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) |