Nebivolol adverse event reports that FDA received

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

Name type: Generic name
Class: beta-Adrenergic blocker
Also reported as: Nebivolol /01339102/, Nebivolol 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.

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 April 2004 to June 2026, FDA received 4,211 adverse event reports that name Nebivolol. In these reports the drug is a suspect or interacting product.

In the same period, 11,771 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 386 reports in the 12 months to June 2026 and 256 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, 386 (under 0.1%) name Nebivolol. Reports from consumers or other non-health professionals were 15.4% of the reports that name Nebivolol and 45.8% 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 Nebivolol 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 70 reports that name Nebivolol.
In January to March 2026, FDA received 142.
In April to June 2025, FDA received 52.

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 515 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 4,189 of the 4,211 reports (99.5%).

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 515 terms.

Reaction terms in the reports that name Nebivolol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,211 reports
Hypotensionlow blood pressure	410	9.7%
Bradycardiaslow heart rate	310	7.4%
Falla fall	265	6.3%
Drug ineffectivethe medicine did not work as expected	261	6.2%
Acute kidney injurysudden loss of kidney function	242	5.7%
Dyspnoeashortness of breath	240	5.7%
Hyperkalaemiahigh blood potassium	181	4.3%
Drug interactionan interaction between medicines	164	3.9%
Dizzinesslight-headedness or unsteadiness	157	3.7%
Completed suicidedeath by suicide	150	3.6%
Syncopefainting	145	3.4%
Hypertensionhigh blood pressure	137	3.3%
Nauseafeeling sick	130	3.1%
Off label useused for a purpose or in a way not on the label	127	3%
Anaemialow red blood cells	124	2.9%
Headachehead pain	123	2.9%
Toxicity to various agentspoisoning or toxic effect of one or more substances	115	2.7%
Fatiguetiredness	113	2.7%
Blood pressure increaseda raised blood pressure reading	112	2.7%
Condition aggravatedthe condition being treated got worse	109	2.6%
Malaisegeneral feeling of being unwell	109	2.6%
Diarrhoealoose or frequent stools	107	2.5%
Cough	104	2.5%
Intentional overdosea deliberate overdose	95	2.3%
Somnolencedrowsiness	95	2.3%
Suicide attempta suicide attempt	89	2.1%
Lactic acidosisa build-up of lactic acid in the blood	88	2.1%
Astheniaweakness or lack of energy	85	2%
Vomitingbeing sick	83	2%
Atrial fibrillationan irregular heart rhythm	82	1.9%
Orthostatic hypotension	77	1.8%
Hyponatraemialow blood sodium	72	1.7%
Renal failurekidney failure	69	1.6%
Interstitial lung diseasescarring or inflammation of lung tissue	68	1.6%
Oedema peripheralswelling of the legs, ankles or hands	68	1.6%
Chest pain	67	1.6%
Palpitationsawareness of the heartbeat	65	1.5%
Loss of consciousnesspassing out	63	1.5%
Renal impairmentreduced kidney function	62	1.5%
Anxiety	59	1.4%
Abdominal painstomach or belly pain	58	1.4%
Insomniadifficulty sleeping	56	1.3%
Product use in unapproved indicationused for a purpose not on the label	54	1.3%
Rhabdomyolysismuscle breakdown	53	1.3%
Presyncope	52	1.2%
Coma	51	1.2%
Hypertensive crisis	49	1.2%
Vertigoa spinning sensation	48	1.1%
Cardiac arrestthe heart stopped	47	1.1%
Electrocardiogram QT prolongeda QT prolongation on the ECG	46	1.1%

Download all 515 terms of Nebivolol (CSV)

The counts add to more than 4,211 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 Nebivolol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Nebivolol (this page)	Generic name	4,211
Nebivolol hydrochloride	Generic name	723
Bystolic	Brand name	2,841

Sum of the separately reported names: 7,775. 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 Nebivolol, 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	1	1	0	0	1	0	0	0	0
2005	3	3	0	0	2	0	0	2	0
2006	2	2	0	0	2	0	0	2	0
2007	0	0	0	0	0	0	0	0	0
2008	5	3	0	0	3	0	0	0	2
2009	13	8	1	1	4	0	1	4	5
2010	39	35	3	4	19	1	0	16	4
2011	25	20	6	0	10	0	0	5	5
2012	120	117	9	10	77	1	2	38	3
2013	127	127	27	8	77	1	0	31	0
2014	118	117	20	6	57	1	0	47	1
2015	146	145	32	6	79	1	1	47	1
2016	129	128	9	20	76	1	7	51	1
2017	118	114	24	2	59	2	1	63	4
2018	424	418	54	63	209	0	1	227	6
2019	430	429	51	35	190	9	0	265	1
2020	343	340	40	20	191	5	0	178	3
2021	314	304	48	16	155	1	2	171	10
2022	443	400	22	32	238	2	15	255	43
2023	409	356	15	23	241	2	0	219	53
2024	443	402	20	69	201	17	0	254	41
2025	297	271	13	51	134	14	3	169	26
2026	262	214	55	25	113	4	0	115	48

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 Nebivolol, 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 Nebivolol, by the year in which FDA received them
Year	Reports
2004	1
2005	3
2006	2
2008	3
2009	9
2010	41
2011	27
2012	131
2013	133
2014	113
2015	150
2016	130
2017	148
2018	452
2019	464
2020	333
2021	345
2022	419
2023	396
2024	437
2025	262
2026	212

Reports that name Nebivolol, 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 Nebivolol
Age	Reports	Share
Under 2	28	0.7%
2 to 11	12	0.3%
12 to 17	17	0.4%
18 to 44	301	7.1%
45 to 64	1,051	25%
65 to 74	798	19%
75 and over	1,191	28.3%
Age not given	813	19.3%

Sex of the patient in the reports that name Nebivolol
Sex	Reports	Share
Female	1,957	46.5%
Male	1,826	43.4%
Unknown or not given	428	10.2%

Type of reporter in the reports that name Nebivolol
Reporter	Reports	Share
Physician	1,625	38.6%
Pharmacist	552	13.1%
Other health professional	1,323	31.4%
Lawyer	2	under 0.1%
Consumer or non-health professional	649	15.4%
Not given	60	1.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 14% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Nebivolol record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	1,453	34.5%
Atrial fibrillation	106	2.5%
Cardiac failure	93	2.2%
Myocardial infarction	51	1.2%
Essential hypertension	24	0.6%
Myocardial ischaemia	23	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,211 reports.

Drugs in the same reports

Other drugs that the reports of Nebivolol name, in any role, in order of name
Drug	Reports that name the two
Allopurinol	279
Amlodipine	478
Aspirin	363
Atorvastatin	489
Furosemide	641
Kardegic	293
Metformin	323
Pantoprazole	407
Ramipril	406
Spironolactone	263

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

Nebivolol hydrochloride same ingredient
Bystolic same ingredient
Nadolol same class
Metoprolol tartrate same class
Propranolol same class
Metoprolol succinate same class
Propranolol hcl same class
Nayzilam next in the A to Z list
Nebivolol Hcl - Bp next in the A to Z list
Navelbine next in the A to Z list
Natulan next in the A to Z list
Necitumumab 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 NebivololThe 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. Nebivolol: adverse event reports that FDA received. https://reportedreactions.com/drug/nebivolol/ 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 Nebivolol as a suspect or interacting product. The 11,771 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 Nebivolol 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 Nebivolol?

No. It is a count of what people reported to FDA: 4,211 reports from April 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?

Physician (38.6%), other health professional (31.4%) and consumer or non-health professional (15.4%). 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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