Drug Safety Information for ZYRTEC (Cetirizine hydrochloride)

Safety-related Labeling Changes for ZERVIATE (CETIRIZINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ZYRTEC* (Cetirizine hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ZYRTEC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective2059
2Nausea2018
3Dyspnoea1882
4Headache1772
5Fatigue*1712
6Pain1646
7Dizziness1411
8Pruritus1346
9Diarrhoea1283
10Vomiting1221
11Rash1147
12Product quality issue1128
13Anxiety*1118
14Cough998
15Arthralgia975
16Pyrexia964
17Depression*939
18Insomnia*930
19Urticaria922
20Asthenia913

* This side effect also appears in "Top 10 Side Effects of ZYRTEC " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ZYRTEC
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypersensitivity*17169
2Product used for unknown indication16195
3Seasonal allergy*5511
4Multiple allergies5098
5Rhinitis allergic*1769
6Pruritus*1375
7Premedication1265
8Urticaria*1260
9Ill-defined disorder713
10Asthma*667

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ZYRTEC

Total Reports Filed with FDA: 153910

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Male Patients
Male
Female Patients
Female
Unknown Patients
Unknown


Number of FDA Adverse Event Reports by Patient Age for ZYRTEC

Total Reports Filed with FDA: 153910*

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Note: * Reports include 27,032 reports of unknown age.


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cetirizine hydrochloride (Zyrtec allergy, Cetirizine hcl, Cetirizine, Childrens zyrtec, Alleroff, Being well allergy, Wal-zyr, 24 hour allergy, All day, Aptrizine, Best choice, Healthmart, H-e-b, Quality choice, Simply right, Zero allergy, Pedia care, Cetirizina, All day allergy, Zyrtec hives relief, Wal zyr, Childrens allergy, Zyrtec)

Charts are based on 153910 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and ZYRTEC Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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