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Advair HFA

Last reviewed on RxList: 11/22/2016
Advair HFA Side Effects Center

Last reviewed on RxList 12/28/2016

Advair HFA (salmeterol and fluticasone) contains a combination of a corticosteroid and a beta2-adrenergic bronchodilator used for treating asthma and chronic bronchitis. Side effects of Advair HFA include:

Use of long acting agents like salmeterol in Advair HFA may increase the risk of asthma-related death. Tell your doctor if you have unlikely but serious side effects of Advair HFA including:

  • signs of infection (such as fever, persistent sore throat),
  • mental/mood changes (such as nervousness),
  • trouble sleeping,
  • vision problems (such as blurred vision),
  • increased thirst or urination,
  • muscle cramps, or
  • shaking (tremors).

For patients aged 12 years and older, the dosage of Advair HFA is 2 inhalations twice daily, approximately 12 hours apart. Advair HFA may interact with amiodarone, diuretics (water pills), HIV medicines, MAO inhibitors, antidepressants, antibiotics, or beta-blockers. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Advair HFA; it is unknown if it is harmful to a fetus. It is unknown if Advair HFA passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Advair HFA 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 HFA 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 HFA (Fluticasone Propionate and Salmeterol)

Advair HFA Professional Information


LABA, such as salmeterol, one of the active ingredients in ADVAIR HFA, increase the risk of asthma-related death. Data from a large placebo-controlled US 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:

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, US clinical trials (Trials 1 and 3) and 1 active-controlled 12-week US 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 inhaled corticosteroids 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 Inhalation Aerosol Fluticasone Propionate CFC Inhalation Aerosol Salmeterol CFC Inhalation Aerosol Placebo HFA Inhalation Aerosol
(n = 187) %
(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
  Headache 21 15 24 16 20 11
  Dizziness 4 1 1 0 < 1 0
  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 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-US clinical trial in 509 subjects previously treated with inhaled corticosteroids 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.

Read the entire FDA prescribing information for Advair HFA (Fluticasone Propionate and Salmeterol)

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