Fluticasone side effects

List of adverse events
Adverse events during clinical trials Observed during clinical practice
 * Ear, nose, and throat
 * Eye
 * Gastrointestinal
 * Miscellaneous
 * Mouth and teeth
 * Musculoskeletal
 * Neurological
 * Respiratory
 * Skin
 * Urogenital
 * Ear, nose, and throat (post approval)
 * Endocrine and metabolic
 * Eye (post approval)
 * Non-site specific
 * Psychiatry
 * Respiratory (post approval)
 * Skin (post approval)
 * Eosinophilic conditions

Adverse events during clinical trials
Adverse events that occurred in clinical trials using FLOVENT Inhalation Aerosol with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were: Return to top

Ear, nose, and throat
Pain in nasal sinus(es), rhinitis. Return to top

Eye
Irritation of the eye(s). Return to top

Gastrointestinal
Nausea and vomiting, diarrhea, dyspepsia and stomach disorder. Return to top

Miscellaneous
Fever. Return to top

Mouth and teeth
Dental problem. Return to top

Musculoskeletal
Pain in joint, sprain/strain, aches and pains, pain in limb. Return to top

Neurological
Dizziness/giddiness. Return to top

Respiratory
Bronchitis, chest congestion. Return to top

Skin
Dermatitis, rash/skin eruption. Return to top

Urogenital
Dysmenorrhea. Return to top

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. 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. Return to top

Ear, nose, and throat (post approval)
Aphonia, facial and oropharyngeal edema, hoarseness, laryngitis, and throat soreness and irritation. Return to top

Endocrine and metabolic
Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis, and weight gain. Return to top

Eye (post approval)
Cataracts. Return to top

Non-site specific
Very rare anaphylactic reaction. Return to top

Psychiatry
Agitation, aggression, depression, and restlessness. Return to top

Respiratory (post approval)
Asthma exacerbation, bronchospasm, chest tightness, cough, dyspnea, immediate bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze. Return to top

Skin (post approval)
Contusions, cutaneous hypersensitivity reactions, ecchymoses, and pruritus. Return to top

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. Return to top