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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.

OMEPRAZOLE OTC: 19 Adverse Event Reports & Safety Profile

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19
Total FAERS Reports
0
Deaths Reported
5
Hospitalizations
19
As Primary/Secondary Suspect
3
Disabilities

First Report: 199911 · Latest Report: 20140401

What Are the Most Common OMEPRAZOLE OTC Side Effects?

#1 Most Reported
Drug ineffective
7 reports (36.8%)
#2 Most Reported
Osteoporosis
6 reports (31.6%)
#3 Most Reported
Drug dose omission
6 reports (31.6%)

All OMEPRAZOLE OTC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 7 36.8% 0 0
Drug dose omission 6 31.6% 0 0
Osteoporosis 6 31.6% 0 4
Bone disorder 5 26.3% 0 3
Intentional product misuse 5 26.3% 0 1

Who Reports OMEPRAZOLE OTC Side Effects? Age & Gender Data

Average age: 57.1 years. Most reports from: US. View detailed demographics →

Is OMEPRAZOLE OTC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2008 1 0 0
2009 2 0 1
2010 2 0 1
2011 1 0 1
2012 4 0 2
2013 2 0 0
2014 5 0 0

View full timeline →

What Is OMEPRAZOLE OTC Used For?

IndicationReports
Gastrooesophageal reflux disease 11

Official FDA Label for OMEPRAZOLE OTC

Official prescribing information from the FDA-approved drug label.