Lisinopril: adverse event reports filed with FDA

44,437

reports as suspect product

0.2% of all reports · about 1,975 a year

1,594

reports, 12 months to June 2026

1,835 in the 12 months before

71.3%

marked serious by the reporter

83.4% across the class

12.7%

record death among outcomes, as reported

5,636 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 Lisinopril reports recording the termmedian drug in angiotensin converting enzyme inhibitor

1. Angioedemadeep swelling of skin or mucous membranes15.4%6,827
2. Completed suicidedeath by suicide6.8%3,022
3. Coughcough6.6%2,927
4. Drug hypersensitivityan allergic-type reaction to a medicine6.5%2,879
5. Drug ineffectivethe medicine did not work as expected5.4%2,407
6. Hypotensionlow blood pressure5.2%2,323
7. Dyspnoeashortness of breath5.2%2,320
8. Dizzinesslight-headedness or unsteadiness5%2,244
9. Acute kidney injurysudden loss of kidney function4.5%1,995
10. Fatiguetiredness4.1%1,834
11. Headachehead pain4%1,787
12. Nauseafeeling sick3.9%1,739
13. Hypertensionhigh blood pressure3.9%1,726
14. Hyperkalaemiahigh blood potassium3.5%1,561
15. Toxicity to various agentspoisoning or toxic effect of one or more substances3.4%1,527
16. Blood pressure increaseda raised blood pressure reading3.2%1,425
17. Off label useused for a purpose or in a way not on the label3.2%1,400
18. Vomitingbeing sick3.1%1,390
19. Diarrhoealoose or frequent stools3%1,344
20. Malaisegeneral feeling of being unwell3%1,326
21. Swollen tongue2.9%1,292
22. Astheniaweakness or lack of energy2.8%1,263
23. Drug interactionan interaction between medicines2.8%1,251
24. Falla fall2.4%1,083
25. Weight decreasedweight loss2.4%1,076
26. Painpain, site not specified2.3%1,040
27. Hypersensitivityan allergic-type reaction2.3%1,024
28. Swelling facea swollen face2.2%977
29. Rashskin rash2.1%941
30. Lip swellingswollen lips2.1%922

Top 30 of 2,558 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. 80.5% 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 44,437 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lisinopril 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 Lisinopril as a suspect or interacting product; reports listing it only as a concomitant medication (255,957) 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.