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|
|12||Product quality issue||1128|
* 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|
|2||Product used for unknown indication||16195|
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for ZYRTEC
Total Reports Filed with FDA: 153910
Number of FDA Adverse Event Reports by Patient Age for ZYRTEC
Total Reports Filed with FDA: 153910*
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.