Perindopril erbumine: adverse event reports filed with FDA

1,166

reports as suspect product

0% of all reports · about 52 a year

36

reports, 12 months to June 2026

42 in the 12 months before

98.6%

marked serious by the reporter

83.4% across the class

8.6%

record death among outcomes, as reported

100 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 Perindopril erbumine reports recording the termmedian drug in angiotensin converting enzyme inhibitor

1. Hypertensionhigh blood pressure9.2%107
2. Dyspnoeashortness of breath9%105
3. Falla fall8.8%103
4. Drug ineffectivethe medicine did not work as expected8.3%97
5. Drug interactionan interaction between medicines8.2%96
6. Renal failure acute7.8%91
7. Headachehead pain7.1%83
8. Hypotensionlow blood pressure6.9%80
9. Off label useused for a purpose or in a way not on the label6.9%80
10. Malaisegeneral feeling of being unwell5.8%68
11. Acute kidney injurysudden loss of kidney function5.6%65
12. Asthmaasthma5.2%61
13. Dizzinesslight-headedness or unsteadiness4.7%55
14. Fatiguetiredness4.6%54
15. Drug intolerancethe medicine was not tolerated4.5%52
16. Diarrhoealoose or frequent stools4.4%51
17. Cardiac disorder4.2%49
18. Fibromyalgia3.9%46
19. Toxicity to various agentspoisoning or toxic effect of one or more substances3.9%46
20. Sleep apnoea syndromepauses in breathing during sleep3.9%45
21. Therapeutic product effect incomplete3.8%44
22. Hyperkalaemiahigh blood potassium3.7%43
23. Vomitingbeing sick3.6%42
24. Angioedemadeep swelling of skin or mucous membranes3.3%39
25. Depressed level of consciousness3.3%39
26. Dehydrationdehydration3.3%38
27. Gastrooesophageal reflux diseaseacid reflux3.3%38
28. Contraindicated product administered3.2%37
29. Hypothyroidismunderactive thyroid3.2%37
30. Burning sensationa burning feeling3.1%36

Top 30 of 524 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. 1.8% 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 1,166 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 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 Perindopril erbumine as a suspect or interacting product; reports listing it only as a concomitant medication (4,374) 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.