Flovent Diskus

[fluticasone propionate]

Ear, Nose, and Throat:

Hoarseness/dysphonia (9% and 0%),
nasal congestion/blockage (16% and 0%),
oral candidiasis (31% and 21%),
rhinitis (13% and 9%),
sinusitis/sinus infection (33% and 12%),
throat irritation (10% and 9%),
upper respiratory tract infection (31% and 24%).

Gastrointestinal:

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Nausea and vomiting (9% and 0%).

Lower Respiratory:

Cough (9% and 3%),
viral respiratory infections (9% and 6%).

Musculoskeletal:

Arthralgia and articular rheumatism (17% and 3%),
muscle pain (12% and 0%).

Non-Site Specific:

Malaise and fatigue (16% and 9%),
pain (10% and 3%).

Skin:

Pruritus (6% and 0%),
skin rashes (8% and 3%).

Observed During Clinical Practice:

In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of fluticasone propionate in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

Ear, Nose, and Throat:
Aphonia and throat soreness.

Endocrine and Metabolic:

Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, weight gain, and osteoporosis.

Eye: Cataracts. FLOVENT DISKUS 50 mcg (fluticasone propionate inhalation powder, 50 mcg) FLOVENT DISKUS 100 mcg (fluticasone propionate inhalation powder, 100 mcg) FLOVENT DISKUS 250 mcg (fluticasone propionate inhalation powder, 250 mcg)

Psychiatry:

Agitation, aggression, depression, and restlessness.

Respiratory:

Asthma exacerbation, bronchospasm, chest tightness, cough, dyspnea, immediate bronchospasm, wheeze, and pneumonia.

Skin: Contusions and ecchymoses.

Eosinophilic Conditions:

In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established (see PRECAUTIONS: Eosinophilic Conditions).

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