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Advair Diskus

Last reviewed on RxList: 5/23/2016
Advair Diskus Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/23/2016

Advair Diskus (fluticasone and salmeterol oral inhaler) is a combination of a corticosteroid and a beta2-adrenergic bronchodilator used to treat asthma and chronic bronchitis, including COPD associated with chronic bronchitis. Advair Diskus is used in patients whose symptoms are not adequately controlled on a long-term asthma control medication, since one of the active ingredients in salmeterol is LABA, which has been linked to asthma-related deaths. Advair Diskus should not be used to treat acute episodes of asthma or COPD. Advair Diskus is available in generic form. Side effects of Advair Diskus include:

For patients aged 12 years and older, the dosage of Advair Diskus is 1 inhalation twice daily, approximately 12 hours apart. Advair Diskus may interact with amiodarone, diuretics (water pills), HIV medicines, MAO inhibitors, antidepressants, antibiotics, antifungal medications, or beta-blockers. Tell your doctor all medications and supplements you use. There have not been adequate studies of salmeterol in pregnant women. Fluticasone and salmeterol use by pregnant women should be avoided unless the potential benefit justifies the potential unknown risk to the fetus. Advair Diskus is secreted in breast milk. Consult your doctor before breastfeeding.

Our Advair Diskus Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Advair Diskus Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • fast or uneven heart beats, restless feeling, tremor;
  • fever, chills, stabbing chest pain, cough with yellow or green mucus;
  • blurred vision, eye pain, or seeing halos around lights;
  • white patches or sores inside your mouth or on your lips; or
  • worsening asthma symptoms.

Less serious side effects include:

  • headache, dizziness;
  • nausea, vomiting, diarrhea;
  • dry mouth, nose, or throat;
  • stuffy nose, sinus pain, cough, sore throat; or
  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Advair Diskus (Fluticasone Propionate)

Advair Diskus Professional Information

SIDE EFFECTS

LABA, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. trial that compared the safety of salmeterol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol [see WARNINGS AND PRECAUTIONS]. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see WARNINGS AND PRECAUTIONS].

Systemic and local corticosteroid use may result in the following:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience In Asthma

Adult And Adolescent Subjects Aged 12 Years And Older

The incidence of adverse reactions associated with ADVAIR DISKUS in Table 2 is based upon two 12-week, placebo-controlled, U.S. clinical trials (Trials 1 and 2). A total of 705 adult and adolescent subjects (349 females and 356 males) previously treated with salmeterol or inhaled corticosteroids were treated twice daily with ADVAIR DISKUS (100/50-or 250/50-mcg doses), fluticasone propionate inhalation powder (100-or 250-mcg doses), salmeterol inhalation powder 50 mcg, or placebo. The average duration of exposure was 60 to 79 days in the active treatment groups compared with 42 days in the placebo group.

Table 2: Adverse Reactions with ADVAIR DISKUS with ≥ 3% Incidence and More Common than Placebo in Adult and Adolescent Subjects with Asthma

Adverse Event ADVAIR DISKUS 100/50
(n = 92) %
ADVAIR DISKUS 250/50
(n = 84) %
Fluticasone Propionate 100 mcg
(n = 90) %
Fluticasone Propionate 250 mcg
(n = 84) %
Salmeterol 50 mcg
(n = 180) %
Placebo
(n = 175) %
Ear, nose, and throat
  Upper respiratory tract infection 27 21 29 25 19 14
  Pharyngitis 13 10 7 12 8 6
  Upper respiratory inflammation 7 6 7 8 8 5
  Sinusitis 4 5 6 1 3 4
  Hoarseness/dysphonia 5 2 2 4 < 1 < 1
  Oral candidiasis 1 4 2 2 0 0
Lower respiratory
  Viral respiratory infections 4 4 4 10 6 3
  Bronchitis 2 8 1 2 2 2
  Cough 3 6 0 0 3 2
Neurology
  Headaches 12 13 14 8 10 7
Gastrointestinal
  Nausea and vomiting 4 6 3 4 1 1
  Gastrointestinal discomfort and pain 4 1 0 2 1 1
  Diarrhea 4 2 2 2 1 1
  Viral gastrointestinal infections 3 0 3 1 2 2
Non-site specific
  Candidiasis unspecified site 3 0 1 4 0 1
Musculoskeletal
  Musculoskeletal pain 4 2 1 5 3 3

The types of adverse reactions and events reported in Trial 3, a 28-week non-U.S. clinical trial in 503 subjects previously treated with inhaled corticosteroids who were treated twice daily with ADVAIR DISKUS 500/50, fluticasone propionate inhalation powder 500 mcg and salmeterol inhalation powder 50 mcg used concurrently, or fluticasone propionate inhalation powder 500 mcg, were similar to those reported in Table 2.

