Pharmacologic class (EPC) · 6 drug pages

Nonergot dopamine agonist: adverse event reports filed with FDA

19,168 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

19,168
reports across the class: 0.1% of all reports; 1,376
reports, 12 months to June 2026: 1,549 in the 12 months before; 70.7%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Nonergot dopamine agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 19,168 adverse event reports received by FDA, 0.1% of the database, from March 2004 to June 2026.

1,376 reports arrived in the 12 months to June 2026, down 11% from 1,549 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 70.7% of the class's reports are marked serious, 10.8% record death among the outcomes and 27.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (9.9%), product adhesion issue (9.9%) and off label use (6.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
NeuproRotigotine	brand	6,256	378	37.7%	Product adhesion issue
Pramipexole	generic	3,883	413	90.6%	Drug ineffective
Rotigotine	generic	3,595	261	92.2%	Death
Ropinirole	generic	2,762	139	78.8%	Drug ineffective
Pramipexole dihydrochloride	generic	1,636	147	86.8%	Drug ineffective
Ropinirole hydrochloride	generic	1,036	38	72.6%	Asthma

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected9.9%1,900
Product adhesion issue9.9%1,900
Off label useused for a purpose or in a way not on the label6.3%1,217
Falla fall5.2%1,003
Hallucinationseeing or hearing things that are not there4.7%908
Tremorshaking4.5%862
Dizzinesslight-headedness or unsteadiness4.4%835
Dyskinesiainvoluntary movements4.1%789
Insomniadifficulty sleeping4%764
Condition aggravatedthe condition being treated got worse3.9%751
Nauseafeeling sick3.8%737
Somnolencedrowsiness3.8%735
Deaththe patient died; cause not stated by this term3.8%719
Fatiguetiredness3.7%704
Restless legs syndrome3.6%699
Parkinson's disease3.6%682
Anxietyanxiety3.4%653
Gait disturbancedifficulty walking3%574
Painpain, site not specified3%572
Astheniaweakness or lack of energy2.7%523
Overdosea dose above the recommended amount2.6%502
Depressionlow mood2.5%477
Confusional stateconfusion2.4%467
Constipationconstipation2.4%461
Application site erythemaredness where the product was applied2.3%444

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.8%2,076

Life-threatening2.9%559

Hospitalisation (initial or prolonged)27.4%5,255

Disability3.8%725

Congenital anomaly0.3%57

Other serious48%9,197

Not serious29.3%5,625

Patient age

Under 20.1%18

2 to 110.1%26

12 to 170.2%37

18 to 444.2%808

45 to 6418.1%3,473

65 to 7418.2%3,492

75 and over19.9%3,820

Age not given39.1%7,494

Who reported

Physician19.8%3,793

Pharmacist8.2%1,565

Other health professional20.4%3,911

Lawyer0.1%28

Consumer or non-health professional45.3%8,680

Not given6.2%1,191

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Nonergot dopamine agonist reports

Which drugs are in the Nonergot dopamine agonist class on this site?

Neupro, Pramipexole, Rotigotine, Ropinirole, Pramipexole dihydrochloride and Ropinirole hydrochloride. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

19,168 reports through June 2026, 1,376 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (9.9%), product adhesion issue (9.9%), off label use (6.3%), fall (5.2%) and hallucination (4.7%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.