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Flovent

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Flovent

Flovent Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Flovent (fluticasone propionate) is used to prevent asthma attacks. It will not treat an asthma attack that has already begun. It is a steroid. Common side effects include hoarseness or throat irritation.

Flovent should be orally inhaled only in patients aged 12 years and older. The recommended starting dose ranges from 88-880 mcg twice daily. The maximum recommended dose is 880 mcg twice daily. Flovent may interact with conivaptan, diclofenac, imatinib, isoniazid, antibiotics, antifungal medications, antidepressants, heart or blood pressure medication, or HIV/AIDS medicine. Tell your doctor all medications you are taking. During pregnancy, Flovent should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Flovent (fluticasone propionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Flovent Overview - Patient Information: Side Effects

SIDE EFFECTS: Hoarseness or throat irritation may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: white patches in your mouth/on your tongue, signs of infection (such as fever, chills, cough, persistent sore throat), vision problems, increased thirst/urination, easy bruising/bleeding, mental/mood changes (such as depression, mood swings, agitation), bone pain.

Infrequently, this medication may cause sudden severe wheezing/trouble breathing immediately after you use it. If this occurs, use your quick-relief inhaler and get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Flovent (Fluticasone Propionate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Flovent FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Flovent (Fluticasone Propionate) »

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Flovent - User Reviews

Flovent User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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