Version May 2024
| Hepatocellular | Cholestatic or mixed | |||||
| Exposure | Initial | Subsequent | Points | Initial | Subsequent | Points |
| Time from drug start (days) | 5 to 90 <5 or >90 | 1 to 15 >15 | +2 +1 | 5 to 90 <5 or >90 | 1 to 90 >90 | +2 +1 |
| Time from drug stop (days) | ≤15 | ≤15 | +1 | ≤30 | ≤30 | +1 |
| Difference between peak ALT and ULN | Difference between peak AP (or bilirubin) and ULN | |||||
| Course after stopping drug | Decrease ≥50 percent in 8 days | +3 | Decrease ≥50 percent in <180 days | +2 | ||
| Decrease ≥50 percent in 30 days | +2 | Decrease <50 percent in <180 days | +1 | |||
| Decrease ≥50 percent in >30 days | 0 | Persistence or increase or no information | 0 | |||
| Decrease <50 percent in >30 days | -2 | |||||
| Risk factor | Ethanol: yes | +1 | Ethanol or pregnancy: yes | +1 | ||
| Ethanol: no | 0 | Ethanol or pregnancy: no | 0 | |||
| Age | ≥55 years | +1 | ≥55 years | +1 | ||
| <55 years | 0 | <55 years | 0 | |||
| Other drugs | None or no information | 0 | None or no information | 0 | ||
| Drug with suggestive timing | -1 | Drug with suggestive timing | -1 | |||
| Known hepatotoxin with suggestive timing | -2 | Known hepatotoxin with suggestive timing | -2 | |||
| Drug with other evidence for a role (eg, + rechallenge) | -3 | Drug with other evidence for a role (eg, + rechallenge) | -3 | |||
| Competing causes | All group I* & II¶ ruled out | +2 | All group I* & II¶ ruled out | +2 | ||
| All of group I ruled out | +1 | All of group I ruled out | +1 | |||
| 4 to 5 of group I ruled out | 0 | 4 to 5 of group I ruled out | 0 | |||
| <4 of group I ruled out | -2 | <4 of group I ruled out | -2 | |||
| Nondrug cause highly probable | -3 | Nondrug cause highly probable | -3 | |||
| Previous information | Reaction in product label | +2 | Reaction in product label | +2 | ||
| Reaction published; no label | +1 | Reaction published; no label | +1 | |||
| Reaction unknown | 0 | Reaction unknown | 0 | |||
| Rechallenge | Positive | +3 | Positive | +3 | ||
| Compatible | +1 | Compatible | +1 | |||
| Negative | -1 | Negative | -1 | |||
| Not done or not interpretable | 0 | Not done or not interpretable | 0 | |||
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