Co-Diovan adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Co-Diovan
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 January 2004 to December 2020, FDA received 1,641 adverse event reports that name Co-Diovan. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 569 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received no report that names Co-Diovan in the five years to June 2026. The latest report was received in December 2020.

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 Co-Diovan 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.

FDA received no report that names Co-Diovan in April to June 2026, in January to March 2026 or in April to June 2025.

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 199 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 1,637 of the 1,641 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 199 terms.

Reaction terms in the reports that name Co-Diovan, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,641 reports
Blood pressure increaseda raised blood pressure reading	175	10.7%
Deaththe patient died; cause not stated by this term	149	9.1%
Malaisegeneral feeling of being unwell	113	6.9%
Diabetes mellitusdiabetes	112	6.8%
Falla fall	108	6.6%
Hypertensionhigh blood pressure	90	5.5%
Dizzinesslight-headedness or unsteadiness	77	4.7%
Wrong technique in product usage processthe product was used in the wrong way	76	4.6%
Wrong technique in drug usage processthe medicine was used in the wrong way	71	4.3%
Headachehead pain	68	4.1%
Feeling abnormalfeeling odd or not right	59	3.6%
Blood pressure decreaseda low blood pressure reading	57	3.5%
Fatiguetiredness	55	3.4%
Drug ineffectivethe medicine did not work as expected	54	3.3%
Blood glucose increasedraised blood sugar reading	53	3.2%
Hypotensionlow blood pressure	53	3.2%
Pain in extremitypain in an arm or leg	51	3.1%
Gait disturbancedifficulty walking	50	3%
Cerebrovascular accidentstroke	47	2.9%
Memory impairmentmemory problems	47	2.9%
Arrhythmia	46	2.8%
Drug prescribing errora prescribing mistake	46	2.8%
Infarction	37	2.3%
Cataractclouding of the eye lens	36	2.2%
Painpain, site not specified	36	2.2%
Blood pressure inadequately controlled	35	2.1%
Deafnesshearing loss	35	2.1%
Arthralgiajoint pain	34	2.1%
Astheniaweakness or lack of energy	34	2.1%
Cardiac disorder	34	2.1%
Blood pressure fluctuation	33	2%
Dyspnoeashortness of breath	33	2%
Anxiety	31	1.9%
Myocardial infarctionheart attack	31	1.9%
Cardiac failureheart failure	29	1.8%
Cough	29	1.8%
Pneumonialung infection	28	1.7%
Syncopefainting	28	1.7%
Drug interactionan interaction between medicines	27	1.6%
General physical health deteriorationgeneral decline in health	26	1.6%
Vomitingbeing sick	26	1.6%
Weight decreasedweight loss	26	1.6%
Anaemialow red blood cells	24	1.5%
Chest pain	24	1.5%
Dehydration	24	1.5%
Gastritisinflamed stomach lining	24	1.5%
Haemorrhagebleeding	24	1.5%
Incorrect dose administeredthe wrong dose was given	24	1.5%
Depressionlow mood	23	1.4%
Hyponatraemialow blood sodium	23	1.4%

Download all 199 terms of Co-Diovan (CSV)

The counts add to more than 1,641 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 Co-Diovan, 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	33	33	5	0	16	0	1	18	0
2005	17	17	0	2	10	1	0	9	0
2006	27	27	3	0	13	1	0	12	0
2007	16	16	2	0	6	0	0	9	0
2008	4	4	0	0	0	0	0	4	0
2009	0	0	0	0	0	0	0	0	0
2010	36	35	5	1	19	0	0	23	1
2011	44	43	12	2	19	0	0	31	1
2012	111	110	34	3	38	1	0	59	1
2013	297	291	79	3	88	10	0	195	6
2014	194	186	39	7	69	6	0	134	8
2015	139	130	20	2	34	11	0	101	9
2016	164	153	29	2	23	7	0	113	11
2017	159	151	36	6	31	2	0	92	8
2018	156	151	20	11	55	1	0	95	5
2019	161	155	16	10	46	3	0	106	6
2020	83	83	10	5	26	4	0	56	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 Co-Diovan, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Co-Diovan, by the year in which FDA received them
Year	Reports
2004	31
2005	20
2006	25
2007	13
2008	1
2009	5
2010	50
2011	92
2012	183
2013	234
2014	178
2015	126
2016	161
2017	155
2018	142
2019	149
2020	76

FDA received no report that names Co-Diovan in the five years to June 2026. FDA received the latest report in December 2020.

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 Co-Diovan
Age	Reports	Share
Under 2	3	0.2%
2 to 11	0	0%
12 to 17	2	0.1%
18 to 44	31	1.9%
45 to 64	269	16.4%
65 to 74	291	17.7%
75 and over	470	28.6%
Age not given	575	35%

Sex of the patient in the reports that name Co-Diovan
Sex	Reports	Share
Female	1,097	66.8%
Male	521	31.7%
Unknown or not given	23	1.4%

Type of reporter in the reports that name Co-Diovan
Reporter	Reports	Share
Physician	256	15.6%
Pharmacist	45	2.7%
Other health professional	70	4.3%
Lawyer	0	0%
Consumer or non-health professional	1,243	75.7%
Not given	27	1.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Co-Diovan record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	1,052	64.1%
Blood pressure increased	18	1.1%
Cardiac disorder	16	1%
Blood pressure abnormal	13	0.8%
Blood pressure measurement	4	0.2%
Essential hypertension	3	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,641 reports.

Pages near this one

Co-Codamol next in the A to Z list
Co-Trimoxazole next in the A to Z list
Co-Amoxiclav next in the A to Z list
Coaprovel next in the A to Z list
Co Diovan next in the A to Z list
Coated Pds next in the A to Z list
Co Amoxiclav next in the A to Z list
Cobenfy next in the A to Z list
Clozaril next in the A to Z list
Cobicistat next in the A to Z list
Clozapine Teva next in the A to Z list
Cobicistat Darunavir Ethanolate next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for Co-DiovanThe 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. Co-Diovan: adverse event reports that FDA received. https://reportedreactions.com/drug/co-diovan/ 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 Co-Diovan as a suspect or interacting product. The 569 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 Co-Diovan 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 Co-Diovan?

No. It is a count of what people reported to FDA: 1,641 reports from January 2004 to December 2020. 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 (75.7%), physician (15.6%) and other health professional (4.3%). 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.

To the top of the page