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Xolair (Omalizumab) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (81)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Xolair (Omalizumab) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 81   Next >>

Possible Xolair side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female, weighing 77.2 kg (169.8 pounds)

Reactions: Anaphylactic Reaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Nasonex; Clarinex; Albuterol; Spiriva; Foradil; Singulair



Possible Xolair side effects in female

Reported by a physician from United States on 2012-08-13

Patient: female, weighing 53.6 kg (117.9 pounds)

Reactions: Pneumonia, Myocardial Infarction, Cerebrovascular Accident, Cardiac Failure Congestive

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Aspirin; Lovaza; Diovan HCT; Clonidine; Zertin; Synthroid; Dulera; Welchol; Coumadin; Singulair; Metoprolol; Xopenex; Proair HFA



Possible Xolair side effects in female

Reported by a physician from Canada on 2012-08-13

Patient: female

Reactions: Injection Site Mass, Asthma, Dyspnoea, Drug Ineffective, Pain, Wheezing, Injection Site Pain, Hormone Level Abnormal, Discomfort, Fatigue, Status Asthmaticus, Hypoxic-Ischaemic Encephalopathy, Oedema Peripheral, Pulseless Electrical Activity, Cough

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair
    Start date: 2012-08-07

Xolair
    Indication: Asthma
    Start date: 2011-07-19

Xolair
    Start date: 2011-12-21

Xolair
    Start date: 2012-05-29

Xolair
    Start date: 2011-11-26

Xolair
    Start date: 2012-03-23

Other drugs received by patient: Singulair; Flonase; Fluticasone Propionate; Ventolin; Losec (Canada); Lupron; Flovent; Prednisone TAB



Possible Xolair side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-07

Patient: female

Reactions: Dyspnoea, Diabetes Mellitus, Coma, Bone Disorder, Hypertension, Generalised Oedema

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in 56 year old male

Reported by a pharmacist from United States on 2012-08-06

Patient: 56 year old male, weighing 75.8 kg (166.8 pounds)

Reactions: Meningitis Cryptococcal, Hyponatraemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-02

Patient: male

Reactions: Asthma, Blood Pressure Increased, Chest Discomfort, Wheezing, Hypoglycaemia, Coma, Hyperhidrosis, Convulsion, Fatigue, Dizziness, Hypertension

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair
    Dosage: last injection was on 02 january 2012
    Indication: Asthma
    Start date: 2010-04-01

Xolair
    Start date: 2011-10-31

Xolair
    Start date: 2011-11-14

Xolair
    Start date: 2011-04-26
    End date: 2011-06-07

Other drugs received by patient: Trazodone Hydrochloride; Citalopram Hydrobromide; Budesonide; Albuterol Sulfate Autohaler; Clonazepam; Formoterol Fumarate; Lipitor; Spiriva



Possible Xolair side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-30

Patient: female

Reactions: Asthma, Cardio-Respiratory Arrest, Malaise

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in female

Reported by a physician from Canada on 2012-07-30

Patient: female

Reactions: Asthma, Injection Site Mass, Dyspnoea, Drug Ineffective, Pain, Wheezing, Injection Site Pain, Hormone Level Abnormal, Discomfort, Fatigue, Status Asthmaticus, Hypoxic-Ischaemic Encephalopathy, Oedema Peripheral, Pulseless Electrical Activity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair
    Start date: 2011-12-21

Xolair
    Start date: 2012-05-29

Xolair
    Start date: 2011-11-26

Xolair
    Start date: 2012-03-23

Xolair
    Indication: Asthma
    Start date: 2011-07-19

Other drugs received by patient: Prednisone; Lupron; Advair Diskus 100 / 50; Losec (Canada); Singulair; Flovent; Ventolin; Flonase



Possible Xolair side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-30

Patient: female

Reactions: Asthma, Drug Ineffective

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female

Reactions: Asthma

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-23

Patient: female

Reactions: Incorrect Route of Drug Administration, Hypersensitivity, Nasopharyngitis, Dyspnoea, Drug Ineffective, Haemorrhage, Drug Administered in Wrong Device, Fatigue, Dysphonia, Asthmatic Crisis, Cough, Influenza

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Amitriptyline HCL; Cyclobenzaprine HCL; Alenia (Brazil); Budesonide; Phenergan



Possible Xolair side effects in 74 year old female

Reported by a physician from United States on 2012-07-18

Patient: 74 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Electrocardiogram QT Prolonged, Torsade DE Pointes, Pneumonia, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in female

Reported by a physician from Canada on 2012-07-17

Patient: female

Reactions: Asthma, Injection Site Mass, Dyspnoea, Drug Ineffective, Pain, Wheezing, Injection Site Pain, Hormone Level Abnormal, Discomfort, Status Asthmaticus, Hypoxic-Ischaemic Encephalopathy, Fatigue, Oedema Peripheral, Pulseless Electrical Activity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair
    Start date: 2011-11-26

Xolair
    Start date: 2011-12-21

Xolair
    Start date: 2012-03-23

Xolair
    Indication: Asthma
    Start date: 2011-07-19

Xolair
    Start date: 2012-05-29

Other drugs received by patient: Advair Diskus 100 / 50; Ventolin; Flovent; Singulair; Losec (Canada); Lupron; Flonase; Prednisone



