| Questionnaire | Yes | No | Do not know | Patient in this report‡ | |
|---|---|---|---|---|---|
| 1. | Are there previous conclusive reports on this reaction? | +1 | 0 | 0 | Yes |
| 2. | Did the adverse event appear after the suspected drug was administered? | +2 | −1 | 0 | Yes |
| 3. | Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? | +1 | 0 | 0 | Yes |
| 4. | Did the adverse reaction reappear when the drug was readministered? | +2 | −1 | 0 | Do not know |
| 5. | Are there alternative causes (other than the drug) that could on their own have caused the reaction? | −1 | +2 | 0 | No |
| 6. | Did the reaction reappear when a placebo was given? | −1 | +1 | 0 | Do not know |
| 7. | Was the drug detected in the blood (or other fluids) in concentrations known to be toxic? | +1 | 0 | 0 | Do not know |
| 8. | Was the reaction more severe when the dose was increased, or less severe when the dose was decreased? | +1 | 0 | 0 | Do not know |
| 9. | Did the patient have a similar reaction to the same or similar drugs in any previous exposure? | +1 | 0 | 0 | Do not know |
| 10. | Was the adverse event confirmed by any objective evidence? | +1 | 0 | 0 | Yes |
* Scoring system for probability of an adverse drug reaction: ≥ 9 = definite, 5–8 = probable, 1–4 = possible, 0 = doubtful.
† Reproduced, with permission, from Naranjo et al.5
↵‡ The patient in this report has a score of 7 (probable range).