Other adverse reactions occurring in the group receiving SEREVENT DISKUS that occurred at a frequency of ≥ 1% and were more common than in the placebo group were as follows: anxiety; arthralgia and articular rheumatism; bone and skeletal pain; candidiasis mouth/throat; dental discomfort and pain; dyspeptic symptoms; edema and swelling; gastrointestinal infections; hyperglycemia ; hyposalivation; keratitis and conjunctivitis ; lower respiratory signs and symptoms; migraines; muscle pain; muscle stiffness, tightness, and rigidity; musculoskeletal inflammation; pain; and skin rashes.
Lactation studies have not been conducted with oral budesonide, including ENTOCORT EC, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. One published study reports that budesonide is present in human milk following maternal inhalation of budesonide [see Data ]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ENTOCORT EC and any potential adverse effects on the breastfed infant from ENTOCORT EC, or from the underlying maternal condition.
The incidence of common adverse events in Table 1 below is based upon pooled data from three 12-week, double-blind, placebo-controlled clinical studies in which 401 adult and adolescent patients (148 males and 253 females) age 12 years and older were treated with 2 inhalations of Symbicort 80/ or Symbicort 160/ twice daily. The Symbicort group was composed of mostly Caucasian (84%) patients with a mean age of 38 years, and a mean percent predicted FEV 1 at baseline of 76 and 68 for the 80/ mcg and 160/ mcg treatment groups, respectively. Control arms for comparison included 2 inhalations of budesonide HFA metered dose inhaler (MDI) 80 or 160 mcg, formoterol dry powder inhaler (DPI) mcg, or placebo (MDI and DPI) twice daily. Table 1 includes all adverse events that occurred at an incidence of > 3% in any one Symbicort group and more commonly than in the placebo group with twice-daily dosing. In considering these data, the increased average duration of patient exposure for Symbicort patients should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.