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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
  1. The Definite score correlates: followed a reasonable temporal sequence after a drug or in which a toxic drug level had been established in body fluids or tissues; followed a recognized response to the suspected drug, was confirmed by improvement in withdrawal of the drug and reappearance upon re-exposure
  2. ADR adverse drug reaction