Flovent HFA Side Effects
Generic Name: fluticasone
Note: This document contains side effect information about fluticasone. Some of the dosage forms listed on this page may not apply to the brand name Flovent HFA.
Some side effects of Flovent HFA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to fluticasone: inhalation aerosol powder, inhalation disk, inhalation powder
Along with its needed effects, fluticasone (the active ingredient contained in Flovent HFA) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fluticasone:More common
- White patches in mouth and throat
- ear ache
- lower abdominal pain
- pain on passing urine
- redness or discharge of the eye, eyelid, or lining of the eye
- shortness of breath
- sore throat
- trouble in swallowing
- vaginal discharge (creamy white) and itching
- Blindness, blurred vision, eye pain
- large hives
- bone fractures
- diabetes mellitus [increased hunger, thirst, or urination]
- excess facial hair in women
- fullness or roundness of face, neck, and trunk
- growth reduction in children or adolescents
- heart problems
- high blood pressure
- hives and skin rash
- impotence in males
- lack of menstrual periods
- muscle wasting
- numbness and weakness of hands and feet
- swelling of face, lips, or eyelids
- tightness in chest, troubled breathing, or wheezing
- Difficulty breathing
- difficulty swallowing
- fast heartbeat
- growth rate decreased in children and teenagers
- itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- noisy breathing
- swelling of the mouth or throat
- Darkening of skin
- loss of appetite
- mental depression
- unusual tiredness or weakness
Some side effects of fluticasone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- general aches and pains or general feeling of illness
- greenish-yellow mucus in nose
- hoarseness or other voice changes
- runny, sore, or stuffy nose
- Bloody mucus or unexplained nosebleeds
- eye irritation
- feeling 'faint'
- irregular or painful menstrual periods
- irritation due to inhalant
- joint pain
- mouth irritation
- muscle soreness, sprain, or strain
- stomach pain or burning
- weight gain
- Abdominal pain
- blurred vision
- decrease in height
- dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of voice
- pain in back, ribs, arms or legs
- trouble sitting still
- unexplained weight loss
For Healthcare Professionals
Applies to fluticasone: inhalation aerosol, inhalation aerosol with adapter, inhalation powder, inhalation suspension
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.
Asthma treatment with high doses of inhaled fluticasone (the active ingredient contained in Flovent HFA) 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.
Due to extensive first-pass metabolism of fluticasone (the active ingredient contained in Flovent HFA) 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 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 (the active ingredient contained in Flovent HFA)
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 side effects have included headache, dizziness, giddiness, fatigue, and insomnia.
Gastrointestinal side effects have included nausea, vomiting, and diarrhea. Oropharyngeal candidiasis and candida like lesions have also been reported. Postmarketing experience has included dental caries and tooth discoloration.
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 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 side effects have included agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely.
Other side effects have included postmarketing reports of facial and oropharyngeal edema.
More about Flovent HFA (fluticasone)
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