Ramipril: adverse event reports filed with FDA

37,202

reports as suspect product

0.2% of all reports · about 1,654 a year

2,250

reports, 12 months to June 2026

3,969 in the 12 months before

95.6%

marked serious by the reporter

83.4% across the class

12.2%

record death among outcomes, as reported

4,548 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 Ramipril reports recording the termmedian drug in angiotensin converting enzyme inhibitor

1. Acute kidney injurysudden loss of kidney function8.8%3,262
2. Dyspnoeashortness of breath7.8%2,891
3. Dizzinesslight-headedness or unsteadiness7.6%2,827
4. Drug ineffectivethe medicine did not work as expected7.2%2,670
5. Hypotensionlow blood pressure7.1%2,636
6. Fatiguetiredness6.8%2,529
7. Nauseafeeling sick6.5%2,427
8. Vomitingbeing sick6.3%2,346
9. Off label useused for a purpose or in a way not on the label6.2%2,292
10. Hypertensionhigh blood pressure6.1%2,277
11. Falla fall5.8%2,160
12. Diarrhoealoose or frequent stools5.8%2,156
13. Painpain, site not specified5.8%2,151
14. Astheniaweakness or lack of energy5.7%2,133
15. Confusional stateconfusion5.7%2,126
16. Headachehead pain5.4%2,016
17. General physical health deteriorationgeneral decline in health5.2%1,946
18. Condition aggravatedthe condition being treated got worse5.2%1,941
19. Malaisegeneral feeling of being unwell5.1%1,901
20. Drug interactionan interaction between medicines5.1%1,897
21. Arthralgiajoint pain4.7%1,746
22. Coughcough4.5%1,658
23. Rashskin rash4.4%1,638
24. Hyperkalaemiahigh blood potassium4.4%1,622
25. Maternal exposure during pregnancythe mother took the medicine during pregnancy4.1%1,523
26. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease4.1%1,516
27. Pneumonialung infection4%1,497
28. Abdominal discomfortstomach discomfort4%1,496
29. Drug intolerancethe medicine was not tolerated3.7%1,387
30. Hyponatraemialow blood sodium3.7%1,379

Top 30 of 2,985 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 13 drugs in the angiotensin converting enzyme inhibitor 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 102,327 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. 5.9% 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 37,202 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ramipril 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 angiotensin converting enzyme inhibitor 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 Ramipril as a suspect or interacting product; reports listing it only as a concomitant medication (88,061) 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.