Drugs › Nonergot dopamine agonist
Brand name · Rotigotine
Neupro: adverse event reports filed with FDA
6,256 reports list it as a suspect or interacting product, 2007–2026. Class: Nonergot dopamine agonist.
- 6,256
- reports as suspect product
- 0% of all reports · about 328 a year
- 378
- reports, 12 months to June 2026
- 423 in the 12 months before
- 37.7%
- marked serious by the reporter
- 70.7% across the class
- 4.1%
- record death among outcomes, as reported
- 257 reports · not verified by FDA
6,256 adverse event reports received by FDA list the brand name Neupro (rotigotine) as a suspect or interacting product, from June 2007 to June 2026. A further 3,788 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 378 reports listed it, down 11% from 423 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 328 reports a year and 0% of the 20,646,523 reports in the database, and 32.6% of the reports for the nonergot dopamine agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are product adhesion issue (26.9%), drug ineffective (9.7%) and application site erythema (5.7%). A report can list several reactions, so shares add to more than 100%; 670 different terms appear across these reports. Product adhesion issue is recorded in 26.9% of these reports, with no counterpart in the median nonergot dopamine agonist drug (0%).
37.7% of the reports are marked serious by the reporter (70.7% across the class); 4.1% record death among the outcomes and 16.2% record hospitalisation, as reported. 52.2% of the reports came from consumers, and the largest patient age group is 75 and over (15.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Neupro reports recording the termmedian drug in nonergot dopamine agonist
- Product adhesion issue26.9%1,680
- Drug ineffectivethe medicine did not work as expected9.7%607
- Application site erythemaredness where the product was applied5.7%359
- Application site pruritusitching where the product was applied5.7%359
- Off label useused for a purpose or in a way not on the label5.1%318
- Device adhesion issue4.9%307
- Overdosea dose above the recommended amount3.8%235
- Nauseafeeling sick3.6%225
- Tremorshaking3.5%217
- Hallucinationseeing or hearing things that are not there3.4%212
- Product dose omission issuea dose was missed3.2%200
- Application site reactiona reaction where the product was applied3%188
- Insomniadifficulty sleeping2.9%184
- Application site rash2.8%175
- Dizzinesslight-headedness or unsteadiness2.7%171
- Falla fall2.7%168
- Somnolencedrowsiness2.7%168
- Parkinson's disease2.7%166
- Wrong technique in product usage processthe product was used in the wrong way2.5%157
- Fatiguetiredness2.4%153
- Pruritusitching2.3%146
- Gait disturbancedifficulty walking2.3%142
- Dyskinesiainvoluntary movements2.1%131
- Rashskin rash1.9%120
- Product quality issuea problem with the product itself1.8%111
- Confusional stateconfusion1.7%104
- Incorrect dose administeredthe wrong dose was given1.7%104
- Condition aggravatedthe condition being treated got worse1.6%102
Top 30 of 670 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 6 drugs in the nonergot dopamine agonist class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 19,168 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 48.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Parkinson's disease | 1,647 | 26.3% |
| Restless legs syndrome | 1,210 | 19.3% |
| Parkinson's disease | 577 | 9.2% |
| Parkinsonism | 22 | 0.4% |
| On and off phenomenon | 17 | 0.3% |
| Off label use | 10 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 6,256 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Neupro reports |
|---|---|---|
| Sinemet | 341 | 5.5% |
| Azilect | 249 | 4% |
| Aspirin | 135 | 2.2% |
| Stalevo | 116 | 1.9% |
| Carbidopa levodopa | 109 | 1.7% |
| Carbidopa and levodopa | 105 | 1.7% |
| Levodopa | 103 | 1.6% |
| Mirapex | 86 | 1.4% |
| Gabapentin | 79 | 1.3% |
| Ramipril | 71 | 1.1% |
Other products listed in reports where Neupro is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Neupro | Nonergot dopamine agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 6,256 | 19,168 | 20,646,523 |
| Share of that pool | — | 32.6% | 0% |
| Reports, latest 12 months | 378 | — | 1,332,454 |
| Marked serious | 37.7% | 70.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 41 | 108 | 91 |
| Hospitalisation recorded, per 1,000 reports | 162 | 274 | 213 |
| Consumer-filed share | 52.2% | 45.3% | 45.8% |
| Top term, share of reports | Product adhesion issue 26.9% | median 0% | 0.2% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the nonergot dopamine agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Pramipexole | generic | 3,883 | 413 | 90.6% |
| Rotigotine | generic | 3,595 | 261 | 92.2% |
| Ropinirole | generic | 2,762 | 139 | 78.8% |
| Pramipexole dihydrochloride | generic | 1,636 | 147 | 86.8% |
| Ropinirole hydrochloride | generic | 1,036 | 38 | 72.6% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Neupro reports
How many adverse event reports has FDA received for Neupro?
6,256 reports list Neupro as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 378 of them arrived in the latest 12 months. Another 3,788 list it only as a concomitant medication.
What reactions are recorded in Neupro reports?
product adhesion issue (26.9%), drug ineffective (9.7%), application site erythema (5.7%), application site pruritus (5.7%) and off label use (5.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Neupro was responsible.
How serious are the reports?
37.7% are marked serious by the reporter. Among the outcomes recorded, 4.1% of reports include death and 16.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (52.2%), physician (14.7%) and pharmacist (13.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Neupro rising?
378 reports in the 12 months to June 2026, down 11% from 423 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Neupro was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Neupro?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Neupro as a suspect or interacting product; reports listing it only as a concomitant medication (3,788) are excluded. 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.