| Possible score | Study patient |
---|---|---|
Time to onset | ||
 5–90 days | + 2 | + 2 |
 < 5 or > 90 days | + 1 |  |
Course of alkaline phosphatase after cessation of drug | ||
 Decrease > 50% within 8 days | + 3 | 0 |
 Decrease > 50% within 30 days | + 2 |  |
Risk factors | ||
 Alcohol +  | − 1 |  |
 Alcohol − | 0 | 0 |
 Age ≥ 55 years | + 1 | + 1 |
 Age < 55 years | 0 |  |
No concomitant drugs/herbs | Â | 0 |
All causes-group I and II-ruled out |  | + 2 |
Previous hepatotoxicity | ||
 Reaction labeled in the product characteristics | + 2 | + 1 |
 Reaction published but not labeled | + 1 |  |
Response to unintentional re-exposure | Â | 0 |
Total score for the case |  | + 6 |