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The incidence of common adverse events in Table 1 is based upon 7 placebo-controlled US clinical trials in which 1,176 pediatric, adolescent, and adult patients (466 females and 710 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated with FLOVENT DISKUS (fluticasone propionate) (doses of 50 to 500 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 DISKUS (fluticasone propionate) in Patients With Asthma Previously
Receiving Bronchodilators and/or Inhaled Corticosteroids
|Adverse Event|| Placebo
(n = 543)
| FLOVENT DISKUS (fluticasone propionate) 50 mcg Twice Daily
(n = 178)
| FLOVENT DISKUS (fluticasone propionate) 100 mcg Twice Daily
(n = 305)
| FLOVENT DISKUS (fluticasone propionate) 250 mcg Twice Daily
(n = 86)
| FLOVENT DISKUS (fluticasone propionate) 500 mcg Twice Daily
(n = 64)
|Ear, nose, and throat|
|Upper respiratory tract infection||16||20||18||21||14|
|Upper respiratory inflammation||3||5||5||0||5|
|Oral candidiasis||7||< 1||9||6||5|
|Nausea and vomiting||4||8||4||1||2|
|Gastrointestinal discomfort and pain||3||4||3||2||2|
|Viral gastrointestinal infection||1||4||3||3||5|
|Viral respiratory infection||4||4||5||1||2|
|Musculoskeletal and trauma|
|Injury||< 1||2||< 1||0||5|
|Average duration of exposure (days)||56||76||73||79||78|
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 DISKUS (fluticasone propionate) 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 events 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 the groups receiving FLOVENT DISKUS (fluticasone propionate) in these studies with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:
Ear, Nose, and Throat: Ear signs and symptoms; rhinorrhea/postnasal drip; hoarseness/dysphonia; epistaxis; tonsillitis; nasal signs and symptoms; laryngitis; unspecified oropharyngeal plaques; otitis; ear, nose, throat, and tonsil signs and symptoms; ear, nose, and throat polyps; allergic ear, nose, and throat disorders; throat constriction.
Endocrine and Metabolic: Fluid disturbances, weight gain, goiter, disorders of uric acid metabolism, appetite disturbances.
Gastrointestinal: Diarrhea, gastrointestinal signs and symptoms, oral ulcerations, dental discomfort and pain, gastroenteritis, gastrointestinal infections, abdominal discomfort and pain, oral erythema and rashes, mouth and tongue disorders, oral discomfort and pain, tooth decay.
Hepatobiliary Tract and Pancreas: Cholecystitis.
Lower Respiratory: Lower respiratory infections.
Psychiatry: Mood disorders.
Reproduction: Bacterial reproductive infections.
Urology: Urinary infections.
Three (3) of the 7 placebo-controlled US clinical trials were pediatric studies. A total of 592 patients 4 to 11 years were treated with FLOVENT DISKUS (fluticasone propionate) (dosages of 50 or 100 mcg twice daily) or placebo; an additional 174 patients 4 to 11 years received FLOVENT ROTADISK at the same doses. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.
In the first 16 weeks of a 52-week clinical trial in adult patients with asthma who previously required oral corticosteroids (daily doses of 5 to 40 mg oral prednisone), the effects of FLOVENT DISKUS (fluticasone propionate) 500 mcg twice daily (n = 41) and 1,000 mcg twice daily (n = 36) were compared with placebo (n = 34) for the frequency of reported adverse events. Adverse events, whether or not considered drug related by the investigators, reported in more than 5 patients in the group taking FLOVENT DISKUS (fluticasone propionate) and that occurred more frequently with FLOVENT DISKUS (fluticasone propionate) than with placebo are shown below (percent FLOVENT DISKUS (fluticasone propionate) and percent placebo). In considering these data, the increased average duration of exposure for patients taking FLOVENT DISKUS (fluticasone propionate) (105 days for FLOVENT DISKUS (fluticasone propionate) versus 75 days for placebo) should be taken into account.
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%), and upper respiratory tract infection (31% and 24%).
Gastrointestinal: Nausea and vomiting (9% and 0%).
Lower Respiratory: Cough (9% and 3%) and viral respiratory infections (9% and 6%).
Musculoskeletal: Arthralgia and articular rheumatism (17% and 3%) and muscle pain (12% and 0%).
Non-Site Specific: Malaise and fatigue (16% and 9%) and pain (10% and 3%).
Skin: Pruritus (6% and 0%) and 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, facial and oropharyngeal edema, and throat soreness.
Non-Site Specific: Very rare anaphylactic reaction, very rare anaphylactic reaction in patients with severe milk protein allergy.
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).
Read the Flovent Diskus (fluticasone propionate) Side Effects Center for a complete guide to possible side effects
Inhibitors of Cytochrome P450: 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 concentration, resulting in significantly reduced serum cortisol concentrations (see CLINICAL PHARMACOLOGY: Pharmacokinetics: 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 plasma fluticasone propionate concentrations, a reduction in plasma cortisol AUC, and no effect on urinary excretion of cortisol. Caution should be exercised when FLOVENT DISKUS (fluticasone propionate) is coadministered with ketoconazole and other known potent cytochrome P450 3A4 inhibitors.
Last reviewed on RxList: 4/27/2009
This monograph has been modified to include the generic and brand name in many instances.
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