Background The objective of this study was to compare the safety profiles
of OCA and UDCA for the treatment of PBC using the FDA Adverse Event Reporting
System database.
Methods We extracted reports for OCA from 2016 to 2023 and UDCA from 2004
to 2023. Demographic details, adverse events (AEs), and concomitant medications
were analyzed using descriptive statistics and signal detection methods.
Results The most common for OCA were pruritus (1345 cases, ROR 20.96) and
fatigue (528 cases, ROR 3.46). UDCA was more frequently associated with
hepatocellular carcinoma (22 cases, ROR 16.37) and type I hypersensitivity
reactions (11 cases, ROR 12.77). OCA was also linked to a higher frequency of
constipation (161 cases, ROR 3.92) and increased blood alkaline phosphatase
levels (145 cases, ROR 44.27).
Conclusion This study reveals distinct safety profiles for OCA and UDCA in
the treatment of PBC. OCA is associated with a higher frequency of pruritus,
fatigue, constipation, and increased blood alkaline phosphatase levels, while
UDCA is linked to hepatocellular carcinoma and type I hypersensitivity
reactions. These findings support personalized treatment approaches based on
individual patient characteristics.