Carvedilol adverse event reports that FDA received

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

Name type: Generic name
Class: alpha-Adrenergic blocker
Also reported as: Carvedilol Tablets, Carvedilol Tablets Usp, Carvedilol Tablet

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 14,163 adverse event reports that name Carvedilol. In these reports the drug is a suspect or interacting product.

In the same period, 85,805 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 700 reports in the 12 months to June 2026 and 855 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 Carvedilol 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 150 reports that name Carvedilol.
In January to March 2026, FDA received 232.
In April to June 2025, FDA received 148.

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 1,090 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 14,067 of the 14,163 reports (99.3%).

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 1,090 terms.

Reaction terms in the reports that name Carvedilol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 14,163 reports
Hypotensionlow blood pressure	1,878	13.3%
Completed suicidedeath by suicide	1,272	9%
Dizzinesslight-headedness or unsteadiness	1,129	8%
Drug ineffectivethe medicine did not work as expected	1,085	7.7%
Dyspnoeashortness of breath	1,040	7.3%
Bradycardiaslow heart rate	986	7%
Drug interactionan interaction between medicines	973	6.9%
Fatiguetiredness	971	6.9%
Toxicity to various agentspoisoning or toxic effect of one or more substances	831	5.9%
Cardiac failureheart failure	644	4.5%
Astheniaweakness or lack of energy	572	4%
Syncopefainting	540	3.8%
Acute kidney injurysudden loss of kidney function	495	3.5%
Hypertensionhigh blood pressure	470	3.3%
Nauseafeeling sick	460	3.2%
Diarrhoealoose or frequent stools	427	3%
Headachehead pain	426	3%
Oedema peripheralswelling of the legs, ankles or hands	415	2.9%
Blood pressure increaseda raised blood pressure reading	407	2.9%
Overdosea dose above the recommended amount	396	2.8%
Cough	395	2.8%
Intentional overdosea deliberate overdose	385	2.7%
Falla fall	384	2.7%
Chest pain	362	2.6%
Atrial fibrillationan irregular heart rhythm	357	2.5%
Off label useused for a purpose or in a way not on the label	356	2.5%
Weight decreasedweight loss	356	2.5%
Hyperkalaemiahigh blood potassium	355	2.5%
Blood pressure decreaseda low blood pressure reading	333	2.4%
Deaththe patient died; cause not stated by this term	333	2.4%
Malaisegeneral feeling of being unwell	332	2.3%
Condition aggravatedthe condition being treated got worse	302	2.1%
Feeling abnormalfeeling odd or not right	287	2%
Somnolencedrowsiness	279	2%
Shockshock, a collapse of the circulation	262	1.8%
Vomitingbeing sick	252	1.8%
BRASH syndrome	251	1.8%
Ejection fraction decreased	249	1.8%
Weight increasedweight gain	243	1.7%
Loss of consciousnesspassing out	238	1.7%
Dehydration	233	1.6%
Heart rate decreased	232	1.6%
Palpitationsawareness of the heartbeat	232	1.6%
Cardiac arrestthe heart stopped	230	1.6%
Blood creatinine increasedraised creatinine, a kidney test	228	1.6%
Pneumonialung infection	228	1.6%
Painpain, site not specified	226	1.6%
Pain in extremitypain in an arm or leg	224	1.6%
Pulmonary oedemafluid in the lungs	221	1.6%
Renal impairmentreduced kidney function	220	1.6%

Download all 1,090 terms of Carvedilol (CSV)

The counts add to more than 14,163 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 Carvedilol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Carvedilol (this page)	Generic name	14,163
Coreg	Brand name	4,989
Coreg CR	Brand name	2,020

Sum of the separately reported names: 21,172. 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 Carvedilol, 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	85	81	11	13	58	5	0	21	4
2005	121	115	10	13	76	3	0	38	6
2006	119	110	22	15	75	2	0	21	9
2007	122	92	8	11	49	3	0	35	30
2008	261	203	40	33	107	8	0	82	58
2009	274	210	21	33	124	10	0	66	64
2010	266	202	27	19	95	4	0	91	64
2011	306	266	61	16	141	6	0	92	40
2012	349	286	62	28	142	6	0	129	63
2013	404	358	82	16	162	12	0	141	46
2014	477	405	79	46	214	13	1	189	72
2015	578	438	181	23	176	4	0	182	140
2016	563	443	140	33	211	6	0	233	120
2017	741	634	192	58	329	6	8	372	107
2018	1,182	1,078	179	92	663	7	0	635	104
2019	1,227	965	196	61	502	11	2	640	262
2020	1,048	920	266	100	509	9	2	548	128
2021	1,121	901	128	93	505	12	3	679	220
2022	1,209	971	182	88	548	13	1	688	238
2023	1,284	1,014	205	158	555	8	0	715	270
2024	1,112	914	185	126	497	15	0	659	198
2025	841	721	132	99	446	7	0	532	120
2026	473	428	169	47	246	3	0	287	45

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 Carvedilol, 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 Carvedilol, by the year in which FDA received them
Year	Reports
2004	79
2005	115
2006	119
2007	117
2008	259
2009	281
2010	261
2011	325
2012	410
2013	417
2014	476
2015	609
2016	578
2017	828
2018	1,270
2019	1,237
2020	1,101
2021	1,248
2022	1,081
2023	1,242
2024	1,031
2025	697
2026	382

Reports that name Carvedilol, 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 Carvedilol
Age	Reports	Share
Under 2	46	0.3%
2 to 11	55	0.4%
12 to 17	81	0.6%
18 to 44	1,139	8%
45 to 64	3,326	23.5%
65 to 74	2,627	18.5%
75 and over	2,923	20.6%
Age not given	3,966	28%

Sex of the patient in the reports that name Carvedilol
Sex	Reports	Share
Female	5,702	40.3%
Male	6,803	48%
Unknown or not given	1,658	11.7%

Type of reporter in the reports that name Carvedilol
Reporter	Reports	Share
Physician	4,208	29.7%
Pharmacist	1,303	9.2%
Other health professional	4,003	28.3%
Lawyer	7	under 0.1%
Consumer or non-health professional	4,248	30%
Not given	394	2.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 58.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Carvedilol record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	2,019	14.3%
Cardiac failure	532	3.8%
Cardiac failure congestive	214	1.5%
Atrial fibrillation	174	1.2%
Cardiac disorder	174	1.2%
Cardiac failure chronic	105	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 14,163 reports.

Drugs in the same reports

Other drugs that the reports of Carvedilol name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	1,827
Aspirin	1,402
Atorvastatin	1,392
Entresto	1,698
Furosemide	2,470
Lisinopril	1,287
Losartan	633
Metformin	699
Ramipril	820
Spironolactone	1,776

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

Coreg same ingredient
Coreg CR same ingredient
Cardura same class
Alfuzosin hydrochloride same class
Doxazosin same class
Carticel next in the A to Z list
Carvykti next in the A to Z list
Cartia Xt next in the A to Z list
Casirivimab next in the A to Z list
Carmustine next in the A to Z list
Casirivimab Imdevimab next in the A to Z list
Carisoprodol 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 CarvedilolThe 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. Carvedilol: adverse event reports that FDA received. https://reportedreactions.com/drug/carvedilol/ 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 Carvedilol as a suspect or interacting product. The 85,805 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 Carvedilol 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 Carvedilol?

No. It is a count of what people reported to FDA: 14,163 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 (30%), physician (29.7%) and other health professional (28.3%). 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.

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