Table 6.
Patients with reported adverse drug reactions (ADRs) classified as hepatobiliary disorders: reassessment by the authors
| Patient # | Preferred term | SOC: hepatobiliary disorder? | Serious? | AMP substance with known hepatotoxic potential? | Outcome | Causality |
|---|---|---|---|---|---|---|
| 1 | Administration related reaction | No: General disorders and administration site conditions | No | No | Resolved | Probable/likely |
| 2 | Hepatic function abnormal | Yes | No | No | Unknown | Unlikely/remote |
| 3 | Biliary colic | Yes | No | No | Resolved | Not assessable |
| Liver disorder | Yes | No | Resolved | Not assessable | ||
| 4 | Autoimmune hepatitis | Yes | Yes | Chelidonium majus | Resolved | Unlikely/remote |
| Drug-induced liver injury | Yes | No | Resolved | Not assessable | ||
| Jaundice | Yes | No | Resolved | Not assessable | ||
| 5 | Flatulence | No: Gastrointestinal disorders | No | Chelidonium majus | Resolved | Possible |
Text in Italics: Classification by authors differs from that of the marketing authorization holder (MAH)
SOC System Organ Class