Criteria |
Description |
Score |
Patient’s Score |
Time to onset of infection |
5-90 days of drug start |
+2 |
|
<5 or > 90 days of drug start |
+1 |
≤15 days from drug cessation |
+1 |
Course of reaction after drug cessation |
Decrease ≥50% within 8 days |
+3 |
|
Decrease ≥50% within 30 days |
+2 |
Not application |
+1 |
No information/Decrease ≥50% after 30 days |
0 |
Recurrent increase |
-2 |
Risk factors |
Age ≥55 |
+1 |
|
|
Alcohol use |
+1 |
Concomitant drugs |
Time to onset incompatible |
0 |
|
Time to onset compatible but unknown reaction |
-1 |
Time to onset compatible but known reaction |
-2 |
Role proved in this case |
-3 |
None or information not available |
0 |
Non drug related causes |
All causes reasonably ruled out |
+2 |
|
6 causes of group 1 ruled out |
+1 |
5 or 4 causes of group 1 ruled out |
0 |
Less than 4 causes of group 1 ruled out |
-2 |
Non drug cause highly probable |
-3 |
Previous information on drug |
Reaction unknown |
0 |
|
Reaction published but unlabelled |
+1 |
Reaction labelled in product characteristics |
+2 |
Response to re-administration |
Positive |
+3 |
|
Compatible |
+1 |
Negative |
-2 |
Not available or Not interpretable |
0 |