Table 1 Clinical characteristics of reports with rotigotine from the FAERS database
From: Rotigotine safety in real-world settings: a pharmacovigilance study using FAERS data
Characteristics | Case number | Proportion (%) |
|---|---|---|
Number of events | 7570 | Â |
Gender (%) | Â | Â |
 Female | 3325 | 43.9 |
 Male | 3180 | 42.0 |
Not specified | 1065 | 14.1 |
Weight (kg) | Â | Â |
 < 50 | 123 | 1.6 |
 > 100 | 212 | 2.8 |
 50~100 | 1346 | 17.8 |
Not specified | 5889 | 77.8 |
Age(years) | Â | Â |
 < 18 | 6 | 0.1 |
 18~65 | 1042 | 13.8 |
 65~85 | 2450 | 32.3 |
Not specified | 3783 | 50 |
Reported Countries | Â | Â |
 United States | 3580 | 47.3 |
 Mexico | 401 | 5.3 |
 Colombia | 655 | 8.7 |
 Germany | 698 | 9.2 |
 Japan | 472 | 6.2 |
 others | 1809 | 23.9 |
 Reporter |  |  |
 Consumer | 4658 | 61.5 |
Health Professional | 201 | 2.7 |
 Medical Doctor | 1005 | 13.3 |
 Pharmacist | 574 | 7.6 |
Other health-professional | 417 | 5.5 |
 Lawyer | 5 | 0.1 |
 Not specified | 710 | 9.3 |
 Year of report |  |  |
 2007 | 141 | 1.8 |
 2008 | 608 | 8.0 |
 2009 | 131 | 1.7 |
 2010 | 111 | 1.4 |
 2011 | 66 | 0.9 |
 2012 | 107 | 1.4 |
 2013 | 214 | 2.8 |
 2014 | 156 | 2.0 |
 2015 | 294 | 3.89 |
 2016 | 421 | 5.6 |
 2017 | 461 | 6.1 |
 2018 | 355 | 4.7 |
 2019 | 367 | 4.8 |
 2020 | 869 | 11.5 |
 2021 | 743 | 9.8 |
 2022 | 841 | 11.1 |
 2023 | 1222 | 16.1 |
 2024 | 463 | 6.1 |
 Outcomes |  |  |
Other serious outcome | 1967 | 26.0 |
 Hospitalization | 1391 | 18.3 |
 Death | 2206 | 29.1 |
 Disability | 107 | 1.5 |
Required Intervention to Prevent Permanent Impairment | 3 | 0.03 |
 Life-Threatening | 74 | 0.98 |
 Not specified | 2926 | 38.7 |
 Indications |  |  |
Parkinson’s disease | 3852 | 50.9 |
Restless legs syndrome | 1406 | 18.6 |
on-off phenomenon | 20 | 0.3 |
 Tremor | 12 | 0.2 |
Neuropathy peripheral | 8 | 0.1 |
 Not specified | 2272 | 30.2 |