ADVAIR HFA - Side Effects fluticasone propionate and salmeterol xinafoate

Side Effects for ADVAIR HFA (fluticasone propionate and salmeterol xinafoate aerosol, metered) are also known as adverse reactions. Below is a summary of known side effects for ADVAIR HFA. If you experience side effects when taking ADVAIR HFA, be sure to tell your doctor.

Adverse Reactions

Use of LABA 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 local corticosteroid use may result in the following:

  • Candida albicans infection [see Warnings and Precautions (5.4)]
  • Pneumonia 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)]
  • Reduction in bone mineral density [see Warnings and Precautions (5.13)]
  • Growth effects [see Warnings and Precautions (5.14)]
  • Glaucoma and cataracts [see Warnings and Precautions (5.15)]

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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult and Adolescent Subjects Aged 12 Years and Older

The incidence of adverse reactions associated with ADVAIR HFA in Table 2 is based upon two 12-week, placebo-controlled, U.S. clinical trials (Trials 1 and 3) and 1 active-controlled 12-week U.S. clinical trial (Trial 2). A total of 1,008 adult and adolescent subjects with asthma (556 females and 452 males) previously treated with albuterol alone, salmeterol, or ICS were treated twice daily with 2 inhalations of ADVAIR HFA 45/21 or ADVAIR HFA 115/21, fluticasone propionate CFC inhalation aerosol (44- or 110-mcg doses), salmeterol CFC inhalation aerosol 21 mcg, or placebo HFA inhalation aerosol. The average duration of exposure was 71 to 81 days in the active treatment groups compared with 51 days in the placebo group.

Table 2. Adverse Reactions with ADVAIR HFA with ≥3% Incidence in Adult and Adolescent Subjects with Asthma

  •   Adverse Event

ADVAIR HFA

Fluticasone Propionate CFC Inhalation Aerosol

Salmeterol CFC Inhalation Aerosol

Placebo HFA Inhalation Aerosol

  •   45/21
  •   (n = 187)
  •   %
  •   115/21
  •   (n = 94)
  •   %
  •   44 mcg
  •   (n = 186)
  •   %
  •   110 mcg
  •   (n = 91)
  •   %
  •   21 mcg
  •   (n = 274)
  •   %
  •   (n = 176)
  •   %

Ear, nose, and throat

   Upper respiratory tract infection

16

24

13

15

17

13

   Throat irritation

9

7

12

13

9

7

   Upper respiratory inflammation

4

4

3

7

5

3

   Hoarseness/dysphonia

3

1

2

0

1

0

Lower respiratory

   Viral respiratory infection

3

5

4

5

3

4

Neurology

   Headache

21

15

24

16

20

11

   Dizziness

4

1

1

0

<1

0

Gastrointestinal

   Nausea and vomiting

5

3

4

2

2

3

   Viral gastrointestinal infection

4

2

2

0

1

2

   Gastrointestinal signs and symptoms

3

2

2

1

1

1

Musculoskeletal

   Musculoskeletal pain

5

7

8

2

4

4

   Muscle pain

4

1

1

1

3

<1

The incidence of common adverse reactions reported in Trial 4, a 12-week non-U.S. clinical trial in 509 subjects previously treated with ICS who were treated twice daily with 2 inhalations of ADVAIR HFA 230/21, fluticasone propionate CFC inhalation aerosol 220 mcg, or 1 inhalation of ADVAIR DISKUS 500/50 was similar to the incidences reported in Table 2.

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that occurred in the groups receiving ADVAIR HFA with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo include the following: tachycardia, arrhythmias, myocardial infarction, postoperative complications, wounds and lacerations, soft tissue injuries, ear signs and symptoms, rhinorrhea/postnasal drip, epistaxis, nasal congestion/blockage, laryngitis, unspecified oropharyngeal plaques, dryness of nose, weight gain, allergic eye disorders, eye edema and swelling, gastrointestinal discomfort and pain, dental discomfort and pain, candidiasis mouth/throat, hyposalivation, gastrointestinal infections, disorders of hard tissue of teeth, abdominal discomfort and pain, oral abnormalities, arthralgia and articular rheumatism, muscle cramps and spasms, musculoskeletal inflammation, bone and skeletal pain, muscle injuries, sleep disorders, migraines, allergies and allergic reactions, viral infections, bacterial infections, candidiasis unspecified site, congestion, inflammation, bacterial reproductive infections, lower respiratory signs and symptoms, lower respiratory infections, lower respiratory hemorrhage, eczema, dermatitis and dermatosis, urinary infections.

Laboratory Test Abnormalities

In Trial 3, there were more reports of hyperglycemia among adults and adolescents receiving ADVAIR HFA, but this was not seen in Trials 1 and 2.

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, fluticasone propionate, and/or salmeterol or a combination of these factors.

Cardiovascular

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

Ear, Nose, and Throat

Aphonia, earache, facial and oropharyngeal edema, paranasal sinus pain, rhinitis, throat soreness, tonsillitis.

Endocrine and Metabolic

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

Eye

Cataracts, glaucoma.

Gastrointestinal

Dyspepsia, xerostomia.

Hepatobiliary Tract and Pancreas

Abnormal liver function tests.

Immune System

Immediate and delayed hypersensitivity reactions, including rash and rare events of angioedema, bronchospasm, and anaphylaxis.

Infections and Infestations

Esophageal candidiasis.

Musculoskeletal

Back pain, myositis.

Neurology

Paresthesia, restlessness.

Non-Site Specific

Fever, pallor.

Psychiatry

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

Respiratory

Asthma; asthma exacerbation; chest congestion; chest tightness; cough; dyspnea; immediate bronchospasm; influenza; paradoxical bronchospasm; tracheitis; wheezing; pneumonia; reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking.

Skin

Contact dermatitis, contusions, ecchymoses, photodermatitis, pruritus.

Urogenital

Dysmenorrhea, irregular menstrual cycle, pelvic inflammatory disease, vaginal candidiasis, vaginitis, vulvovaginitis.

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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