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Flovent Rotadisk (Fluticasone Propionate Inhalation) - Side Effects and Adverse Reactions



The incidence of common adverse events in Table 1 is based upon 6 placebo-controlled clinical trials in which 1,384 patients >/= 4 years of age (520 females and 864 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated with FLOVENT ROTADISK (doses of 50 to 500 mcg twice daily for up to 12 weeks) or placebo.

Table 1. Overall Adverse Events With >3% Incidence in Controlled Clinical Trials With FLOVENT ROTADISK in Patients >/=4 Years Previously Receiving Bronchodilators and/or Inhaled Corticosteroids
Adverse Event Placebo
(N = 438)
50 mcg
Twice Daily
(N = 255)
100 mcg
Twice Daily
(N = 331)
250 mcg
Twice Daily
(N = 176)
500 mcg
Twice Daily
(N = 184)
Ear, nose, and throat
Pharyngitis 7 6 8 8 13
Nasal congestion 5 4 4 7 7
Sinusitis 4 5 4 6 4
Rhinitis 4 4 9 2 3
Dysphonia 0 <1 4 6 4
Oral candidiasis 1 3 3 4 11
Upper respiratory infection 13 16 17 22 16
Influenza 2 3 3 3 4
Bronchitis 2 4 2 1 2
Headache 11 11 9 14 15
Diarrhea 1 2 2 0 4
Back problems <1 <1 1 1 4
Fever 3 4 4 2 2
Average duration of
exposure (days) 53 77 68 78 60

Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in any of the groups treated with FLOVENT ROTADISK and were more common than in the placebo group. In considering these data, differences in average duration of exposure should be taken into account.

These adverse reactions were mostly mild to moderate in severity, with <2% of patients discontinuing the studies because of adverse events. Rare cases of immediate and delayed hypersensitivity reactions, including rash and other rare events of angioedema and bronchospasm, have been reported.

Other adverse events that occurred in these clinical trials using FLOVENT ROTADISK with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

Ear, Nose, and Throat: Otitis media, tonsillitis, nasal discharge, earache, laryngitis, epistaxis, sneezing.

Eye: Conjunctivitis.

Gastrointestinal: Abdominal pain, viral gastroenteritis, gastroenteritis/colitis, abdominal discomfort.

Miscellaneous: Injury.

Mouth and Teeth: Mouth irritation.

Musculoskeletal: Sprain/strain, pain in joint, disorder/symptoms of neck, muscular soreness, aches and pains.

Neurological: Migraine, nervousness.

Respiratory: Chest congestion, acute nasopharyngitis, dyspnea, irritation due to inhalant.

Skin: Dermatitis, urticaria.

Urogenital: Dysmenorrhea, candidiasis of vagina, pelvic inflammatory disease, vaginitis/vulvovaginitis, irregular menstrual cycle.

There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.

FLOVENT Inhalation Aerosol (660 or 880 mcg twice daily) was administered for 16 weeks to patients with asthma requiring oral corticosteroids. Adverse events reported more frequently in these patients compared to patients not on oral corticosteroids included sinusitis, nasal discharge, oropharyngeal candidiasis, headache, joint pain, nausea and vomiting, muscular soreness, malaise/fatigue, and insomnia.

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 experiences 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, facial and oropharyngeal edema, hoarseness, and throat soreness and irritation.

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

Eye: Cataracts.

Non-Site Specific: Very rare anaphylactic reaction, very rare anaphylactic reaction in patients with severe milk protein allergy.

Psychiatry: Agitation, aggression, depression, and restlessness.

Respiratory: Asthma exacerbation, bronchospasm, chest tightness, cough, immediate bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze.

Skin: Contusions, ecchymoses, and pruritus.

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).

Drug label data at the top of this Page last updated: 2006-12-16

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