Reported Reactions

Drugs › Angiotensin converting enzyme inhibitor

Generic name

Quinapril: adverse event reports filed with FDA

1,231 reports list it as a suspect or interacting product, 2005–2026. Class: Angiotensin converting enzyme inhibitor. Also reported as Quinapril Tablets Usp 40mg, Quinapril Tablets Usp, Quinapril 40mg Tablets.

1,231
reports as suspect product
0% of all reports · about 57 a year
12
reports, 12 months to June 2026
23 in the 12 months before
59.7%
marked serious by the reporter
83.4% across the class
5%
record death among outcomes, as reported
61 reports · not verified by FDA

1,231 adverse event reports received by FDA list quinapril, a generic name as a suspect or interacting product, from January 2005 to June 2026. A further 5,642 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 12 reports listed it, down 48% from 23 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 57 reports a year and 0% of the 20,646,523 reports in the database, and 1.2% of the reports for the angiotensin converting enzyme inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded fall (17.7%), recalled product administered (16.4%) and no adverse event (15%). A report can list several reactions, so shares add to more than 100%; 275 different terms appear across these reports. Fall is recorded in 17.7% of these reports, a larger share than in the median angiotensin converting enzyme inhibitor drug (2.7%).

59.7% of the reports are marked serious by the reporter (83.4% across the class); 5% record death among the outcomes and 33.1% record hospitalisation, as reported. 51.1% of the reports came from consumers, and the largest patient age group is 75 and over (26.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

058115Jul 2021: 7Aug 2021: 6Sep 2021: 12Oct 2021: 18Nov 2021: 4Dec 2021: 32022Jan 2022: 5Feb 2022: 4Mar 2022: 9Apr 2022: 11May 2022: 32Jun 2022: 16Jul 2022: 15Aug 2022: 7Sep 2022: 11Oct 2022: 2Nov 2022: 9Dec 2022: 122023Jan 2023: 115Feb 2023: 74Mar 2023: 25Apr 2023: 9May 2023: 10Jun 2023: 7Jul 2023: 2Aug 2023: 1Sep 2023: 6Oct 2023: 6Nov 2023: 4Dec 2023: 32024Jan 2024: 2Feb 2024: 4Mar 2024: 5Apr 2024: 4May 2024: 4Jun 2024: 1Jul 2024: 2Aug 2024: 6Sep 2024: 3Oct 2024: 2Nov 2024: 2Dec 2024: 22025Jan 2025: 0Feb 2025: 3Mar 2025: 1Apr 2025: 0May 2025: 1Jun 2025: 1Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 1Nov 2025: 1Dec 2025: 42026Jan 2026: 0Feb 2026: 1Mar 2026: 1Apr 2026: 0May 2026: 2Jun 2026: 2

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

01312622005: 2720052006: 152007: 112008: 1720082009: 202010: 222011: 2420112012: 362013: 332014: 4920142015: 702016: 492017: 6920172018: 792019: 902020: 7920202021: 912022: 1332023: 26220232024: 372025: 122026: 62026

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Quinapril reports recording the termmedian drug in angiotensin converting enzyme inhibitor

  1. Falla fall17.7%218
  2. No adverse eventno adverse event was reported15%185
  3. Cognitive disorderproblems with thinking or memory14.5%178
  4. Hypotensionlow blood pressure14.2%175
  5. Balance disorderproblems with balance13.5%166
  6. Constipationconstipation13.5%166
  7. Sedationdrowsiness from a medicine12.8%158
  8. Sedation complication12.1%149
  9. Painpain, site not specified11.9%147
  10. Toxicity to various agentspoisoning or toxic effect of one or more substances11.9%146
  11. Mobility decreasedreduced ability to move about11.8%145
  12. Creatinine renal clearance decreased11.1%137
  13. Dyspnoeashortness of breath9.2%113
  14. Drug ineffectivethe medicine did not work as expected9.1%112
  15. Drug interactionan interaction between medicines6.4%79
  16. Coughcough5.3%65
  17. Drug hypersensitivityan allergic-type reaction to a medicine5.2%64
  18. Malaisegeneral feeling of being unwell4.5%56
  19. Angioedemadeep swelling of skin or mucous membranes4.1%50
  20. Product substitution issuea problem after switching products3.8%47
  21. Blood pressure increaseda raised blood pressure reading3.5%43
  22. Overdosea dose above the recommended amount3.5%43
  23. Product use in unapproved indicationused for a purpose not on the label3.5%43
  24. Chest painchest pain3.4%42
  25. Renal function test abnormal3.3%41
  26. Multiple drug therapy3.2%39

