Table 1 Occurrence of MedDRA terms in three ADR related labeling sections
From: Study of serious adverse drug reactions using FDA-approved drug labeling and MedDRA
ADR Section Name | # Drugs | # Low Level Terms* | # Preferred Terms* |
|---|---|---|---|
Boxed Warning (BW) | 367 | 593 (8.1%) | 460 (12.0%) |
Warnings and Precautions (WP) | 1148 | 3206 (44.0%) | 2023 (53.0%) |
Adverse Reactions (AR) | 1152 | 5300 (72.7%) | 2961 (77.5%) |
Whole Labeling Document | 1164 | 7287 (100.00%) | 3819 (100.00%) |