Flovent HFA Risks, Warnings, and Complications

ORAL CANDIDIASIS: Inhaled steroid medicines such as Flovent HFA (inhaled fluticasone) can lead to oral candidiasis (localized fungal infections in the mouth and throat by a fungus called Candida albicans). To lower the risk of oropharyngeal candidiasis, rinse your mouth with water after each use of Flovent HFA. Spit the water out after rinsing your mouth. Do not swallow the water. 

Tell your doctor immediately if you develop painful white patches in your mouth or throat. You may need to take an antifungal medicine to treat oral thrush while continuing treatment with Flovent HFA. Your healthcare provider may recommend interrupting treatment with the inhaled steroid if the fungal infection is severe.

NOT FOR TREATMENT OF ACUTE ASTHMA EPISODES: Flovent HFA is an inhaled steroid and it is used for long-term maintenance treatment and prevention of asthma attacks. This medicine should not be used to treat a severe asthma attack after it has begun. Your doctor will prescribe a short-acting rescue inhaler, such as albuterol, for sudden breathing problems and acute asthma episodes. Tell your doctor if your symptoms during an asthma attack do not improve with bronchodilators (rescue inhalers) or if you need to use rescue inhalers more frequently.

IMMUNOSUPPRESSION: Flovent HFA contains inhaled fluticasone which is a corticosteroid medicine. It can lead to suppression of the body’s immune system. This can put people using Flovent HFA at a greater risk of getting infections and having more severe outcomes from infections. For example, infections like chickenpox and measles may have fatal outcomes in such individuals.

 Before starting treatment with Flovent HFA, tell your healthcare provider if you are not immunized against chickenpox and measles and have not had these infections in the past. Avoid contact with people who are sick with these infections. Tell your doctor immediately if you are exposed to someone with chickenpox or measles. You may need to be treated with varicella zoster immune globulin (VZIG) for protection against chickenpox or pooled intravenous immunoglobulin (IVIG) for protection against measles.

 Inhaled steroids should be used with caution or avoided in people with tuberculosis, ocular herpes infection, respiratory infections, and other bacterial, viral, fungal, or parasitic infections.

TRANSITION FROM SYSTEMIC CORTICOSTEROIDS: Some inhaled fluticasone (Flovent HFA) is absorbed into the body, but it provides less systemically available steroid medicine compared to oral corticosteroids. If a person is on oral steroids, their healthcare provider may lower the dose after starting Flovent HFA. However, if this transition is done too quickly, it can lead to potentially life-threatening adrenal insufficiency due to suppression of the hypothalamic-pituitary-adrenal (HPA) axis. This is more likely to occur during periods of stress, trauma, surgery, infection, or illness.

Your doctor will gradually lower the dose of oral corticosteroids after starting you on Flovent HFA. Follow the dosing instructions carefully. They will also monitor lung function during this time.

 Seek immediate medical care for signs and symptoms of adrenal insufficiency, such as fatigue, weakness, low energy, joint pain, muscle pain, nausea, vomiting, and low blood pressure.

 Transitioning from oral to inhaled steroids can also unmask signs and symptoms of conditions such as allergic rhinitis, conjunctivitis, arthritis, eczema, and eosinophilic conditions.

HYPERCORTICISM AND ADRENAL INSUFFICIENCY: Inhaled steroids such as Flovent HFA can be absorbed into the bloodstream and have systemic effects similar to oral corticosteroids. This can lead to hypercorticism (high cortisol levels) and adrenal insufficiency or adrenal crisis (low adrenal gland hormones). The risk of these complications is more during periods of stress and in patients who are on high doses of Flovent HFA or long-term treatment. If you develop systemic corticosteroid effects, your healthcare provider will lower the dose of Flovent HFA slowly and use other medicines to control asthma.

SEVERE ALLERGIC REACTIONS: Severe allergic reactions, including skin rash, hives, itching, swelling, bronchospasm (narrowing of the airways), hypotension (low blood pressure), and anaphylaxis (throat closing) can occur after use of Flovent HFA. Stop using the medicine and seek emergency medical attention in case of a serious hypersensitivity reaction.

REDUCTION IN BONE MINERAL DENSITY: Long-term use of inhaled steroids, including Flovent HFA, can lead to a decrease in bone mineral density (BMD). It is unclear if this reduction in BMD is severe enough to cause osteoporosis or increase the risk of bone fractures. Tell your healthcare provider if you have other risk factors for osteoporosis, such as a family history of the condition, prolonged immobilization, smoking, advanced age, postmenopausal status, poor nutrition, or long-term use of other drugs that can also affect bone mineral density, such as oral steroids or anticonvulsants.

SLOW GROWTH IN CHILDREN: Steroid medications can lead to slow growth rates in children. Your child’s healthcare provider will monitor growth carefully if the child is on Flovent HFA for the prevention of asthma attacks. They will prescribe the lowest dose possible for the shortest period of time to manage your child’s asthma. Treatment with Flovent HFA may need to be stopped if it is affecting your child’s growth.

EYE PROBLEMS: Long-term use of Flovent HFA can increase the risk of eye conditions such as cataracts and glaucoma (increased intraocular pressure). Tell your healthcare provider without delay if you notice any eye pain or changes in vision.

PARADOXICAL BRONCHOSPASM: Flovent HFA can sometimes paradoxically cause bronchospasm (narrowing or tightening of the airways), leading to wheezing, cough, difficulty breathing, and chest discomfort. Use a rescue inhaler and get medical attention immediately if you develop sudden breathing problems immediately after using Flovent HFA. Talk to your doctor before using Flovent HFA again.

INTERACTIONS WITH OTHER DRUGS: Using Flovent HFA (inhaled fluticasone) with certain other drugs called cytochrome P450 3A4 inhibitors can lead to increased levels of fluticasone in the body and an increased risk of adverse effects. Examples of strong cytochrome P450 3A4 inhibitors include HIV medicines such as ritonavir, atazanavir, indinavir, nelfinavir, and saquinavir; antibiotics such as clarithromycin and telithromycin; antifungal agents such as ketoconazole and itraconazole; and antidepressants such as nefazodone. Give your healthcare provider a complete list of your medications before starting treatment with Flovent HFA to avoid potentially dangerous interactions.