Enalapril maleate: adverse event reports filed with FDA

4,087

reports as suspect product

0% of all reports · about 182 a year

77

reports, 12 months to June 2026

66 in the 12 months before

93.6%

marked serious by the reporter

83.4% across the class

10.1%

record death among outcomes, as reported

412 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 Enalapril maleate reports recording the termmedian drug in angiotensin converting enzyme inhibitor

1. Drug interactionan interaction between medicines9.9%404
2. Hyperkalaemiahigh blood potassium9.5%387
3. Renal failure acute7.8%319
4. Hypotensionlow blood pressure6.3%259
5. Dyspnoeashortness of breath5.7%231
6. Angioedemadeep swelling of skin or mucous membranes5.6%230
7. Acute kidney injurysudden loss of kidney function5.4%222
8. Diarrhoealoose or frequent stools5.1%207
9. Hypertensionhigh blood pressure4.3%175
10. Nauseafeeling sick4.3%175
11. Drug ineffectivethe medicine did not work as expected4.2%173
12. Coughcough4.2%172
13. Malaisegeneral feeling of being unwell3.6%149
14. Dehydrationdehydration3.6%148
15. Renal failurekidney failure3.6%148
16. Cardiac failureheart failure3.5%142
17. Dizzinesslight-headedness or unsteadiness3.5%142
18. Hyponatraemialow blood sodium3.4%140
19. Blood creatinine increasedraised creatinine, a kidney test3.4%138
20. Vomitingbeing sick3.2%130
21. Headachehead pain3.1%125
22. Blood pressure increaseda raised blood pressure reading2.9%120
23. Astheniaweakness or lack of energy2.7%111
24. Falla fall2.7%111
25. Rashskin rash2.7%109
26. Drug hypersensitivityan allergic-type reaction to a medicine2.6%107
27. Bradycardiaslow heart rate2.5%103
28. Condition aggravatedthe condition being treated got worse2.5%103
29. Syncopefainting2.4%97
30. Lactic acidosisa build-up of lactic acid in the blood2.3%92

Top 30 of 962 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. 20.2% 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 4,087 reports.

Drugs most often listed in the same reports

Other products listed in reports where Enalapril maleate 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 Enalapril maleate as a suspect or interacting product; reports listing it only as a concomitant medication (14,951) 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.