BREYNA
Generic: BUDESONIDE AND FORMOTEROL FUMARATE
Basic Information
Manufacturer
Mylan Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
RESPIRATORY (INHALATION)
FDA Set ID
dc529fc4-bddb-4673-8202-dc401f86166f
Indications & Usage
1 INDICATIONS AND USAGE BREYNA is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older.
( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
( 1.2 ) Important limitations: • Not indicated for the relief of acute bronchospasm.
( 1.1 , 1.2 ) 1.1 Treatment of Asthma BREYNA is indicated for the treatment of asthma in patients 6 years of age and older.
BREYNA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta 2 -adrenergic agonist (LABA).
Important Limitations of Use: • BREYNA is NOT indicated for the relief of acute bronchospasm.
1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BREYNA 160 mcg/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
BREYNA 160 mcg/4.5 mcg is also indicated to reduce exacerbations of COPD.
BREYNA 160 mcg/4.5 mcg is the only strength indicated for the treatment of COPD.
Important Limitations of Use: • BREYNA is NOT indicated for the relief of acute bronchospasm.
( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
( 1.2 ) Important limitations: • Not indicated for the relief of acute bronchospasm.
( 1.1 , 1.2 ) 1.1 Treatment of Asthma BREYNA is indicated for the treatment of asthma in patients 6 years of age and older.
BREYNA should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta 2 -adrenergic agonist (LABA).
Important Limitations of Use: • BREYNA is NOT indicated for the relief of acute bronchospasm.
1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BREYNA 160 mcg/4.5 mcg is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
BREYNA 160 mcg/4.5 mcg is also indicated to reduce exacerbations of COPD.
BREYNA 160 mcg/4.5 mcg is the only strength indicated for the treatment of COPD.
Important Limitations of Use: • BREYNA is NOT indicated for the relief of acute bronchospasm.
Adverse Reactions
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 Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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 inhalation aerosol 80 mcg/4.5 mcg or 160 mcg/4.5 mcg taken 2 inhalations once or twice daily for 12 to 52 weeks.
In these trials, the patients on budesonide and formoterol fumarate dihydrate inhalation aerosol 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 inhalation aerosol 80 mcg/4.5 mcg or budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg twice daily.
The budesonide and formoterol fumarate dihydrate inhalation aerosol 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/4.5 mcg and 160 mcg/4.5 mcg treatment groups, respectively.
Control arms for comparison included 2 inhalations of budesonide HFA metered dose inhaler (MDI) 80 mcg or 160 mcg, formoterol dry powder inhaler (DPI) 4.5 mcg, or placebo (MDI and DPI) twice daily.
Table 2 includes all adverse events that occurred at an incidence of ≥ 3% in any one budesonide and formoterol fumarate dihydrate inhalation aerosol 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 budesonide and formoterol fumarate dihydrate inhalation aerosol patients should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.
Table 2.
Adverse Reactions Occurring at an Incidence of ≥ 3% and More Commonly Than Placebo in the Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol Groups: Pooled Data from Three 12-week, Double-blind, Placebo-controlled Clinical Asthma Trials in Patients 12 Years and Older Treatment All treatments were administered as 2 inhalations twice daily.
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol Budesonide Formoterol Placebo Adverse Event 80 mcg/4.5 mcg N = 277 % 160 mcg/4.5 mcg N = 124 % 80 mcg N = 121 % 160 mcg N = 109 % 4.5 mcg N = 237 % N = 400 % Nasopharyngitis 10.5 9.7 14.0 11.0 10.1 9.0 Headache 6.5 11.3 11.6 12.8 8.9 6.5 Upper respiratory tract infection 7.6 10.5 8.3 9.2 7.6 7.8 Pharyngolaryngeal pain 6.1 8.9 5.0 7.3 3.0 4.8 Sinusitis 5.8 4.8 5.8 2.8 6.3 4.8 Influenza 3.2 2.4 6.6 0.9 3.0 1.3 Back pain 3.2 1.6 2.5 5.5 2.1 0.8 Nasal congestion 2.5 3.2 2.5 3.7 1.3 1.0 Stomach discomfort 1.1 6.5 2.5 4.6 1.3 1.8 Vomiting 1.4 3.2 0.8 2.8 1.7 1.0 Oral Candidiasis 1.4 3.2 0 0 0 0.8 Average Duration of Exposure (days) 77.7 73.8 77.0 71.4 62.4 55.9 Long-term Safety - Asthma Clinical Trials in Patients 12 Years and Older Long-term safety studies in adolescent and adult patients 12 years of age and older, treated for up to 1 year at doses up to 1280/36 mcg/day (640/18 mcg twice daily), revealed neither clinically important changes in the incidence nor new types of adverse events emerging after longer periods of treatment.
