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Xolair Adverse Events Reported to the FDA Over Time

How are Xolair adverse event reports trending over time?

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

Most Common Xolair Adverse Events Reported to the FDA

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

Asthma
2284 (4.88%)
Dyspnoea
1760 (3.76%)
Cough
1085 (2.32%)
Nasopharyngitis
999 (2.13%)
Wheezing
964 (2.06%)
Fatigue
854 (1.82%)
Anaphylactic Reaction
753 (1.61%)
Headache
709 (1.51%)
Hypersensitivity
621 (1.33%)
Pneumonia
618 (1.32%)
Chest Discomfort
609 (1.3%)
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Malaise
577 (1.23%)
Pruritus
537 (1.15%)
Dizziness
481 (1.03%)
Productive Cough
465 (.99%)
Urticaria
453 (.97%)
Blood Pressure Increased
433 (.92%)
Bronchitis
432 (.92%)
Sinusitis
429 (.92%)
Nausea
421 (.9%)
Drug Ineffective
403 (.86%)
Arthralgia
401 (.86%)
Influenza
388 (.83%)
Nasal Congestion
366 (.78%)
Oedema Peripheral
351 (.75%)
Pyrexia
345 (.74%)
Heart Rate Increased
343 (.73%)
Asthenia
341 (.73%)
Rash
324 (.69%)
Chest Pain
316 (.67%)
Pain In Extremity
305 (.65%)
Rhinorrhoea
284 (.61%)
Death
279 (.6%)
Pain
279 (.6%)
Blood Pressure Decreased
276 (.59%)
Lung Infection
271 (.58%)
Vomiting
269 (.57%)
Myalgia
267 (.57%)
Drug Exposure During Pregnancy
257 (.55%)
Oropharyngeal Pain
244 (.52%)
Hypertension
239 (.51%)
Condition Aggravated
235 (.5%)
Weight Increased
234 (.5%)
Lower Respiratory Tract Infection
230 (.49%)
Pulmonary Congestion
218 (.47%)
Sputum Discoloured
212 (.45%)
Weight Decreased
198 (.42%)
Throat Tightness
193 (.41%)
Erythema
188 (.4%)
Paraesthesia
186 (.4%)
Dysphonia
185 (.39%)
Back Pain
166 (.35%)
Lung Disorder
159 (.34%)
Upper Respiratory Tract Infection
158 (.34%)
Sinus Congestion
157 (.34%)
Influenza Like Illness
156 (.33%)
Myocardial Infarction
156 (.33%)
Swelling Face
155 (.33%)
Respiratory Disorder
154 (.33%)
Hypotension
153 (.33%)
Flushing
152 (.32%)
Bronchospasm
151 (.32%)
Diarrhoea
143 (.31%)
Injection Site Pain
138 (.29%)
Contusion
137 (.29%)
Muscle Spasms
135 (.29%)
Obstructive Airways Disorder
135 (.29%)
Throat Irritation
135 (.29%)
Feeling Abnormal
134 (.29%)
Hyperhidrosis
134 (.29%)
Pharyngeal Oedema
134 (.29%)
Alopecia
128 (.27%)
Increased Upper Airway Secretion
128 (.27%)
Infection
128 (.27%)
Tremor
126 (.27%)
Fall
125 (.27%)
Loss Of Consciousness
125 (.27%)
Convulsion
123 (.26%)
Dyspnoea Exertional
122 (.26%)
Abdominal Pain
119 (.25%)
Hypoaesthesia
117 (.25%)
Insomnia
116 (.25%)
Atrial Fibrillation
111 (.24%)
Migraine
111 (.24%)
Allergic Granulomatous Angiitis
109 (.23%)
Syncope
108 (.23%)
Lymphadenopathy
105 (.22%)
Cerebrovascular Accident
103 (.22%)
Swollen Tongue
103 (.22%)
Palpitations
101 (.22%)
Rales
99 (.21%)
Abortion Spontaneous
97 (.21%)
Respiratory Failure
97 (.21%)
Asthmatic Crisis
96 (.2%)
Heart Rate Irregular
94 (.2%)
Pulmonary Embolism
94 (.2%)
Sneezing
93 (.2%)
Viral Infection
92 (.2%)
Tachycardia
90 (.19%)
Diabetes Mellitus
88 (.19%)
Anxiety
87 (.19%)

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This graph shows the top adverse events submitted to the FDA for Xolair, 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 Xolair 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 Xolair

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

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This graph shows the top categories of adverse events submitted to the FDA for Xolair, 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 Xolair 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.

Common Uses of Xolair According to Those Reporting Adverse Events

Why are people taking Xolair, according to those reporting adverse events to the FDA?

Asthma
7884
Drug Use For Unknown Indication
1424
Product Used For Unknown Indication
787
Hypersensitivity
109
Rhinitis Allergic
67
Bronchopulmonary Aspergillosis Alle...
27
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Bronchitis
24
Dyspnoea
23
Rhinitis
21
Urticaria
19
Chronic Obstructive Pulmonary Disea...
19
Dermatitis Atopic
18
Urticaria Chronic
16
Blood Immunoglobulin E Increased
13
Rhinitis Seasonal
12
Status Asthmaticus
11
Sinusitis
9
Hypereosinophilic Syndrome
8
Multiple Allergies
7
Drug Exposure During Pregnancy
7
Food Allergy
7
Bronchospasm
5
Mastocytosis
5
Latex Allergy
5
Bronchial Disorder
4
Anaphylactic Reaction
4
Aspergillosis
4
Lung Disorder
4
Bronchiectasis
4
Allergic Granulomatous Angiitis
3
Respiratory Disorder
3
Pneumonia
3
Seasonal Allergy
3
Chronic Sinusitis
3
Allergic Bronchitis
3
Nasal Polyps
3
Idiopathic Urticaria
3
Allergy To Animal
2
Hyper Ige Syndrome
2
Emphysema
2
Accidental Exposure
2
Asthmatic Crisis
2
Eczema
2
Pulmonary Function Test Decreased
2
Drug Dependence
2
Dermatitis
2
Wheezing
2
Milk Allergy
2
Atopy
2
Cystic Fibrosis
2
Allergy To Venom
2

Drug Labels

LabelLabelerEffective
XolairGenentech, Inc.30-JUL-10

Xolair Case Reports

What Xolair safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Xolair. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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