The results of these two post-authorization safety studies of dapagliflozin to assess the risk of hospitalization for acute liver injury (hALI) and the risk of severe complications of urinary tract infection (sUTI), including pyelonephritis and urosepsis, did not suggest increased risks of hALI and sUTI in patients initiating dapagliflozin compared with those initiating comparator glucose-lowering drugs.

These findings contributed to the removal of liver injury and urinary tract infection as important identified risks in the dapagliflozin risk-management plan in Europe.