OBJECTIVE To mine the signals of adverse dr ug events (ADE)for
tolvaptan based on FAERS database ,and to provide reference for safe use of
drugs in clinic.
METHODS The data of
tolvaptan-induced ADE were collected from FAERS database during the first quarter of 2004 to the third quarter of 2020;the
reporting odds ratio (ROR)
method and the proportional
reporting ratio (PRR)
method of disproportional
method were used for
data mining. RESULTS A total of 4 744 ADE
reports of the target
drug tolvaptan were extracted ,involving 1 279 ADEs. The
reporting countries were mainly the
United States and
Japan ,etc. A total of 199 ADE signals were obtained ,involving 21 system organ classes (SOCs),which mainly focused on various examinations(n=56),
hepatobiliary disorders (n=17),renal and urinary disorders (n=14),etc. Among them ,80 signals were not mentioned in existing instructions for
tolvaptan in
China ,such as decreased
glomerular filtration rate ,
positional vertigo ,
rupture of renal
cyst ,renal
cyst infection ,pulmonary malignant
tumor. CONCLUSIONS Before using
tolvaptan ,
drug evaluation should be performed well ,especially the
patients with basic
diseases such as
heart failure ,
liver insufficiency and
renal insufficiency. During
treatment ,the indexes of
liver function and renal function should be closely monitored ;timely intervention
measures should be taken to avoid related
injury and
disease deterioration caused by ADE when ADE or
disease progression occurs.