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Flonase (Fluticasone Propionate Nasal) - Side Effects and Adverse Reactions

 
 



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.

 

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 SUSPECTED FLONASE SIDE EFFECTS / ADVERSE REACTIONS

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 considered as verified clinical evidence.

Possible Flonase side effects / adverse reactions in 61 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 61 year old female

Reactions: Productive Cough, Pneumonia, Coronary Artery Bypass, Drug Ineffective, Epistaxis

Suspect drug(s):
Allegra-D - Slow Release
    End date: 2011-01-01

Flonase

Allegra-D - Slow Release
    Start date: 2011-01-01

Allegra
    Start date: 2009-01-01
    End date: 2009-01-01



Possible Flonase side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from United States on 2011-10-07

Patient: 58 year old female

Reactions: Fatigue, Tonsillitis, Pyrexia, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Flonase

Other drugs received by patient: Thyroid TAB; Alprazolam



Possible Flonase side effects / adverse reactions in 55 year old female

Reported by a consumer/non-health professional from United States on 2011-10-12

Patient: 55 year old female

Reactions: Memory Impairment, Cardiac Disorder

Suspect drug(s):
Valsartan
    Dosage: 160 mg , 1 d, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2002-01-01

Bupropion HCL
    Dosage: 300 mg, 1 d, oral
    Administration route: Oral
    Indication: Depression

Ventolin
    Dosage: 90 mcg, 2 hr
    Indication: Asthma

Gabapentin
    Dosage: 6 dosage forms (2 dosage forms, 3 in 1 d), oral
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2004-01-01

Gabapentin
    Dosage: 6 dosage forms (2 dosage forms, 3 in 1 d), oral
    Administration route: Oral
    Indication: Diabetic Neuropathy
    Start date: 2004-01-01

Vicodin
    Dosage: 4 hr, oral
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2006-01-01

Metformin Hydrodchloride/sitagliptin (Metformin and Sitagliptin)
    Dosage: 1 d, oral
    Administration route: Oral
    Indication: Diabetes Mellitus

Klonopin
    Dosage: 1 mg (0.5 mg, 2 in 1 d),oral
    Administration route: Oral
    Indication: Anxiety

Klonopin
    Dosage: 1 mg (0.5 mg, 2 in 1 d),oral
    Administration route: Oral
    Indication: Panic Attack

Prilosec
    Dosage: 40 mg (20 mg, 2 in d, oral
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Epipen
    Dosage: transdermal
    Indication: Hypersensitivity

Imiprex (Imipraminoxide Hydrochloride)
    Dosage: 100 mg, as required, oral
    Administration route: Oral
    Indication: Migraine

Nitroglycerin
    Dosage: 0.4 mg, as required, other
    Indication: Chest Pain

Flovent
    Dosage: 220 mcg (110 mcg, 2 in 1 d)
    Indication: Asthma

Simvastatin
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zyrtec
    Dosage: 10 mg (10 mg, 1 in 1 d),oral
    Administration route: Oral
    Indication: Hypersensitivity
    Start date: 2009-01-01

Lozol
    Dosage: 1.25 mg, 1 d, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2002-01-01

Carafate
    Dosage: 2 gm (1 gm, 2 in 1 d),oral
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Flonase
    Dosage: 500 mcg, 1 d), nasal
    Indication: Hypersensitivity

Multivitamin
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zanaflex
    Dosage: 4 mg (2 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Muscle Spasms
    Start date: 2009-01-01

Lortab
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metofrmin (Metformin)
    Dosage: 500 mg, 1 in d, oral
    Administration route: Oral
    Indication: Diabetes Mellitus

Aggrenox
    Dosage: 2 in 1 d, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-12-01



See index of all Flonase side effect reports >>

Drug label data at the top of this Page last updated: 2013-06-11

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