Fosinopril adverse event reports that FDA received

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

Name type: Generic name
Class: Angiotensin converting enzyme inhibitor
Also reported as: Fosinopril Tablets 10mg

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.

Reports on file

From August 2004 to May 2026, FDA received 391 adverse event reports that name Fosinopril. In these reports the drug is a suspect or interacting product.

In the same period, 1,785 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 7 reports in the 12 months to June 2026 and 24 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Fosinopril 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 3 reports that name Fosinopril.
In January to March 2026, FDA received 3.
In April to June 2025, FDA received 2.

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 81 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 352 of the 391 reports (90%).

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 81 terms.

Reaction terms in the reports that name Fosinopril, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 391 reports
Acute kidney injurysudden loss of kidney function	67	17.1%
Angioedemadeep swelling of skin or mucous membranes	41	10.5%
Rhabdomyolysismuscle breakdown	35	9%
Insomniadifficulty sleeping	28	7.2%
Metabolic acidosistoo much acid in the body fluids	26	6.6%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	24	6.1%
Condition aggravatedthe condition being treated got worse	22	5.6%
Drug ineffectivethe medicine did not work as expected	21	5.4%
Renal failurekidney failure	21	5.4%
Hypotensionlow blood pressure	20	5.1%
Treatment noncompliancethe treatment was not taken as directed	20	5.1%
Alopeciahair loss	18	4.6%
Cerebrovascular accidentstroke	18	4.6%
Painpain, site not specified	18	4.6%
Schizophrenia	18	4.6%
Hyperkalaemiahigh blood potassium	17	4.3%
Bradycardiaslow heart rate	16	4.1%
Diverticular perforation	15	3.8%
Drug interactionan interaction between medicines	15	3.8%
Drug intolerancethe medicine was not tolerated	15	3.8%
End stage renal diseasekidney failure needing dialysis or transplant	15	3.8%
Joint swellinga swollen joint	15	3.8%
Peripheral swellingswelling of the arms or legs	15	3.8%
Psoriasispsoriasis, a skin condition	15	3.8%
Psoriatic arthropathy	15	3.8%
Rashskin rash	15	3.8%
Skin reaction	15	3.8%
Therapeutic product effect decreased	15	3.8%
Acidosis	14	3.6%
Knee arthroplasty	14	3.6%
Therapeutic product effect incomplete	14	3.6%
Drug resistance	13	3.3%
Astheniaweakness or lack of energy	11	2.8%
Completed suicidedeath by suicide	11	2.8%
Hypoglycaemialow blood sugar	11	2.8%
Malaisegeneral feeling of being unwell	11	2.8%
Toxicity to various agentspoisoning or toxic effect of one or more substances	11	2.8%
Confusional stateconfusion	10	2.6%
Dyspnoeashortness of breath	10	2.6%
Hyperlactacidaemia	10	2.6%
Intentional overdosea deliberate overdose	10	2.6%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	10	2.6%
Orthostatic hypotension	10	2.6%
Apathy	9	2.3%
Behaviour disorder	9	2.3%
Delusiona fixed false belief	9	2.3%
General physical health deteriorationgeneral decline in health	9	2.3%
Nauseafeeling sick	9	2.3%
Swollen tongue	9	2.3%
Thinking abnormal	9	2.3%

Download all 81 terms of Fosinopril (CSV)

The counts add to more than 391 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 Fosinopril with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Fosinopril (this page)	Generic name	391
Fosinopril sodium	Generic name	399

Sum of the separately reported names: 790. 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 Fosinopril, 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	Other Serious (Important Medical Events)	Not serious
2004	9	8	1	0	2	0	6	1
2005	18	17	0	3	10	0	6	1
2006	7	7	0	0	4	1	2	0
2009	2	2	1	0	0	0	1	0
2010	1	1	0	0	1	0	0	0
2011	1	1	0	0	1	0	0	0
2012	4	4	0	0	4	0	3	0
2013	28	25	1	2	6	1	18	3
2014	29	27	6	3	14	1	13	2
2015	24	23	2	2	17	0	7	1
2016	20	16	2	3	5	0	8	4
2017	27	24	2	4	12	1	10	3
2018	33	28	4	2	20	0	9	5
2019	30	26	1	3	15	2	10	4
2020	42	40	1	2	16	3	30	2
2021	39	36	0	1	22	0	31	3
2022	16	15	0	5	13	0	13	1
2023	18	18	0	3	15	0	15	0
2024	30	30	8	2	19	0	21	0
2025	7	6	0	1	2	0	6	1
2026	6	6	0	2	6	0	2	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 Fosinopril, 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 Fosinopril, by the year in which FDA received them
Year	Reports
2004	9
2005	18
2006	7
2009	2
2010	1
2011	2
2012	5
2013	28
2014	27
2015	25
2016	21
2017	27
2018	36
2019	35
2020	53
2021	38
2022	10
2023	14
2024	22
2025	5
2026	6

Reports that name Fosinopril, 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 Fosinopril
Age	Reports	Share
Under 2	1	0.3%
2 to 11	1	0.3%
12 to 17	0	0%
18 to 44	38	9.7%
45 to 64	91	23.3%
65 to 74	89	22.8%
75 and over	94	24%
Age not given	77	19.7%

Sex of the patient in the reports that name Fosinopril
Sex	Reports	Share
Female	116	29.7%
Male	232	59.3%
Unknown or not given	43	11%

Type of reporter in the reports that name Fosinopril
Reporter	Reports	Share
Physician	110	28.1%
Pharmacist	91	23.3%
Other health professional	125	32%
Lawyer	0	0%
Consumer or non-health professional	53	13.6%
Not given	12	3.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 41.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Fosinopril record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	146	37.3%
Ischaemic heart disease prophylaxis	4	1%
Cardiac failure	2	0.5%
Essential hypertension	2	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 391 reports.

Pages near this one

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

Official pages

DailyMed labels for FosinoprilThe 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. Fosinopril: adverse event reports that FDA received. https://reportedreactions.com/drug/fosinopril/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Fosinopril as a suspect or interacting product. The 1,785 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 Fosinopril 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 Fosinopril?

No. It is a count of what people reported to FDA: 391 reports from August 2004 to May 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 (32%), physician (28.1%) and pharmacist (23.3%). 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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