Similarly, no significant or unexpected patterns of abnormalities were observed for up to 1 year in safety measures including chemistry, hematology, ECG, Holter monitor, and HPA-axis assessments.
Pediatric Patients 6 to Less Than 12 Years of Age The safety data for pediatric patients aged 6 to less than 12 years is based on 1 trial of 12 weeks treatment duration.
Patients (79 female and 105 male) receiving inhaled corticosteroid at trial entry were randomized to budesonide and formoterol fumarate dihydrate inhalation aerosol 80 mcg/4.5 mcg (n = 92) or budesonide pMDI 80 mcg (n = 92), 2 inhalations twice daily.
The overall safety profile of these patients was similar to that observed in patients 12 years of age and older who received budesonide and formoterol fumarate dihydrate inhalation aerosol 80 mcg/4.5 mcg twice daily in studies of similar design.
Common adverse reactions that occurred in patients treated with budesonide and formoterol fumarate dihydrate inhalation aerosol 80 mcg/4.5 mcg with a frequency of ≥ 3% and more frequently than patients treated only with budesonide pMDI 80 mcg included upper respiratory tract infection, pharyngitis, headache, and rhinitis.
6.2 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease The safety data described below reflect exposure to budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg in 1783 patients.
Budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg was studied in two placebo-controlled lung function studies (6 and 12 months in duration), and two active-controlled exacerbation studies (6 and 12 months in duration) in patients with COPD.
The incidence of common adverse events in Table 3 below is based upon pooled data from two double-blind, placebo-controlled lung function clinical studies (6 and 12 months in duration) in which 771 adult COPD patients (496 males and 275 females) 40 years of age and older were treated with budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg, two inhalations twice daily.
Of these patients 651 were treated for 6 months and 366 were treated for 12 months.
The budesonide and formoterol fumarate dihydrate inhalation aerosol group was composed of mostly Caucasian (93%) patients with a mean age of 63 years, and a mean percent predicted FEV 1 at baseline of 33%.
Control arms for comparison included 2 inhalations of budesonide HFA (MDI) 160 mcg, formoterol (DPI) 4.5 mcg or placebo (MDI and DPI) twice daily.
Table 3 includes all adverse events that occurred at an incidence of ≥ 3% in the budesonide and formoterol fumarate dihydrate inhalation aerosol group and more commonly than in the placebo group.
In considering these data, the increased average duration of patient exposure to budesonide and formoterol fumarate dihydrate inhalation aerosol should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.
Table 3.
Adverse Reactions Occurring at an Incidence of ≥ 3% and More Commonly Than Placebo in the Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol Group: Pooled Data From Two Double-blind, Placebo-controlled Clinical COPD Trials Treatment All treatments were administered as 2 inhalations twice daily.
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol Budesonide Formoterol Placebo Adverse Event 160 mcg/4.5 mcg N = 771 % 160 mcg N = 275 % 4.5 mcg N = 779 % N = 781 % Nasopharyngitis 7.3 3.3 5.8 4.9 Oral candidiasis 6.0 4.4 1.2 1.8 Bronchitis 5.4 4.7 4.5 3.5 Sinusitis 3.5 1.5 3.1 1.8 Upper respiratory tract infection viral 3.5 1.8 3.6 2.7 Average Duration of Exposure (days) 255.2 157.1 240.3 223.7 Lung infections other than pneumonia (mostly bronchitis) occurred in a greater percentage of subjects treated with budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg compared with placebo (7.9% vs.
5.1%, respectively).
There were no clinically important or unexpected patterns of abnormalities observed for up to 1 year in chemistry, hematology, ECG, ECG (Holter) monitoring, HPA-axis, bone mineral density and ophthalmology assessments.
The safety findings from the two double-blind, active-controlled exacerbations studies (6 and 12 months in duration) in which 1012 adult COPD patients (616 males and 396 females) 40 years of age and older were treated with budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg, two inhalations twice daily were consistent with the lung function studies.
6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of budesonide and formoterol fumarate dihydrate inhalation aerosol.
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.
Some of these adverse reactions may also have been observed in clinical studies with budesonide and formoterol fumarate dihydrate inhalation aerosol.
