Quinapril hydrochloride adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Quinapril hydrochloride
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Angiotensin converting enzyme inhibitor
Also reported as: Quinapril Hcl

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 941 adverse event reports that name Quinapril hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 1,099 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 19 reports in the 12 months to June 2026 and 4 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 19 (under 0.1%) name Quinapril hydrochloride. Reports for patients 75 and over were 49.2% of the reports that name Quinapril hydrochloride and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Quinapril hydrochloride is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 2 reports that name Quinapril hydrochloride.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 0.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 98 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 859 of the 941 reports (91.3%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 98 terms.

Reaction terms in the reports that name Quinapril hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 941 reports
Falla fall	514	54.6%
Cognitive disorderproblems with thinking or memory	471	50.1%
Orthostatic hypotension	466	49.5%
Balance disorderproblems with balance	458	48.7%
Hypotensionlow blood pressure	455	48.4%
Constipation	449	47.7%
Sedationdrowsiness	436	46.3%
Depressed level of consciousness	420	44.6%
Blood calcium decreased	404	42.9%
Creatinine renal clearance decreased	404	42.9%
Mobility decreasedreduced ability to move about	404	42.9%
Sedation complication	404	42.9%
Painpain, site not specified	399	42.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	378	40.2%
Dyspnoeashortness of breath	125	13.3%
Drug interactionan interaction between medicines	73	7.8%
Multiple drug therapy	57	6.1%
Cough	54	5.7%
Product use in unapproved indicationused for a purpose not on the label	53	5.6%
Productive cougha cough with phlegm	52	5.5%
Renal function test abnormal	52	5.5%
Asthma	51	5.4%
Overdosea dose above the recommended amount	50	5.3%
Dyspnoea exertional	48	5.1%
Wheezing	48	5.1%
Off label useused for a purpose or in a way not on the label	47	5%
Drug abusemisuse of a medicine	46	4.9%
Chest pain	43	4.6%
Insomniadifficulty sleeping	43	4.6%
Malaisegeneral feeling of being unwell	43	4.6%
Weight decreasedweight loss	43	4.6%
Injurya physical injury	42	4.5%
Angina pectoris	41	4.4%
Lower respiratory tract infectiona chest infection	41	4.4%
Pyrexiafever	41	4.4%
Upper respiratory tract infectiona cold or similar infection	41	4.4%
Appetite disorder	40	4.3%
Creatinine renal clearance increased	40	4.3%
Depressed moodlow mood	40	4.3%
Influenzaflu	40	4.3%
Nasal congestiona blocked nose	40	4.3%
Nasopharyngitisa cold	40	4.3%
Respiration abnormal	40	4.3%
Rhinorrhoeaa runny nose	40	4.3%
Sleep disorder due to a general medical condition	40	4.3%
Stress	40	4.3%
Chest discomfort	38	4%
Depressive symptom	38	4%
Heart sounds	38	4%
Prolonged expiration	38	4%

Download all 98 terms of Quinapril hydrochloride (CSV)

The counts add to more than 941 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Quinapril with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Quinapril	Generic name	1,231
Quinapril hydrochloride (this page)	Generic name	941

Sum of the separately reported names: 2,172. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Quinapril hydrochloride, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	30	30	4	3	25	2	0	13	0
2005	26	23	3	0	12	0	0	14	3
2006	30	28	3	1	12	0	0	18	2
2007	30	18	2	1	6	0	0	11	12
2008	47	30	11	1	4	0	0	15	17
2009	14	9	5	0	3	0	0	1	5
2010	22	17	3	1	2	0	0	11	5
2011	35	27	1	4	12	1	0	18	8
2012	52	30	5	2	8	1	1	20	22
2013	31	17	1	1	7	0	0	13	14
2014	10	6	1	0	3	0	0	5	4
2015	1	1	1	0	0	0	0	0	0
2016	6	5	0	0	5	0	0	2	1
2017	8	6	6	1	2	0	0	1	2
2018	7	6	1	0	4	1	0	5	1
2019	11	9	0	0	9	0	0	6	2
2020	64	62	0	0	51	0	0	61	2
2021	187	186	0	4	173	0	0	186	1
2022	200	200	1	12	181	2	0	197	0
2023	49	49	0	15	44	0	0	47	0
2024	27	27	0	12	22	0	0	25	0
2025	38	38	0	23	30	0	0	36	0
2026	16	16	0	11	12	1	0	16	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Quinapril hydrochloride, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Quinapril hydrochloride, by the year in which FDA received them
Year	Reports
2004	25
2005	26
2006	30
2007	21
2008	32
2009	8
2010	53
2011	37
2012	60
2013	26
2014	9
2015	4
2016	8
2017	9
2018	8
2019	19
2020	87
2021	212
2022	178
2023	49
2024	21
2025	16
2026	3

Reports that name Quinapril hydrochloride, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Quinapril hydrochloride
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	3	0.3%
18 to 44	24	2.6%
45 to 64	127	13.5%
65 to 74	89	9.5%
75 and over	463	49.2%
Age not given	235	25%

Sex of the patient in the reports that name Quinapril hydrochloride
Sex	Reports	Share
Female	679	72.2%
Male	140	14.9%
Unknown or not given	122	13%

Type of reporter in the reports that name Quinapril hydrochloride
Reporter	Reports	Share
Physician	126	13.4%
Pharmacist	25	2.7%
Other health professional	490	52.1%
Lawyer	0	0%
Consumer or non-health professional	253	26.9%
Not given	47	5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 25.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Quinapril hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	383	40.7%
Coronary artery disease	122	13%
Seizure prophylaxis	20	2.1%
Ill-defined disorder	16	1.7%
Angina pectoris	11	1.2%
Chest pain	6	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 941 reports.

Drugs in the same reports

Other drugs that the reports of Quinapril hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Acebutolol hydrochloride	459
Acetaminophen	473
Amitriptyline hydrochloride	453
Carbamazepine	488
Diltiazem hydrochloride	467
Furosemide	523
Lactulose	524
Magnesium hydroxide	471
Oxazepam	470
Tiotropium bromide	459

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Quinapril same ingredient
Ramipril same class
Perindopril erbumine same class
Trandolapril same class
Lotensin same class
Vasotec same class
Quinidine next in the A to Z list
Quilonum Retard next in the A to Z list
Quinine next in the A to Z list
Quillivant next in the A to Z list
Quinine sulfate next in the A to Z list
QuilliChew ER next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Quinapril hydrochlorideThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Quinapril hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/quinapril-hydrochloride/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Quinapril hydrochloride as a suspect or interacting product. The 1,099 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Quinapril hydrochloride was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Quinapril hydrochloride?

No. It is a count of what people reported to FDA: 941 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (52.1%), consumer or non-health professional (26.9%) and physician (13.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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