Lisinopril and hydrochlorothiazide adverse event reports that FDA received

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

Name type: Generic name
Class: Thiazide diuretic
Also reported as: Lisinopril/Hydrochlorothiazide, Lisinopril/ Hydrochlorothiazide, Lisinopril / Hydrochlorothiazide

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 1,636 adverse event reports that name Lisinopril and hydrochlorothiazide. In these reports the drug is a suspect or interacting product.

In the same period, 6,322 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 65 reports in the 12 months to June 2026 and 37 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, 65 (under 0.1%) name Lisinopril and hydrochlorothiazide. Reports from pharmacists were 26.7% of the reports that name Lisinopril and hydrochlorothiazide and 6.3% 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 Lisinopril and hydrochlorothiazide 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 17 reports that name Lisinopril and hydrochlorothiazide.
In January to March 2026, FDA received 5.
In April to June 2025, FDA received 5.

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 149 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 1,616 of the 1,636 reports (98.8%).

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 149 terms.

Reaction terms in the reports that name Lisinopril and hydrochlorothiazide, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,636 reports
Angioedemadeep swelling of skin or mucous membranes	243	14.9%
Cough	148	9%
Dizzinesslight-headedness or unsteadiness	113	6.9%
Drug ineffectivethe medicine did not work as expected	102	6.2%
Dyspnoeashortness of breath	81	5%
Nauseafeeling sick	78	4.8%
Hypotensionlow blood pressure	68	4.2%
Blood pressure increaseda raised blood pressure reading	65	4%
Headachehead pain	65	4%
Hypertensionhigh blood pressure	65	4%
Fatiguetiredness	64	3.9%
Completed suicidedeath by suicide	57	3.5%
Hyponatraemialow blood sodium	47	2.9%
Vomitingbeing sick	45	2.8%
Rashskin rash	44	2.7%
Diarrhoealoose or frequent stools	43	2.6%
Renal failure acute	43	2.6%
Acute kidney injurysudden loss of kidney function	42	2.6%
Astheniaweakness or lack of energy	42	2.6%
Malaisegeneral feeling of being unwell	42	2.6%
Swollen tongue	41	2.5%
Pruritusitching	39	2.4%
Syncopefainting	39	2.4%
Dehydration	38	2.3%
Feeling abnormalfeeling odd or not right	36	2.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	36	2.2%
Drug interactionan interaction between medicines	35	2.1%
Product substitution issuea problem after switching products	34	2.1%
Muscle spasmsmuscle cramps	33	2%
Painpain, site not specified	30	1.8%
Swelling facea swollen face	28	1.7%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	27	1.7%
Insomniadifficulty sleeping	26	1.6%
Recalled product administered	26	1.6%
Arthralgiajoint pain	25	1.5%
Dysphagiadifficulty swallowing	25	1.5%
Hypoaesthesianumbness	25	1.5%
Pharmaceutical product complaint	25	1.5%
Confusional stateconfusion	24	1.5%
Lip swellingswollen lips	24	1.5%
Product quality issuea problem with the product itself	24	1.5%
Hypokalaemialow blood potassium	23	1.4%
No adverse eventno adverse event was reported	23	1.4%
Blood creatinine increasedraised creatinine, a kidney test	20	1.2%
Cardiac arrestthe heart stopped	20	1.2%
Falla fall	20	1.2%
Paraesthesiatingling or pins and needles	20	1.2%
Hyperkalaemiahigh blood potassium	19	1.2%
Abdominal discomfortstomach discomfort	18	1.1%
Abdominal pain upperupper stomach pain	18	1.1%

Download all 149 terms of Lisinopril and hydrochlorothiazide (CSV)

The counts add to more than 1,636 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 Lisinopril and hydrochlorothiazide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Lisinopril and hydrochlorothiazide (this page)	Generic name	1,636
Zestoretic	Brand name	487

