Rotigotine: adverse event reports filed with FDA

3,595

reports as suspect product

0% of all reports · about 186 a year

261

reports, 12 months to June 2026

521 in the 12 months before

92.2%

marked serious by the reporter

70.7% across the class

32.5%

record death among outcomes, as reported

1,167 reports · not verified by FDA

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 Rotigotine reports recording the termmedian drug in nonergot dopamine agonist

1. Deaththe patient died; cause not stated by this term15%539
2. Off label useused for a purpose or in a way not on the label12.4%447
3. Falla fall9.6%345
4. Parkinson's disease7.7%277
5. Product adhesion issue6.1%220
6. Drug ineffectivethe medicine did not work as expected5.7%206
7. Tremorshaking4.6%167
8. Pneumonialung infection4.5%162
9. Overdosea dose above the recommended amount4.1%149
10. Hallucinationseeing or hearing things that are not there4.1%146
11. Dizzinesslight-headedness or unsteadiness4%145
12. Therapy interrupted3.8%135
13. Anxietyanxiety3.7%133
14. Insomniadifficulty sleeping3.4%121
15. Gait disturbancedifficulty walking3.1%112
16. Vomitingbeing sick2.9%104
17. Painpain, site not specified2.8%101
18. Dysphagiadifficulty swallowing2.8%100
19. Nauseafeeling sick2.7%98
20. Urinary tract infectionbladder or urinary infection2.7%97
21. Constipationconstipation2.6%92
22. Dyskinesiainvoluntary movements2.4%88
23. Somnolencedrowsiness2.4%88
24. Balance disorderproblems with balance2.4%87
25. Restless legs syndrome2.4%87
26. Product availability issuethe product was not available2.4%86
27. Application site erythemaredness where the product was applied2.3%83
28. Astheniaweakness or lack of energy2.3%83
29. Application site pruritusitching where the product was applied2.3%81
30. Loss of consciousnesspassing out2.1%75

Top 30 of 615 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 32% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,595 reports.

Drugs most often listed in the same reports

Other products listed in reports where Rotigotine 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

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

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.

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 Rotigotine as a suspect or interacting product; reports listing it only as a concomitant medication (893) 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.