Flovent HFA Side Effects

Generic name: fluticasone

Note: This document contains side effect information about fluticasone. Some of the dosage forms listed on this page may not apply to the brand name Flovent HFA.

Some side effects of Flovent HFA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fluticasone: inhalation aerosol, inhalation powder

Get emergency medical help if you have any of these signs of an allergic reaction while taking fluticasone (the active ingredient contained in Flovent HFA) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fluticasone and call your doctor at once if you have a serious side effect such as:

• weakness, tired feeling, nausea, vomiting, feeling like you might pass out;

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• blurred vision, eye pain, or seeing halos around lights;

• signs of infection such as fever, chills, sore throat, ear pain, flu symptoms;

• wheezing or breathing problems after using this medication; or

• worsening asthma symptoms.

Less serious side effects of fluticasone may include:

• headache;

• dryness in your mouth, nose, or throat;

• white patches or sores inside your mouth or on your lips;

• stuffy nose, sinus pain, cough; 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.

For Healthcare Professionals

Applies to fluticasone: inhalation aerosol, inhalation aerosol with adapter, inhalation powder, inhalation suspension

Hypersensitivity

Cases of serious eosinophilic conditions also have been reported with other inhaled corticosteroids in this clinical setting.

Hypersensitivity adverse effects have included rare cases of immediate and delayed reactions including rash, angioedema and bronchospasm. Hypersensitivity adverse effects have also included postmarketing reports of a systemic eosinophilic condition and anaphylactic reactions, including very rare anaphylactic reactions in patients with severe milk protein allergy. Clinical features of this condition have included a vasculitis consistent with Churg-Strauss syndrome, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy. These events have usually been associated with a reduction and/or discontinuation of oral corticosteroid therapy following introduction of fluticasone.

Local

Asthma treatment with high doses of inhaled fluticasone (the active ingredient contained in Flovent HFA) powder apparently led to a serious case of laryngeal aspergillosis in a 75-year-old man. The patient had been using fluticasone 1 mg twice daily via Diskhaler for about 3 years. The patient experienced progressive hoarseness which lead to complete aphonia. Aspergillosis fumigatus was cultured from the vocal cords. Amphotericin B lozenges were used to treat the infection. After 14 weeks the patient's voice was still gruff but intelligible. It is recommended that tests for fungal infection be performed in patients on fluticasone therapy who become hoarse, particularly if taking high doses.

Local side effects associated with inhaled fluticasone have included dysphonia, sore throat, bronchitis, chest congestion, nasal congestion, nasal discharge, and eye irritation.

Endocrine

Due to extensive first-pass metabolism of fluticasone (the active ingredient contained in Flovent HFA) to an inactive carboxylic acid, significant systemic effects are not expected from any amount of the drug that may be ingested via inhalation of normally recommended dosages.

Endocrine side effects have included rare reports of symptoms of hypothalamic-pituitary-adrenal (HPA) axis suppression. These effects are more likely when higher potency corticosteroids are used in large doses. The use of a large-volume spacer may help minimize HPA suppression when fluticasone is inhaled orally.

Immunologic

Immunologic effects of infections from immune suppression associated with inhaled corticosteroids have been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled fluticasone (the active ingredient contained in Flovent HFA)

In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its decision regarding the labeled risks of the use of inhaled corticosteroids during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.

Nervous system

Nervous system side effects have included headache, dizziness, giddiness, fatigue, and insomnia.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and diarrhea. Oropharyngeal candidiasis and candida like lesions have also been reported. Postmarketing experience has included dental caries and tooth discoloration.

Ocular

Ocular side effects have included posterior capsular cataracts, especially with long-term use.

One epidemiologic study suggests that prolonged use of high-dose inhaled corticosteroids (>= 1500 mcg of fluticasone) may be associated with increased risk of ocular hypertension and open-angle glaucoma.

Musculoskeletal

Musculoskeletal adverse effects have included joint pain and muscle soreness. Long-term use of inhaled corticosteroids may be associated with a reduction in bone density. This effect may be dose related and has been reported with high dosages of orally inhaled beclomethasone and budesonide (>=800 mcg/day for >=1 year). Reduced levels of total body calcium have also been demonstrated in patients receiving lower dosages.

Psychiatric

Psychiatric side effects have included agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely.

Other

Other side effects have included postmarketing reports of facial and oropharyngeal edema.

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