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Xolair (Omalizumab) - Side Effect Reports to FDA

 
 



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 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 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 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 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



Possible Xolair side effects in 57 year old female

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

Patient: 57 year old female, weighing 57.7 kg (126.8 pounds)

Reactions: Weight Decreased, Myalgia, Dyspnoea, Fatigue, Arthralgia, Somnolence, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xolair

Other drugs received by patient: Fluticasone Propionate; Singulair



Possible Xolair side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male, weighing 129.0 kg (283.8 pounds)

Reactions: Productive Cough, Eyelid Oedema, Respiratory Disorder, Nasopharyngitis, Lung Infection, Wound, Headache, Hyperhidrosis, Fatigue, Oedema Peripheral, Feeling Hot, Meningitis, Sinusitis, Respiration Abnormal, Cough, Hypersomnia, Pain in Extremity, Decreased Activity, Rhinorrhoea, Nasal Congestion, Facial Pain, Convulsion, Incision Site Infection, Sinus Headache, Insomnia, Sputum Discoloured, Infection, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xolair
    Dosage: 375 mg, biw
    Start date: 2010-04-12

Xolair
    Dosage: 375 mg, biw
    Indication: Asthma
    Start date: 2010-03-29

Methadone Hydrochloride

Other drugs received by patient: Ramipril; Fluticasone Propionate; Sennosides A+B; Flomax; Docusate Sodium; Uniphyl; Gabapentin; Cymbalta

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