Sum of the separately reported names: 2,123. 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 Lisinopril and hydrochlorothiazide, 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	20	14	2	1	6	0	0	6	6
2005	18	18	0	5	10	1	0	10	0
2006	30	24	1	5	13	2	0	8	6
2007	65	46	2	9	31	2	0	14	19
2008	101	77	2	16	41	6	0	36	24
2009	163	124	16	17	72	2	1	39	39
2010	212	149	11	27	74	2	0	62	63
2011	161	128	15	22	80	6	0	41	33
2012	129	105	10	25	61	3	0	41	24
2013	22	18	2	0	4	1	0	14	4
2014	48	35	5	4	20	1	0	15	13
2015	85	44	2	5	27	1	0	24	41
2016	43	23	6	0	9	2	0	11	20
2017	53	27	6	3	14	1	0	16	26
2018	70	41	7	2	18	1	0	26	29
2019	54	32	3	7	16	2	0	27	22
2020	67	55	8	11	26	3	0	38	12
2021	65	48	4	5	24	2	0	39	17
2022	47	35	9	5	19	2	0	22	12
2023	54	38	4	3	15	1	0	25	16
2024	42	33	1	4	14	1	0	22	9
2025	61	28	1	6	18	0	0	15	33
2026	26	20	4	7	14	1	0	13	6

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 Lisinopril and hydrochlorothiazide, 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 Lisinopril and hydrochlorothiazide, by the year in which FDA received them
Year	Reports
2004	19
2005	17
2006	31
2007	62
2008	96
2009	155
2010	214
2011	164
2012	159
2013	21
2014	43
2015	79
2016	51
2017	49
2018	76
2019	54
2020	68
2021	62
2022	42
2023	57
2024	37
2025	58
2026	22

Reports that name Lisinopril and hydrochlorothiazide, 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 Lisinopril and hydrochlorothiazide
Age	Reports	Share
Under 2	2	0.1%
2 to 11	0	0%
12 to 17	0	0%
18 to 44	112	6.8%
45 to 64	597	36.5%
65 to 74	263	16.1%
75 and over	212	13%
Age not given	450	27.5%

Sex of the patient in the reports that name Lisinopril and hydrochlorothiazide
Sex	Reports	Share
Female	775	47.4%
Male	738	45.1%
Unknown or not given	123	7.5%

Type of reporter in the reports that name Lisinopril and hydrochlorothiazide
Reporter	Reports	Share
Physician	275	16.8%
Pharmacist	437	26.7%
Other health professional	251	15.3%
Lawyer	3	0.2%
Consumer or non-health professional	487	29.8%
Not given	183	11.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 88% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lisinopril and hydrochlorothiazide record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	883	54%
Blood pressure abnormal	49	3%
Blood pressure	28	1.7%
Blood pressure increased	14	0.9%
Blood pressure measurement	9	0.6%
Essential hypertension	6	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,636 reports.

Pages near this one

Zestoretic same ingredient
Hyzaar same class
Losartan potassium and hydrochlorothiazide same class
Hydrochlorothiazide same class
Tribenzor same class
Enalapril maleate and hydrochlorothiazide same class
Lisinopril next in the A to Z list
Lisocabtagene maraleucel next in the A to Z list
Lisdexamfetamine dimesylate next in the A to Z list
Listerine next in the A to Z list
Lisdexamfetamine next in the A to Z list
Listerine Original 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 Lisinopril and hydrochlorothiazideThe 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. Lisinopril and hydrochlorothiazide: adverse event reports that FDA received. https://reportedreactions.com/drug/lisinopril-and-hydrochlorothiazide/ 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 Lisinopril and hydrochlorothiazide as a suspect or interacting product. The 6,322 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 Lisinopril and hydrochlorothiazide 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 Lisinopril and hydrochlorothiazide?

No. It is a count of what people reported to FDA: 1,636 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?

Consumer or non-health professional (29.8%), pharmacist (26.7%) and physician (16.8%). 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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