This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xolair (Omalizumab) 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 (2149)
Death (139)
Life Threatening Events (81)
Disability (64)
Reports by Reaction Type
Asthma (543),
Dyspnoea (439),
Cough (369),
Nasopharyngitis (333),
Fatigue (306),
Wheezing (250),
Malaise (230),
Pneumonia (186),
Blood Pressure Increased (178),
Headache (169),
Hypersensitivity (150),
Dizziness (140)
Below are a few examples of reports where side effects / adverse reactions may be related to Xolair (Omalizumab). For a complete list or a specific selection of reports, please use the links above.
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Rheumatoid Arthritis, Middle Insomnia, Malaise, Throat Irritation, Blood Pressure Abnormal
Drug(s) suspected as cause:
Xolair
Start date: 2011-04-27
Xolair
Indication: Asthma
Start date: 2008-06-10
Xolair
Start date: 2011-04-13
Possible Xolair side effects in male
Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-08-27
Patient: male
Reactions: Fatigue, Pain in Extremity, Chills, Pyrexia, Asthmatic Crisis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Prednisolone; Albuterol Sulate; Theophylline; Beclomethasone Dipropionate; Ipratropium Bromide; Fluticasone Propionate / Salmeterol
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Blood Pressure Increased, Back Pain, Asthma, Spinal Compression Fracture, Dyspnoea, Increased Upper Airway Secretion, Nasopharyngitis, Oropharyngeal Pain, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Avelox
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Hypersensitivity, Chest Discomfort, Nasopharyngitis, Dyspnoea, Staphylococcal Abscess, Wheezing, Nasal Congestion
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Prednisone TAB; Symbicort; Singulair; Ventolin; Reactine (Canada)
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Xolair
Possible Xolair side effects in male
Reported by a physician from Canada on 2012-08-27
Patient: male
Reactions: Atelectasis, Nasopharyngitis, Dyspnoea, International Normalised Ratio Increased, Pulmonary Embolism, Lobar Pneumonia, Lung Consolidation, Pleural Effusion, Hypovolaemia, Cough, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Warfarin Sodium
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Asthma, Weight Decreased, Diabetes Mellitus, Furuncle, Eczema, Lower Respiratory Tract Infection, Weight Increased, Fatigue, Chest Pain, Decreased Appetite, Eye Pruritus, Cough, Chest Discomfort, Underdose, Seasonal Allergy, Feeling Abnormal
Drug(s) suspected as cause:
Xolair
Indication: Asthma
Start date: 2005-07-22
Xolair
Start date: 2011-04-06
Xolair
Start date: 2006-01-18
Other drugs received by patient: Fluticasone Propionate; Metformin HCL; Flovent; Ventolin
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Myalgia, Asthma, Pneumonia, Rhinorrhoea, Bronchitis, Sinusitis, Menorrhagia
Drug(s) suspected as cause:
Xolair
Start date: 2012-02-28
Xolair
Indication: Asthma
Start date: 2012-02-17
Other drugs received by patient: Alvesco; Zenhale; Prednisone TAB; Singulair
Possible Xolair side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Malaise
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Venezuela on 2012-08-27
Patient: female
Reactions: Haemoglobin Decreased, Malaise, Fatigue, Tachycardia, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Budesonide
Indication: Lung Disorder
Start date: 2010-01-01
Foradil
Indication: Lung Disorder
Start date: 2010-01-01
Xolair
Indication: Lung Disorder
Start date: 2011-10-01
End date: 2012-03-01
Other drugs received by patient: Vitamin B-12; Calcium; Folic Acid
Possible Xolair side effects in 54 year old female
Reported by a physician from United Kingdom on 2012-08-27
Patient: 54 year old female
Reactions: DRY Mouth, Thirst, DRY Eye
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Salivix; Lacri-Lube (United Kingdom); Amantadine HCL; Arthrotec; Novolog MIX 70 / 30; Ferrous Fumarate; Albuterol Sulate; Hydroxychloroquine Sulfate; Gabapentin; Victoza; Liquifilm Tears; Quinine Sulfate; Serotid Inhaler (Unk Ingredients); Furosemide; Atorvastatin; Morphine Sulfate; Oramorph SR; Vitamin B-12; Metoclopramide Hydrochloride; Prednisolone; Alendronate Sodium; Amitriptyline HCL; Montelukast; Metformin Hydrochloride
Possible Xolair side effects in female
Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-08-27
Patient: female
Reactions: Dyspnoea, Hypersensitivity, Pruritus, Ear Disorder, Headache, Joint Injury, Road Traffic Accident, Insomnia, Feeling Abnormal
Drug(s) suspected as cause:
Xolair
Possible Xolair side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: female
Reactions: Rheumatoid Arthritis
Drug(s) suspected as cause:
Xolair
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Asthma, Chest Discomfort, Pneumonia, Soft Tissue Injury, Rales, Wheezing, Malaise, Balance Disorder, Application Site Haematoma, Pulmonary Congestion, Pulmonary Oedema, Asthenia, Lethargy, Anuria
