Childrens Zyrtec Allergy: adverse event reports filed with FDA

514

reports as suspect product

0% of all reports · about 32 a year

10

reports, 12 months to June 2026

15 in the 12 months before

1.8%

marked serious by the reporter

57.7% across the class

0%

record death among outcomes, as reported

0 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Childrens Zyrtec Allergy reports recording the termmedian drug in histamine-1 receptor antagonist

1. Product use in unapproved indicationused for a purpose not on the label13.6%70
2. Off label useused for a purpose or in a way not on the label11.5%59
3. Product use issuea problem in how the product was used9.3%48
4. Therapeutic response unexpected8.6%44
5. Overdosea dose above the recommended amount7.8%40
6. Accidental overdosean accidental overdose7.4%38
7. Drug ineffectivethe medicine did not work as expected7%36
8. Wrong technique in product usage processthe product was used in the wrong way6.6%34
9. Incorrect dose administeredthe wrong dose was given6.4%33
10. Somnolencedrowsiness6.2%32
11. Product physical issuea physical defect in the product5.6%29
12. Dysgeusiaaltered taste4.7%24
13. Extra dose administered3.7%19
14. Expired product administeredthe product was used past its expiry date2.7%14
15. Abdominal pain upperupper stomach pain2.5%13
16. Accidental exposure to product2.5%13
17. Fatiguetiredness2.3%12
18. Accidental exposure to product by child1.9%10
19. Diarrhoealoose or frequent stools1.9%10
20. Vomitingbeing sick1.9%10
21. Drug ineffective for unapproved indication1.8%9
22. Product taste abnormalthe product tasted odd1.8%9
23. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times1.6%8
24. Product administration errora mistake in giving the product1.6%8
25. Product label issuea problem with the label1.6%8
26. Hypersensitivityan allergic-type reaction1.4%7
27. Product packaging issuea problem with the packaging1.4%7
28. Rashskin rash1.4%7
29. Abnormal behaviourunusual behaviour1.2%6
30. Adverse eventan unwanted medical event, type not specified1.2%6

Top 30 of 103 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 34 drugs in the histamine-1 receptor antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 135,666 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 514 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the histamine-1 receptor antagonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Childrens Zyrtec Allergy as a suspect or interacting product; reports listing it only as a concomitant medication (38) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.