Diovan HCT (valsartan and hydrochlorothiazide) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Valsartan and hydrochlorothiazide
Class: Angiotensin 2 receptor blocker

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 January 2004 to June 2026, FDA received 5,670 adverse event reports that name Diovan HCT. In these reports the drug is a suspect or interacting product.

In the same period, 5,421 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 30 reports in the 12 months to June 2026 and 20 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 Diovan HCT 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 15 reports that name Diovan HCT.
In January to March 2026, FDA received 6.
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 427 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 all 5,670 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 427 terms.

Reaction terms in the reports that name Diovan HCT, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 5,670 reports
Blood pressure increaseda raised blood pressure reading	610	10.8%
Hypertensionhigh blood pressure	511	9%
Deaththe patient died; cause not stated by this term	370	6.5%
Dizzinesslight-headedness or unsteadiness	366	6.5%
Malaisegeneral feeling of being unwell	330	5.8%
Cerebrovascular accidentstroke	302	5.3%
Falla fall	294	5.2%
Headachehead pain	290	5.1%
Diabetes mellitusdiabetes	278	4.9%
Drug ineffectivethe medicine did not work as expected	277	4.9%
Dyspnoeashortness of breath	234	4.1%
Feeling abnormalfeeling odd or not right	205	3.6%
Hypotensionlow blood pressure	204	3.6%
Blood pressure inadequately controlled	203	3.6%
Fatiguetiredness	194	3.4%
Blood pressure decreaseda low blood pressure reading	173	3.1%
Painpain, site not specified	170	3%
Blood pressure fluctuation	166	2.9%
Myocardial infarctionheart attack	158	2.8%
Nauseafeeling sick	156	2.8%
Pneumonialung infection	156	2.8%
Astheniaweakness or lack of energy	146	2.6%
Oedema peripheralswelling of the legs, ankles or hands	144	2.5%
Cough	138	2.4%
Pain in extremitypain in an arm or leg	130	2.3%
Weight decreasedweight loss	128	2.3%
Gait disturbancedifficulty walking	125	2.2%
Chest pain	124	2.2%
Cardiac disorder	119	2.1%
Arrhythmia	118	2.1%
Vomitingbeing sick	116	2%
Depressionlow mood	115	2%
Anxiety	110	1.9%
Blood glucose increasedraised blood sugar reading	109	1.9%
Syncopefainting	98	1.7%
Infarction	94	1.7%
Renal failurekidney failure	92	1.6%
Diarrhoealoose or frequent stools	90	1.6%
Memory impairmentmemory problems	90	1.6%
Weight increasedweight gain	90	1.6%
Nervousness	88	1.6%
Arthralgiajoint pain	87	1.5%
Cataractclouding of the eye lens	87	1.5%
Visual impairmentreduced vision	85	1.5%
Loss of consciousnesspassing out	81	1.4%
Wrong technique in drug usage processthe medicine was used in the wrong way	81	1.4%
Surgeryan operation	80	1.4%
Renal disorder	78	1.4%
Hyponatraemialow blood sodium	77	1.4%
Back pain	76	1.3%

Download all 427 terms of Diovan HCT (CSV)

The counts add to more than 5,670 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	Generic name	1,513
Diovan HCT (this page)	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 Diovan HCT, 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	115	110	8	3	28	3	2	80	5
2005	128	128	7	5	52	1	0	87	0
2006	171	167	28	10	53	4	0	114	4
2007	303	292	45	8	108	8	0	199	11
2008	301	294	27	10	97	8	1	198	7
2009	801	794	190	25	316	10	1	489	7
2010	578	568	133	33	189	5	1	356	10
2011	695	678	189	16	200	27	0	442	17
2012	725	714	136	18	222	13	0	539	11
2013	478	461	60	17	122	16	0	384	17
2014	252	249	27	10	89	1	0	217	3
2015	211	178	23	5	58	3	0	147	33
2016	220	177	21	10	45	4	1	140	43
2017	105	90	15	5	20	0	0	64	15
2018	98	76	7	4	25	3	0	62	22
2019	59	52	5	3	9	1	0	44	7
2020	108	98	11	5	19	5	0	82	10
2021	115	109	9	3	32	3	0	97	6
2022	59	51	5	1	15	2	0	45	8
2023	45	41	1	2	5	0	0	39	4
2024	53	50	3	2	9	0	0	47	3
2025	26	20	1	1	9	0	0	17	6
2026	24	9	0	2	2	0	0	8	15

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 Diovan HCT, 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 Diovan HCT, by the year in which FDA received them
Year	Reports
2004	62
2005	124
2006	115
2007	257
2008	279
2009	757
2010	567
2011	827
2012	932
2013	413
2014	253
2015	209
2016	216
2017	103
2018	81
2019	63
2020	138
2021	88
2022	61
2023	40
2024	47
2025	17
2026	21

Reports that name Diovan HCT, 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 Diovan HCT
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	0	0%
18 to 44	86	1.5%
45 to 64	656	11.6%
65 to 74	581	10.2%
75 and over	708	12.5%
Age not given	3,639	64.2%

Sex of the patient in the reports that name Diovan HCT
Sex	Reports	Share
Female	3,762	66.3%
Male	1,740	30.7%
Unknown or not given	168	3%

Type of reporter in the reports that name Diovan HCT
Reporter	Reports	Share
Physician	1,063	18.7%
Pharmacist	121	2.1%
Other health professional	287	5.1%
Lawyer	46	0.8%
Consumer or non-health professional	3,678	64.9%
Not given	475	8.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 26.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Diovan HCT record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	3,107	54.8%
Blood pressure abnormal	92	1.6%
Blood pressure	89	1.6%
Cardiac disorder	27	0.5%
Blood pressure increased	16	0.3%
Essential hypertension	6	0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 5,670 reports.

Drugs in the same reports

Other drugs that the reports of Diovan HCT name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	154
Aspirin	316
Atenolol	194
Crestor	101
Diovan	638
Lipitor	133
Metformin	110
Norvasc	120
Omeprazole	113
Simvastatin	186

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

Valsartan and hydrochlorothiazide same ingredient
Diovan same class
Edarbi same class
Cozaar same class
Entresto same class
Candesartan cilexetil same class
Exforge same class
Diovan D next in the A to Z list
Diphenhydramine next in the A to Z list
Diovan Amlo Fix next in the A to Z list
Diphenhydramine hcl next in the A to Z list
Diphenhydramine hydrochloride 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 Diovan HCTThe 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. Diovan HCT: adverse event reports that FDA received. https://reportedreactions.com/drug/diovan-hct/ 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 Diovan HCT as a suspect or interacting product. The 5,421 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 Diovan HCT 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 Diovan HCT?

No. It is a count of what people reported to FDA: 5,670 reports from January 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 (64.9%), physician (18.7%) and other health professional (5.1%). 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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