JANUVIA: 1,157 Adverse Event Reports & Safety Profile

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1,157

Total FAERS Reports

234 (20.2%)

Deaths Reported

282

Hospitalizations

1,157

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 2006 · Latest Report: 20140629

What Are the Most Common JANUVIA Side Effects?

#1 Most Reported

Pancreatic carcinoma

185 reports (16.0%)

#2 Most Reported

Pancreatitis

106 reports (9.2%)

#3 Most Reported

Blood glucose increased

68 reports (5.9%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Pancreatic carcinoma	185	16.0%	115	49
Pancreatitis	106	9.2%	14	44
Blood glucose increased	68	5.9%	8	14
Drug ineffective	67	5.8%	3	7
Death	55	4.8%	55	7
Nausea	53	4.6%	9	14
Diarrhoea	52	4.5%	6	12
Hypoglycaemia	38	3.3%	5	17
Anxiety	33	2.9%	17	26
Pancreatic carcinoma metastatic	31	2.7%	22	24
Back pain	30	2.6%	6	14
Dizziness	30	2.6%	4	8
Headache	29	2.5%	3	6
Gastrooesophageal reflux disease	27	2.3%	17	25
Metastases to liver	27	2.3%	21	20
Abdominal pain	26	2.3%	6	11
Vomiting	26	2.3%	6	9
Fatigue	25	2.2%	0	8
Adverse event	24	2.1%	6	3
Pancreatitis acute	24	2.1%	5	20

Average age: 63.5 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2006	4	2	3
2007	9	7	8
2008	20	11	14
2009	11	4	6
2010	23	14	11
2011	64	38	27
2012	97	53	36
2013	163	30	55
2014	230	26	66

Indication	Reports
Type 2 diabetes mellitus	377
Diabetes mellitus	289
Product used for unknown indication	17
Blood glucose	7
Diabetes mellitus management	5

Official prescribing information from the FDA-approved drug label.