Cetirizine hydrochloride, pseudoephedrine hydrochloride: adverse event reports filed with FDA

4,914

reports as suspect product

0% of all reports · about 364 a year

909

reports, 12 months to June 2026

1,304 in the 12 months before

99.3%

marked serious by the reporter

57.7% across the class

57.7%

record death among outcomes, as reported

2,833 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 Cetirizine hydrochloride, pseudoephedrine hydrochloride reports recording the termmedian drug in histamine-1 receptor antagonist

1. Systemic lupus erythematosuslupus, an autoimmune disease55.8%2,743
2. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease55.2%2,713
3. Glossodynia54.4%2,673
4. Pemphigus54.3%2,668
5. Fatiguetiredness53.7%2,640
6. Painpain, site not specified53.3%2,619
7. Hand deformity52.1%2,558
8. Rashskin rash51.7%2,542
9. Drug ineffectivethe medicine did not work as expected51.3%2,521
10. Wound51%2,507
11. Off label useused for a purpose or in a way not on the label50.9%2,500
12. Alopeciahair loss50.8%2,496
13. Abdominal discomfortstomach discomfort50.3%2,473
14. Swellingswelling50.1%2,462
15. Infusion related reactiona reaction during or soon after an infusion49.3%2,422
16. Joint swellinga swollen joint48.2%2,371
17. Synovitis48.1%2,362
18. Pericarditisinflammation of the sac around the heart47.6%2,341
19. Arthropathy46.1%2,265
20. Hepatic enzyme increasedraised liver enzymes46%2,262
21. Drug intolerancethe medicine was not tolerated45.7%2,245
22. Hypersensitivityan allergic-type reaction45.5%2,236
23. Maternal exposure during pregnancythe mother took the medicine during pregnancy45.1%2,217
24. Contraindicated product administered44%2,163
25. Helicobacter infection42%2,062
26. Duodenal ulcer perforation41.8%2,052
27. Anti-cyclic citrullinated peptide antibody positive40.4%1,985
28. Product use issuea problem in how the product was used38.7%1,904
29. Discomfortdiscomfort38.6%1,899
30. General physical health deteriorationgeneral decline in health38.2%1,875

Top 30 of 474 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. 0.7% 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 4,914 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cetirizine hydrochloride, pseudoephedrine hydrochloride 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 Cetirizine hydrochloride, pseudoephedrine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (807) 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.