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with ADVAIR DISKUS compared with subjects treated with placebo include the following: lymphatic signs and symptoms; muscle injuries; fractures; wounds and lacerations; contusions and hematomas; ear signs and symptoms; nasal signs and symptoms; nasal sinus disorders; keratitis and conjunctivitis; dental discomfort and pain; gastrointestinal signs and symptoms; oral ulcerations; oral discomfort and pain; lower respiratory signs and symptoms; pneumonia; muscle stiffness, tightness, and rigidity; bone and cartilage disorders; sleep disorders; compressed nerve syndromes; viral infections; pain; chest symptoms; fluid retention; bacterial infections; unusual taste; viral skin infections; skin flakiness and acquired ichthyosis; disorders of sweat and sebum.

Pediatric Subjects Aged 4 To 11 Years

The safety data for pediatric subjects aged 4 to 11 years is based upon 1 U.S. trial of 12 weeks' treatment duration. A total of 203 subjects (74 females and 129 males) who were receiving inhaled corticosteroids at trial entry were randomized to either ADVAIR DISKUS 100/50 or fluticasone propionate inhalation powder 100 mcg twice daily. Common adverse reactions (greater than or equal to 3% and greater than placebo) seen in the pediatric subjects but not reported in the adult and adolescent clinical trials include: throat irritation and ear, nose, and throat infections.

Laboratory Test Abnormalities

Elevation of hepatic enzymes was reported in greater than or equal to 1% of subjects in clinical trials. The elevations were transient and did not lead to discontinuation from the trials. In addition, there were no clinically relevant changes noted in glucose or potassium.

Clinical Trials Experience In Chronic Obstructive Pulmonary Disease

Short-Term (6 Months to 1 Year) Trials

The short-term safety data are based on exposure to ADVAIR DISKUS 250/50 twice daily in one 6-month and two 1-year clinical trials. In the 6-month trial, a total of 723 adult subjects (266 females and 457 males) were treated twice daily with ADVAIR DISKUS 250/50, fluticasone propionate inhalation powder 250 mcg, salmeterol inhalation powder, or placebo. The mean age of the subjects was 64, and the majority (93%) was Caucasian. In this trial, 70% of the subjects treated with ADVAIR DISKUS reported an adverse reaction compared with 64% on placebo. The average duration of exposure to ADVAIR DISKUS 250/50 was 141.3 days compared with 131.6 days for placebo. The incidence of adverse reactions in the 6-month trial is shown in Table 3.

Table 3: Overall Adverse Reactions with ADVAIR DISKUS 250/50 with ≥ 3% Incidence in Subjects with Chronic Obstructive Pulmonary Disease Associated with Chronic Bronchitis

Adverse Event ADVAIR DISKUS 250/50
(n = 178) %
Fluticasone Propionate 250 mcg
(n = 183) %
Salmeterol 50 mcg
(n = 177) %
Placebo
(n = 185) %
Ear, nose, and throat
  Candidiasis mouth/throat 10 6 3 1
  Throat irritation 8 5 4 7
  Hoarseness/dysphonia 5 3 < 1 0
  Sinusitis 3 8 5 3
Lower respiratory
  Viral respiratory infections 6 4 3 3
Neurology
  Headaches 16 11 10 12
  Dizziness 4 < 1 3 2
Non-site specific
  Fever  4 3 0 3
  Malaise and fatigue 3 2 2 3
Musculoskeletal
  Musculoskeletal pain 9 8 12 9
  Muscle cramps and spasms 3 3 1 1

In the two 1-year trials, ADVAIR DISKUS 250/50 was compared with salmeterol in 1,579 subjects (863 males and 716 females). The mean age of the subjects was 65 years, and the majority (94%) was Caucasian. To be enrolled, all of the subjects had to have had a COPD exacerbation in the previous 12 months. In this trial, 88% of the subjects treated with ADVAIR DISKUS and 86% of the subjects treated with salmeterol reported an adverse event. The most common events that occurred with a frequency of greater than 5% and more frequently in the subjects treated with ADVAIR DISKUS were nasopharyngitis, upper respiratory tract infection, nasal congestion, back pain, sinusitis, dizziness, nausea, pneumonia, candidiasis, and dysphonia. Overall, 55 (7%) of the subjects treated with ADVAIR DISKUS and 25 (3%) of the subjects treated with salmeterol developed pneumonia.

