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 liquid, inhalation aerosol powder, inhalation disk
Along with its needed effects, fluticasone / salmeterol 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 / salmeterol:More common
- Black, tarry stools
- blurred vision
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- decreased vision
- difficulty with breathing or swallowing
- eye pain
- fast heartbeat
- hives or welts
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- nausea or vomiting
- noisy breathing
- painful or difficult urination
- sensation of pins and needles
- shortness of breath
- skin itching, rash, or redness
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stabbing pain in the arms or legs
- swelling of the face, throat, or tongue
- swollen glands
- unusual bleeding or bruising
- Abdominal or stomach pain
- darkening of the skin
- decrease in height
- difficulty with moving
- facial hair growth in females
- fast, slow, pounding, or irregular heartbeat or pulse
- flushed, dry skin
- fruit-like breath odor
- full or round face, neck, or trunk
- heavy bleeding
- increased hunger
- increased thirst or urination
- large, flat, blue, or purplish patches in the skin
- loss of sexual desire or ability
- menstrual irregularities
- mental depression
- muscle pain or stiffness
- muscle wasting
- pain in the back, ribs, arms, or legs
- pain in the joints
- troubled breathing
- unexplained weight loss
- unusual tiredness or weakness
- weight gain
Get emergency help immediately if any of the following symptoms of overdose occur while taking fluticasone / salmeterol:Symptoms of overdose
- Chest pain or tightness
- convulsions (seizures)
- decreased urine output
- dry mouth
- faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- general feeling of discomfort or illness
- high blood pressure
- loss of appetite
- mood changes
- numbness or tingling in the hands, feet, or lips
- sudden sweating
- trouble with sleeping
Some side effects of fluticasone / salmeterol 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
- Body aches or pain
- dryness of the throat
- high-pitched noise when breathing
- runny nose
- trouble with swallowing
- voice changes
- Cough-producing mucus
- flu-like symptoms
- irritation or inflammation of the eye
- muscle pain
- pain or tenderness around the eyes and cheekbones
- sleep disorders
- stuffy nose
- white patches in the mouth or throat or on the tongue
For Healthcare Professionals
Applies to fluticasone / salmeterol: inhalation aerosol, inhalation powder
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 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.
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 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 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 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.
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 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.
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.
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.
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 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 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 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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