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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PRILOSEC: 442 Adverse Event Reports & Safety Profile

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442
Total FAERS Reports
10 (2.3%)
Deaths Reported
147
Hospitalizations
442
As Primary/Secondary Suspect
8
Life-Threatening
106
Disabilities

First Report: 1987 · Latest Report: 20140610

What Are the Most Common PRILOSEC Side Effects?

#1 Most Reported
Osteoporosis
155 reports (35.1%)
#2 Most Reported
Drug ineffective
116 reports (26.2%)
#3 Most Reported
Arthritis
95 reports (21.5%)

All PRILOSEC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Osteoporosis 155 35.1% 4 88
Drug ineffective 116 26.2% 1 24
Arthritis 95 21.5% 3 55
Multiple fractures 90 20.4% 2 54
Depression 83 18.8% 2 47
Bone disorder 78 17.7% 3 45
Gastrooesophageal reflux disease 75 17.0% 0 15
Fall 73 16.5% 2 44
Drug dose omission 67 15.2% 2 24
Off label use 60 13.6% 0 17
Dyspepsia 50 11.3% 1 12
Osteoarthritis 49 11.1% 2 34
Foot fracture 48 10.9% 1 32
Osteopenia 48 10.9% 1 29
Vitamin d deficiency 44 10.0% 1 29
Abdominal pain upper 38 8.6% 0 13
Intentional product misuse 38 8.6% 0 3
Malaise 37 8.4% 1 15
Calcium deficiency 34 7.7% 1 22
Ankle fracture 33 7.5% 1 20

Who Reports PRILOSEC Side Effects? Age & Gender Data

Average age: 56.4 years. Most reports from: US. View detailed demographics →

Is PRILOSEC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 6 0 4
2001 12 0 6
2002 11 0 5
2003 16 0 5
2004 17 1 8
2005 17 0 6
2006 7 0 5
2007 19 1 12
2008 18 1 10
2009 28 2 15
2010 24 0 13
2011 22 0 7
2012 22 0 7
2013 55 3 16
2014 21 0 4

View full timeline →

What Is PRILOSEC Used For?

IndicationReports
Gastrooesophageal reflux disease 174
Dyspepsia 20
Product used for unknown indication 10
Barrett's oesophagus 7
Gastric disorder 7
Gastritis 7
Hiatus hernia 7
Abdominal pain upper 6
Gastric ulcer 5

PRILOSEC vs Alternatives: Which Is Safer?

PRILOSEC vs PRILOSEC OTC PRILOSEC vs PRIMAQUINE PRILOSEC vs PRIMIDONE PRILOSEC vs PRISTINAMYCIN PRILOSEC vs PRISTIQ PRILOSEC vs PRIVIGEN PRILOSEC vs PROAIR HFA PRILOSEC vs PROBIOTICS NOS PRILOSEC vs PROBUCOL PRILOSEC vs PROCAINAMIDE

Official FDA Label for PRILOSEC

Official prescribing information from the FDA-approved drug label.