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Serevent (Salmeterol Xinafoate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Serevent (Salmeterol Xinafoate) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (87)
Death (10)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Product Quality Issue (32)Dyspnoea (20)Asthma (17)Drug Ineffective (11)Wheezing (6)Cough (6)Oropharyngeal Pain (5)Overdose (5)Atrial Fibrillation (5)Choking (5)Bronchitis (5)Pneumonia (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Serevent (Salmeterol Xinafoate). For a complete list or a specific selection of reports, please use the links above.

Possible Serevent side effects in 79 year old male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 79 year old male

Reactions: Dyspnoea, Therapeutic Response Delayed, Cough

Drug(s) suspected as cause:
Serevent
    Dosage: 1puff twice per day
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-05-04

Fluticasone Propionate
    Dosage: 2puff twice per day
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2012-04-01
    End date: 2012-05-04

Other drugs received by patient: Oxygen



Possible Serevent side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient: female

Reactions: Hypersensitivity, Dyspepsia, Hernia, Constipation, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivent
    Indication: Product Used FOR Unknown Indication

Flovent
    Indication: Asthma

Serevent
    Indication: Product Used FOR Unknown Indication



Possible Serevent side effects in female

Reported by a physician from Japan on 2012-07-13

Patient: female

Reactions: Product Quality Issue, Asthma, Overdose, Dyspnoea

Drug(s) suspected as cause:
Serevent
    Dosage: 200mcg per day
    Start date: 2012-01-01
    End date: 2012-01-01

Serevent
    Dosage: 100mcg per day
    Indication: Asthma
    Start date: 2008-01-01

Other drugs received by patient: Mucodyne; Fluticasone Propionate; Theo-DUR; Zaditen



Possible Serevent side effects in male

Reported by a consumer/non-health professional from Japan on 2012-07-10

Patient: male

Reactions: Glaucoma, Rash

Drug(s) suspected as cause:
Fluticasone Propionate
    Indication: Product Used FOR Unknown Indication

Serevent
    Indication: Product Used FOR Unknown Indication



Possible Serevent side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 67 year old female

Reactions: Insomnia, Tremor

Drug(s) suspected as cause:
Flovent
    Dosage: 2puff twice per day
    Indication: Asthma
    Start date: 1997-01-01
    End date: 2012-04-05

Serevent
    Dosage: 1puff per day
    Indication: Asthma
    Start date: 1997-01-01
    End date: 2012-04-05

Other drugs received by patient: Combivent; Nasonex; Singulair; Esomeprazole; Benadryl; Melatonin



Possible Serevent side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: female

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Flovent
    Indication: Asthma

Serevent
    Indication: Asthma

Other drugs received by patient: Hyzaar



Possible Serevent side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: female

Reactions: Hypersensitivity, Pain, Intestinal Obstruction, Hernia, Enuresis, Constipation, Muscle Rupture, Dyspepsia, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flovent
    Indication: Asthma

Serevent

Combivent
    Indication: Product Used FOR Unknown Indication



Possible Serevent side effects in 88 year old female

Reported by a consumer/non-health professional from United States on 2012-06-29

Patient: 88 year old female

Reactions: Dyspnoea, Pneumonia, Contusion, Oropharyngeal Pain, Scar

Drug(s) suspected as cause:
Advair Diskus 100 / 50
    Dosage: 1puff twice per day
    Indication: Asthma
    Start date: 2001-04-01
    End date: 2012-05-01

Serevent
    Dosage: 1puff twice per day
    Indication: Asthma

Other drugs received by patient: Avastin; Ventolin HFA; Aspirin; Nexium



Possible Serevent side effects in 84 year old female

Reported by a pharmacist from South Africa on 2012-06-25

Patient: 84 year old female

Reactions: Product Quality Issue, Aphasia

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Levothyroxine Sodium; Amlodipine Besylate; Purbac



Possible Serevent side effects in

Reported by a consumer/non-health professional from Germany on 2012-06-19

Patient:

Reactions: Anaemia, Pancytopenia, Erythropenia, Thrombocytopenia, Leukopenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Anagrelide HCL

