Table 1. Summary of reported statin-induced hepatitis cases.
| Case report | Age/Sex | Statin | Symptoms | Labs (peak) | Timeframe | Liver biopsy | Rechallenge | Reference ranges |
|---|---|---|---|---|---|---|---|---|
| Mohamed 201910 | 67 M | Atorvastatin 80 mg | Generalized body aches, muscle weakness, jaundice, dark urine, decreased urine output | Bili: 211; AST/ALT: 1,612/1,325; ALP: 278 | 4 months | No | No | Bili >20.5 µmol/L, AST/ALT >34/55 UI/L, ALP >150 UI/L |
| Kawasaki 202011 | 46 M | Atorvastatin 10 mg | Generalized weakness, abdominal pain | Bili: 5.1; AST/ALT: 860/1,632; ALP: NA; ANA (+) | 6 months | Yes | No | Not provided |
| 54 M | Rosuvastatin 2.5 mg | Generalized weakness, abdominal pain | Bili: N/a; AST/ALT: 606/709; ALP 2,055; IgG: 1,857 | 8 months | Yes | No | ||
| Khan 202012 | 57 F | Atorvastatin 40 mg | Generalized weakness, abdominal pain | Bili: 122.8; AST/ALT:; 2,999/3,195; ALP: 435; ANA (+); ASMA (+) | 3 months | No | Yes, no recurrence | Bili >20.5 µmol/L, AST/ALT >34/55 UI/L, ALP >150 UI/L |
| Sanchez 201813 | 47 M | Rosuvastatin 5 mg | Generalized weakness, abdominal pain | Bili: NA; AST/ALT: 112/201; ALP: N/a; ANA (+); ASMA (+) | 4 months | No | No | Bili >1.1 mg/dl, AST/ALT >37/41 UI/L, ALP >129 UI/L |
| Saha 202114 | 71 M | Atorvastatin 80 mg | No symptoms | Bili: 1.5; AST/ALT: 1,093/1,385; ALP: 265; ASMA (+) | 1 month | No | Yes, simvastatin 20mg rechallenge after 3 months, no recurrence | Bili >1.2 mg/dL, AST/ALT >41/58 UI/L, ALP >129 UI/L |
| Shah 201915 | 47 M | Rosuvastatin 5 mg | Jaundice, pruritis, fatigue | Bili: 3.53; AST/ALT:; 1,142/2,260; ALP: 277 | 1.5 months | Yes | No | Bili >1.2 mg/dL; AST/ALT >40/40 UI/L, ALP >115 UI/L |
| Vishwakarma 201416 | 63 M | Atorvastatin 20 mg | Jaundice, Nausea, fatigue, appetite loss, abdominal pain | Bili: 5.2; AST/ALT: 1,124/1,049; ALP: 214 | 2 months | No, patient refused | Yes, rosuvastatin 10mg rechallenge upon noted elevation with enzyme normalization and no recurrence | Not provided |
| Liu 201017 | 58 M | Atorvastatin 20 mg | Fatigue, anorexia | Bili: 9.2; AST/ALT: 23/120; ALP: 62 | 10 hours | No | Yes, Pravastatin (dose unknown) with no recurrence | Bili >22 µmol/L, AST/ALT >40/40 UI/L, ALP >120 UI/L |
| 53 M | Atorvastatin 10 mg | None symptoms | Bili: 9.3; AST/ALT: 119/124; ALP: 93 | Immediate | No | Yes, Pravastatin 20mg after 14 days with no recurrence | ||
| Famularo 200718 | 64 M | Rosuvastatin 10 mg | Fatigue, anorexia, malaise, abdominal pain, jaundice | Bili: 2.6; AST/ALT: 880/775; ALP: “normal” | 4 months | No | No | Bili >2.0 mg/dL, AST/ALT >36/36 UI/L, ALP not given |
ALP, alkaline phosphatase, ANA, antinuclear antibody; ALT, alanine aminotransferase; ASMA, anti-smooth antibody AST, aspartate aminotransferase; Bili, bilirubin; IgG, immunoglobulin G.