Valsartan and hydrochlorothiazide adverse event reports that FDA received

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

Name type: Generic name
Class: Angiotensin 2 receptor blocker
Also reported as: Valsartan/Hydrochlorothiazide, Valsartan And Hydrochlorothiazide Tablets, Valsartan / 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 September 2006 to May 2026, FDA received 1,513 adverse event reports that name Valsartan and hydrochlorothiazide. In these reports the drug is a suspect or interacting product.

In the same period, 2,138 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 17 reports in the 12 months to June 2026 and 26 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, 17 (under 0.1%) name Valsartan and hydrochlorothiazide. Reports for patients aged 65 to 74 were 21.1% of the reports that name Valsartan and hydrochlorothiazide and 11.3% 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 Valsartan 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 2 reports that name Valsartan and hydrochlorothiazide.
In January to March 2026, FDA received 9.
In April to June 2025, FDA received 7.

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 156 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 1,457 of the 1,513 reports (96.3%).

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 156 terms.

Reaction terms in the reports that name Valsartan and hydrochlorothiazide, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,513 reports
Dizzinesslight-headedness or unsteadiness	115	7.6%
Drug ineffectivethe medicine did not work as expected	110	7.3%
Blood pressure increaseda raised blood pressure reading	82	5.4%
Headachehead pain	77	5.1%
Hyponatraemialow blood sodium	71	4.7%
Nauseafeeling sick	64	4.2%
Fatiguetiredness	59	3.9%
Product substitution issuea problem after switching products	59	3.9%
Vomitingbeing sick	57	3.8%
Dyspnoeashortness of breath	56	3.7%
Malaisegeneral feeling of being unwell	55	3.6%
Falla fall	45	3%
Hypertensionhigh blood pressure	40	2.6%
Pruritusitching	40	2.6%
Recalled product administered	40	2.6%
Astheniaweakness or lack of energy	38	2.5%
Diarrhoealoose or frequent stools	37	2.4%
Acute kidney injurysudden loss of kidney function	35	2.3%
Cough	34	2.2%
Hypotensionlow blood pressure	33	2.2%
Painpain, site not specified	33	2.2%
Renal failure acute	32	2.1%
Abdominal pain upperupper stomach pain	29	1.9%
Dehydration	28	1.9%
Syncopefainting	28	1.9%
Feeling abnormalfeeling odd or not right	26	1.7%
Rashskin rash	26	1.7%
General physical health deteriorationgeneral decline in health	25	1.7%
Colorectal cancer	24	1.6%
Abdominal discomfortstomach discomfort	23	1.5%
Blood creatinine increasedraised creatinine, a kidney test	23	1.5%
Pain in extremitypain in an arm or leg	23	1.5%
Loss of consciousnesspassing out	22	1.5%
Chest pain	21	1.4%
Confusional stateconfusion	20	1.3%
Gait disturbancedifficulty walking	20	1.3%
Muscle spasmsmuscle cramps	20	1.3%
Renal failurekidney failure	20	1.3%
Arthralgiajoint pain	19	1.3%
Back pain	19	1.3%
Deaththe patient died; cause not stated by this term	19	1.3%
Drug interactionan interaction between medicines	19	1.3%
Hepatic cancer	19	1.3%
Hypokalaemialow blood potassium	19	1.3%
Somnolencedrowsiness	19	1.3%
Abdominal painstomach or belly pain	17	1.1%
Neoplasm malignanta cancer, type not specified	17	1.1%
Peripheral swellingswelling of the arms or legs	17	1.1%
Prostate cancer	17	1.1%
Respiratory failurethe lungs could not supply enough oxygen	17	1.1%

Download all 156 terms of Valsartan and hydrochlorothiazide (CSV)

The counts add to more than 1,513 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 Valsartan and hydrochlorothiazide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Valsartan and hydrochlorothiazide (this page)	Generic name	1,513
Diovan HCT	Brand name	5,670

Sum of the separately reported names: 7,183. 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 Valsartan 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
2006	11	11	2	0	5	0	0	6	0
2007	65	63	3	1	42	1	0	20	2
2008	24	24	3	3	14	2	0	12	0
2009	19	19	0	3	18	0	0	4	0
2010	33	32	2	3	27	2	0	12	1
2011	76	76	16	4	44	0	0	29	0
2012	95	94	22	6	60	3	1	44	1
2013	80	17	1	3	7	0	0	10	63
2014	58	21	1	2	7	2	0	13	37
2015	54	26	2	3	11	1	0	15	28
2016	73	48	2	5	23	3	1	28	25
2017	70	41	5	4	10	0	0	29	29
2018	235	177	4	11	72	8	0	125	58
2019	187	132	2	8	44	3	1	113	55
2020	122	94	5	10	31	9	0	81	28
2021	158	144	23	2	29	1	0	132	14
2022	39	34	5	4	10	0	0	27	5
2023	38	37	7	2	21	0	0	25	1
2024	31	24	3	0	14	2	0	16	7
2025	33	30	7	0	10	1	0	28	3
2026	12	8	5	0	4	0	0	4	4

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 Valsartan 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 Valsartan and hydrochlorothiazide, by the year in which FDA received them
Year	Reports
2006	2
2007	62
2008	20
2009	18
2010	33
2011	83
2012	107
2013	80
2014	62
2015	56
2016	78
2017	73
2018	274
2019	182
2020	181
2021	76
2022	33
2023	31
2024	28
2025	23
2026	11

Reports that name Valsartan 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 Valsartan and hydrochlorothiazide
Age	Reports	Share
Under 2	1	0.1%
2 to 11	0	0%
12 to 17	0	0%
18 to 44	43	2.8%
45 to 64	337	22.3%
65 to 74	319	21.1%
75 and over	253	16.7%
Age not given	560	37%

Sex of the patient in the reports that name Valsartan and hydrochlorothiazide
Sex	Reports	Share
Female	800	52.9%
Male	546	36.1%
Unknown or not given	167	11%

Type of reporter in the reports that name Valsartan and hydrochlorothiazide
Reporter	Reports	Share
Physician	244	16.1%
Pharmacist	101	6.7%
Other health professional	327	21.6%
Lawyer	62	4.1%
Consumer or non-health professional	717	47.4%
Not given	62	4.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 52.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Valsartan and hydrochlorothiazide record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	772	51%
Blood pressure increased	52	3.4%
Blood pressure abnormal	28	1.9%
Blood pressure measurement	20	1.3%
Blood pressure	8	0.5%
Intentional self-injury	3	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,513 reports.

Pages near this one

Diovan HCT same ingredient
Valsartan same class
Telmisartan same class
Olmesartan medoxomil same class
Valtoco next in the A to Z list
Valpromide next in the A to Z list
Valtrex next in the A to Z list
Valproic acid next in the A to Z list
Valturna next in the A to Z list
Valproate sodium next in the A to Z list
Vancocin next in the A to Z list
Valproate semisodium 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 Valsartan 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. Valsartan and hydrochlorothiazide: adverse event reports that FDA received. https://reportedreactions.com/drug/valsartan-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 Valsartan and hydrochlorothiazide as a suspect or interacting product. The 2,138 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 Valsartan 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 Valsartan and hydrochlorothiazide?

No. It is a count of what people reported to FDA: 1,513 reports from September 2006 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?

Consumer or non-health professional (47.4%), other health professional (21.6%) and physician (16.1%). 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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