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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\SODIUM BICARBONATE: 1,937 Adverse Event Reports & Safety Profile

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1,937
Total FAERS Reports
128 (6.6%)
Deaths Reported
165
Hospitalizations
1,937
As Primary/Secondary Suspect
6
Life-Threatening
20
Disabilities

First Report: 1994 · Latest Report: 20250630

What Are the Most Common OMEPRAZOLE\SODIUM BICARBONATE Side Effects?

#1 Most Reported
Chronic kidney disease
1,005 reports (51.9%)
#2 Most Reported
Acute kidney injury
564 reports (29.1%)
#3 Most Reported
Renal failure
528 reports (27.3%)

All OMEPRAZOLE\SODIUM BICARBONATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Chronic kidney disease 1,005 51.9% 98 144
Acute kidney injury 564 29.1% 66 113
Renal failure 528 27.3% 84 113
Renal injury 282 14.6% 30 45
End stage renal disease 275 14.2% 63 72
Product use issue 210 10.8% 0 1
Drug ineffective 146 7.5% 1 1
Tubulointerstitial nephritis 133 6.9% 11 26
Gastrooesophageal reflux disease 126 6.5% 3 13
Rebound acid hypersecretion 95 4.9% 12 14
Nephrogenic anaemia 94 4.9% 16 33
Off label use 84 4.3% 0 0
Renal impairment 64 3.3% 10 12
Nephropathy 63 3.3% 15 18
Incorrect product administration duration 52 2.7% 0 0
Hyperparathyroidism secondary 48 2.5% 8 15
Death 46 2.4% 46 5
Nausea 40 2.1% 1 2
Product use in unapproved indication 38 2.0% 0 0
Product prescribing issue 37 1.9% 0 0

Who Reports OMEPRAZOLE\SODIUM BICARBONATE Side Effects? Age & Gender Data

Gender: 61.3% female, 38.7% male. Average age: 57.3 years. Most reports from: US. View detailed demographics →

Is OMEPRAZOLE\SODIUM BICARBONATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 10 4 0
2001 1 0 0
2003 15 2 0
2004 4 1 1
2005 16 2 4
2006 15 4 3
2007 31 4 10
2008 27 3 7
2009 35 3 6
2010 43 4 4
2011 51 3 11
2012 93 6 16
2013 90 11 17
2014 120 8 18
2015 131 8 15
2016 154 5 15
2017 132 5 8
2018 73 0 1
2019 42 1 0
2020 14 2 0
2021 23 0 0
2022 12 0 0
2023 13 0 1
2024 14 0 0
2025 4 0 1

View full timeline →

What Is OMEPRAZOLE\SODIUM BICARBONATE Used For?

IndicationReports
Gastrooesophageal reflux disease 762
Product used for unknown indication 311
Dyspepsia 207
Gastrointestinal disorder 119
Gastric ph decreased 21
Gastritis 12
Abdominal pain upper 11
Barrett's oesophagus 8
Prophylaxis 8
Ulcer 8

OMEPRAZOLE\SODIUM BICARBONATE vs Alternatives: Which Is Safer?

OMEPRAZOLE\SODIUM BICARBONATE vs OMNIPAQUE OMEPRAZOLE\SODIUM BICARBONATE vs OMNISCAN OMEPRAZOLE\SODIUM BICARBONATE vs ONABOTULINUMTOXINA OMEPRAZOLE\SODIUM BICARBONATE vs ONASEMNOGENE ABEPARVOVEC OMEPRAZOLE\SODIUM BICARBONATE vs ONASEMNOGENE ABEPARVOVEC-XIOI OMEPRAZOLE\SODIUM BICARBONATE vs ONBREZ OMEPRAZOLE\SODIUM BICARBONATE vs ONDANSETRON OMEPRAZOLE\SODIUM BICARBONATE vs ONFI OMEPRAZOLE\SODIUM BICARBONATE vs OPANA OMEPRAZOLE\SODIUM BICARBONATE vs OPICAPONE

Official FDA Label for OMEPRAZOLE\SODIUM BICARBONATE

Official prescribing information from the FDA-approved drug label.