Top 30 of 275 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

Death5%61
Life-threatening8%98
Hospitalisation (initial or prolonged)33.1%407
Disability1.9%24
Congenital anomaly0.2%2
Other serious41.2%507
Not serious40.3%496

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

Patient age

Under 20%0
2 to 110%0
12 to 170.1%1
18 to 442.7%33
45 to 6415.8%194
65 to 7414.5%179
75 and over26.9%331
Age not given40%493

Patient sex

Female48.8%601
Male26.3%324
Not given24.9%306

Who reported

Physician12.7%156
Pharmacist6.5%80
Other health professional26.1%321
Lawyer0.2%3
Consumer or non-health professional51.1%629
Not given3.4%42

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 58.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Hypertension41533.7%
Coronary artery disease524.2%
Blood pressure abnormal504.1%
Pain110.9%
Blood pressure measurement100.8%
Essential hypertension90.7%

The indication field is filled in by the reporter and is often blank; shares are of all 1,231 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Quinapril reports
Furosemide26521.5%
Omeprazole22017.9%
Nitroglycerin21917.8%
Lactulose21517.5%
Acetaminophen20816.9%
Carbamazepine20216.4%
Oxazepam19515.8%
Magnesium hydroxide19015.4%
Amlodipine18815.3%
Levofloxacin18615.1%

Other products listed in reports where Quinapril 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

MeasureQuinaprilAngiotensin converting enzyme inhibitorAll reports
Reports as suspect product1,231102,32720,646,523
Share of that pool—1.2%0%
Reports, latest 12 months12—1,332,454
Marked serious59.7%83.4%57.4%
Death recorded among outcomes, per 1,000 reports5011891
Hospitalisation recorded, per 1,000 reports331476213
Consumer-filed share51.1%22.6%45.8%
Top term, share of reportsFall 17.7%median 2.7%1.6%

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

DrugName typeReportsLatest 12 monthsMarked serious
Lisinoprilgeneric44,4371,59471.3%
Ramiprilgeneric37,2022,25095.6%
Enalaprilgeneric6,75429495.5%
Enalapril maleategeneric4,0877793.6%
Zestrilbrand1,92018171.9%
Captoprilgeneric1,6724792.7%
Perindopril erbuminegeneric1,1663698.6%
Lotrelbrand1,0461379.2%
Quinapril hydrochloridegeneric9411989.3%
Benazepril hydrochloridegeneric7915767.6%
Vasotecbrand558270.6%
Lotensinbrand5226474.5%

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.

Questions about Quinapril reports

How many adverse event reports has FDA received for Quinapril?

1,231 reports list Quinapril as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 12 of them arrived in the latest 12 months. Another 5,642 list it only as a concomitant medication.

What reactions are recorded in Quinapril reports?

fall (17.7%), recalled product administered (16.4%), no adverse event (15%), cognitive disorder (14.5%) and orthostatic hypotension (14.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Quinapril was responsible.

How serious are the reports?

59.7% are marked serious by the reporter. Among the outcomes recorded, 5% of reports include death and 33.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

consumer or non-health professional (51.1%), other health professional (26.1%) and physician (12.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Quinapril rising?

12 reports in the 12 months to June 2026, down 48% from 23 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

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

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Quinapril?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Quinapril as a suspect or interacting product; reports listing it only as a concomitant medication (5,642) 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.

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