Spiriva

Clindamycin

Busulfan

Furosemide

Aspirin

Hydroxyurea

Verapamil

Esidrix

Fluticasone Propionate / Salmeterol

Ramipril

Serevent

Novalgin



Possible Serevent side effects in female

Reported by a consumer/non-health professional from Japan on 2012-06-18

Patient: female

Reactions: Metrorrhagia

Drug(s) suspected as cause:
Serevent



Possible Serevent side effects in male

Reported by a consumer/non-health professional from Japan on 2012-06-07

Patient: male

Reactions: Glaucoma, Extrasystoles, Eczema

Drug(s) suspected as cause:
Fluticasone Propionate
    Indication: Product Used FOR Unknown Indication

Serevent
    Indication: Asthma



Possible Serevent side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-06-04

Patient: 51 year old female

Reactions: DRY Mouth, Atrial Fibrillation

Drug(s) suspected as cause:
Flovent
    Dosage: 2puff twice per day
    Indication: Asthma

Serevent
    Dosage: 1puff twice per day
    Indication: Asthma
    Start date: 1994-06-01
    End date: 1994-12-01

Other drugs received by patient: Flecainide Acetate; Lipitor; Combivent; Xopenex



Possible Serevent side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-05-08

Patient: 81 year old female

Reactions: Product Quality Issue, Dyspnoea, Choking

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Asmanex Twisthaler



Possible Serevent side effects in 26 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-23

Patient: 26 year old male, weighing 100.7 kg (221.5 pounds)

Reactions: Victim of Abuse, Adverse Event

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Advair Diskus 100 / 50; Serevent



Possible Serevent side effects in 24 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-23

Patient: 24 year old female, weighing 63.6 kg (139.9 pounds)

Reactions: Respiratory Failure, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Advair Diskus 100 / 50
    Dosage: 1puff twice per day
    Indication: Asthma
    Start date: 2010-08-29
    End date: 2010-09-27

Serevent
    Indication: Asthma

Other drugs received by patient: Bactrim DS; Flovent; Albuterol; Nexium; Verapamil; Medrol



Possible Serevent side effects in 67 year old male

Reported by a physician from Japan on 2012-04-20

Patient: 67 year old male

Reactions: Urinary Retention

Drug(s) suspected as cause:
Taxotere
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-01-19
    End date: 2012-02-16

Serevent
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Clarithromycin; Spiriva; Dabigatran Etexilate; Bisoprolol Fumarate



Possible Serevent side effects in 79 year old male

Reported by a consumer/non-health professional from United States on 2012-04-12

Patient: 79 year old male

Reactions: Product Quality Issue, Dyspnoea, Pneumonia, Visual Impairment, Wheezing, Bronchitis, DRY Eye

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Flomax; Duoneb; Tylenol W / Codeine; Klor-CON; Lopressor; Cozaar; Ventolin; Zocor; Theophylline; Eligard; Niacin; Meclizine; Aspirin; Lexapro; Pepcid; Ultram



Possible Serevent side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-04-09

Patient: 81 year old female

Reactions: Product Quality Issue, Dyspnoea, Choking

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Asmanex Twisthaler



Possible Serevent side effects in 54 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-05

Patient: 54 year old male, weighing 80.9 kg (178.0 pounds)

Reactions: Nightmare, Muscle Spasms

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Beclomethasone Dipropionate; Calcium Carbonate; Varenicline Tartrate; Colecalciferol; Prednisolone; Nicotine; Zopiclone; Diazepam; Mirtazapine; Thiamine HCL; Dihydrocodeine Bitartrate INJ; Gabapentin; Ibuprofen



Possible Serevent side effects in female

Reported by a physician from France on 2012-04-04

Patient: female

Reactions: Photosensitivity Reaction, Eczema Impetiginous, Drug Hypersensitivity

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ventolin
    Indication: Asthma
    Start date: 1950-01-01

Isoptin
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2000-01-01
    End date: 2011-09-27

Budesonide
    Dosage: 200mcg twice per day
    Indication: Asthma
    Start date: 2008-01-01

Serevent
    Dosage: 1puff twice per day
    Indication: Asthma
    Start date: 2005-01-01

Micardis
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2000-01-01
    End date: 2011-09-27

Singulair
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Asthma
    Start date: 2005-01-01



