Mirapex adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Mirapex
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 June 2026, FDA received 4,732 adverse event reports that name Mirapex. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 8,956 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 22 reports in the 12 months to June 2026 and 26 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, 22 (under 0.1%) name Mirapex. Reports from consumers or other non-health professionals were 59.4% of the reports that name Mirapex 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 Mirapex 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 4 reports that name Mirapex.
In January to March 2026, FDA received 3.
In April to June 2025, FDA received 10.

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 270 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 4,723 of the 4,732 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 270 terms.

Reaction terms in the reports that name Mirapex, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,732 reports
Pathological gambling	968	20.5%
Obsessive-compulsive disorder	662	14%
Emotional distress	471	10%
Drug ineffectivethe medicine did not work as expected	442	9.3%
Depressionlow mood	412	8.7%
Painpain, site not specified	352	7.4%
Anxiety	273	5.8%
Insomniadifficulty sleeping	268	5.7%
Somnolencedrowsiness	262	5.5%
Compulsive shopping	239	5.1%
Hallucinationseeing or hearing things that are not there	217	4.6%
Nauseafeeling sick	212	4.5%
Hypersexuality	196	4.1%
Weight increasedweight gain	180	3.8%
Suicidal ideationthoughts of suicide	177	3.7%
Gambling	174	3.7%
Restless legs syndrome	169	3.6%
Dizzinesslight-headedness or unsteadiness	163	3.4%
Hyperphagia	163	3.4%
Fatiguetiredness	159	3.4%
Condition aggravatedthe condition being treated got worse	145	3.1%
Falla fall	130	2.7%
Tremorshaking	124	2.6%
Stress	118	2.5%
Oedema peripheralswelling of the legs, ankles or hands	105	2.2%
Headachehead pain	102	2.2%
Dyskinesiainvoluntary movements	99	2.1%
Confusional stateconfusion	94	2%
Dyspnoeashortness of breath	91	1.9%
Feeling abnormalfeeling odd or not right	91	1.9%
Economic problema financial problem	90	1.9%
Abnormal behaviourunusual behaviour	88	1.9%
Fear	87	1.8%
Pain in extremitypain in an arm or leg	83	1.8%
Gait disturbancedifficulty walking	82	1.7%
Injurya physical injury	77	1.6%
Astheniaweakness or lack of energy	76	1.6%
Sleep disordera sleep problem	76	1.6%
Drug effect decreasedthe medicine had less effect	74	1.6%
Vomitingbeing sick	72	1.5%
Deaththe patient died; cause not stated by this term	71	1.5%
Libido increased	70	1.5%
Off label useused for a purpose or in a way not on the label	69	1.5%
Hypotensionlow blood pressure	65	1.4%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	64	1.4%
Loss of consciousnesspassing out	63	1.3%
Sudden onset of sleep	63	1.3%
Muscle spasmsmuscle cramps	61	1.3%
Suicide attempta suicide attempt	60	1.3%
Hallucination, visual	54	1.1%

Download all 270 terms of Mirapex (CSV)

The counts add to more than 4,732 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 Mirapex, 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	119	109	16	2	35	3	0	60	10
2005	55	48	7	1	22	1	0	22	7
2006	71	62	4	6	35	5	0	23	9
2007	650	109	7	6	62	7	0	38	541
2008	1,267	135	5	14	81	10	0	57	1,132
2009	578	132	10	10	47	8	1	69	446
2010	235	78	9	3	34	6	1	44	157
2011	182	45	5	3	26	5	0	24	137
2012	192	54	10	2	29	5	0	22	138
2013	166	81	12	4	43	5	1	36	85
2014	186	80	7	7	34	5	0	42	106
2015	197	88	10	3	52	7	1	32	109
2016	155	81	13	2	42	4	0	37	74
2017	115	62	13	2	30	3	0	23	53
2018	99	54	3	2	29	6	0	27	45
2019	128	52	5	0	22	2	0	35	76
2020	109	74	2	2	38	6	0	56	35
2021	74	40	3	3	20	2	0	31	34
2022	49	22	3	0	15	1	0	18	27
2023	22	14	0	0	8	0	0	10	8
2024	35	24	2	1	16	2	0	19	11
2025	39	29	2	3	20	0	0	18	10
2026	9	5	0	0	2	0	0	3	4

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 Mirapex, 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 Mirapex, by the year in which FDA received them
Year	Reports
2004	101
2005	59
2006	70
2007	473
2008	1,434
2009	602
2010	234
2011	190
2012	215
2013	147
2014	184
2015	204
2016	151
2017	115
2018	104
2019	132
2020	112
2021	75
2022	48
2023	17
2024	31
2025	27
2026	7

Reports that name Mirapex, 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 Mirapex
Age	Reports	Share
Under 2	6	0.1%
2 to 11	6	0.1%
12 to 17	2	under 0.1%
18 to 44	168	3.6%
45 to 64	628	13.3%
65 to 74	391	8.3%
75 and over	407	8.6%
Age not given	3,124	66%

Sex of the patient in the reports that name Mirapex
Sex	Reports	Share
Female	2,318	49%
Male	1,659	35.1%
Unknown or not given	755	16%

Type of reporter in the reports that name Mirapex
Reporter	Reports	Share
Physician	1,099	23.2%
Pharmacist	279	5.9%
Other health professional	357	7.5%
Lawyer	11	0.2%
Consumer or non-health professional	2,812	59.4%
Not given	174	3.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 63.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Mirapex record
Indication as recorded (MedDRA)	Reports	Share
Restless legs syndrome	1,848	39.1%
Parkinson's disease	932	19.7%
Parkinson's disease	274	5.8%
Fibromyalgia	20	0.4%
Muscle spasms	17	0.4%
Tremor	13	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,732 reports.

Drugs in the same reports

Other drugs that the reports of Mirapex name, in any role, in order of name
Drug	Reports that name the two
Aspirin	172
Clonazepam	104
Cymbalta	109
Gabapentin	93
Lexapro	94
Lipitor	122
Lisinopril	103
Neurontin	87
Sinemet	313
Synthroid	86

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for MirapexThe 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. Mirapex: adverse event reports that FDA received. https://reportedreactions.com/drug/mirapex/ 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 Mirapex as a suspect or interacting product. The 8,956 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 Mirapex 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 Mirapex?

No. It is a count of what people reported to FDA: 4,732 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 (59.4%), physician (23.2%) and other health professional (7.5%). 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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