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Table 5 The top 30 most frequent adverse events for rotigotine excluding common medication co-usage at the PT level from FAERS data

From: Rotigotine safety in real-world settings: a pharmacovigilance study using FAERS data

Preferred terms (PTs)

Case reports

ROR (95% CI)

PRR (χ2)

EBGM

(EBGM05)

BCPNN (IC025)

Product Adhesion Issue*

1264

160.34 (151.19–170.04)

147.15 (175675.65)

140.85 (134.1)

7.14 (5.47)

Drug Ineffective*

548

1.64 (1.5–1.78)

1.61 (130.25)

1.61 (1.5)

0.69 (-0.98)

Death*

473

2.17 (1.98–2.38)

2.14 (290.25)

2.14 (1.98)

1.1 (-0.57)

Application Site Erythema*

366

55.94 (50.39–62.11)

54.63 (18959.93)

53.75 (49.24)

5.75 (4.08)

Application Site Pruritus*

363

65.95 (59.37–73.26)

64.41 (22229.51)

63.18 (57.86)

5.98 (4.32)

Device Adhesion Issue*

362

103.72 (93.3–115.29)

101.28 (34871.71)

98.27 (89.94)

6.62 (4.95)

Off Label Use*

323

1.55 (1.39–1.73)

1.54 (62.36)

1.54 (1.41)

0.62 (-1.04)

Overdose*

306

5.39 (4.82–6.04)

5.31 (1071.41)

5.3 (4.82)

2.41 (0.74)

Parkinson’S Disease*

213

45.97 (40.12–52.67)

45.34 (9112.88)

44.73 (39.92)

5.48 (3.82)

Fall*

212

2.52 (2.2–2.89)

2.5 (191.58)

2.5 (2.23)

1.32 (-0.35)

Application Site Reaction*

191

132.75 (114.77–153.54)

131.1 (23711.11)

126.08 (111.63)

6.98 (5.31)

Tremor*

190

4.58 (3.97–5.28)

4.53 (523.69)

4.53 (4.02)

2.18 (0.51)

Restless Legs Syndrome*

189

40.9 (35.41–47.25)

40.41 (7177.46)

39.93 (35.39)

5.32 (3.65)

Application Site Rash*

180

48.55 (41.87–56.29)

47.99 (8163.67)

47.31 (41.8)

5.56 (3.9)

Insomnia*

175

2.6 (2.24–3.02)

2.58 (170.57)

2.58 (2.28)

1.37 (-0.3)

Nausea

171

0.86 (0.74–1.01)

0.87 (3.59)

0.87 (0.76)

-0.21 (-1.87)

Dizziness*

151

1.21 (1.03–1.42)

1.21 (5.44)

1.21 (1.06)

0.27 (-1.39)

Somnolence*

137

2.74 (2.32–3.25)

2.73 (150.25)

2.73 (2.37)

1.45 (-0.22)

Wrong Technique In Product Usage Process*

130

2.51 (2.12–2.99)

2.5 (117.48)

2.5 (2.16)

1.32 (-0.34)

Hallucination*

128

7.05 (5.92–8.39)

7 (657.71)

6.99 (6.04)

2.8 (1.14)

Pruritus*

116

1.3 (1.08–1.56)

1.3 (7.97)

1.3 (1.11)

0.38 (-1.29)

Rash*

114

1.07 (0.89–1.28)

1.07 (0.46)

1.07 (0.91)

0.09 (-1.58)

Pneumonia*

110

1.36 (1.13–1.64)

1.36 (10.43)

1.36 (1.16)

0.44 (-1.22)

Intentional Product Misuse*

109

4.74 (3.93–5.73)

4.71 (319.05)

4.71 (4.02)

2.24 (0.57)

Product Dose Omission Issue*

106

1.87 (1.54–2.26)

1.86 (42.52)

1.86 (1.59)

0.9 (-0.77)

Therapy Interrupted*

103

7.53 (6.2–9.14)

7.49 (578.03)

7.47 (6.35)

2.9 (1.24)

Product QualityIssue*

102

2.68 (2.21–3.26)

2.67 (106.8)

2.67 (2.27)

1.42 (-0.25)

Fatigue

97

0.48 (0.4–0.59)

0.49 (53.02)

0.49 (0.41)

-1.04 (-2.7)

Application Site Irritation*

87

28.44 (23.02–35.14)

28.28 (2270.62)

28.05 (23.5)

4.81 (3.14)

Gait Disturbance*

87

1.7 (1.38–2.1)

1.7 (25.2)

1.7 (1.43)

0.77 (-0.9)

  1. Asterisks (*) indicate statistically significant signals. EBGM and IC are Bayesian-based metrics used to quantify the strength of associations between drugs and adverse events. EBGM represents the geometric mean of the posterior distribution of the reporting ratio, while IC measures the information gained from the association. Both metrics are accompanied by their 95% confidence intervals (EBGM05 and IC025), which indicate statistical significance. Abbreviations: ROR, reporting odds ratio; PRR, proportional reporting ratio; EBGM, empirical Bayesian geometric mean; EBGM05, the lower limit of the 95% confidence interval of EBGM; BCPNN, bayesian confidence propagation neural network, the lower limit of the 95% confidence interval of the IC