OMALIZUMAB

Omalizumab Adverse Events Reported to the FDA Over Time

How are Omalizumab adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Omalizumab, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Omalizumab is flagged as the suspect drug causing the adverse event.

Most Common Omalizumab Adverse Events Reported to the FDA

What are the most common Omalizumab adverse events reported to the FDA?

Asthma	514 (5.89%)
Dyspnoea	219 (2.51%)
Nasopharyngitis	172 (1.97%)
Cough	170 (1.95%)
Drug Exposure During Pregnancy	156 (1.79%)
Pneumonia	142 (1.63%)
Wheezing	142 (1.63%)
Hypersensitivity	127 (1.45%)
Fatigue	120 (1.37%)
Bronchitis	110 (1.26%)
Chest Pain	105 (1.2%)
	Show More
Productive Cough	104 (1.19%)
Heart Rate Increased	103 (1.18%)
Nasal Congestion	102 (1.17%)
Blood Pressure Increased	97 (1.11%)
Influenza	90 (1.03%)
Lower Respiratory Tract Infection	90 (1.03%)
Anaphylactic Reaction	89 (1.02%)
Death	79 (.9%)
Sinusitis	76 (.87%)
Dizziness	71 (.81%)
Headache	70 (.8%)
Lung Infection	68 (.78%)
Pruritus	67 (.77%)
Rhinorrhoea	62 (.71%)
Dysphonia	60 (.69%)
Malaise	57 (.65%)
Abortion Spontaneous	53 (.61%)
Oropharyngeal Pain	53 (.61%)
Fall	51 (.58%)
Pyrexia	50 (.57%)
Aspergillosis	48 (.55%)
Ear Infection	47 (.54%)
Laryngitis	47 (.54%)
Migraine	47 (.54%)
Respiratory Distress	47 (.54%)
Respiratory Tract Infection	47 (.54%)
Chest Discomfort	46 (.53%)
Premature Baby	46 (.53%)
Drug Ineffective	44 (.5%)
Respiratory Rate Increased	43 (.49%)
Blood Pressure Decreased	42 (.48%)
Gastrooesophageal Reflux Disease	42 (.48%)
Pain	42 (.48%)
Abdominal Pain Upper	41 (.47%)
Asthenia	41 (.47%)
Nausea	41 (.47%)
Sinus Congestion	41 (.47%)
Hypotension	39 (.45%)
Pain In Extremity	39 (.45%)
Sputum Discoloured	39 (.45%)
Hypertension	38 (.44%)
Urticaria	38 (.44%)
Blood Pressure Abnormal	36 (.41%)
Increased Upper Airway Secretion	35 (.4%)
Rash	35 (.4%)
Sinus Headache	35 (.4%)
Swelling	35 (.4%)
Respiratory Disorder	34 (.39%)
Feeling Cold	33 (.38%)
Rhinitis Allergic	33 (.38%)
Rib Fracture	33 (.38%)
Vomiting	33 (.38%)
Atrial Fibrillation	32 (.37%)
Visual Impairment	32 (.37%)
Anxiety	31 (.35%)
Caesarean Section	31 (.35%)
Chronic Obstructive Pulmonary Disea...	31 (.35%)
Erythema	31 (.35%)
Throat Irritation	31 (.35%)
Increased Bronchial Secretion	30 (.34%)
Insomnia	30 (.34%)
Movement Disorder	29 (.33%)
Musculoskeletal Chest Pain	29 (.33%)
Musculoskeletal Pain	29 (.33%)
Obstructive Airways Disorder	29 (.33%)
Dyspnoea Exertional	28 (.32%)
Hypoaesthesia	28 (.32%)
Respiratory Tract Congestion	28 (.32%)
Spirometry	28 (.32%)
Status Asthmaticus	28 (.32%)
Pneumothorax	27 (.31%)
Polyp	27 (.31%)
Weight Increased	27 (.31%)
Neck Pain	26 (.3%)
Upper Respiratory Tract Infection	26 (.3%)
Dry Skin	25 (.29%)
Haemoptysis	25 (.29%)
Joint Swelling	25 (.29%)
Viral Infection	25 (.29%)
Jaundice	24 (.27%)
Pre-eclampsia	24 (.27%)
Pulmonary Function Test Abnormal	24 (.27%)
Arrested Labour	23 (.26%)
Back Pain	23 (.26%)
Cardiac Failure	23 (.26%)
Eye Pain	23 (.26%)
Gestational Diabetes	23 (.26%)
Pregnancy	23 (.26%)
Throat Tightness	23 (.26%)
Alopecia	22 (.25%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Omalizumab, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Omalizumab is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Omalizumab

What are the most common Omalizumab adverse events reported to the FDA?

