Pseudoephedrine hydrochloride: adverse event reports filed with FDA

8,381

reports as suspect product

0% of all reports · about 381 a year

1,163

reports, 12 months to June 2026

1,557 in the 12 months before

90.4%

marked serious by the reporter

50.8% across the class

38.6%

record death among outcomes, as reported

3,231 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 Pseudoephedrine hydrochloride reports recording the termmedian drug in alpha-adrenergic agonist

1. Systemic lupus erythematosuslupus, an autoimmune disease57.7%4,832
2. Painpain, site not specified56.6%4,743
3. Drug ineffectivethe medicine did not work as expected56.4%4,730
4. Pemphigus56.4%4,730
5. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease56.2%4,713
6. Abdominal discomfortstomach discomfort55.1%4,616
7. Alopeciahair loss54%4,525
8. Glossodynia52.1%4,369
9. Wound50.3%4,216
10. Swellingswelling50.2%4,206
11. Fatiguetiredness49.4%4,137
12. Rashskin rash49.1%4,116
13. Hand deformity49%4,110
14. Pericarditisinflammation of the sac around the heart46.3%3,884
15. Arthropathy46.1%3,866
16. Synovitis46.1%3,865
17. Contraindicated product administered45.5%3,815
18. Infusion related reactiona reaction during or soon after an infusion44.8%3,755
19. Maternal exposure during pregnancythe mother took the medicine during pregnancy43.7%3,661
20. Joint swellinga swollen joint43.1%3,609
21. Hypersensitivityan allergic-type reaction41.7%3,493
22. Hepatic enzyme increasedraised liver enzymes41%3,438
23. Drug intolerancethe medicine was not tolerated40.9%3,427
24. Discomfortdiscomfort40.5%3,391
25. Off label useused for a purpose or in a way not on the label40.3%3,376
26. Anti-cyclic citrullinated peptide antibody positive38.9%3,264
27. Product use issuea problem in how the product was used38.1%3,194
28. Duodenal ulcer perforation33.1%2,777
29. Arthralgiajoint pain32.8%2,749
30. Treatment failurethe treatment did not work32.4%2,714

Top 30 of 590 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 11 drugs in the alpha-adrenergic agonist 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 23,291 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. 12.1% 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 8,381 reports.

Drugs most often listed in the same reports

Other products listed in reports where 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 alpha-adrenergic agonist 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 Pseudoephedrine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,410) 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.