Serevent Diskus Side Effects

Generic Name: salmeterol,salmeterol xinafoate

Please note - some side effects for Serevent Diskus 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 of Serevent Diskus - for the Consumer

Serevent Diskus

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Serevent Diskus:

Headache; nasal or sinus congestion; nervousness; stuffy or runny nose; throat irritation; tremor.

Seek medical attention right away if any of these SEVERE side effects occur when using Serevent Diskus:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; choking; fast or irregular heartbeat; fever; new or worsening asthma symptoms (eg, coughing, increased chest tightness, shortness of breath, wheezing); overexcitement; severe or persistent headache or dizziness; severe or persistent muscle pain or cramps; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Serevent Diskus Side Effects - for the Professional

Serevent Diskus

LABA, including salmeterol, the active ingredient in Serevent Diskus, increase the risk of asthma-related death. Data from a large 28-week placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see Warnings and Precautions (5.1), Clinical Studies (14.1)].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience in Asthma

Adult and Adolescent Patients Aged 12 Years and Older: Two multicenter, 12-week, controlled studies evaluated twice-daily doses of Serevent Diskus in patients aged 12 years and older with asthma. Table 1 reports the incidence of adverse reactions in these 2 studies.

Table 1. Adverse Reaction Incidence in Two 12-Week Clinical Trials in Adult and Adolescent Patients With Asthma

Adverse Event	Percent of Patients
	Placebo (N = 152)	Serevent Diskus 50 mcg Twice Daily (N = 149)	Albuterol Inhalation Aerosol 180 mcg 4 Times Daily (N = 150)
Ear, nose, and throat
Nasal/sinus congestion, pallor	6	9	8
Rhinitis	4	5	4
Neurological
Headache	9	13	12
Respiratory
Asthma	1	3	<1
Tracheitis/bronchitis	4	7	3
Influenza	2	5	5

Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving Serevent Diskus and were more common than in the placebo group.

Pharyngitis, sinusitis, upper respiratory tract infection, and cough occurred at ≥3% but were more common in the placebo group. However, throat irritation has been described at rates exceeding that of placebo in other controlled clinical trials.

Additional Adverse Reactions: Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by patients with asthma treated with Serevent Diskus compared with patients treated with placebo include the following: contact dermatitis, eczema, localized aches and pains, nausea, oral mucosal abnormality, pain in joint, paresthesia, pyrexia of unknown origin, sinus headache, and sleep disturbance.

Pediatric Patients Aged 4 to 11 Years: Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of Serevent Diskus in patients aged 4 to 11 years with asthma. Table 2 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving Serevent Diskus and were more common than in the placebo group.

Table 2. Adverse Reaction Incidence in Two 12-Week Pediatric Clinical Trials in Patients With Asthma

Adverse Event	Percent of Patients
	Placebo (N = 215)	Serevent Diskus 50 mcg Twice Daily (N = 211)	Albuterol Inhalation Aerosol 200 mcg 4 Times Daily (N = 115)
Ear, nose, and throat
Ear signs and symptoms	3	4	9
Pharyngitis	3	6	3
Neurological
Headache	14	17	20
Respiratory
Asthma	2	4	<1
Skin
Skin rashes	3	4	2
Urticaria	0	3	2

The following events were reported at an incidence of >1% in the salmeterol group and with a higher incidence than in the albuterol and placebo groups: gastrointestinal signs and symptoms, lower respiratory signs and symptoms, photodermatitis, and arthralgia and articular rheumatism.

In clinical trials evaluating concurrent therapy of salmeterol with inhaled corticosteroids, adverse events were consistent with those previously reported for salmeterol, or with events that would be expected with the use of inhaled corticosteroids.

Laboratory Test Abnormalities: Elevation of hepatic enzymes was reported in ≥1% of patients in clinical trials. The elevations were transient and did not lead to discontinuation from the studies. In addition, there were no clinically relevant changes noted in glucose or potassium.

Clinical Trials Experience in Chronic Obstructive Pulmonary Disease

Two multicenter, 24-week, controlled studies have evaluated twice-daily doses of Serevent Diskus in patients with COPD. For presentation (Table 3), the placebo data from a third trial, identical in design, patient entrance criteria, and overall conduct but comparing fluticasone propionate with placebo, were integrated with the placebo data from these 2 studies (total N = 341 for salmeterol and 576 for placebo).

Table 3. Adverse Reactions With ≥3% Incidence in US Controlled Clinical Trials With Serevent Diskus in Patients With Chronic Obstructive Pulmonary Diseasea

Adverse Event	Percent of Patients
	Placebo (N = 576)	Serevent Diskus 50 mcg Twice Daily (N = 341)
Cardiovascular
Hypertension	2	4
Ear, nose, and throat
Throat irritation	6	7
Nasal congestion/blockage	3	4
Sinusitis	2	4
Ear signs and symptoms	1	3
Gastrointestinal
Nausea and vomiting	3	3
Lower respiratory
Cough	4	5
Rhinitis	2	4
Viral respiratory infection	4	5
Musculoskeletal
Musculoskeletal pain	10	12
Muscle cramps and spasms	1	3
Neurological
Headache	11	14
Dizziness	2	4
Average duration of exposure (days)	128.9	138.5

aTable 3 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving Serevent Diskus and were more common in the group receiving Serevent Diskus than in the placebo group.

Additional Adverse Reactions: Other events occurring in the group receiving Serevent Diskus that occurred at a frequency of ≥1% and were more common than in the placebo group were as follows: anxiety; arthralgia and articular rheumatism; bone and skeletal pain; candidiasis mouth/throat; dental discomfort and pain; dyspeptic symptoms; edema and swelling; gastrointestinal infections; hyperglycemia; hyposalivation; keratitis and conjunctivitis; lower respiratory signs and symptoms; migraines; muscle pain; muscle stiffness, tightness, and rigidity; musculoskeletal inflammation; pain; and skin rashes.

Adverse reactions to salmeterol are similar in nature to those seen with other selective beta2-adrenoceptor agonists, e.g., tachycardia; palpitations; immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm; headache; tremor; nervousness; and paradoxical bronchospasm.

Laboratory Abnormalities: There were no clinically relevant changes in these trials. Specifically, no changes in potassium were noted.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of salmeterol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to salmeterol or a combination of these factors.

In extensive US and worldwide postmarketing experience with salmeterol, serious exacerbations of asthma, including some that have been fatal, have been reported. In most cases, these have occurred in patients with severe asthma and/or in some patients in whom asthma has been acutely deteriorating [see Warnings and Precautions (5.2)], but they have also occurred in a few patients with less severe asthma. It was not possible from these reports to determine whether salmeterol contributed to these events.

Cardiovascular: Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) and anaphylaxis.

Non-Site Specific: Very rare anaphylactic reaction in patients with severe milk protein allergy.

Respiratory: Reports of upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking; oropharyngeal irritation.

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Side Effects by Body System - for Healthcare Professionals

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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