Cardiac Disorders: angina pectoris, tachycardia, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles, palpitations Endocrine Disorders: hypercorticism, growth velocity reduction in pediatric patients Eye Disorders: cataract, glaucoma, increased intraocular pressure Gastrointestinal Disorders: oropharyngeal candidiasis, nausea Immune System Disorders: immediate and delayed hypersensitivity reactions, such as anaphylactic reaction, angioedema, bronchospasm, urticaria, exanthema, dermatitis, pruritus Metabolic and Nutrition Disorders: hyperglycemia, hypokalemia Musculoskeletal, Connective Tissue, and Bone Disorders: muscle cramps Nervous System Disorders: tremor, dizziness Psychiatric Disorders: behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness Respiratory, Thoracic, and Mediastinal Disorders: dysphonia, cough, throat irritation Skin and Subcutaneous Tissue Disorders: skin bruising Vascular Disorders: hypotension, hypertension
• 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 Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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 inhalation aerosol 80 mcg/4.5 mcg or 160 mcg/4.5 mcg taken 2 inhalations once or twice daily for 12 to 52 weeks.
In these trials, the patients on budesonide and formoterol fumarate dihydrate inhalation aerosol 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 inhalation aerosol 80 mcg/4.5 mcg or budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg twice daily.
The budesonide and formoterol fumarate dihydrate inhalation aerosol 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/4.5 mcg and 160 mcg/4.5 mcg treatment groups, respectively.
Control arms for comparison included 2 inhalations of budesonide HFA metered dose inhaler (MDI) 80 mcg or 160 mcg, formoterol dry powder inhaler (DPI) 4.5 mcg, or placebo (MDI and DPI) twice daily.
Table 2 includes all adverse events that occurred at an incidence of ≥ 3% in any one budesonide and formoterol fumarate dihydrate inhalation aerosol 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 budesonide and formoterol fumarate dihydrate inhalation aerosol patients should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.
Table 2.
Adverse Reactions Occurring at an Incidence of ≥ 3% and More Commonly Than Placebo in the Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol Groups: Pooled Data from Three 12-week, Double-blind, Placebo-controlled Clinical Asthma Trials in Patients 12 Years and Older Treatment All treatments were administered as 2 inhalations twice daily.
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol Budesonide Formoterol Placebo Adverse Event 80 mcg/4.5 mcg N = 277 % 160 mcg/4.5 mcg N = 124 % 80 mcg N = 121 % 160 mcg N = 109 % 4.5 mcg N = 237 % N = 400 % Nasopharyngitis 10.5 9.7 14.0 11.0 10.1 9.0 Headache 6.5 11.3 11.6 12.8 8.9 6.5 Upper respiratory tract infection 7.6 10.5 8.3 9.2 7.6 7.8 Pharyngolaryngeal pain 6.1 8.9 5.0 7.3 3.0 4.8 Sinusitis 5.8 4.8 5.8 2.8 6.3 4.8 Influenza 3.2 2.4 6.6 0.9 3.0 1.3 Back pain 3.2 1.6 2.5 5.5 2.1 0.8 Nasal congestion 2.5 3.2 2.5 3.7 1.3 1.0 Stomach discomfort 1.1 6.5 2.5 4.6 1.3 1.8 Vomiting 1.4 3.2 0.8 2.8 1.7 1.0 Oral Candidiasis 1.4 3.2 0 0 0 0.8 Average Duration of Exposure (days) 77.7 73.8 77.0 71.4 62.4 55.9 Long-term Safety - Asthma Clinical Trials in Patients 12 Years and Older Long-term safety studies in adolescent and adult patients 12 years of age and older, treated for up to 1 year at doses up to 1280/36 mcg/day (640/18 mcg twice daily), revealed neither clinically important changes in the incidence nor new types of adverse events emerging after longer periods of treatment.
Similarly, no significant or unexpected patterns of abnormalities were observed for up to 1 year in safety measures including chemistry, hematology, ECG, Holter monitor, and HPA-axis assessments.
Pediatric Patients 6 to Less Than 12 Years of Age The safety data for pediatric patients aged 6 to less than 12 years is based on 1 trial of 12 weeks treatment duration.
Patients (79 female and 105 male) receiving inhaled corticosteroid at trial entry were randomized to budesonide and formoterol fumarate dihydrate inhalation aerosol 80 mcg/4.5 mcg (n = 92) or budesonide pMDI 80 mcg (n = 92), 2 inhalations twice daily.
