Significant ADR is defined as any unexpected, unintended, undesired, or excessive response to a drug that

1. Requires discontinuing the drug (therapeutic or diagnostic).

2. Requires changing the drug therapy.

3. Requires modifying the dose (except for minor dosage adjustments).

4. Necessitates admission to a hospital.

5. Prolongs stay in a health care facility.

6. Necessitates supportive treatment.

7. Significantly complicates diagnosis.

8. Negatively affects prognosis.

9. Results in temporary or permanent harm, disability, or death.