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 budesonide capsules (enteric coated) 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 budesonide capsules (enteric coated) 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.
|Budesonide capsules (enteric coated)||Prednisolone †|
|Adverse Reaction||9 mg n=520 Number (%)||Placebo n=107 Number (%)||40 mg n=145 Number (%)||Comparator ‡ 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)|
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.
|Budesonide capsules (enteric coated)||Prednisolone *|
|Signs/Symptom||9 mg n=427 Number (%)||Placebo n=107 Number (%)||40 mg n=145 Number (%)|
|Total||145 (34%)||29 (27%)||69 (48%)|
|Acne||63 (15)||14 (13)||33 (23) †|
|Bruising Easily||63 (15)||12 (11)||13 (9)|
|Moon Face||46 (11)||4 (4)||53 (37) †|
|Swollen Ankles||32 (7)||6 (6)||13 (9)|
|Hirsutism ‡||22 (5)||2 (2)||5 (3)|
|Buffalo Hump||6 (1)||2 (2)||5 (3)|
|Skin Striae||4 (1)||2 (2)||0 (0)|
Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease
The safety of budesonide capsules (enteric coated) 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 budesonide capsules (enteric coated) 6 mg once daily.
The adverse reaction profile of budesonide capsules (enteric coated) 6 mg once daily in maintenance of Crohn’s disease was similar to that of short-term treatment with budesonide capsules (enteric coated) 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.
|Budesonide capsules (enteric coated)||Budesonide capsules (enteric coated)|
|Signs/Symptom||3 mg n=88 Number (%)||6 mg n=145 Number (%)||Placebo n=143 Number (%)|
|Bruising Easily||4 (5)||15 (10)||5 (4)|
|Acne||4 (5)||14 (10)||3 (2)|
|Moon Face||3 (3)||6 (4)||0|
|Hirsutism||2 (2)||5 (3)||1 (1)|
|Swollen Ankles||2 (2)||3 (2)||3 (2)|
|Buffalo Hump||1 (1)||1 (1)||0|
|Skin Striae||2 (2)||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 budesonide capsules (enteric coated) 9 mg (total daily dose) in short-term treatment clinical studies and/or budesonide capsules (enteric coated) 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, dizziness, 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 budesonide capsules (enteric coated) (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 budesonide capsules (enteric coated) 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 budesonide capsules (enteric coated), 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.
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