Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS LABA use may result in the following: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1) ].
• Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12) ].
Systemic and inhaled corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions (5.4) ] • Pneumonia or lower respiratory tract infections in patients with COPD [see Warnings and Precautions (5.5) ] • Immunosuppression [see Warnings and Precautions (5.6) ] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8) ] • Growth effects in pediatric patients [see Warnings and Precautions (5.14) ] • Glaucoma and cataracts [see Warnings and Precautions (5.15) ] 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.
Most common adverse reactions (incidence > 3%) are: • Asthma: nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.
( 6.1 ) • COPD: nasopharyngitis, oral candidiasis, bronchitis, sinusitis, upper respiratory tract infections.
( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience in Asthma Adult and Adolescent Patients 12 Years of Age and Older The overall safety data in adults and adolescents are based upon 10 active- and placebo-controlled clinical trials in which 3393 patients ages 12 years and older (2052 females and 1341 males) with asthma of varying severity were treated with budesonide and formoterol fumarate dihydrate 80/4.5 or 160/4.5 taken 2 inhalations once or twice daily for 12 to 52 weeks.
In these trials, the patients on budesonide and formoterol fumarate dihydrate had a mean age of 38 years and were predominantly Caucasian (82%).
The incidence of common adverse events in Table 2 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 budesonide and formoterol fumarate dihydrate 80/4.5 or budesonide and formoterol fumarate dihydrate 160/4.5 twice daily.
The budesonide and formoterol fumarate dihydrate 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 80/4.5 mcg and 160/4.5 mcg treatment groups, respectively.
5 WARNINGS AND PRECAUTIONS • Serious asthma-related events: Long-acting beta2-adrenergic agonists as monotherapy increase the risk.
( 5.1 ) • Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or COPD or to treat acute symptoms.
( 5.2 ) • Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose.
( 5.3 ) • Localized infections: Candida albicans infection of the mouth and throat may occur.
Monitor patients periodically for signs of adverse effects on the oral cavity.
Like all medications, Budesonide And Formoterol Fumarate Dihydrate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: