Flovent Diskus

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Flovent Diskus Side Effects Center

What Is Flovent Diskus?

Flovent Diskus (fluticasone propionate) Inhalation Powder is a corticosteroid used to prevent asthma attacks.

What Are Side Effects of Flovent Diskus?

Common side effects of Flovent Diskus include:

• headache,
• dryness in your mouth/nose/throat,
• throat irritation,
• white patches or sores inside your mouth or on your lips,
• stuffy or runny nose,
• sinus pain,
• cough,
• hoarseness or deepened voice,
• upper respiratory tract infections, or
• wheezing.

Tell your doctor if you have serious side effects of Flovent Diskus including:

• signs of infection (such as fever, chills, cough, persistent sore throat),
• vision problems,
• increased thirst or urination,
• easy bruising or bleeding,
• mental/mood changes (such as depression, mood swings, agitation), or
• bone pain.

Dosage for Flovent Diskus

Talk to your doctor about your individual recommended dosage.

What Drugs, Substances, or Supplements Interact with Flovent Diskus?

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.

Flovent Diskus During Pregnancy or Breastfeeding

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.

Additional Information

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.

 

Flovent Diskus Consumer Information

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

Call your doctor at once if you have:

• weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
• wheezing, choking, or other breathing problems after using this medicine;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• worsening of your asthma symptoms;
• blood vessel inflammation--fever, cough, stomach pain, weight loss, skin rash, severe tingling, numbness, chest pain; or
• liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Fluticasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat, sinus pain;
• low fever, cough, wheezing, chest tightness;
• hoarseness or deepened voice;
• white patches or sores inside your mouth or on your lips;
• headache; or
• nausea, vomiting, upset stomach.

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)

 

Flovent Diskus Professional Information

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

• Candida albicans infection [see WARNINGS AND PRECAUTIONS]
• Immunosuppression [see WARNINGS AND PRECAUTIONS]
• Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
• Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
• Growth effects [see WARNINGS AND PRECAUTIONS]
• Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

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 1 is based upon 7 placebo-controlled U.S. 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 1. 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 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. 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 U.S. 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.

Infections And Infestations

Esophageal candidiasis.

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)

&Copy; Flovent Diskus Patient Information is supplied by Cerner Multum, Inc. and Flovent Diskus Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.