Respiratory	1141 (13.06%)
Infections - Pathogen Unspecified	994 (11.38%)
Bronchial Disorders	778 (8.91%)
Cardiac And Vascular Investigations	288 (3.3%)
Epidermal And Dermal Conditions	269 (3.08%)
Allergic Conditions	245 (2.81%)
Upper Respiratory Tract Disorders	233 (2.67%)
Neurological	229 (2.62%)
Chemical Injury And Poisoning	172 (1.97%)
Viral Infectious	167 (1.91%)
Musculoskeletal And Connective Tiss...	165 (1.89%)
	Show More
Gastrointestinal Signs	159 (1.82%)
Headaches	152 (1.74%)
Injuries	109 (1.25%)
Physical Examination Topics	100 (1.14%)
Cardiac Arrhythmias	99 (1.13%)
Administration Site Reactions	90 (1.03%)
Fatal Outcomes	81 (.93%)
Maternal Complications Of Labour An...	74 (.85%)
Abortions And Stillbirth	71 (.81%)
Fungal Infectious	67 (.77%)
Neonatal And Perinatal Conditions	67 (.77%)
Joint	66 (.76%)
Respiratory And Pulmonary Investiga...	64 (.73%)
Therapeutic And Nontherapeutic Effe...	63 (.72%)
Skin Appendage Conditions	56 (.64%)
Bone And Joint Injuries	54 (.62%)
Muscle	54 (.62%)
Bacterial Infectious	53 (.61%)
Gastrointestinal Motility And Defec...	52 (.6%)
Sleep Disorders	52 (.6%)
Body Temperature Conditions	50 (.57%)
Movement Disorders	46 (.53%)
Anxiety Disorders	45 (.52%)
Angiedema And Urticaria	44 (.5%)
Hematology Investigations	44 (.5%)
Lower Respiratory Tract Disorders	44 (.5%)
Decreased And Nonspecific Blood Pre...	42 (.48%)
Pregnancy, Labour, Delivery And Pos...	41 (.47%)
Hepatic And Hepatobiliary	39 (.45%)
Heart Failures	38 (.44%)
Vascular Hypertensive	38 (.44%)
Glucose Metabolism Disorders	34 (.39%)
Obstetric And Gynecological Therape...	34 (.39%)
Vision	34 (.39%)
Eye	32 (.37%)
Pleural	32 (.37%)
Appetite And General Nutritional	31 (.35%)
Coronary Artery	31 (.35%)
Cardiac Disorder Signs	28 (.32%)
Maternal Complications Of Pregnancy	26 (.3%)
Metabolic, Nutritional And Blood Ga...	25 (.29%)
Oral Soft Tissue Conditions	25 (.29%)
Abdominal Hernias And Other Abdomin...	24 (.27%)
Vascular Hemorrhagic	24 (.27%)
Cardiac And Vascular Disorders Cong...	23 (.26%)
Tongue Conditions	23 (.26%)
Gastrointestinal Stenosis And Obstr...	22 (.25%)
Anemias Nonhemolytic And Marrow Dep...	21 (.24%)
Lifestyle Issues	21 (.24%)
Pigmentation	21 (.24%)
Pulmonary Vascular	21 (.24%)
Vascular	21 (.24%)
Fetal Complications	19 (.22%)
Immunology And Allergy	19 (.22%)
Respiratory Disorders Congenital	19 (.22%)
Bone Disorders	18 (.21%)
Reproductive Tract And Breast Disor...	18 (.21%)
Deliria	17 (.19%)
Respiratory And Mediastinal Neoplas...	17 (.19%)
Skin Vascular Abnormalities	17 (.19%)
Hepatobiliary	16 (.18%)
Renal And Urinary Tract Investigati...	16 (.18%)
Uterine, Pelvic And Broad Ligament	16 (.18%)
Gastrointestinal Hemorrhages	15 (.17%)
Mood Disorders	15 (.17%)
Gallbladder	14 (.16%)
Reproductive Neoplasms Male Maligna...	14 (.16%)
Spinal Cord And Nerve Root	14 (.16%)
Therapeutic Procedures And Supporti...	14 (.16%)
Cutaneous Neoplasms Benign	13 (.15%)
Depressed Mood Disorders	13 (.15%)
Head And Neck Therapeutic Procedure...	13 (.15%)
Miscellaneous And Site Unspecified ...	13 (.15%)
Procedural And Device Related Injur...	13 (.15%)
Urinary Tract Signs	13 (.15%)
White Blood Cell	13 (.15%)
Arteriosclerosis, Stenosis, Vascula...	12 (.14%)
Cranial Nerve Disorders	12 (.14%)
Malabsorption Conditions	12 (.14%)
Medication Errors	12 (.14%)
Protein And Chemistry Analyses	12 (.14%)
Seizures	12 (.14%)
Myocardial	11 (.13%)
Gastrointestinal Inflammatory Condi...	10 (.11%)
Gastrointestinal Neoplasms Malignan...	10 (.11%)
Musculoskeletal And Connective Tiss...	10 (.11%)
Central Nervous System Vascular	9 (.1%)
Embolism And Thrombosis	9 (.1%)
Microbiology And Serology	9 (.1%)
Disturbances In Thinking	8 (.09%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Omalizumab, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Omalizumab is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.