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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