ENTECAVIR for Chronic hepatitis b: Side Effects & Safety Data

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There are 705 adverse event reports in the FDA FAERS database where ENTECAVIR was used for Chronic hepatitis b.

Most Reported Side Effects for ENTECAVIR

Side Effect	Reports	%	Deaths	Hosp.
Drug resistance	312	7.0%	9	61
Death	298	6.6%	290	27
Drug ineffective	207	4.6%	22	32
Hepatitis b	166	3.7%	64	17
Off label use	129	2.9%	10	36
Maternal exposure during pregnancy	126	2.8%	5	8
Viral mutation identified	121	2.7%	3	8
Renal impairment	118	2.6%	1	38
Pathogen resistance	115	2.6%	2	12
Fatigue	108	2.4%	6	16
Hepatic cancer	94	2.1%	28	19
Hepatocellular carcinoma	94	2.1%	41	40
Hospitalisation	88	2.0%	3	75
Hepatic failure	86	1.9%	72	22
Drug dose omission	82	1.8%	0	4