Chlorpheniramine maleate: adverse event reports filed with FDA

942

reports as suspect product

0% of all reports · about 42 a year

81

reports, 12 months to June 2026

77 in the 12 months before

96.6%

marked serious by the reporter

57.7% across the class

29.4%

record death among outcomes, as reported

277 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 Chlorpheniramine maleate reports recording the termmedian drug in histamine-1 receptor antagonist

1. Off label useused for a purpose or in a way not on the label13.7%129
2. Toxicity to various agentspoisoning or toxic effect of one or more substances10.7%101
3. Drug hypersensitivityan allergic-type reaction to a medicine8.8%83
4. Drug ineffectivethe medicine did not work as expected8.7%82
5. Nauseafeeling sick8.7%82
6. Somnolencedrowsiness8.7%82
7. Dyspnoeashortness of breath8.3%78
8. Condition aggravatedthe condition being treated got worse7.4%70
9. Product use in unapproved indicationused for a purpose not on the label7.4%70
10. Vomitingbeing sick7.1%67
11. Sepsisa severe body-wide response to infection6.5%61
12. Abdominal painstomach or belly pain6.4%60
13. Dry mouthdry mouth5.7%54
14. Pyrexiafever5.7%54
15. Drug abusemisuse of a medicine5.1%48
16. Hypotensionlow blood pressure5.1%48
17. Pneumonialung infection4.9%46
18. Sleep disordera sleep problem4.8%45
19. Drug intolerancethe medicine was not tolerated4.6%43
20. Flushingsudden reddening or warmth of the skin4.6%43
21. General physical health deteriorationgeneral decline in health4.6%43
22. Hyponatraemialow blood sodium4.6%43
23. Swellingswelling4.5%42
24. Overdosea dose above the recommended amount4.4%41
25. Intentional product misusedeliberate use not as intended4.1%39
26. Ventricular fibrillationa chaotic rhythm from the lower heart chambers4.1%39
27. Coughcough4%38
28. Drug interactionan interaction between medicines4%38
29. Paraesthesiatingling or pins and needles4%38
30. Constipationconstipation3.9%37

Top 30 of 521 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. 20.4% 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 942 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 Chlorpheniramine maleate as a suspect or interacting product; reports listing it only as a concomitant medication (4,752) 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.