Fluticasone / salmeterol Side Effects

Some side effects of fluticasone / salmeterol 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 / salmeterol: inhalation aerosol, inhalation powder

Get emergency medical help if you have any of these signs of an allergic reaction while taking fluticasone / salmeterol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• bronchospasm (wheezing, chest tightness, trouble breathing);

• fast or uneven heart beats, restless feeling, tremor;

• fever, chills, stabbing chest pain, cough with yellow or green mucus;

• blurred vision, eye pain, or seeing halos around lights;

• white patches or sores inside your mouth or on your lips; or

• worsening asthma symptoms.

Less serious side effects include:

• headache, dizziness;

• nausea, vomiting, diarrhea;

• dry mouth, nose, or throat;

• stuffy nose, sinus pain, cough, sore throat; 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.

For Healthcare Professionals

Applies to fluticasone / salmeterol: inhalation aerosol, inhalation powder

Endocrine

Endocrine side effects of fluticasone have rarely included symptoms of hypothalamic-pituitary-adrenal (HPA) axis suppression. These effects were more likely when higher potency corticosteroids were used in large doses. The use of a large-volume spacer has helped minimize HPA suppression when fluticasone was inhaled orally.

Due to extensive first-pass metabolism of fluticasone 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.

Gastrointestinal

Gastrointestinal side effects of fluticasone have included nausea, vomiting, and diarrhea. Oropharyngeal candidiasis and candida-like lesions have also been reported. Gastrointestinal intolerance to salmeterol has occurred resulting in nausea and diarrhea.

Hypersensitivity

Cases of serious eosinophilic conditions also have been reported with other inhaled corticosteroids in this clinical setting.

Hypersensitivity side effects of fluticasone have included rare cases of immediate and delayed reactions including rash, angioedema and bronchospasm. Hypersensitivity side effects have also included postmarketing reports of a systemic eosinophilic condition. 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. Hypersensitivity reactions to salmeterol have presented as rash or urticaria.

Immunologic

Immunologic side effects of fluticasone may have included infections resulting from immune suppression associated with inhaled corticosteroids. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled fluticasone.

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.

Local

Local side effects associated with inhaled fluticasone have included dysphonia, sore throat, bronchitis, chest congestion, nasal congestion, nasal discharge, and eye irritation.

Asthma treatment with high doses of inhaled fluticasone 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 led 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.

Musculoskeletal

Musculoskeletal side effects of fluticasone have included joint pain and muscle soreness. Long-term use of inhaled corticosteroids has been associated with a reduction in bone density. This effect may have been 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. The musculoskeletal effects of salmeterol are mediated by beta-2 receptors and have been manifested as tremors, especially at higher doses. Tolerance can lead to the tremorogenic effects. Severe muscle cramping is rarely reported.

Nervous system

One patient has reported episodes of vertigo lasting 36 hours each following inhalation of salmeterol. These episodes occurred several months apart during separate attempts to reinstitute therapy.

Nervous system side effects of fluticasone have included headache, dizziness, giddiness, fatigue, and insomnia. The nervous system has been adversely affected by salmeterol resulting in headache, restlessness, anxiety, nervousness, irritability, and insomnia.

Ocular

Ocular side effects of fluticasone have included occasional reports of posterior capsular cataracts. In addition, one epidemiologic study suggested that prolonged use of high-dose inhaled corticosteroids (>= 1500 mcg of fluticasone) may have been associated with increased risk of ocular hypertension and open-angle glaucoma.

Cardiovascular

Changes in heart rate of approximately 8 to 16 beats per minute may be produced by 0.2 mg of salmeterol given by MDI. At an inhaled dose of 0.4 mg, two subjects have experienced nonspecific T-wave changes, and one subject experienced QT prolongation. Higher doses of salmeterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.

Cardiovascular side effects of salmeterol have included palpitations and peripheral vasodilation, commonly resulting in reflex tachycardia. Blood pressure has been increased and decreased. Higher doses have rarely aggravated angina, myocardial ischemia, or caused atrial or ventricular arrhythmias.

General

Salmeterol has been generally well-tolerated and adverse effects seen were consistent with its pharmacological action. In general, the severity of these adverse effects were dependent on dose. Tolerance to the adverse effects of salmeterol has occurred.

Metabolic

Following a 400-mcg dose of salmeterol via MDI, a decrease in plasma potassium concentrations of 0.45 mEq/L has been reported. Salmeterol may stimulate sodium-potassium ATPase resulting in an intracellular shift of potassium.

Metabolic side effects associated with salmeterol have included hypokalemia, and less commonly hyperglycemia.

Respiratory

Respiratory side effects of salmeterol have occasionally included cough and paradoxical bronchospasm. Additional side effects reported have included upper respiratory tract infections, viral respiratory infections, bronchitis, and pneumonia.

Less commonly respiratory side effects have included chest congestion, chest tightness, dyspnea, immediate bronchospasm, influenza, tracheitis, wheezing, and reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids. There was a higher incidence of pneumonia among patients receiving fluticasone-salmeterol (7%) than among those receiving salmeterol (4%) in a clinical study.

Other

Other side effects have concerned the development of tachyphylaxis to the bronchodilating and bronchoprotective effects of beta-agonists. Although conflicting data exist, the development of complete tolerance has not been reported.

Psychiatric

Psychiatric side effects have included post marketing reports of agitation, aggression, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

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