Pharmacologic class (EPC) · 13 drug pages

Angiotensin converting enzyme inhibitor: adverse event reports filed with FDA

102,327 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

102,327
reports across the class: 0.5% of all reports; 4,646
reports, 12 months to June 2026: 6,546 in the 12 months before; 83.4%
marked serious by the reporter: 57.4% across all reports; 13
drugs with a page: brand and generic names counted separately

Angiotensin converting enzyme inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 13 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 102,327 adverse event reports received by FDA, 0.5% of the database, from January 2004 to June 2026.

4,646 reports arrived in the 12 months to June 2026, down 29% from 6,546 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 83.4% of the class's reports are marked serious, 11.8% record death among the outcomes and 47.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are angioedema (9%), hypotension (6.6%) and dyspnoea (6.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Lisinopril	generic	44,437	1,594	71.3%	Angioedema
Ramipril	generic	37,202	2,250	95.6%	Acute kidney injury
Enalapril	generic	6,754	294	95.5%	Acute kidney injury
Enalapril maleate	generic	4,087	77	93.6%	Drug interaction
ZestrilLisinopril	brand	1,920	181	71.9%	Headache
Captopril	generic	1,672	47	92.7%	Drug ineffective
Quinapril	generic	1,231	12	59.7%	Fall
Perindopril erbumine	generic	1,166	36	98.6%	Hypertension
LotrelAmlodipine besylate and benazepril hydrochloride	brand	1,046	13	79.2%	Dizziness
Quinapril hydrochloride	generic	941	19	89.3%	Fall
Benazepril hydrochloride	generic	791	57	67.6%	Dizziness
VasotecEnalapril maleate	brand	558	2	70.6%	Drug hypersensitivity
LotensinBenazepril hydrochloride	brand	522	64	74.5%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Angioedemadeep swelling of skin or mucous membranes9%9,195
Hypotensionlow blood pressure6.6%6,774
Dyspnoeashortness of breath6.4%6,598
Acute kidney injurysudden loss of kidney function6.4%6,572
Drug ineffectivethe medicine did not work as expected6.3%6,488
Dizzinesslight-headedness or unsteadiness5.9%6,014
Coughcough5.5%5,597
Hypertensionhigh blood pressure5.1%5,210
Nauseafeeling sick5%5,110
Fatiguetiredness5%5,068
Drug hypersensitivityan allergic-type reaction to a medicine4.8%4,880
Drug interactionan interaction between medicines4.7%4,803
Headachehead pain4.6%4,749
Falla fall4.4%4,545
Off label useused for a purpose or in a way not on the label4.4%4,452
Vomitingbeing sick4.3%4,420
Diarrhoealoose or frequent stools4.3%4,375
Hyperkalaemiahigh blood potassium4.1%4,191
Painpain, site not specified4.1%4,153
Malaisegeneral feeling of being unwell4%4,094
Astheniaweakness or lack of energy3.9%4,023
Completed suicidedeath by suicide3.4%3,441
Confusional stateconfusion3.2%3,318
Condition aggravatedthe condition being treated got worse3.1%3,162
Blood pressure increaseda raised blood pressure reading3.1%3,126

Solid bar: share of all class reports. Hollow bar: the median share across the 13 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death11.8%12,112

Life-threatening12.5%12,804

Hospitalisation (initial or prolonged)47.6%48,687

Disability5.7%5,782

Congenital anomaly2.6%2,679

Other serious47.8%48,951

Not serious16.6%16,988

Patient age

Under 20.4%455

2 to 110.4%397

12 to 170.7%714

18 to 448.6%8,755

45 to 6426%26,645

65 to 7418.9%19,307

75 and over21.6%22,100

Age not given23.4%23,954

Who reported

Physician26.2%26,850

Pharmacist16.5%16,905

Other health professional28.2%28,825

Lawyer0.1%119

Consumer or non-health professional22.6%23,155

Not given6.3%6,473

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Angiotensin converting enzyme inhibitor reports

Which drugs are in the Angiotensin converting enzyme inhibitor class on this site?

Lisinopril, Ramipril, Enalapril, Enalapril maleate, Zestril and Captopril and 7 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

102,327 reports through June 2026, 4,646 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

angioedema (9%), hypotension (6.6%), dyspnoea (6.4%), acute kidney injury (6.4%) and drug ineffective (6.3%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.