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* | 1336 | 115.28 (108.94–121.98) | 108.46 (135850.43) | 103.57 (98.79) | 6.69 (5.03) |
Drug Ineffective* | 651 | 1.32 (1.22–1.43) | 1.31 (50.04) | 1.31 (1.23) | 0.39 (-1.27) |
Death* | 529 | 1.67 (1.53–1.82) | 1.65 (137.14) | 1.65 (1.53) | 0.72 (-0.94) |
Off Label Use* | 437 | 1.46 (1.33–1.6) | 1.45 (62.01) | 1.45 (1.34) | 0.54 (-1.13) |
Application Site Pruritus* | 417 | 50.28 (45.59–55.46) | 49.37 (19348.15) | 48.34 (44.54) | 5.6 (3.93) |
Application Site Erythema* | 409 | 41.5 (37.6–45.81) | 40.77 (15592.76) | 40.07 (36.89) | 5.32 (3.66) |
Device Adhesion Issue* | 383 | 75.95 (68.54–84.16) | 74.67 (26959.86) | 72.33 (66.38) | 6.18 (4.51) |
Fall* | 361 | 2.93 (2.64–3.25) | 2.9 (451.76) | 2.9 (2.66) | 1.54 (-0.13) |
Parkinson’S Disease* | 345 | 51.57 (46.31–57.42) | 50.79 (16476.71) | 49.7 (45.43) | 5.64 (3.97) |
Overdose* | 334 | 4.01 (3.59–4.46) | 3.96 (740.61) | 3.96 (3.61) | 1.98 (0.32) |
Tremor* | 308 | 5.01 (4.48–5.61) | 4.96 (974) | 4.95 (4.51) | 2.31 (0.64) |
Dizziness* | 249 | 1.35 (1.2–1.53) | 1.35 (22.84) | 1.35 (1.22) | 0.43 (-1.23) |
Insomnia* | 245 | 2.46 (2.17–2.79) | 2.45 (210.31) | 2.45 (2.2) | 1.29 (-0.38) |
Hallucination* | 233 | 8.7 (7.64–9.9) | 8.62 (1564.37) | 8.59 (7.71) | 3.1 (1.44) |
Nausea | 224 | 0.77 (0.67–0.87) | 0.77 (15.69) | 0.77 (0.69) | -0.38 (-2.04) |
Application Site Reaction* | 215 | 98.76 (86.11–113.28) | 97.82 (19756.77) | 93.83 (83.66) | 6.55 (4.89) |
Restless Legs Syndrome* | 210 | 30.74 (26.81–35.24) | 30.46 (5905.93) | 30.07 (26.82) | 4.91 (3.24) |
Somnolence* | 199 | 2.69 (2.34–3.1) | 2.68 (209.82) | 2.68 (2.38) | 1.42 (-0.25) |
Application Site Rash* | 191 | 35 (30.32–40.4) | 34.71 (6159.97) | 34.2 (30.33) | 5.1 (3.43) |
Gait Disturbance* | 169 | 2.28 (1.96–2.65) | 2.27 (120.64) | 2.27 (2) | 1.18 (-0.48) |
Pneumonia* | 164 | 1.39 (1.19–1.62) | 1.38 (17.6) | 1.38 (1.22) | 0.47 (-1.2) |
Wrong Technique In Product Usage Process* | 160 | 2.15 (1.84–2.51) | 2.14 (97.65) | 2.14 (1.88) | 1.1 (-0.57) |
Anxiety* | 159 | 1.47 (1.26–1.72) | 1.47 (23.73) | 1.47 (1.29) | 0.55 (-1.11) |
Fatigue | 152 | 0.52 (0.44–0.61) | 0.52 (66.3) | 0.52 (0.46) | -0.93 (-2.6) |
Vomiting | 140 | 0.82 (0.69–0.97) | 0.82 (5.59) | 0.82 (0.71) | -0.29 (-1.95) |
Pain | 140 | 0.59 (0.5–0.69) | 0.59 (40.4) | 0.59 (0.51) | -0.76 (-2.43) |
Intentional Product Misuse* | 139 | 4.2 (3.56–4.97) | 4.18 (336.66) | 4.18 (3.63) | 2.06 (0.4) |
Asthenia | 137 | 0.99 (0.83–1.17) | 0.99 (0.03) | 0.99 (0.86) | -0.02 (-1.69) |
Pruritus | 137 | 1.05 (0.89–1.24) | 1.05 (0.35) | 1.05 (0.91) | 0.07 (-1.59) |
Dysphagia* | 128 | 3.7 (3.11–4.4) | 3.68 (249.92) | 3.68 (3.18) | 1.88 (0.21) |