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Serevent (Salmeterol Xinafoate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Adverse reactions to salmeterol are similar in nature to reactions to other selective beta2-adrenoceptor agonists, i.e., tachycardia; palpitations; immediate hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm (see WARNINGS); headache; tremor; nervousness; and paradoxical bronchospasm (see WARNINGS).

Asthma

Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT Inhalation Aerosol in patients 12 years of age and older with asthma. Table 3 reports the incidence of adverse events in these 2 studies.

Table 3. Adverse Event Incidence in 2 Large 12-Week Clinical Trials in Patients With Asthma*

Adverse Event

Percent of Patients

Placebo

(N = 187)

SEREVENT Inhalation Aerosol 42 mcg Twice Daily (N = 184)

Albuterol Inhalation Aerosol 180 mcg 4 Times Daily (N = 185)

Ear, nose, and throat

Upper respiratory tract infection

13

14

16*

Nasopharyngitis

12

14

11

Disease of nasal cavity/sinus

4

6

1

Sinus headache

2

4

<1

Gastrointestinal

Stomachache

0

4

0

Neurological

Headache

23

28

27

Tremor

2

4

3

Respiratory

Cough

6

7

3

Lower respiratory infection

2

4

2

* The only adverse event classified as serious was 1 case of upper respiratory tract infection in a patient treated with albuterol.

Table 3 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in the group treated with SEREVENT Inhalation Aerosol and were more common in the group treated with SEREVENT Inhalation Aerosol than in the placebo group.

Pharyngitis, allergic rhinitis, dizziness/giddiness, and influenza occurred at 3% or more but were equally common on placebo. Other events occurring in the group treated with SEREVENT Inhalation Aerosol at a frequency of 1% to 3% were as follows:

Cardiovascular

Tachycardia, palpitations.

Ear, Nose, and Throat

Rhinitis, laryngitis.

Gastrointestinal

Nausea, viral gastroenteritis, nausea and vomiting, diarrhea, abdominal pain.

Hypersensitivity

Urticaria.

Mouth and Teeth

Dental pain.

Musculoskeletal

Pain in joint, back pain, muscle cramp/contraction, myalgia/myositis, muscular soreness.

Neurological

Nervousness, malaise/fatigue.

Respiratory

Tracheitis/bronchitis.

Skin

Rash/skin eruption.

Urogenital

Dysmenorrhea.

Data from small dose-response studies show an apparent dose relationship for tremor, nervousness, and palpitations.

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

Chronic Obstructive Pulmonary Disease

Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT Inhalation Aerosol in patients with COPD. Table 4 reports the incidence of adverse events in these 2 studies.

Table 4. Adverse Event Incidence in 2 Large 12-Week COPD Clinical Trials in Patients With Chronic Obstructive Pulmonary Disease

Adverse Event

Percent of Patients

Placebo

(N = 278)

SEREVENT Inhalation Aerosol 42 mcg Twice Daily (N = 267)

Ipratropium Inhalation Aerosol 36 mcg 4 Times Daily (N = 271)

Ear, nose, and throat

Upper respiratory tract infection

7

9

9

Sore throat

3

8

6

Nasal sinus infection

1

4

2

Gastrointestinal

Diarrhea

3

5

4

Musculoskeletal

Back pain

3

4

3

Neurological

Headache

10

12

8

Respiratory

Chest congestion

3

4

3

Table 4 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in the group treated with SEREVENT Inhalation Aerosol and were more common in the group treated with SEREVENT Inhalation Aerosol than in the placebo group.

Common cold, rhinorrhea, bronchitis, cough, exacerbation of chest congestion, chest pain, and dizziness occurred at 3% or more but were equally common on placebo. Other events occurring in the group treated with SEREVENT Inhalation Aerosol at a frequency of 1% to 3% were as follows:

Ear, Nose, and Throat

Cold symptoms, earache, epistaxis, nasal congestion, nasal sinus congestion, sneezing.

Gastrointestinal

Nausea, dyspepsia, gastric pain, gastric upset, abdominal pain, constipation, heartburn, oral candidiasis, xerostomia, vomiting, surgical removal of tooth.

Musculoskeletal

Leg cramps, myalgia, neck pain, pain in arm, shoulder pain, muscle injury of neck.

Neurological

Insomnia, sinus headache.

Non-Site Specific

Fatigue, fever, pain in body, discomfort in chest.

Respiratory

Acute bronchitis, dyspnea, influenza, lower respiratory tract infection, pneumonia, respiratory tract infection, shortness of breath, wheezing.

Urogenital

Urinary tract infection.

Electrocardiographic Monitoring in Patients With Chronic Obstructive Pulmonary Disease

Continuous electrocardiographic (Holter) monitoring was performed on 284 patients in 2 large COPD clinical trials during five 24-hour periods. No cases of sustained ventricular tachycardia were observed. At baseline, non-sustained, asymptomatic ventricular tachycardia was recorded for 7 (7.1%), 8 (9.4%), and 3 (3.0%) patients in the placebo, SEREVENT, and ipratropium groups, respectively. During treatment, nonsustained, asymptomatic ventricular tachycardia that represented a clinically significant change from baseline was reported for 11 (11.6%), 15 (18.3%), and 20 (20.8%) patients receiving placebo, SEREVENT, and ipratropium, respectively. Four of these cases of ventricular tachycardia were reported as adverse events (1 placebo, 3 SEREVENT) by 1 investigator based upon review of Holter data. One case of ventricular tachycardia was observed during ECG evaluation of chest pain (ipratropium) and reported as an adverse event.

Observed During Clinical Practice

In extensive US and worldwide postmarketing experience, 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 no. 1), but they have occurred in a few patients with less severe asthma as well. It was not possible from these reports to determine whether SEREVENT Inhalation Aerosol contributed to these events or simply failed to relieve the deteriorating asthma.

The following events have also been identified during postapproval use of SEREVENT in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to SEREVENT.

Respiratory

Rare reports of upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking; oropharyngeal irritation.

Cardiovascular

Hypertension, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles).



REPORTS OF SUSPECTED SEREVENT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Serevent. The information is not vetted and should not be considered as verified clinical evidence.

Possible Serevent side effects / adverse reactions in 62 year old female

Reported by a consumer/non-health professional from United States on 2011-10-11

Patient: 62 year old female

Reactions: Product Quality Issue, Asthma, Oropharyngeal Pain

Suspect drug(s):
Serevent
    Dosage: 1puff as required
    Indication: Asthma
    Start date: 1986-10-04

Advair Diskus 100/50
    Indication: Asthma

Other drugs received by patient: Trazodone Hydrochloride; Qvar 40; Meloxicam; Diavan; Fluoxetine; Albuterol



Possible Serevent side effects / adverse reactions in 56 year old female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 56 year old female

Reactions: Drug Dose Omission, Dyspnoea

Suspect drug(s):
Serevent

Symbicort

Qvar 40



Possible Serevent side effects / adverse reactions in 84 year old female

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient: 84 year old female

Reactions: Product Quality Issue, Mitral Valve Prolapse, Overdose, Atrial Fibrillation

Suspect drug(s):
Serevent

Other drugs received by patient: Potassium; Lisinopril; Furosemide; Paroxetine HCL; Spiriva; Coumadin; Losartan Potassium; Dynacirc



See index of all Serevent side effect reports >>

Drug label data at the top of this Page last updated: 2006-05-10

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