Levocetirizine dihydrochloride: adverse event reports filed with FDA

728

reports as suspect product

0% of all reports · about 34 a year

92

reports, 12 months to June 2026

116 in the 12 months before

63.6%

marked serious by the reporter

57.7% across the class

19.8%

record death among outcomes, as reported

144 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 Levocetirizine dihydrochloride reports recording the termmedian drug in histamine-1 receptor antagonist

1. Fatiguetiredness15.4%112
2. Nauseafeeling sick15.1%110
3. Dyspnoeashortness of breath15%109
4. Dizzinesslight-headedness or unsteadiness14.8%108
5. Drug ineffectivethe medicine did not work as expected14.6%106
6. Pruritusitching14%102
7. Arthralgiajoint pain13.7%100
8. Diarrhoealoose or frequent stools13.7%100
9. Falla fall13.6%99
10. Abdominal painstomach or belly pain13%95
11. Haemorrhagic stroke13%95
12. Chillschills or shivering12.9%94
13. Altered state of consciousness12.6%92
14. Amaurosis fugax12.5%91
15. Coma12.5%91
16. Blindnessloss of sight12.4%90
17. Haematemesis12.4%90
18. Insomniadifficulty sleeping12.2%89
19. Somnolencedrowsiness12.2%89
20. Eye paineye pain12.1%88
21. Cardio-respiratory arrestthe heart and breathing stopped12%87
22. Head discomfortdiscomfort in the head12%87
23. Tachycardiafast heart rate11.8%86
24. Headachehead pain11.7%85
25. Sepsisa severe body-wide response to infection11.5%84
26. Ocular discomfort11.4%83
27. Ascitesfluid in the abdomen11.3%82
28. Abdominal pain upperupper stomach pain9.8%71
29. Malaisegeneral feeling of being unwell9.8%71
30. Vomitingbeing sick9.6%70

Top 30 of 368 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. 43.7% 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 728 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 Levocetirizine dihydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (2,978) 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.