Flovent Side Effects

Generic Name: fluticasone,fluticasone

Please note - some side effects for Flovent may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Flovent - for the Consumer

Flovent HFA Aerosol Inhaler

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flovent HFA Aerosol Inhaler:

Dry mouth; flu; headache; hoarseness; mouth or throat irritation; nasal discharge; runny nose; sinus swelling; sore throat; stuffy nose; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; lack of energy; nausea; severe dizziness; slowed growth in children; sudden weight loss; tingling of the arms and legs; tiredness; vision changes; vomiting; weakness; wheezing; white patches or sores in the mouth.

Flovent Aerosol Inhaler

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flovent Aerosol Inhaler:

Dry mouth; flu; headache; hoarseness; nasal discharge; runny nose; sinus swelling; sore throat; stuffy nose; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; lack of energy; nausea; severe dizziness; slowed growth in children; sudden weight loss; tingling of the arms and legs; tiredness; vomiting; weakness; wheezing; white curd-like patches in the mouth.

Flovent Rotadisk Powder

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flovent Rotadisk Powder:

Back problems; bronchitis; cough; diarrhea; difficulty speaking; dry mouth; fever; flu; headache; hoarseness; muscle pain; nausea; oral yeast infection; runny nose; sinus inflammation; sore throat; stomach pain or discomfort; stuffy nose; throat irritation; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cataracts; choking; fainting; growth suppression in children; irregular heartbeat; numbness or tingling in arms or legs; pounding in the chest; severe dizziness; sudden weight loss; swelling of the throat; unusual weakness; vomiting; wheezing; white curd-like patches in the mouth; worsening of asthma.

Flovent Diskus Powder

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flovent Diskus Powder:

Back problems; bronchitis; cough; diarrhea; difficulty speaking; dry mouth; fever; flu; headache; hoarseness; muscle pain; nausea; oral yeast infection; runny nose; sinus inflammation; sore throat; stomach pain or discomfort; stuffy nose; throat irritation; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cataracts; choking; fainting; growth suppression in children; irregular heartbeat; numbness or tingling in arms or legs; pounding in the chest; severe dizziness; sudden weight loss; swelling of the throat; unusual weakness; vomiting; wheezing; white curd-like patches in the mouth; worsening of asthma.

Flovent Side Effects - for the Professional

Flovent Inhalation Powder

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 (doses of 50 to 500 mcg twice daily for up to 12 weeks) or placebo.

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 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 in these studies with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were:

Palpitations.

Soft tissue injuries, contusions and hematomas, wounds and lacerations, postoperative complications, burns, poisoning and toxicity, pressure-induced disorders.

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.

Fluid disturbances, weight gain, goiter, disorders of uric acid metabolism, appetite disturbances.

Keratitis and conjunctivitis, blepharoconjunctivitis.

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.

Cholecystitis.

Lower respiratory infections.

Muscle pain, arthralgia and articular rheumatism, muscle cramps and spasms, musculoskeletal inflammation.

Dizziness, sleep disorders, migraines, paralysis of cranial nerves.

Chest symptoms; malaise and fatigue; pain; edema and swelling; bacterial infections; fungal infections; mobility disorders; cysts, lumps, and masses.

Mood disorders.

Bacterial reproductive infections.

Skin rashes, urticaria, photodermatitis, dermatitis and dermatosis, viral skin infections, eczema, fungal skin infections, pruritus, acne and folliculitis.

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 (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 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 and that occurred more frequently with Flovent DISKUS than with placebo are shown below (percent Flovent DISKUS and percent placebo). In considering these data, the increased average duration of exposure for patients taking Flovent DISKUS (105 days for Flovent DISKUS versus 75 days for placebo) should be taken into account.

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%).

Nausea and vomiting (9% and 0%).

Cough (9% and 3%) and viral respiratory infections (9% and 6%).

Arthralgia and articular rheumatism (17% and 3%) and muscle pain (12% and 0%).

Malaise and fatigue (16% and 9%) and pain (10% and 3%).

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.

Aphonia, facial and oropharyngeal edema, and throat soreness.

Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis.

Cataracts.

Agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Very rare anaphylactic reaction, very rare anaphylactic reaction in patients with severe milk protein allergy.

Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.

Contusions and ecchymoses.

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.

Side Effects by Body System

Hypersensitivity

Cases of serious eosinophilic conditions also have been reported with other inhaled corticosteroids in this clinical setting.

Hypersensitivity adverse effects have included rare cases of immediate and delayed reactions including rash, angioedema and bronchospasm. Hypersensitivity adverse effects have also included postmarketing reports of a systemic eosinophilic condition and anaphylactic reactions, including very rare anaphylactic reactions in patients with severe milk protein allergy. Clinical features of this condition have included a vasculitis consistent with Churg-Strauss syndrome, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy. These events have usually been associated with a reduction and/or discontinuation of oral corticosteroid therapy following introduction of fluticasone.

Local

Asthma treatment with high doses of inhaled fluticasone powder apparently led to a serious case of laryngeal aspergillosis in a 75-year-old man. The patient had been using fluticasone 1 mg twice daily via Diskhaler for about 3 years. The patient experienced progressive hoarseness which lead to complete aphonia. Aspergillosis fumigatus was cultured from the vocal cords. Amphotericin B lozenges were used to treat the infection. After 14 weeks the patient's voice was still gruff but intelligible. It is recommended that tests for fungal infection be performed in patients on fluticasone therapy who become hoarse, particularly if taking high doses.

Local side effects associated with inhaled fluticasone have included dysphonia, sore throat, bronchitis, chest congestion, nasal congestion, nasal discharge, and eye irritation.

Endocrine

Due to extensive first-pass metabolism of fluticasone to an inactive carboxylic acid, significant systemic effects are not expected from any amount of the drug that may be ingested via inhalation of normally recommended dosages.

Endocrine side effects have included rare reports of symptoms of hypothalamic-pituitary-adrenal (HPA) axis suppression. These effects are more likely when higher potency corticosteroids are used in large doses. The use of a large-volume spacer may help minimize HPA suppression when fluticasone is inhaled orally.

Immunologic

Immunologic effects of infections from immune suppression associated with inhaled corticosteroids have been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled fluticasone.

In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its decision regarding the labeled risks of the use of inhaled corticosteroids during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.

Nervous system

Nervous system side effects have included headache, dizziness, giddiness, fatigue, and insomnia.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and diarrhea. Oropharyngeal candidiasis and candida-like lesions have also been reported.

Ocular

Ocular side effects have included posterior capsular cataracts, especially with long-term use.

One epidemiologic study suggests that prolonged use of high-dose inhaled corticosteroids (>= 1500 mcg of fluticasone) may be associated with increased risk of ocular hypertension and open-angle glaucoma.

Musculoskeletal

Musculoskeletal adverse effects have included joint pain and muscle soreness. Long-term use of inhaled corticosteroids may be associated with a reduction in bone density. This effect may be dose related and has been reported with high dosages of orally inhaled beclomethasone and budesonide (>=800 mcg/day for >=1 year). Reduced levels of total body calcium have also been demonstrated in patients receiving lower dosages.

Psychiatric

Psychiatric side effects have included agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely.

Other

Other side effects have included postmarketing reports of facial and oropharyngeal edema.

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