Possible Serevent side effects in 41 year old male

Reported by a physician from United States on 2012-03-23

Patient: 41 year old male

Reactions: Asthma, Rhinitis, Bronchospasm, Bronchitis, Arteriosclerosis, Hypertension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Serevent
    Dosage: 2puff twice per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2001-03-01
    End date: 2003-01-01

Serevent
    Dosage: 1puff twice per day
    Indication: Asthma

Other drugs received by patient: Azmacort; Theo-DUR; Flovent; Ventolin; Prednisone TAB; Primatene Mist; Vanceril; Antibiotic; Singulair



Possible Serevent side effects in 79 year old male

Reported by a consumer/non-health professional from United States on 2012-03-20

Patient: 79 year old male

Reactions: Product Quality Issue, Dyspnoea, Pneumonia, Visual Impairment, Wheezing, Bronchitis, DRY Eye

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Lexapro; Meclizine; Ultram; Theophylline; Aspirin; Flomax; Ventolin; Duoneb; Zocor; Lopressor; Pepcid; Cozaar; Eligard; Niacin; Klor-CON; Tylenol W / Codeine



Possible Serevent side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: 60 year old female

Reactions: Palpitations, Heart Rate Increased, Headache, Sensation of Blood Flow, Myocardial Infarction, Nervousness

Drug(s) suspected as cause:
Flovent
    Dosage: 1puff twice per day
    Indication: Asthma
    Start date: 2012-01-31

Advair Diskus 100 / 50
    Dosage: 2puff twice per day
    Indication: Asthma
    Start date: 2010-05-01
    End date: 2011-05-01

Serevent
    Indication: Asthma
    Start date: 1997-01-01

Other drugs received by patient: Albuterol; Aspirin; Crestor; Ramipril



Possible Serevent side effects in 40 year old female

Reported by a physician from Ireland on 2012-03-14

Patient: 40 year old female

Reactions: Chest Discomfort, Wheezing, Bronchospasm Paradoxical

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Pantoprazole; Yasmin; Folic Acid; Ferrous Gluconate; Methotrexate; Lipitor; Ventolin; Beclomethasone Dipropionate



Possible Serevent side effects in 41 year old male

Reported by a lawyer from United States on 2012-03-09

Patient: 41 year old male

Reactions: Asthma, Rhinitis, Bronchospasm, Bronchitis, Hypertension, Arteriosclerosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Serevent
    Dosage: 1puff twice per day
    Indication: Asthma
    End date: 2001-03-01

Serevent
    Dosage: 2puff twice per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2001-03-01
    End date: 2003-01-01

Other drugs received by patient: Azmacort; Ventolin; Vanceril; Theo-DUR; Prednisone TAB; Singulair; Primatene Mist; Antibiotic; Flovent



Possible Serevent side effects in 72 year old male

Reported by a lawyer from United States on 2012-03-09

Patient: 72 year old male, weighing 90.9 kg (200.0 pounds)

Reactions: Hypoxic-Ischaemic Encephalopathy, Cardio-Respiratory Arrest, Coronary Artery Disease, Myocardial Infarction, Cardiac Failure Congestive, Arrhythmia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Serevent
    Indication: Product Used FOR Unknown Indication

Advair Diskus 100 / 50
    Indication: Product Used FOR Unknown Indication

Avandia
    Administration route: Oral
    Indication: Diabetes Mellitus



Possible Serevent side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-03-05

Patient: 81 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Serevent
    Dosage: 50mcg unknown
    Indication: Asthma
    Start date: 2006-09-08
    End date: 2012-02-15

Flovent
    Dosage: 220mcg unknown
    Indication: Asthma
    Start date: 2006-09-08
    End date: 2012-02-15



Possible Serevent side effects in 84 year old female

Reported by a pharmacist from South Africa on 2012-03-05

Patient: 84 year old female

Reactions: Product Quality Issue, Aphasia

Drug(s) suspected as cause:
Serevent

Other drugs received by patient: Purbac; Amlodipine Besylate; Levothyroxine Sodium



Possible Serevent side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-03-01

Patient: 62 year old female

Reactions: Asthma, Product Quality Issue, Oropharyngeal Pain

Drug(s) suspected as cause:
Serevent
    Dosage: 1puff as required
    Indication: Asthma
    Start date: 1986-10-04

Advair Diskus 100 / 50
    Indication: Asthma

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

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