The overall safety profile of these patients was similar to that observed in patients 12 years of age and older who received budesonide and formoterol fumarate dihydrate inhalation aerosol 80 mcg/4.5 mcg twice daily in studies of similar design.
Common adverse reactions that occurred in patients treated with budesonide and formoterol fumarate dihydrate inhalation aerosol 80 mcg/4.5 mcg with a frequency of ≥ 3% and more frequently than patients treated only with budesonide pMDI 80 mcg included upper respiratory tract infection, pharyngitis, headache, and rhinitis.
6.2 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease The safety data described below reflect exposure to budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg in 1783 patients.
Budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg was studied in two placebo-controlled lung function studies (6 and 12 months in duration), and two active-controlled exacerbation studies (6 and 12 months in duration) in patients with COPD.
The incidence of common adverse events in Table 3 below is based upon pooled data from two double-blind, placebo-controlled lung function clinical studies (6 and 12 months in duration) in which 771 adult COPD patients (496 males and 275 females) 40 years of age and older were treated with budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg, two inhalations twice daily.
Of these patients 651 were treated for 6 months and 366 were treated for 12 months.
The budesonide and formoterol fumarate dihydrate inhalation aerosol group was composed of mostly Caucasian (93%) patients with a mean age of 63 years, and a mean percent predicted FEV 1 at baseline of 33%.
Control arms for comparison included 2 inhalations of budesonide HFA (MDI) 160 mcg, formoterol (DPI) 4.5 mcg or placebo (MDI and DPI) twice daily.
Table 3 includes all adverse events that occurred at an incidence of ≥ 3% in the budesonide and formoterol fumarate dihydrate inhalation aerosol group and more commonly than in the placebo group.
In considering these data, the increased average duration of patient exposure to budesonide and formoterol fumarate dihydrate inhalation aerosol should be taken into account, as incidences are not adjusted for an imbalance of treatment duration.
Table 3.
Adverse Reactions Occurring at an Incidence of ≥ 3% and More Commonly Than Placebo in the Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol Group: Pooled Data From Two Double-blind, Placebo-controlled Clinical COPD Trials Treatment All treatments were administered as 2 inhalations twice daily.
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol Budesonide Formoterol Placebo Adverse Event 160 mcg/4.5 mcg N = 771 % 160 mcg N = 275 % 4.5 mcg N = 779 % N = 781 % Nasopharyngitis 7.3 3.3 5.8 4.9 Oral candidiasis 6.0 4.4 1.2 1.8 Bronchitis 5.4 4.7 4.5 3.5 Sinusitis 3.5 1.5 3.1 1.8 Upper respiratory tract infection viral 3.5 1.8 3.6 2.7 Average Duration of Exposure (days) 255.2 157.1 240.3 223.7 Lung infections other than pneumonia (mostly bronchitis) occurred in a greater percentage of subjects treated with budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg compared with placebo (7.9% vs.
5.1%, respectively).
There were no clinically important or unexpected patterns of abnormalities observed for up to 1 year in chemistry, hematology, ECG, ECG (Holter) monitoring, HPA-axis, bone mineral density and ophthalmology assessments.
The safety findings from the two double-blind, active-controlled exacerbations studies (6 and 12 months in duration) in which 1012 adult COPD patients (616 males and 396 females) 40 years of age and older were treated with budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg, two inhalations twice daily were consistent with the lung function studies.
6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of budesonide and formoterol fumarate dihydrate inhalation aerosol.
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.
Some of these adverse reactions may also have been observed in clinical studies with budesonide and formoterol fumarate dihydrate inhalation aerosol.
Cardiac Disorders: angina pectoris, tachycardia, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles, palpitations Endocrine Disorders: hypercorticism, growth velocity reduction in pediatric patients Eye Disorders: cataract, glaucoma, increased intraocular pressure Gastrointestinal Disorders: oropharyngeal candidiasis, nausea Immune System Disorders: immediate and delayed hypersensitivity reactions, such as anaphylactic reaction, angioedema, bronchospasm, urticaria, exanthema, dermatitis, pruritus Metabolic and Nutrition Disorders: hyperglycemia, hypokalemia Musculoskeletal, Connective Tissue, and Bone Disorders: muscle cramps Nervous System Disorders: tremor, dizziness Psychiatric Disorders: behavior disturbances, sleep disturbances, nervousness, agitation, depression, restlessness Respiratory, Thoracic, and Mediastinal Disorders: dysphonia, cough, throat irritation Skin and Subcutaneous Tissue Disorders: skin bruising Vascular Disorders: hypotension, hypertension