Felodipine: adverse event reports filed with FDA

2,049

reports as suspect product

0% of all reports · about 91 a year

145

reports, 12 months to June 2026

128 in the 12 months before

91.4%

marked serious by the reporter

82.3% across the class

6.6%

record death among outcomes, as reported

136 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 Felodipine reports recording the termmedian drug in dihydropyridine calcium channel blocker

1. Fatiguetiredness28.1%576
2. Headachehead pain28%573
3. Palpitationsawareness of the heartbeat27.2%558
4. Abdominal discomfortstomach discomfort26.5%544
5. Pyrexiafever26.5%542
6. Covid-19COVID-19 infection26.2%536
7. Tinnitusringing in the ears26.1%534
8. Migrainemigraine26%532
9. Painpain, site not specified25.9%530
10. Dizzinesslight-headedness or unsteadiness24.3%498
11. Off label useused for a purpose or in a way not on the label23.7%486
12. Vomitingbeing sick23%472
13. Dyspnoeashortness of breath23%471
14. Nauseafeeling sick21.5%440
15. Diarrhoealoose or frequent stools20.6%422
16. Chest painchest pain20.5%421
17. Peripheral swellingswelling of the arms or legs20.5%421
18. Intentional product use issuedeliberate use not as intended20.5%420
19. Malaisegeneral feeling of being unwell20.4%419
20. Arthralgiajoint pain20.2%414
21. Pruritusitching20.2%414
22. Angioedemadeep swelling of skin or mucous membranes20.1%412
23. Muscular weaknessmuscle weakness20%410
24. Back painback pain19.8%406
25. Dehydrationdehydration19.7%404
26. Visual impairmentreduced vision19.7%403
27. Anxietyanxiety19.6%401
28. Feeling abnormalfeeling odd or not right19.5%400
29. Heart rate increaseda fast heart rate reading19.5%399
30. Insomniadifficulty sleeping19.2%394

Top 30 of 488 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 6 drugs in the dihydropyridine calcium channel blocker 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 26,910 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. 18% 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 2,049 reports.

Drugs most often listed in the same reports

Other products listed in reports where Felodipine 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 dihydropyridine calcium channel blocker 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 Felodipine as a suspect or interacting product; reports listing it only as a concomitant medication (9,372) 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.