NEXAVAR: 365 Adverse Event Reports & Safety Profile

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365

Total FAERS Reports

99 (27.1%)

Deaths Reported

131

Hospitalizations

365

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 20071112 · Latest Report: 20140620

What Are the Most Common NEXAVAR Side Effects?

#1 Most Reported

Diarrhoea

46 reports (12.6%)

#2 Most Reported

Hepatocellular carcinoma

42 reports (11.5%)

#3 Most Reported

Palmar-plantar erythrodysaesthesia syndrome

36 reports (9.9%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Diarrhoea	46	12.6%	14	18
Hepatocellular carcinoma	42	11.5%	33	12
Palmar-plantar erythrodysaesthesia syndrome	36	9.9%	16	11
Hepatic cancer	27	7.4%	9	8
Decreased appetite	24	6.6%	9	12
Hypertension	22	6.0%	8	8
Fatigue	20	5.5%	5	7
Renal cancer	20	5.5%	1	0
Rash	19	5.2%	6	6
Abdominal pain	18	4.9%	4	10
Nausea	18	4.9%	5	12
Pain in extremity	18	4.9%	3	6
Ascites	17	4.7%	10	12
Death	17	4.7%	16	4
Hepatic encephalopathy	17	4.7%	9	13
Vomiting	17	4.7%	6	10
Asthenia	15	4.1%	2	6
Hepatic failure	15	4.1%	12	5
Pyrexia	15	4.1%	7	10
Abdominal pain upper	14	3.8%	2	7

Average age: 63.7 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2007	1	0	0
2008	2	0	2
2009	4	2	1
2010	6	3	2
2011	12	6	5
2012	19	13	9
2013	93	33	46
2014	108	21	38

Official prescribing information from the FDA-approved drug label.