Cabergoline adverse event reports that FDA received

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

Name type: Generic name

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 June 2026, FDA received 2,573 adverse event reports that name Cabergoline. In these reports the drug is a suspect or interacting product.

In the same period, 2,312 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 144 reports in the 12 months to June 2026 and 105 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, 144 (under 0.1%) name Cabergoline. Reports from consumers or other non-health professionals were 15.2% of the reports that name Cabergoline 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 Cabergoline 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 26 reports that name Cabergoline.
In January to March 2026, FDA received 31.
In April to June 2025, FDA received 23.

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 312 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 2,573 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 312 terms.

Reaction terms in the reports that name Cabergoline, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,573 reports
Drug ineffectivethe medicine did not work as expected	257	10%
Off label useused for a purpose or in a way not on the label	138	5.4%
Headachehead pain	128	5%
Cerebrospinal fluid leakage	104	4%
Nauseafeeling sick	103	4%
Drug interactionan interaction between medicines	98	3.8%
Mitral valve incompetence	97	3.8%
Condition aggravatedthe condition being treated got worse	88	3.4%
Aortic valve incompetence	87	3.4%
Dizzinesslight-headedness or unsteadiness	73	2.8%
Dyspnoeashortness of breath	62	2.4%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	62	2.4%
Pleural effusionfluid around the lung	59	2.3%
Fatiguetiredness	58	2.3%
Cardiac valve disease	55	2.1%
Drug resistance	52	2%
Anxiety	49	1.9%
Drug intolerancethe medicine was not tolerated	47	1.8%
Malaisegeneral feeling of being unwell	47	1.8%
Pathological gambling	47	1.8%
Product use in unapproved indicationused for a purpose not on the label	47	1.8%
Tricuspid valve incompetence	46	1.8%
Vomitingbeing sick	45	1.7%
Cardiac failureheart failure	44	1.7%
Blood prolactin increased	42	1.6%
Disease progressionthe disease advanced	41	1.6%
Oedema peripheralswelling of the legs, ankles or hands	41	1.6%
Hypertensionhigh blood pressure	38	1.5%
Hallucinationseeing or hearing things that are not there	37	1.4%
Neoplasm progression	37	1.4%
Insulin-like growth factor increased	36	1.4%
Pituitary haemorrhage	35	1.4%
Pulmonary hypertensionhigh pressure in the lung arteries	34	1.3%
Therapeutic product effect decreased	33	1.3%
Insomniadifficulty sleeping	32	1.2%
Pneumocephalus	32	1.2%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	31	1.2%
Falla fall	30	1.2%
Visual impairmentreduced vision	30	1.2%
Confusional stateconfusion	29	1.1%
Diarrhoealoose or frequent stools	29	1.1%
Chest pain	28	1.1%
Diabetes mellitusdiabetes	28	1.1%
Drug abusemisuse of a medicine	28	1.1%
Delusiona fixed false belief	27	1%
Weight decreasedweight loss	27	1%
Abortion spontaneousmiscarriage	25	1%
Cerebrospinal fluid rhinorrhoea	24	0.9%
Ovarian hyperstimulation syndrome	24	0.9%
Parkinson's disease	24	0.9%

Download all 312 terms of Cabergoline (CSV)

The counts add to more than 2,573 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 Cabergoline, 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	123	121	16	15	63	6	0	49	2
2005	144	141	8	9	61	12	1	76	3
2006	137	131	9	9	59	13	1	80	6
2007	102	91	4	4	13	6	0	73	11
2008	82	71	6	8	33	3	4	40	11
2009	60	58	3	4	15	0	0	48	2
2010	103	100	2	1	30	0	9	77	3
2011	78	78	5	3	29	6	0	61	0
2012	92	87	5	1	29	2	5	63	5
2013	56	53	0	6	13	0	2	39	3
2014	87	76	4	4	21	2	0	62	11
2015	80	59	0	4	18	8	0	45	21
2016	75	61	3	1	21	2	1	43	14
2017	105	77	7	2	25	1	0	60	28
2018	174	151	14	3	49	4	4	126	23
2019	136	115	6	10	37	5	5	91	21
2020	173	159	0	7	40	0	6	130	14
2021	114	109	1	3	26	0	1	96	5
2022	94	80	2	0	19	0	5	68	14
2023	170	155	5	4	50	2	1	126	15
2024	159	143	3	10	65	1	0	80	16
2025	149	136	2	7	58	6	0	115	13
2026	80	74	5	7	23	5	0	66	6

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 Cabergoline, 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 Cabergoline, by the year in which FDA received them
Year	Reports
2004	122
2005	143
2006	134
2007	92
2008	75
2009	59
2010	128
2011	78
2012	103
2013	58
2014	89
2015	77
2016	81
2017	110
2018	186
2019	134
2020	187
2021	98
2022	88
2023	168
2024	158
2025	148
2026	57

Reports that name Cabergoline, 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 Cabergoline
Age	Reports	Share
Under 2	6	0.2%
2 to 11	14	0.5%
12 to 17	41	1.6%
18 to 44	765	29.7%
45 to 64	529	20.6%
65 to 74	272	10.6%
75 and over	165	6.4%
Age not given	781	30.4%

Sex of the patient in the reports that name Cabergoline
Sex	Reports	Share
Female	1,223	47.5%
Male	996	38.7%
Unknown or not given	354	13.8%

Type of reporter in the reports that name Cabergoline
Reporter	Reports	Share
Physician	924	35.9%
Pharmacist	168	6.5%
Other health professional	919	35.7%
Lawyer	2	0.1%
Consumer or non-health professional	392	15.2%
Not given	168	6.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Cabergoline record
Indication as recorded (MedDRA)	Reports	Share
Prolactin-producing pituitary tumour	460	17.9%
Parkinson's disease	424	16.5%
Prolactinoma	181	7%
Hyperprolactinaemia	159	6.2%
Pituitary tumour benign	137	5.3%
Acromegaly	66	2.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,573 reports.

Drugs in the same reports

Other drugs that the reports of Cabergoline name, in any role, in order of name
Drug	Reports that name the two
Entacapone	53
Hydrocortisone	63
Ketoconazole	44
Levodopa	78
Levothyroxine	77
Metformin	59
Sandostatin LAR Depot	62
Sinemet	76
Temozolomide	57
Testosterone	51

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

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for CabergolineThe 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. Cabergoline: adverse event reports that FDA received. https://reportedreactions.com/drug/cabergoline/ 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 Cabergoline as a suspect or interacting product. The 2,312 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 Cabergoline 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 Cabergoline?

No. It is a count of what people reported to FDA: 2,573 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?

Physician (35.9%), other health professional (35.7%) and consumer or non-health professional (15.2%). 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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