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XYZAL

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Xyzal Adverse Events Reported to the FDA Over Time

How are Xyzal adverse event reports trending over time?

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

Most Common Xyzal Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
56 (2.21%)
Dyspnoea
38 (1.5%)
Fatigue
35 (1.38%)
Somnolence
33 (1.3%)
Malaise
32 (1.26%)
Urticaria
32 (1.26%)
Pyrexia
31 (1.22%)
Abortion Spontaneous
29 (1.15%)
Nausea
23 (.91%)
Rash
23 (.91%)
Alanine Aminotransferase Increased
22 (.87%)
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Headache
22 (.87%)
Convulsion
21 (.83%)
Drug Ineffective
21 (.83%)
Aspartate Aminotransferase Increase...
20 (.79%)
Asthenia
18 (.71%)
Liver Disorder
18 (.71%)
Liver Function Test Abnormal
18 (.71%)
Pain
18 (.71%)
Loss Of Consciousness
17 (.67%)
Blood Alkaline Phosphatase Increase...
16 (.63%)
Dizziness
16 (.63%)
Gamma-glutamyltransferase Increased
16 (.63%)
Jaundice
16 (.63%)
Prothrombin Time Prolonged
16 (.63%)
Anaphylactic Shock
15 (.59%)
Decreased Appetite
15 (.59%)
Erythema
15 (.59%)
Oedema Peripheral
15 (.59%)
Blood Bilirubin Increased
14 (.55%)
Blood Pressure Increased
13 (.51%)
Insomnia
13 (.51%)
Abortion Induced
12 (.47%)
Condition Aggravated
12 (.47%)
Gait Disturbance
12 (.47%)
Pneumonia
12 (.47%)
Pruritus
12 (.47%)
Transaminases Increased
12 (.47%)
Blood Lactate Dehydrogenase Increas...
11 (.43%)
Chest Pain
11 (.43%)
Cytolytic Hepatitis
11 (.43%)
Diarrhoea
11 (.43%)
Electrocardiogram Qt Prolonged
11 (.43%)
Hepatic Function Abnormal
11 (.43%)
Hypertension
11 (.43%)
Paraesthesia
11 (.43%)
Platelet Count Decreased
11 (.43%)
Purpura
11 (.43%)
Abdominal Pain Upper
10 (.39%)
Altered State Of Consciousness
10 (.39%)
Oedema
10 (.39%)
Pregnancy
10 (.39%)
Renal Failure
10 (.39%)
Sudden Death
10 (.39%)
Swelling Face
10 (.39%)
Thrombocytopenia
10 (.39%)
Tremor
10 (.39%)
Abdominal Discomfort
9 (.36%)
Agranulocytosis
9 (.36%)
Asthma
9 (.36%)
Bilirubin Conjugated Increased
9 (.36%)
Blister
9 (.36%)
Bronchitis
9 (.36%)
Hallucination
9 (.36%)
Lung Disorder
9 (.36%)
Metrorrhagia
9 (.36%)
Overdose
9 (.36%)
Suicide Attempt
9 (.36%)
Syncope
9 (.36%)
Vision Blurred
9 (.36%)
Activated Partial Thromboplastin Ti...
8 (.32%)
Angioedema
8 (.32%)
Blood Albumin Decreased
8 (.32%)
C-reactive Protein Increased
8 (.32%)
Chromaturia
8 (.32%)
Epstein-barr Virus Antibody Positiv...
8 (.32%)
Faeces Pale
8 (.32%)
Heart Rate Increased
8 (.32%)
Hepatitis
8 (.32%)
International Normalised Ratio Incr...
8 (.32%)
Myalgia
8 (.32%)
Pancytopenia
8 (.32%)
Protein Total Decreased
8 (.32%)
Prothrombin Time Ratio Decreased
8 (.32%)
Tachycardia
8 (.32%)
Vomiting
8 (.32%)
Allergic Granulomatous Angiitis
7 (.28%)
Cough
7 (.28%)
Cutaneous Vasculitis
7 (.28%)
Erythema Multiforme
7 (.28%)
Fall
7 (.28%)
Feeling Abnormal
7 (.28%)
Hepatitis Cholestatic
7 (.28%)
Inflammation
7 (.28%)
Leukocytosis
7 (.28%)
Muscle Spasms
7 (.28%)
Pain In Extremity
7 (.28%)
Peripheral Sensory Neuropathy
7 (.28%)
Respiratory Disorder
7 (.28%)
Urinary Incontinence
7 (.28%)
Venous Insufficiency
7 (.28%)

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

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

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This graph shows the top categories of adverse events submitted to the FDA for Xyzal, 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 Xyzal 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 Xyzal According to Those Reporting Adverse Events

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

Hypersensitivity
185
Product Used For Unknown Indication
149
Drug Use For Unknown Indication
131
Rhinitis Allergic
95
Pruritus
90
Multiple Allergies
79
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Seasonal Allergy
78
Urticaria
34
Rash
33
Rhinitis
28
Dermatitis Atopic
20
Asthma
18
Prophylaxis
16
Antiallergic Therapy
15
Palmar-plantar Erythrodysaesthesia ...
13
Eczema
11
Sinus Disorder
10
Urticaria Chronic
8
Premedication
7
Nasopharyngitis
7
Sinusitis
6
Injection Site Reaction
6
Nasal Congestion
6
Pruritus Generalised
6
Food Allergy
5
Rhinitis Seasonal
5
Atopy
5
Erythema
4
Eosinophilic Pustular Folliculitis
4
Dermatitis Contact
4
Dermatitis Allergic
4
Acute Sinusitis
3
Dermatitis
3
Allergy Prophylaxis
3
Allergic Sinusitis
3
Adverse Event
3
Acne
3
Prurigo
3
Cough
3
Rhinitis Perennial
3
Eczema Nummular
2
Urticaria Papular
2
Vein Disorder
2
Drug Eruption
2
Allergic Cough
2
Erythrosis
2
Postnasal Drip
2
Tongue Oedema
2
Otitis Media
2
House Dust Allergy
2
Acarodermatitis
2

Drug Labels

LabelLabelerEffective
XyzalUCB Farchim S.A.15-MAR-10
XyzalPhysicians Total Care, Inc.11-MAY-10
XyzalLake Erie Medical DBA Quality Care Products LLC10-AUG-10
XyzalSanofi-Aventis U.S. LLC12-SEP-12

Xyzal Case Reports

What Xyzal 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 Xyzal. 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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