Table 3.
Basic information from 1028 ADR reports in the TADRRS-HM (1998–2016).
| Basic information from 1028 ADR reports | Numbers of ADR reports n (%) |
|---|---|
| Serious adverse events | |
| Yes | 136 (13.3) |
| No | 887 (86.7) |
| Missing data* | 5 (0.0) |
| Type of adverse reactions | |
| Excessively enhanced drug effects** | 221 (21.5) |
| Unexpected side effects# | 733 (71.3) |
| Missing data | 74 (7.2) |
| Severity (modified Hartwig and Siegel scale) | |
| Mild | 744 (72.4) |
| Moderate | 179 (17.4) |
| Severe | 67 (6.5) |
| Missing data | 38 (3.7) |
| Naranjo score | |
| Doubtful (≤ 0) | 135 (13.1) |
| Possible (1–4) | 608 (59.1) |
| Probable (5–8) | 267 (26.0) |
| Definite (≥ 9) | 18 (1.8) |
TADRRS-HM Taiwan Adverse Drug Reaction Reporting System for Herbal Medicine.
*Missing data refer to ADR records that were incompletely filled.
**Excessively enhanced drug effects refer to those that occur in patients prescribed a normal therapeutic dosage who experience amplified side effects from the medicine due to their individual characteristics. For example, during normal use/dosage, licorice can result in abdominal fullness, but some patients may experience excessive abdominal fullness.
#Unexpected side effects are those that are previously unknown in relation to a particular herb.