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Flovent Diskus

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Flovent Diskus

Flovent Diskus Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Flovent Diskus (fluticasone propionate) Inhalation Powder is a corticosteroid used to prevent asthma attacks. Common side effects of Flovent Diskus include headache, dryness in your mouth, nose, and throat, white patches or sores inside your mouth or on your lips, stuffy nose, sinus pain, cough, and hoarseness.

Talk to your doctor about your individual recommended dosage. Vaprisol, Gleevec, isoniazid, Biaxin, Erythrocin, Pediazole, Nizoral, nefazodone, Dilacor, Rescriptor, and Norvir may interact with Flovent Diskus. Tell your doctor all medications you take. Before using Flovent Diskus tell your doctor if you have been sick or had an infection, are under stress, or have recently had an asthma attack. If you are pregnant only take Flovent Diskus if the potential benefit outweighs the potential risk to the fetus. Do not take Flovent Diskus if you are breastfeeding.

Our Flovent Diskus (fluticasone propionate) Inhalation Powder 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 in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Flovent Diskus in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fluticasone and call your doctor at once if you have a serious side effect such as:

  • weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • blurred vision, eye pain, or seeing halos around lights;
  • signs of infection such as fever, chills, sore throat, ear pain, flu symptoms;
  • wheezing or breathing problems after using this medication; or
  • worsening asthma symptoms.

Less serious side effects may include:

  • headache;
  • dryness in your mouth, nose, or throat;
  • white patches or sores inside your mouth or on your lips;
  • stuffy nose, sinus pain, cough; or
  • hoarseness or deepened voice.

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.

Read the entire detailed patient monograph for Flovent Diskus (Fluticasone Propionate) »

What is Patient Information Overview?

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

Flovent Diskus Overview - Patient Information: Side Effects

SIDE EFFECTS: Hoarseness, throat irritation, or headache may occur. If any of these effects persist or worsen, 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 Diskus (Fluticasone Propionate)»

What is Prescribing information?

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

Flovent Diskus FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidence of common adverse reactions in Table 2 is based upon 7 placebocontrolled US clinical trials in which 1,176 pediatric, adolescent, and adult subjects (466 females and 710 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated twice daily for up to 12 weeks with FLOVENT DISKUS (doses of 50 to 500 mcg) or placebo.

Table 2: Adverse Reactions With FLOVENT DISKUS With > 3% Incidence and More Common Than Placebo in Subjects With Asthma

Adverse Event FLOVENT DISKUS 50 mcg Twice Daily
(n = 178) %
FLOVENT DISKUS 100 mcg Twice Daily
(n = 305) %
FLOVENT DISKUS 250 mcg Twice Daily
(n = 86) %
FLOVENT DISKUS 500 mcg Twice Daily
(n = 64) %
Placebo
(n = 543) %
Ear, nose, and throat
  Upper respiratory tract infection 20 18 21 14 16
  Throat irritation 13 13 3 22 8
  Sinusitis/sinus infection 9 10 6 6 6
  Upper respiratory inflammation 5 5 0 5 3
  Rhinitis 4 3 1 2 2
  Oral candidiasis < 1 9 6 5 7
Gastrointestinal
  Nausea and vomiting 8 4 1 2 4
  Gastrointestinal discomfort and pain 4 3 2 2 3
  Viral gastrointestinal infection 4 3 3 5 1
Non-site specific
  Fever 7 7 1 2 4
  Viral infection 2 2 0 5 2
Lower respiratory
  Viral respiratory infection 4 5 1 2 4
  Cough 3 5 1 5 4
  Bronchitis 2 3 0 8 1
Neurological
  Headache 12 12 2 14 7
Musculoskeletal and trauma
  Muscle injury 2 0 1 5 1
  Musculoskeletal pain 4 3 2 5 2
  Injury 2 < 1 0 5 < 1

Table 2 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. Less than 2% of subjects discontinued from the trials because of adverse reactions. The average duration of exposure was 73 to 79 days in the active treatment groups compared with 56 days in the placebo group.

Additional Adverse Reactions

Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT DISKUS compared with subjects treated with placebo include the following: palpitations; soft tissue injuries; contusions and hematomas; wounds and lacerations; burns; poisoning and toxicity; pressure-induced disorders; hoarseness/dysphonia; epistaxis; 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; appetite disturbances; keratitis and conjunctivitis; blepharoconjunctivitis; gastrointestinal signs and symptoms; oral ulcerations; dental discomfort and pain; oral erythema and rashes; mouth and tongue disorders; oral discomfort and pain; tooth decay; cholecystitis; arthralgia and articular rheumatism; muscle cramps and spasms; musculoskeletal inflammation; dizziness; sleep disorders; migraines; paralysis of cranial nerves; edema and swelling; bacterial infections; fungal infections; mobility disorders; mood disorders; bacterial reproductive infections; photodermatitis; dermatitis and dermatosis; viral skin infections; eczema; pruritus; acne and folliculitis; urinary infections.

Three (3) of the 7 placebo-controlled US clinical trials were pediatric trials. A total of 592 subjects aged 4 to 11 years were treated with FLOVENT DISKUS (dosages of 50 or 100 mcg twice daily) or placebo; an additional 174 subjects aged 4 to 11 years received FLOVENT® ROTADISK® (fluticasone propionate inhalation powder) 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 subjects 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. The average duration of exposure for subjects taking FLOVENT DISKUS was 105 days compared with 75 days for placebo. Adverse events, whether or not considered drug related by the investigators, reported in more than 5 subjects 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).

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%).

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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.

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

Eye: Cataracts.

Immune System Disorders: Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported. Anaphylactic reactions in patients with severe milk protein allergy have been reported.

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

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

Skin: Contusions and ecchymoses.

Read the entire FDA prescribing information for Flovent Diskus (Fluticasone Propionate) »

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Flovent Diskus - User Reviews

Flovent Diskus User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Flovent Diskus sorted by most helpful. Patient Discussions FAQs

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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