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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.

ASPIRIN\OMEPRAZOLE: 53 Adverse Event Reports & Safety Profile

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53
Total FAERS Reports
3 (5.7%)
Deaths Reported
17
Hospitalizations
53
As Primary/Secondary Suspect
3
Life-Threatening

First Report: 201407 · Latest Report: 20240101

What Are the Most Common ASPIRIN\OMEPRAZOLE Side Effects?

#1 Most Reported
Aspirin-exacerbated respiratory disease
24 reports (45.3%)
#2 Most Reported
Otitis media
22 reports (41.5%)
#3 Most Reported
Nasal polyps
22 reports (41.5%)

All ASPIRIN\OMEPRAZOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Aspirin-exacerbated respiratory disease 24 45.3% 0 2
Nasal polyps 22 41.5% 0 0
Otitis media 22 41.5% 0 0

Who Reports ASPIRIN\OMEPRAZOLE Side Effects? Age & Gender Data

Gender: 69.0% female, 31.0% male. Average age: 54.1 years. Most reports from: FI. View detailed demographics →

Is ASPIRIN\OMEPRAZOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 1
2015 1 0 0
2016 1 0 0
2017 1 0 1
2018 25 0 2
2019 3 0 3
2020 3 1 1
2021 3 1 1
2022 2 0 2
2023 4 0 3
2024 4 1 3

View full timeline →

What Is ASPIRIN\OMEPRAZOLE Used For?

IndicationReports
Product used for unknown indication 28

Official FDA Label for ASPIRIN\OMEPRAZOLE

Official prescribing information from the FDA-approved drug label.