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Advair HFA

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Advair HFA

Advair HFA Side Effects Center

Pharmacy Author: Omudhome Ogbru, PharmD
Medical Editor: Melissa Conrad Stöppler, MD

Advair HFA (salmeterol and fluticasone) contain a combination of inhaled drugs used for treating asthma and chronic bronchitis. Adverse effects of Advair HFA include upper respiratory tract infections, headaches, nausea, vomiting, diarrhea, mouth or throat candidiasis, and musculoskeletal pain. Use of long acting agents like salmeterol may increase the risk of asthma-related death. Therefore, Advair HFA should only be used in patients with asthma uncontrolled by other agents and who are using long-term asthma-controlling medications.

Advair HFA is administered twice daily at least 12 hours apart. Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants may increase the effect of salmeterol on the heart and blood pressure. Since Advair HFA contains salmeterol, it should not be used with or within two weeks of discontinuing monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants. Adequate studies of Advair HFA during pregnancy have not been done. It is not known if Advair HFA is secreted in breast milk.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Advair HFA in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Advair HFA Overview - Patient Information: Side Effects

SIDE EFFECTS: Hoarseness, throat irritation, headache, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.

Tell your doctor right away if any of these unlikely but serious side effects occur: white patches on tongue/in mouth, 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/urination, muscle cramps, shaking (tremors).

Get medical help right away if any of these rare but serious side effects occur: chest pain, fast/irregular heartbeat, severe dizziness, fainting, seizures.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Advair HFA (Fluticasone Propionate and Salmeterol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Advair HFA FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

LABAs, 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 study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients 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 LABAs. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

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 Patients Aged 12 Years and Older

The incidence of adverse reactions associated with ADVAIR HFA in Table 2 is based upon 2 placebo-controlled 12-week US clinical studies (Studies 1 and 3) and 1 active-controlled 12-week US clinical study (Study 2). A total of 1,008 adult and adolescent patients 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 chlorofluorocarbon (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 ≥ 3% Incidence With ADVAIR HFA Inhalation Aerosol in Adult and Adolescent Patients With Asthma

Adverse Event ADVAIR HFA Inhalation Aerosol 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, & 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 & vomiting 5 3 4 2 2 3
  Viral gastrointestinal infection 4 2 2 0 1 2
  Gastrointestinal signs & 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 Study 4, a 12-week non-US clinical study of 509 patients 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 Study 3, there were more reports of hyperglycemia among adults and adolescents receiving ADVAIR HFA, but this was not seen in Studies 1 and 2.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing 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.

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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Advair HFA - User Reviews

Advair HFA User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Advair HFA sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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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