| | PT | Reports | PRR (95% CI) | ROR (95% CI) | IC (IC-2SD) | Listed in the drug labels |
| | Blood and lymphatic system disorders | | | | | | | Anemia | 256 | 12.45 (11.09, 13.98) | 12.48 (11.68, 13.34) | 3.42 (3.22) | Yes | | Neutropenia | 87 | 7.40 (6.03, 9.10) | 7.41 (6.65, 8.27) | 2.74 (2.42) | Yes | | Splenomegaly | 9 | 6.48 (3.38, 12.45) | 6.49 (4.65, 9.07) | 2.06 (1.15) | No | | Aplastic anemia | 8 | 13.65 (6.83, 27.29) | 13.68 (9.60, 19.51) | 2.50 (1.54) | Yes | | Endocrine disorders | | | | | | | Hypothyroidism | 31 | 9.36 (6.60, 13.28) | 9.37 (7.82, 11.24) | 2.88 (2.36) | Yes | | Thyroid disorder | 22 | 9.03 (5.95, 13.69) | 9.04 (7.30, 11.20) | 2.73 (2.12) | Yes | | Hyperthyroidism | 18 | 11.61 (7.33, 18.41) | 11.64 (9.18, 14.75) | 2.89 (2.36) | Yes | | Eye disorders | | | | | | | Visual acuity reduced | 23 | 4.27 (2.84, 6.42) | 4.28 (3.47, 5.27) | 1.90 (1.30) | Yes | | Retinal exudates | 13 | 95.68 (55.36, 165.36) | 97.48 (73.62, 129.09) | 3.62 (2.85) | Yes | | Vogt-Koyanagi-Harada syndrome | 9 | 355.71 (180.91, 699.39) | 382.31 (270.42, 540.51) | 3.29 (2.37) | Yes | | Gastrointestinal disorders | | | | | | | Vomiting | 107 | 2.04 (1.70, 2.45) | 2.04 (1.85, 2.25) | 0.98 (0.69) | Yes | | Diarrhea | 85 | 1.30 (1.05, 1.60) | 1.30 (1.16, 1.45) | 0.36 (0.03) | Yes | | Abdominal pain | 39 | 1.47 (1.08, 2.01) | 1.47 (1.25, 1.73) | 0.53 (0.07) | Yes | | Ascites | 31 | 8.55 (6.03, 12.14) | 8.57 (7.15, 10.27) | 2.78 (2.26) | No | | Abdominal distension | 26 | 2.23 (1.52, 3.27) | 2.23 (1.83, 2.72) | 1.08 (0.52) | Yes | | Proctalgia | 22 | 29.82 (19.65, 45.25) | 29.99 (24.19, 37.17) | 3.72 (3.11) | No | | Hemorrhoids | 22 | 8.95 (5.90, 13.56) | 8.96 (7.23, 11.10) | 2.72 (2.12) | No | | Pancreatitis acute | 21 | 7.34 (4.79, 11.23) | 7.35 (5.90, 9.15) | 2.50 (1.88) | Yes | | Rectal hemorrhage | 19 | 3.47 (2.22, 5.44) | 3.47 (2.76, 4.38) | 1.62 (0.97) | No | | Mouth ulceration | 14 | 6.10 (3.62, 10.28) | 6.10 (4.67, 7.98) | 2.18 (1.43) | Yes | | Anorectal discomfort | 13 | 16.62 (9.66, 28.60) | 16.67 (12.62, 22.03) | 2.97 (2.19) | No | | Anal pruritus | 10 | 24.09 (12.96, 44.78) | 24.20 (17.61, 33.25) | 2.96 (2.08) | No | | Tooth loss | 9 | 6.58 (3.43, 12.63) | 6.59 (4.71, 9.20) | 2.07 (1.16) | No | | Irritable bowel syndrome | 8 | 3.96 (1.98, 7.91) | 3.96 (2.78, 5.65) | 1.57 (0.61) | No | | General disorders and administration site conditions | | | | | | | Oedema peripheral | 29 | 1.69 (1.18, 2.43) | 1.69 (1.40, 2.04) | 0.72 (0.18) | Yes | | Hepatobiliary disorders | | | | | | | Hepatic cirrhosis | 56 | 27.84 (21.48, 36.08) | 27.98 (24.43, 32.05) | 4.22 (3.83) | No | | Hepatic failure | 34 | 4.96 (3.55, 6.93) | 4.97 (4.18, 5.90) | 2.14 (1.64) | No | | Hepatic fibrosis | 23 | 40.15 (26.69, 60.38) | 40.46 (32.78, 