Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Flovent HFA

Last reviewed on RxList: 6/27/2017
Flovent HFA Side Effects Center

Last reviewed on RxList 6/27/2017

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

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

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

  • signs of infection (such as fever, chills, 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.

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 breastfeeding.

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.

Flovent HFA 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 HFA (Fluticasone Propionate HFA)

Flovent HFA Professional Information

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 placebo-controlled US clinical trials in which 812 adult and adolescent subjects (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 FLOVENT HFA with > 3% Incidence and More Common than Placebo in Subjects Aged 12 Years and Older with Asthma

Adverse Event FLOVENT HFA88 mcg Twice Daily
(n=203)%
FLOVENT HFA 220 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 and 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 subjects discontinued from the trials 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 drugrelated or not by the investigators, that were reported more frequently by subjects with asthma treated with FLOVENT HFA compared with subjects 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 subjects with asthma requiring oral corticosteroids (Trial 3). Adverse reactions not included above, but reported by more than 3 subjects 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 trials (26 and 52 weeks), the pattern of adverse reactions in subjects treated with FLOVENT HFA at dosages up to 440 mcg twice daily was similar to that observed in the 12-week trials. There were no new and/or unexpected adverse reactions with long-term treatment.

Pediatric Subjects Aged 4 To 11 Years

FLOVENT HFA has been evaluated for safety in 56 pediatric subjects who received 88 mcg twice daily for 4 weeks. Types of adverse reactions in these pediatric subjects 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 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 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.

Immune System Disorders: Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, and angioedema and bronchospasm, 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, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze.

Skin: Contusions, cutaneous hypersensitivity reactions, ecchymoses, and pruritus.

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

Related Resources for Flovent HFA

Related Health

Read the Flovent HFA User Reviews »

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

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED ARTICLE