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Possible Xolair side effects in female
Reported by a physician from United States on 2012-08-25
Patient: female
Reactions: Dyspnoea, Chest Discomfort, Mass, Wheezing, Musculoskeletal Pain, Fatigue, Arthralgia, Swelling
Drug(s) suspected as cause:
Xolair
Possible Xolair side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-24
Patient: female
Reactions: Nasal Turbinate Hypertrophy, Alopecia, Headache
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Symbicort; Theophylline; Montelukast; Fluoxetine HCL
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-24
Patient: female
Reactions: Weight Increased, Nasopharyngitis, Malaise, Dyspnoea, Fibromyalgia, Drug Ineffective, Depression
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Cortisone Acetate
Possible Xolair side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-24
Patient: male
Reactions: Arthropod Sting
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Ventolin; Zenhale; Singulair
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-24
Patient: female, weighing 83.4 kg (183.5 pounds)
Reactions: Asthma, Dyspnoea, Pruritus, Chest Discomfort, Pain in Extremity, Stress, Rash Pruritic, Pharyngeal Oedema, Hypoaesthesia Oral, Upper Respiratory Tract Infection, Dizziness, Blood Pressure Decreased, Cough, Nasal Polyps
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Start date: 2011-12-07
Avelox
Indication: Product Used FOR Unknown Indication
Xolair
Start date: 2009-06-19
Xolair
Dosage: 300 mg, q2w, vial
Indication: Asthma
Start date: 2009-04-22
Other drugs received by patient: Alvesco; Symbicort; Singulair; Prednisone TAB
Possible Xolair side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-24
Patient: male
Reactions: Pain, Wheezing, Food Poisoning, Headache, Oropharyngeal Pain, Myalgia, Malaise, Fatigue, Dizziness, Muscle Spasms, Dyspnoea, Chest Discomfort, Pain in Extremity, Rash, Calcinosis, Pulmonary Function Test Abnormal, Insomnia, Multiple Allergies
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Symbicort; Ventolin; Prednisone TAB
Possible Xolair side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Wheezing, Condition Aggravated
Drug(s) suspected as cause:
Xolair
Possible Xolair side effects in
Reported by a physician from United States on 2012-08-24
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Xolair
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 consumer/non-health professional from Venezuela on 2012-08-23
Patient: female
Reactions: Haemoglobin Decreased, Malaise, Fatigue, Tachycardia, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Dosage: 450 mg, every month
Indication: Lung Disorder
Start date: 2011-10-01
End date: 2012-03-01
Budesonide
Start date: 2010-01-01
Foradil
Start date: 2010-01-01
Other drugs received by patient: Vitamin B-12
Possible Xolair side effects in 72 year old female
Reported by a physician from Japan on 2012-08-23
Patient: 72 year old female
Reactions: Cerebral Infarction
Adverse event resulted in: death
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Bisoprolol Fumarate; Adalat CC
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-23
Patient: female
Reactions: Productive Cough, Nasopharyngitis, Hypersensitivity, Wheezing, Oropharyngeal Pain, Fatigue, Sneezing, Toothache, Cough, Respiration Abnormal, Dyspnoea, Rhinorrhoea, Body Temperature Decreased, Respiratory Tract Congestion, Arthralgia, Sinus Headache, Ear Pain, Influenza Like Illness, Influenza
Drug(s) suspected as cause:
Xolair
Indication: Asthma
Start date: 2010-08-16
Xolair
Start date: 2011-10-26
Fluticasone Propionate
Indication: Product Used FOR Unknown Indication
Possible Xolair side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: female
Reactions: Asthma, Malaise, Lower Respiratory Tract Infection
Drug(s) suspected as cause:
Xolair
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-23
Patient: female
Reactions: Asthma, Pneumonia, Sinusitis, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Bricanyl; Advil; Symbicort; Nasonex; Sinus Rinse (Unk Ingredients); Ventolin; Neoral; Septra; Singulair; Cyclosporine
Possible Xolair side effects in female
Reported by a physician from Canada on 2012-08-23
Patient: female
Reactions: Bedridden, Asthma, Pneumonia, Nasopharyngitis, Muscular Dystrophy, Oropharyngeal Pain, Loss of Consciousness, Lower Respiratory Tract Infection, Respiratory Failure, Sepsis, Cough, Influenza
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Prednisone TAB
Possible Xolair side effects in female
Reported by a consumer/non-health professional from Venezuela on 2012-08-23
Patient: female
Reactions: Increased Upper Airway Secretion, Bronchospasm, Rhinitis
Drug(s) suspected as cause:
Xolair
Other drugs received by patient: Fexofenadine; Albuterol Sulate
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