Table 3.
Ten most commonly reported HBD SOC ADRs for reports with single suspect herbal medicines.
Reported adverse drug reaction (MedDRA PT name) | Number | Percentage (%)top 10/total n = 764 | |
---|---|---|---|
1 | Jaundice | 146 | 26.4/19.1 |
2 | Hepatitis | 115 | 20.8/15.1 |
3 | Hepatic function abnormal | 90 | 16.3/11.8 |
4 | Drug-induced liver injury | 36 | 6.5/4.7 |
5 = 5 | Liver injury | 29 | 5.2/3.8 |
5 = 6 | Acute hepatic failure | 29 | 5.2/3.8 |
5 = 7 | Hepatic failure | 29 | 5.2/3.8 |
8 | Hepatitis cholestatic | 28 | 5.0/3.7 |
9 = 9 | Liver disorder | 26 | 4.7/3.4 |
9 = 10 | Hepatitis acute | 26 | 4.7/3.4 |
Total | 554 | 100 |
ADRs, adverse drug reactions; HBD, Hepatobiliary Disorder; SOC, System Organ Class.