Serevent Diskhaler Disk Side Effects

Please note - some side effects for Serevent Diskhaler Disk may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: inhalation aerosol; inhalation aerosol with adapter; inhalation powder

General

Salmeterol is usually well-tolerated and adverse effects seen are consistent with its pharmacological action. In general, the severity of these adverse effects are dependent on dose. Tolerance to the adverse effects of salmeterol can occur.

Cardiovascular

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

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.

Musculoskeletal

Musculoskeletal side effects have included tremors, especially at higher doses. Tolerance has developed to the tremorogenic effects. Severe muscle cramping is rarely reported.

Metabolic

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

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.

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.

The nervous system side effects have included headache, restlessness, anxiety, nervousness, irritability, and insomnia.

Respiratory

Respiratory side effects have included cough, paradoxical bronchospasm, and oropharyngeal irritation.

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.

Hypersensitivity

Hypersensitivity reactions have included rash or urticaria.

Other

Concern over the development of tachyphylaxis to the bronchodilating and bronchoprotective effects of beta-agonists has been expressed. Although conflicting data exist, the development of complete tolerance has not been reported.

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