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ZYRTEC

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Zyrtec Adverse Events Reported to the FDA Over Time

How are Zyrtec adverse event reports trending over time?

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

Most Common Zyrtec Adverse Events Reported to the FDA

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

Product Quality Issue
666 (2.78%)
Drug Ineffective
340 (1.42%)
Pruritus
288 (1.2%)
Dyspnoea
282 (1.18%)
Dizziness
278 (1.16%)
Urticaria
273 (1.14%)
Convulsion
268 (1.12%)
Wrong Drug Administered
265 (1.11%)
Somnolence
264 (1.1%)
Drug Exposure During Pregnancy
251 (1.05%)
Vomiting
237 (.99%)
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Rash
236 (.99%)
Pyrexia
212 (.89%)
Headache
199 (.83%)
Insomnia
198 (.83%)
Off Label Use
192 (.8%)
Hypersensitivity
190 (.79%)
Fatigue
184 (.77%)
Malaise
182 (.76%)
Overdose
180 (.75%)
Condition Aggravated
176 (.74%)
Nausea
174 (.73%)
Completed Suicide
170 (.71%)
Drug Toxicity
166 (.69%)
Loss Of Consciousness
157 (.66%)
Diarrhoea
153 (.64%)
Feeling Abnormal
146 (.61%)
Medication Error
137 (.57%)
Depression
130 (.54%)
Fall
126 (.53%)
Pain
124 (.52%)
Abdominal Pain Upper
121 (.51%)
Abnormal Behaviour
120 (.5%)
Withdrawal Syndrome
117 (.49%)
Anxiety
114 (.48%)
Death
112 (.47%)
Drug Interaction
105 (.44%)
Palpitations
105 (.44%)
Hallucination
101 (.42%)
Cough
96 (.4%)
Asthma
95 (.4%)
Oedema Peripheral
93 (.39%)
Cardiac Arrest
92 (.38%)
Tremor
92 (.38%)
Aggression
91 (.38%)
Asthenia
91 (.38%)
Erythema
91 (.38%)
Pruritus Generalised
91 (.38%)
Suicide Attempt
88 (.37%)
Hypertension
87 (.36%)
Abortion Spontaneous
84 (.35%)
Heart Rate Increased
83 (.35%)
Irritability
83 (.35%)
Arthralgia
80 (.33%)
Drug Withdrawal Syndrome
79 (.33%)
Muscle Spasms
79 (.33%)
Weight Decreased
79 (.33%)
Chest Pain
76 (.32%)
Liver Disorder
75 (.31%)
Dry Mouth
74 (.31%)
Pain In Extremity
74 (.31%)
Weight Increased
73 (.3%)
Suicidal Ideation
72 (.3%)
Blood Pressure Increased
71 (.3%)
Crying
71 (.3%)
Syncope
69 (.29%)
Vision Blurred
67 (.28%)
Drug Hypersensitivity
66 (.28%)
Eye Swelling
66 (.28%)
Accidental Overdose
65 (.27%)
Rash Generalised
65 (.27%)
Agitation
64 (.27%)
Drug Dependence
63 (.26%)
Epilepsy
63 (.26%)
Alanine Aminotransferase Increased
61 (.25%)
Aspartate Aminotransferase Increase...
61 (.25%)
Cardio-respiratory Arrest
60 (.25%)
Hyperhidrosis
59 (.25%)
Hypoaesthesia
59 (.25%)
Confusional State
58 (.24%)
Intentional Overdose
58 (.24%)
Lethargy
58 (.24%)
Tachycardia
58 (.24%)
Angioedema
56 (.23%)
Swelling Face
55 (.23%)
Multiple Drug Overdose
54 (.23%)
Blood Glucose Increased
53 (.22%)
Chest Discomfort
53 (.22%)
Paraesthesia
53 (.22%)
Abdominal Pain
52 (.22%)
Chills
52 (.22%)
Drug Dispensing Error
52 (.22%)
Dyskinesia
52 (.22%)
Sinusitis
52 (.22%)
Coma
51 (.21%)
Anger
50 (.21%)
Hepatitis
49 (.2%)
Electrocardiogram Qt Prolonged
48 (.2%)
Pneumonia
48 (.2%)
Contusion
47 (.2%)
Memory Impairment
47 (.2%)

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

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

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

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

Hypersensitivity
2742
Drug Use For Unknown Indication
1482
Product Used For Unknown Indication
1282
Seasonal Allergy
1014
Multiple Allergies
986
Rhinitis Allergic
453
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Pruritus
331
Ill-defined Disorder
273
Asthma
224
Urticaria
224
Nasopharyngitis
191
Premedication
143
Sinus Disorder
141
Nasal Congestion
139
Rash
121
Rhinitis
103
Sinusitis
101
Cough
84
Rhinorrhoea
78
Prophylaxis
67
Sinus Congestion
54
Eczema
46
Allergic Sinusitis
44
Influenza
41
Dermatitis Atopic
40
Upper Respiratory Tract Infection
39
Sinus Headache
36
Suicide Attempt
31
Headache
30
Sneezing
28
Swelling
28
Antiallergic Therapy
27
Dermatitis
27
Conjunctivitis
25
Food Allergy
24
Rhinitis Seasonal
24
Pain
23
Allergy Prophylaxis
23
Accidental Exposure
22
Pyrexia
21
Eye Pruritus
21
Urticaria Chronic
21
Chronic Sinusitis
21
Influenza Like Illness
18
Malaise
18
Dermatitis Allergic
18
Allergy To Animal
17
Nasal Decongestion Therapy
16
Pharyngitis
16
House Dust Allergy
15
Postnasal Drip
15

Drug Labels

LabelLabelerEffective
Zyrtec-dallergy And Congestion McNeil Consumer Healthcare Div McNeil-PPC, Inc05-OCT-09
Childrens ZyrtecMcNeil Consumer Healthcare Div McNeil-PPC, Inc27-OCT-09
ZyrtecMcNeil Consumer Healthcare Div McNeil-PPC, Inc22-DEC-09
ZyrtecMcNeil Consumer Healthcare Div McNeil-PPC, Inc24-DEC-09
ZyrtecMcNeil Consumer Healthcare Division of McNeil-PPC, Inc.13-JAN-10
Childrens Zyrtec Hives ReliefMcNeil Consumer Healthcare Div McNeil-PPC, Inc15-JAN-10
Childrens ZyrtecMcNeil Consumer Healthcare Div McNeil-PPC, Inc19-JAN-10
Zyrtec Itchy EyeMcNeil Consumer Healthcare Division of McNeil-PPC, Inc.25-FEB-10
Zyrtecd Allergy And Congestion Physicians Total Care, Inc.23-MAY-12

Zyrtec Case Reports

What Zyrtec 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 Zyrtec. 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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