Hydrochlorothiazide Valsartan adverse event reports that FDA received

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

Name type: Product name as reported

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 July 2009 to June 2026, FDA received 1,807 adverse event reports that name Hydrochlorothiazide Valsartan. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,809 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 133 reports in the 12 months to June 2026 and 205 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, 133 (under 0.1%) name Hydrochlorothiazide Valsartan. Reports for patients 75 and over were 22% of the reports that name Hydrochlorothiazide Valsartan 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 Hydrochlorothiazide Valsartan 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 34 reports that name Hydrochlorothiazide Valsartan.
In January to March 2026, FDA received 25.
In April to June 2025, FDA received 46.

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 418 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 1,803 of the 1,807 reports (99.8%).

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 418 terms.

Reaction terms in the reports that name Hydrochlorothiazide Valsartan, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,807 reports
Dizzinesslight-headedness or unsteadiness	140	7.7%
Drug ineffectivethe medicine did not work as expected	136	7.5%
Blood pressure increaseda raised blood pressure reading	126	7%
Hypertensionhigh blood pressure	122	6.8%
Headachehead pain	121	6.7%
Fatiguetiredness	120	6.6%
Hyponatraemialow blood sodium	108	6%
Dyspnoeashortness of breath	105	5.8%
Nauseafeeling sick	104	5.8%
Acute kidney injurysudden loss of kidney function	83	4.6%
Falla fall	80	4.4%
Malaisegeneral feeling of being unwell	79	4.4%
Cough	71	3.9%
Off label useused for a purpose or in a way not on the label	70	3.9%
Arthralgiajoint pain	68	3.8%
General physical health deteriorationgeneral decline in health	63	3.5%
Painpain, site not specified	62	3.4%
Wrong technique in product usage processthe product was used in the wrong way	60	3.3%
Back pain	58	3.2%
Deaththe patient died; cause not stated by this term	55	3%
Diarrhoealoose or frequent stools	55	3%
Vomitingbeing sick	55	3%
Hypokalaemialow blood potassium	54	3%
Arrhythmia	53	2.9%
Astheniaweakness or lack of energy	53	2.9%
Diabetes mellitusdiabetes	52	2.9%
Peripheral swellingswelling of the arms or legs	52	2.9%
Feeling abnormalfeeling odd or not right	51	2.8%
Palpitationsawareness of the heartbeat	50	2.8%
Abdominal painstomach or belly pain	48	2.7%
Drug intolerancethe medicine was not tolerated	48	2.7%
Overdosea dose above the recommended amount	48	2.7%
Pain in extremitypain in an arm or leg	48	2.7%
Pyrexiafever	48	2.7%
Inflammation	45	2.5%
Anxiety	44	2.4%
Haematomaa collection of blood under the skin or in tissue	44	2.4%
Chest pain	43	2.4%
Tachycardiafast heart rate	43	2.4%
Cerebrovascular accidentstroke	42	2.3%
Drug interactionan interaction between medicines	42	2.3%
Oedema peripheralswelling of the legs, ankles or hands	42	2.3%
Somnolencedrowsiness	42	2.3%
Hypotensionlow blood pressure	41	2.3%
Hypothyroidismunderactive thyroid	41	2.3%
Memory impairmentmemory problems	41	2.3%
Sleep disordera sleep problem	41	2.3%
Prostate cancer	40	2.2%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	39	2.2%
Gait disturbancedifficulty walking	39	2.2%

Download all 418 terms of Hydrochlorothiazide Valsartan (CSV)

The counts add to more than 1,807 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.

Outcomes by year

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

Outcomes in the reports that name Hydrochlorothiazide Valsartan, 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
2011	2	2	2	0	1	0	1	0
2012	2	2	0	0	1	0	1	0
2013	31	29	2	2	7	1	24	2
2014	70	70	2	7	43	1	29	0
2015	41	17	0	2	11	1	6	24
2016	72	28	0	2	10	0	16	44
2017	13	9	1	1	2	0	5	4
2018	28	26	0	0	17	0	10	2
2019	16	14	0	2	7	0	10	2
2020	17	14	0	0	5	0	11	3
2021	164	160	21	11	54	1	129	4
2022	455	439	63	19	169	8	319	16
2023	325	307	23	26	135	4	230	18
2024	264	245	26	31	125	9	140	19
2025	205	201	20	13	93	5	141	4
2026	102	102	17	15	45	5	75	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 Hydrochlorothiazide Valsartan, 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 Hydrochlorothiazide Valsartan, by the year in which FDA received them
Year	Reports
2009	1
2010	2
2011	2
2012	3
2013	33
2014	70
2015	46
2016	71
2017	18
2018	44
2019	57
2020	89
2021	255
2022	370
2023	292
2024	239
2025	156
2026	59

Reports that name Hydrochlorothiazide Valsartan, 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 Hydrochlorothiazide Valsartan
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	3	0.2%
18 to 44	69	3.8%
45 to 64	338	18.7%
65 to 74	348	19.3%
75 and over	398	22%
Age not given	651	36%

Sex of the patient in the reports that name Hydrochlorothiazide Valsartan
Sex	Reports	Share
Female	965	53.4%
Male	707	39.1%
Unknown or not given	135	7.5%

Type of reporter in the reports that name Hydrochlorothiazide Valsartan
Reporter	Reports	Share
Physician	362	20%
Pharmacist	181	10%
Other health professional	285	15.8%
Lawyer	220	12.2%
Consumer or non-health professional	748	41.4%
Not given	11	0.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 25% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Hydrochlorothiazide Valsartan record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	1,088	60.2%
Blood pressure abnormal	21	1.2%
Blood pressure increased	20	1.1%
Essential hypertension	20	1.1%
Blood pressure measurement	17	0.9%
Ill-defined disorder	6	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,807 reports.

Drugs in the same reports

Other drugs that the reports of Hydrochlorothiazide Valsartan name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	124
Amlodipine besylate	95
Aspirin	206
Atorvastatin	99
Bisoprolol	90
Diovan	134
Diovan HCT	99
Metformin	146
Metoprolol	96
Valsartan	301

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

Hydrochlorothiazide Unk next in the A to Z list
Hydrochlorothiazide/Irbesartan next in the A to Z list
Hydrochlorothiazide Triamterene next in the A to Z list
Hydrochlorothiazide/Lisinopril next in the A to Z list
Hydrochlorothiazide Telmisartan next in the A to Z list
Hydrocodone next in the A to Z list
Hydrochlorothiazide Ramipril next in the A to Z list
Hydrocodone and Acetaminophen next in the A to Z list
Hydrochlorothiazide Olmesartan Medoxomil next in the A to Z list
Hydrocodone bitartrate next in the A to Z list
Hydrochlorothiazide Losartan Potassium next in the A to Z list
Hydrocodone Bitartrate + Acetaminophen next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for Hydrochlorothiazide ValsartanThe 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. Hydrochlorothiazide Valsartan: adverse event reports that FDA received. https://reportedreactions.com/drug/hydrochlorothiazide-valsartan/ 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 Hydrochlorothiazide Valsartan as a suspect or interacting product. The 1,809 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 Hydrochlorothiazide Valsartan 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 Hydrochlorothiazide Valsartan?

No. It is a count of what people reported to FDA: 1,807 reports from July 2009 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 (41.4%), physician (20%) and other health professional (15.8%). 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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