TOLVAPTAN for Fluid retention: Side Effects & Safety Data

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There are 300 adverse event reports in the FDA FAERS database where TOLVAPTAN was used for Fluid retention.

Most Reported Side Effects for TOLVAPTAN

Side Effect	Reports	%	Deaths	Hosp.
Death	800	8.9%	799	82
Thirst	624	6.9%	37	120
Off label use	560	6.2%	63	69
Renal impairment	534	5.9%	48	103
Underdose	448	5.0%	117	153
Product use in unapproved indication	446	5.0%	159	172
Wrong technique in product usage process	426	4.7%	161	178
Polyuria	390	4.3%	12	90
Product dose omission issue	379	4.2%	11	70
Inappropriate schedule of product administration	376	4.2%	111	157
Blood creatinine increased	337	3.7%	33	100
Dehydration	315	3.5%	49	157
Fatigue	287	3.2%	11	59
Pollakiuria	280	3.1%	4	57
Blood sodium decreased	278	3.1%	32	199