ADVERSE REACTIONS
In controlled US studies, more than 3,300 patients with seasonal allergic, perennial allergic, or perennial nonallergic rhinitis received treatment with intranasal fluticasone propionate. In general, adverse reactions in clinical studies have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions were reported with approximately the same frequency by patients treated with the vehicle itself. The complaints did not usually interfere with treatment. Less than 2% of patients in clinical trials discontinued because of adverse events; this rate was similar for vehicle placebo and active comparators.
Systemic corticosteroid side effects were not reported during controlled clinical studies up to 6 months’ duration with FLONASE Nasal Spray. If recommended doses are exceeded, however, or if individuals are particularly sensitive or taking FLONASE Nasal Spray in conjunction with administration of other corticosteroids, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.
The following incidence of common adverse reactions (>3%, where incidence in fluticasone propionate-treated subjects exceeded placebo) is based upon 7 controlled clinical trials in which 536 patients (57 girls and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) were treated with FLONASE Nasal Spray 200 mcg once daily over 2 to 4 weeks and 2 controlled clinical trials in which 246 patients (119 female and 127 male adolescents and adults) were treated with FLONASE Nasal Spray 200 mcg once daily over 6 months. Also included in the table are adverse events from 2 studies in which 167 children (45 girls and 122 boys aged 4 to 11 years) were treated with FLONASE Nasal Spray 100 mcg once daily for 2 to 4 weeks.
Overall Adverse Experiences With >3% Incidence on Fluticasone Propionate in Controlled Clinical Trials With FLONASE Nasal Spray in Patients≥4 Years With Seasonal or Perennial Allergic Rhinitis
|
Adverse Experience
|
Vehicle Placebo
(n = 758)
%
|
FLONASE 100 mcg Once Daily (n = 167)
%
|
FLONASE 200 mcg Once Daily (n = 782)
%
|
|
Headache
|
14.6
|
6.6
|
16.1
|
|
Pharyngitis
|
7.2
|
6.0
|
7.8
|
|
Epistaxis
|
5.4
|
6.0
|
6.9
|
|
Nasal burning/nasal irritation
|
2.6
|
2.4
|
3.2
|
|
Nausea/vomiting
|
2.0
|
4.8
|
2.6
|
|
Asthma symptoms
|
2.9
|
7.2
|
3.3
|
|
Cough
|
2.8
|
3.6
|
3.8
|
Other adverse events that occurred in ≤3% but ≥1% of patients and that were more common with fluticasone propionate (with uncertain relationship to treatment) included: blood in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like symptoms, aches and pains, dizziness, bronchitis.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of intranasal 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.
General
Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which in rare instances were severe.
Ear, Nose, and Throat
Alteration or loss of sense of taste and/or smell and, rarely, nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, cough, hoarseness, and voice changes.
Eye
Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts.
Cases of growth suppression have been reported for intranasal corticosteroids, including FLONASE (see PRECAUTIONS: Pediatric Use).
|
REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO FLONASE
Below is a sample of reports where side effects / adverse reactions may be related to Flonase. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Flonase side effects / adverse reactions in 55 year old female
Reported by a consumer/non-health professional from United States on 2007-03-19
Patient: 55 year old female weighing 74.8 kg (164.7 pounds)
Reactions: Incorrect Route of Drug Administration, Self-Medication
Adverse event resulted in: disablity
Suspect drug(s):
Flonase
Possible Flonase side effects / adverse reactions in 17 year old male
Reported by a consumer/non-health professional from United States on 2007-03-23
Patient: 17 year old male
Reactions: Overdose, Dementia, Abnormal Behaviour, Disturbance in Attention, Drug Abuser, Ill-Defined Disorder
Suspect drug(s):
Wellbutrin
Indication: Drug USE FOR Unknown Indication
Start date: 2006-01-01
Methamphetamine Hydrochloride
Concerta
Flonase
Possible Flonase side effects / adverse reactions in 20 year old female
Reported by a consumer/non-health professional from United States on 2007-03-23
Patient: 20 year old female
Reactions: Visual Acuity Reduced
Suspect drug(s):
Flonase
Other drugs received by patient: NO Concurrent Medication
|
