Table 3. Causality assessment using Naranjo’s algorithm
From: Omeprazole-induced galactorrhea in kidney transplant patients—a case report
Question | Yes | No | Don’t know | Score |
|---|---|---|---|---|
1. Are there previous conclusive reports on this reaction? | +1 | 0 | 0 | 1 |
2. Did the ADR appear after the suspected drug was administered? | +2 | − 1 | 0 | 2 |
3. Did the ADR improve when the drug was discontinued? | +2 | 0 | 0 | 2 |
4. Did the ADR appear with rechallenge? | +2 | − 1 | 0 | 2 |
5. Are there alternative causes for the ADR? | − 1 | +2 | 0 | 2 |
6. Did the reaction appear when placebo was given? | − 1 | +2 | 0 | 0 |
7. Was the drug detected in blood at toxic levels? | +1 | 0 | 0 | 0 |
8. Was the reaction more severe when the dose was increased or less severe when the dose was decreased? | +1 | 0 | 0 | 0 |
9. Did the patient have a similar reaction to the same or similar drug in any previous exposure? | +1 | 0 | 0 | 1 |
10. Was the ADR confirmed by any objective evidence? | +1 | 0 | 0 | 0 |
Total score | 10 |
Total score | Check one □ |
|---|---|
≥ 9 | √ Definite |
5–8 | □ Probable |
1–4 | □ Possible |
≤ 0 | □ Doubtful |