Xyzal: adverse event reports filed with FDA

3,824

reports as suspect product

0% of all reports · about 181 a year

181

reports, 12 months to June 2026

264 in the 12 months before

44.6%

marked serious by the reporter

57.7% across the class

7.7%

record death among outcomes, as reported

295 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 Xyzal reports recording the termmedian drug in histamine-1 receptor antagonist

1. Drug ineffectivethe medicine did not work as expected16.8%643
2. Somnolencedrowsiness16.7%639
3. Pruritusitching8.6%327
4. Fatiguetiredness8.1%308
5. Headachehead pain7.4%282
6. Dyspnoeashortness of breath6.2%238
7. Haemorrhagic stroke5.7%219
8. Dizzinesslight-headedness or unsteadiness5.6%213
9. Altered state of consciousness5.4%206
10. Insomniadifficulty sleeping5.3%201
11. Cardio-respiratory arrestthe heart and breathing stopped4.9%187
12. Malaisegeneral feeling of being unwell4.8%183
13. No adverse eventno adverse event was reported4.8%182
14. Astheniaweakness or lack of energy4.7%180
15. Sepsisa severe body-wide response to infection4.7%179
16. Coughcough4.7%178
17. Blood pressure increaseda raised blood pressure reading4.6%175
18. Pyrexiafever4.6%175
19. Nauseafeeling sick4.5%172
20. Falla fall4.4%169
21. Diarrhoealoose or frequent stools4.4%168
22. Tachycardiafast heart rate4.3%165
23. Arthralgiajoint pain4.3%164
24. Decreased appetitereduced appetite4.1%157
25. Vomitingbeing sick4.1%157
26. Syncopefainting4.1%156
27. Chillschills or shivering4.1%155
28. Head discomfortdiscomfort in the head3.9%151
29. Blindnessloss of sight3.9%149
30. Amaurosis fugax3.9%148

Top 30 of 689 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. 64.7% 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 3,824 reports.

Drugs most often listed in the same reports

Other products listed in reports where Xyzal is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

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 Xyzal as a suspect or interacting product; reports listing it only as a concomitant medication (10,543) 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.