Possible Xolair side effects in male

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

Patient: male

Reactions: Cerebrovascular Accident

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in female

Reported by a physician from Canada on 2012-07-02

Patient: female

Reactions: Injection Site Mass, Asthma, Dyspnoea, Pain, Wheezing, Injection Site Pain, Hormone Level Abnormal, Discomfort, Hypoxic-Ischaemic Encephalopathy, Status Asthmaticus, Fatigue, Oedema Peripheral, Pulseless Electrical Activity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair
    Start date: 2011-11-26

Xolair
    Start date: 2012-03-23

Xolair
    Indication: Asthma
    Start date: 2011-07-19

Xolair
    Start date: 2011-12-21

Xolair
    Start date: 2012-05-29

Other drugs received by patient: Flonase; Prednisone TAB; Lupron; Flovent; Advair Diskus 100 / 50; Losec (Canada); Singulair; Ventolin



Possible Xolair side effects in female

Reported by a physician from Denmark on 2012-07-02

Patient: female, weighing 54.0 kg (118.8 pounds)

Reactions: Chest Discomfort, Dyspnoea, Feeling Hot, Type I Hypersensitivity, Swollen Tongue, Erythema

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in male

Reported by a consumer/non-health professional from Colombia on 2012-06-27

Patient: male

Reactions: Cerebrovascular Accident

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in 23 year old female

Reported by a pharmacist from United States on 2012-06-25

Patient: 23 year old female

Reactions: Anaphylactic Reaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in male

Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-06-22

Patient: male

Reactions: Asthma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Albuterol



Possible Xolair side effects in 57 year old female

Reported by a pharmacist from United States on 2012-06-22

Patient: 57 year old female

Reactions: Abdominal Pain, Flushing, Dyspnoea, Hyperhidrosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in male

Reported by a consumer/non-health professional from Japan on 2012-06-22

Patient: male

Reactions: Dysarthria, Movement Disorder, Pneumonia, Dyspnoea, Hemiplegia, Pathogen Resistance, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-06-11

Patient: 72 year old female, weighing 103.4 kg (227.5 pounds)

Reactions: Lymphadenopathy, Weight Increased, Fatigue, Upper Respiratory Tract Infection, Dizziness, Sinusitis, Chest Discomfort, Dyspnoea, Dysphagia, Pain in Extremity, Hypotension, Drug Hypersensitivity, Anxiety, Dysphonia, Alopecia, Vision Blurred, Arthritis

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-07

Patient: female, weighing 173.0 kg (380.5 pounds)

Reactions: Dyspnoea

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Astelin; Biaxin (United States); Albuterol; Singulair; Singulair; Rhinocort; Hydroxyzine; Allegra; Zyrtec; Hydroxyzine; Advair Diskus 100 / 50; Ranitidine; Ranitidine; Flonase; Flovent



Possible Xolair side effects in female

Reported by a physician from Canada on 2012-06-06

Patient: female

Reactions: Injection Site Mass, Asthma, Dyspnoea, Wheezing, Pain, Injection Site Pain, Discomfort, Hypoxic-Ischaemic Encephalopathy, Status Asthmaticus, Fatigue, Oedema Peripheral, Pulseless Electrical Activity

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair
    Indication: Asthma
    Start date: 2011-07-19

Xolair
    Start date: 2012-03-23

Xolair
    Start date: 2011-12-21

Xolair
    Start date: 2011-11-26

Other drugs received by patient: Advair Diskus 100 / 50; Flonase; Lupron; Losec (Canada); Prednisone TAB; Ventolin; Flovent; Singulair



Possible Xolair side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: female, weighing 74.9 kg (164.8 pounds)

Reactions: Choking Sensation, Dysphagia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in 33 year old female

Reported by a physician from United Kingdom on 2012-05-29

Patient: 33 year old female

Reactions: Asthma, Drug Ineffective

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair



Possible Xolair side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24

Patient: female, weighing 173.0 kg (380.5 pounds)

Reactions: Dyspnoea

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Astelin; Singulair; Advair Diskus 100 / 50; Singulair; Hydroxyzine; Ranitidine; Zyrtec; Biaxin (United States); Hydroxyzine; Albuterol; Ranitidine



Possible Xolair side effects in male

Reported by a physician from France on 2012-05-18

Patient: male

Reactions: Cardiac Failure, Pulmonary Embolism, Splenic Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair
    Start date: 2012-02-01
    End date: 2012-03-07

Xolair
    Indication: Asthma
    Start date: 2008-09-26

Other drugs received by patient: Ventolin; Singulair; Symbicort; Oxeol; Bricanyl; Atrovent



Possible Xolair side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-11

Patient: male, weighing 99.0 kg (217.7 pounds)

Reactions: Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Aspirin; Hydralazine HCL; Nasacort; Previscan; Singulair; Flovent; Xopenex; Glucophage; Claritin; Prilosec; Januvia; Lisinopril; Inspra; Niaspan; Multi-Vitamins; Advair Diskus 100 / 50; Patanol; Coreg; Potassium Chloride; Lipitor; Citalopram; Fish OIL; Demadex



Possible Xolair side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-05-10

Patient: female

Reactions: Incorrect Route of Drug Administration, Dyspnoea, Hypersensitivity, Haemorrhage, Drug Administered in Wrong Device, Fatigue, Dysphonia, Cough, Influenza

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Cyclobenzaprine HCL; Phenergan; Budesonide; Amitriptyline HCL; Alenia (Brazil)



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