The incidence of pneumonia was higher in subjects older than 65 years, 9% in the subjects treated with ADVAIR DISKUS compared with 4% in the subjects treated with ADVAIR DISKUS younger than 65 years. In the subjects treated with salmeterol, the incidence of pneumonia was the same (3%) in both age-groups. [See WARNINGS AND PRECAUTIONS, Use In Specific Populations]

Long-Term (3 Years) Trial

The safety of ADVAIR DISKUS 500/50 was evaluated in a randomized, double-blind, placebo-controlled, multicenter, international, 3-year trial in 6,184 adult subjects with COPD (4,684 males and 1,500 females). The mean age of the subjects was 65 years, and the majority (82%) was Caucasian. The distribution of adverse events was similar to that seen in the 1-year trials with ADVAIR DISKUS 250/50. In addition, pneumonia was reported in a significantly increased number of subjects treated with ADVAIR DISKUS 500/50 and fluticasone propionate 500 mcg (16% and 14%, respectively) compared with subjects treated with salmeterol 50 mcg or placebo (11% and 9%, respectively). When adjusted for time on treatment, the rates of pneumonia were 84 and 88 events per 1,000 treatment-years in the groups treated with fluticasone propionate 500 mcg and with ADVAIR DISKUS 500/50, respectively, compared with 52 events per 1,000 treatment-years in the salmeterol and placebo groups. Similar to what was seen in the 1-year trials with ADVAIR DISKUS 250/50, the incidence of pneumonia was higher in subjects older than 65 years (18% with ADVAIR DISKUS 500/50 versus 10% with placebo) compared with subjects younger than 65 years (14% with ADVAIR DISKUS 500/50 versus 8% with placebo). [See WARNINGS AND PRECAUTIONS, Use In Specific Populations]

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with COPD treated with ADVAIR DISKUS compared with subjects treated with placebo include the following: syncope; ear, nose, and throat infections; ear signs and symptoms; laryngitis; nasal congestion/blockage; nasal sinus disorders; pharyngitis/throat infection; hypothyroidism; dry eyes; eye infections; gastrointestinal signs and symptoms; oral lesions; abnormal liver function tests; bacterial infections; edema and swelling; viral infections.

Laboratory Abnormalities

There were no clinically relevant changes in these trials. Specifically, no increased reporting of neutrophilia or changes in glucose or potassium was noted.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of any formulation of ADVAIR, fluticasone propionate, and/or salmeterol regardless of indication. 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. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to ADVAIR DISKUS, fluticasone propionate, and/or salmeterol or a combination of these factors.

Cardiac Disorders

Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), ventricular tachycardia.

Endocrine Disorders

Cushing's syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism.

Eye Disorders

Glaucoma.

Gastrointestinal Disorders

Abdominal pain, dyspepsia, xerostomia.

Immune System Disorders

Immediate and delayed hypersensitivity reaction (including very rare anaphylactic reaction). Very rare anaphylactic reaction in patients with severe milk protein allergy.

Infections And Infestations

Esophageal candidiasis.

Metabolic and Nutrition Disorders

Hyperglycemia, weight gain.

Musculoskeletal, Connective Tissue, And Bone Disorders

Arthralgia, cramps, myositis, osteoporosis. Nervous System Disorders Paresthesia, restlessness.

Psychiatric Disorders

Agitation, aggression, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Reproductive System And Breast Disorders

Dysmenorrhea.

Respiratory, Thoracic, And Mediastinal Disorders

Chest congestion; chest tightness; dyspnea; facial and oropharyngeal edema, immediate bronchospasm; paradoxical bronchospasm; tracheitis; wheezing; reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking.

Skin And Subcutaneous Tissue Disorders

Ecchymoses, photodermatitis.

Vascular Disorders

Pallor.

Read the entire FDA prescribing information for Advair Diskus (Fluticasone Propionate)

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