49.93) | 3.93 (3.33) | No | | Hepatic function abnormal | 15 | 3.47 (2.09, 5.75) | 3.47 (2.68, 4.50) | 1.58 (0.85) | Yes | | Hepatotoxicity | 9 | 4.27 (2.22, 8.20) | 4.27 (3.06, 5.97) | 1.68 (0.77) | Yes | | Cholestatic hepatitis | 9 | 11.83 (6.16, 22.73) | 11.86 (8.49, 16.57) | 2.50 (1.59) | No | | Investigations | | | | | | | Platelet count decreased | 80 | 7.29 (5.88, 9.04) | 7.30 (6.51, 8.18) | 2.72 (2.38) | Yes | | White blood cell count decreased | 79 | 7.29 (5.87, 9.05) | 7.30 (6.51, 8.19) | 2.71 (2.38) | Yes | | Hemoglobin decreased | 72 | 5.91 (4.71, 7.42) | 5.92 (5.25, 6.67) | 2.43 (2.08) | Yes | | Red blood cell count decreased | 25 | 7.07 (4.79, 10.45) | 7.08 (5.79, 8.66) | 2.51 (1.94) | Yes | | Blood creatinine increased | 19 | 2.40 (1.53, 3.75) | 2.40 (1.90, 3.02) | 1.16 (0.51) | No | | Haematocrit decreased | 12 | 4.15 (2.36, 7.30) | 4.15 (3.11, 5.55) | 1.74 (0.93) | No | | Metabolism and nutrition disorders | | | | | | | Dehydration | 42 | 2.55 (1.89, 3.44) | 2.55 (2.18, 2.98) | 1.28 (0.84) | Yes | | Diabetes mellitus | 30 | 3.15 (2.20, 4.49) | 3.15 (2.62, 3.78) | 1.54 (1.02) | Yes | | Lactic acidosis | 10 | 3.18 (1.71, 5.91) | 3.18 (2.32, 4.37) | 1.41 (0.53) | No | | Nervous system disorders | | | | | | | Loss of consciousness | 28 | 1.77 (1.22, 2.56) | 1.77 (1.46, 2.14) | 0.78 (0.23) | Yes | | Dysgeusia | 21 | 2.18 (1.42, 3.34) | 2.18 (1.75, 2.71) | 1.04 (0.42) | Yes | | Cerebral infarction | 18 | 4.72 (2.98, 7.48) | 4.72 (3.73, 5.98) | 1.97 (1.31) | Yes | | Hepatic encephalopathy | 15 | 9.65 (5.82, 15.98) | 9.66 (7.46, 12.53) | 2.64 (1.91) | No | | Facial palsy | 11 | 23.63 (13.09, 42.67) | 23.74 (17.53, 32.14) | 3.03 (2.19) | No | | Psychiatric disorders | | | | | | | Depression | 149 | 5.32 (4.55, 6.21) | 5.32 (4.89, 5.79) | 2.29 (2.04) | Yes | | Insomnia | 81 | 2.52 (2.04, 3.12) | 2.52 (2.25, 2.83) | 1.28 (0.95) | Yes | | Anorexia | 35 | 13.00 (9.36, 18.07) | 13.03 (10.99, 15.46) | 3.27 (2.78) | Yes | | Suicidal ideation | 30 | 2.61 (1.83, 3.72) | 2.61 (2.17, 3.14) | 1.30 (0.77) | Yes | | Psychotic disorder | 16 | 3.95 (2.42, 6.43) | 3.95 (3.07, 5.08) | 1.74 (1.04) | Yes | | Renal and urinary disorders | | | | | | | Renal impairment | 18 | 2.16 (1.36, 3.42) | 2.16 (1.70, 2.73) | 1.02 (0.35) | Yes | | Respiratory, thoracic, and mediastinal disorders | | | | | | | Interstitial lung disease | 13 | 2.32 (1.35, 3.99) | 2.32 (1.76, 3.07) | 1.08 (0.3) | Yes | | Hemoptysis | 9 | 2.63 (1.37, 5.04) | 2.63 (1.88, 3.67) | 1.17 (0.26) | No | | Skin and subcutaneous tissue disorders | | | | | | | Rash | 173 | 4.22 (3.66, 4.87) | 4.22 (3.90, 4.57) | 1.96 (1.73) | Yes | | Pruritus | 113 | 3.35 (2.80, 4.01) | 3.35 (3.04, 3.69) | 1.66 (1.38) | Yes |
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