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Flovent HFA

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Flovent HFA

Flovent HFA

Flovent HFA Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Flovent HFA (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 HFA should be orally inhaled only in patients aged 4 years and older. For adults and children 12 years of age and older, the recommended starting dose ranges from 88-440 mcg twice daily, and the highest recommended dose is 880 mcg. The pediatric dose is 88 mcg twice daily. Flovent HFA 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 HFA should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Flovent HFA (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 in Detail?

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

Flovent HFA 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 HFA (Fluticasone Propionate HFA) »

What is Patient Information Overview?

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

Flovent HFA 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 HFA (Fluticasone Propionate HFA)»

What is Prescribing information?

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

Flovent HFA 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 2 placebocontrolled US clinical trials in which 812 adult and adolescent patients (457 females and 355 males) previously treated with as-needed bronchodilators and/or inhaled corticosteroids were treated twice daily for up to 12 weeks with 2 inhalations of FLOVENT HFA 44 mcg Inhalation Aerosol, FLOVENT HFA 110 mcg Inhalation Aerosol, FLOVENT HFA 220 mcg Inhalation Aerosol (dosages of 88, 220, or 440 mcg twice daily), or placebo.

Table 2: Adverse Reactions With > 3% Incidence in US Controlled Clinical Trials With FLOVENT HFA in Patients Aged 12 Years and Older With Asthma Previously Receiving Bronchodilators and/or Inhaled Corticosteroids

Adverse Event FLOVENT HFA 88 mcg Twice Daily
(n = 203) %
FLOVENT HFA220 mcg Twice Daily
(n = 204) %
FLOVENT HFA 440 mcg Twice Daily
(n = 202) %
Placebo
(n = 203) %
Ear, nose, and throat
  Upper respiratory tract infection 18 16 16 14
  Throat irritation 8 8 10 5
  Upper respiratory inflammation 2 5 5 1
  Sinusitis/sinus infection 6 7 4 3
  Hoarseness/dysphonia 2 3 6 < 1
Gastrointestinal
  Candidiasis mouth/throat & non-site specific 4 2 5 < 1
Lower respiratory
  Cough 4 6 4 5
  Bronchitis 2 2 6 5
Neurological
  Headache 11 7 5 6

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 HFA and were more common than in the placebo group. Less than 2% of patients discontinued from the studies because of adverse reactions. The average duration of exposure was 73 to 76 days in the active treatment groups compared with 60 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 patients with asthma treated with FLOVENT HFA compared with patients treated with placebo include the following: rhinitis, rhinorrhea/post-nasal drip, nasal sinus disorders, laryngitis, diarrhea, viral gastrointestinal infections, dyspeptic symptoms, gastrointestinal discomfort and pain, hyposalivation, musculoskeletal pain, muscle pain, muscle stiffness/tightness/rigidity, dizziness, migraines, fever, viral infections, pain, chest symptoms, viral skin infections, muscle injuries, soft tissue injuries, urinary infections.

Fluticasone propionate inhalation aerosol (440 or 880 mcg twice daily) was administered for 16 weeks to 168 patients with asthma requiring oral corticosteroids (Study 3). Adverse reactions not included above, but reported by more than 3 patients in either group treated with FLOVENT HFA and more commonly than in the placebo group included nausea and vomiting, arthralgia and articular rheumatism, and malaise and fatigue.

In 2 long-term studies (26 and 52 weeks), the pattern of adverse reactions in patients treated with FLOVENT HFA at dosages up to 440 mcg twice daily was similar to that observed in the 12-week studies. There were no new and/or unexpected adverse reactions with long-term treatment.

Pediatric Patients Aged 4 to 11 Years

FLOVENT HFA has been evaluated for safety in 56 pediatric patients who received 88 mcg twice daily for 4 weeks. Types of adverse reactions in these pediatric patients were generally similar to those observed in adults and adolescents.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postmarketing 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 and irritation.

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

Eye: Cataracts.

Gastrointestinal Disorders: Dental caries and tooth discoloration.

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

Immune System Disorders: Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, and angioedema and bronchospasm, have been reported.

Respiratory: Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed 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 [see WARNINGS AND PRECAUTIONS].

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

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Flovent HFA - User Reviews

Flovent HFA 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 HFA 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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