Crohn's disease are ileocolitis, ileitis, gastroduodenal Crohn’s disease, jejunoileitis, Crohn's (granulomatous) colitis. Each have different characteristic symptoms and signs.
Can Ulcerative Colitis Be Cured With Surgery?
Ulcerative colitis is a chronic inflammatory condition of the colon (the large bowel) characterized by frequent bloody diarrhea (10 to 30 episodes) throughout the day. Medicines can only reduce the intensity of its symptoms and surgery is the only option to cure it.
Treatment & Diagnosis
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- Can Diet Cause UC or Crohn's Disease?
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.