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SIDE EFFECTS

The incidence of common adverse events in Table 1 is based upon 7 placebo-controlled US clinical trials in which 1,243 patients (509 female and 734 male adolescents and adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with FLOVENT (fluticasone propionate) Inhalation Aerosol (doses of 88 to 440 mcg twice daily for up to 12 weeks) or placebo.

Table 1. Overall Adverse Events With >3% Incidence in US Controlled Clinical Trials With FLOVENT Inhalation Aerosol in Patients Previously Receiving Bronchodilators and/or Inhaled Corticosteroids

Adverse Event

Placebo (N = 475) %

FLOVENT 88 mcg Twice Daily (N = 488) %

FLOVENT 220 mcg Twice Daily (N = 95) %

FLOVENT 440 mcg Twice Daily (N = 185) %

Ear, nose, and throat

       

Pharyngitis

7

10

14

14

Nasal congestion

8

8

16

10

Sinusitis

4

3

6

5

Nasal discharge

3

5

4

4

Dysphonia

1

4

3

8

Allergic rhinitis

4

5

3

3

Oral candidiasis

1

2

3

5

Respiratory

       

Upper respiratory infection

12

15

22

16

Influenza

2

3

8

5

Neurological

       

Headache

14

17

22

17

Average duration of exposure (days)

44

66

64

59

Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in groups treated with FLOVENT (fluticasone propionate) Inhalation Aerosol 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 urticaria and rash and other rare events of angioedema and bronchospasm, have been reported.

Systemic glucocorticoid side effects were not reported during controlled clinical trials with FLOVENT (fluticasone propionate) Inhalation Aerosol. If recommended doses are exceeded, however, or if individuals are particularly sensitive, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.

Other adverse events that occurred in these clinical trials using FLOVENT (fluticasone propionate) Inhalation Aerosol with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

Ear, Nose, and Throat: Pain in nasal sinus(es), rhinitis.

Eye: Irritation of the eye(s).

Gastrointestinal: Nausea and vomiting, diarrhea, dyspepsia and stomach disorder.

Miscellaneous: Fever.

Mouth and Teeth: Dental problem.

Musculoskeletal: Pain in joint, sprain/strain, aches and pains, pain in limb.

Neurological: Dizziness/giddiness.

Respiratory: Bronchitis, chest congestion.

Skin: Dermatitis, rash/skin eruption.

Urogenital: Dysmenorrhea.

In a 16-week study in patients with asthma requiring oral corticosteroids, the effects of FLOVENT (fluticasone propionate) Inhalation Aerosol, 660 mcg twice daily (N = 32) and 880 mcg twice daily (N = 32), were compared with placebo. Adverse events (whether considered drug-related or nondrug-related by the investigator) reported by more than 3 patients in either group treated with FLOVENT (fluticasone propionate) Inhalation Aerosol and that were more common with FLOVENT (fluticasone propionate) than placebo are shown below:

Ear, Nose, and Throat: Pharyngitis (9% and 25%), nasal congestion (19% and 22%), sinusitis (19% and 22%), nasal discharge (16% and 16%), dysphonia (19% and 9%), pain in nasal sinus(es) (13% and 0%), Candida-like oral lesions (16% and 9%), oropharyngeal candidiasis (25% and 19%).

Respiratory: Upper respiratory infection (31% and 19%), influenza (0% and 13%). Other: Headache (28% and 34%), pain in joint (19% and 13%), nausea and vomiting (22% and 16%), muscular soreness (22% and 13%), malaise/fatigue (22% and 28%), insomnia (3% and 13%).

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.

Ear, Nose, and Throat: Aphonia, facial and oropharyngeal edema, hoarseness, laryngitis, 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.

Psychiatry: Agitation, aggression, depression, and restlessness.

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

Skin: Contusions, cutaneous hypersensitivity reactions, 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).

Read the Flovent (fluticasone propionate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Fluticasone propionate is a substrate of cytochrome P450 3A4. A drug interaction study with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations (see CLINICAL PHARMACOLOGY: Drug Interactions). During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression. Therefore, coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.

In a placebo-controlled, crossover study in 8 healthy volunteers, coadministration of a single dose of orally inhaled fluticasone propionate (1,000 mcg) with multiple doses of ketoconazole (200 mg) to steady state resulted in increased mean plasma fluticasone propionate exposure, a reduction in plasma cortisol AUC, and no effect on urinary excretion of cortisol. Caution should be exercised when FLOVENT (fluticasone propionate) Inhalation Aerosol is coadministered with ketoconazole and other known potent cytochrome P450 3A4 inhibitors.

Last reviewed on RxList: 12/30/2004
This monograph has been modified to include the generic and brand name in many instances.

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