Beclomethasoneside effects

Systemic and local corticosteroid use may result in the following: Candida albicans infection Immunosuppression Hypercorticism and adrenal suppression Growth effects Eye Disorders Most common adverse reactions (incidence ≥3% and > placebo) include headache, pharyngitis, oral symptoms (inhalation route), and sinusitis. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 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 following reporting rates of common adverse experiences are based upon 4 clinical trials in which 1196 patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with beclomethasone dipropionate HFA inhalation aerosol (doses of 40, 80, 160, or 320 mcg twice daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice daily) or placebo. Table 1 below includes all events reported by patients taking beclomethasone dipropionate HFA inhalation aerosol (whether considered drug related or not) that occurred at a rate over 3% for beclomethasone dipropionate HFA inhalation aerosol. In considering these data, difference in average duration of exposure and clinical trial design should be taken into account. Table 1 Adverse Events Reported by at Least 3% of the Patients for Beclomethasone Dipropionate HFA Inhalation Aerosol by Treatment and Daily Dose Adverse Events Placebo (N=289) % Beclomethasone Dipropionate HFA Inhalation Aerosol Total (N=624) % 80 to 160 mcg (N=233) % 320 mcg (N=335) % 640 mcg (N=56) % Headache 9 12 15 8 25 Pharyngitis 4 8 6 5 27 Upper Respiratory Tract Infection 11 9 7 11 5 Rhinitis 9 6 8 3 7 Increased Asthma Symptoms 18 3 2 4 0 Oral Symptoms Inhalation Route 2 3 3 3 2 Sinusitis 2 3 3 3 0 Pain <1 2 1 2 5 Back Pain 1 1 2 <1 4 Dysphonia 2 <1 1 0 4 Other adverse events that occurred in these clinical trials using beclomethasone dipropionate HFA inhalation aerosol with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were nausea, dysmenorrhea, and coughing. Oropharyngeal candidiasis occurred in <1% of patients in both beclomethasone dipropionate HFA inhalation aerosol and placebo treatment groups. Pediatric Studies In two 12-week placebo-controlled studies in steroid naive pediatric patients 5 to 12 years of age, no clinically relevant differences were found in the pattern, severity, or frequency of adverse events compared with those reported in adults, with the exception of conditions which are more prevalent in a pediatric population generally.

6.2 Postmarketing

Experience In addition to adverse reactions experienced in the clinical trials, the following adverse events have been reported during post-approval use of beclomethasone dipropionate HFA inhalation aerosol. Because they 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.

Local Effects: Localized infections with Candida albicans have occurred in patients treated with beclomethasone dipropionate HFA inhalation aerosol or other orally inhaled corticosteroids.

Psychiatric and Behavioral Changes: Aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported (primarily in children).

Eye Disorders: Blurred vision, central serous chorioretinopathy (CSC).