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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.

ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE: 353 Adverse Event Reports & Safety Profile

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353
Total FAERS Reports
26 (7.4%)
Deaths Reported
129
Hospitalizations
353
As Primary/Secondary Suspect
23
Life-Threatening
23
Disabilities

Active Ingredient: ESOMEPRAZOLE\ESOMEPRAZOLE MAGNESIUM\ESOMEPRAZOLE MAGNESIUM DIHYDRATE ·

First Report: 20071214 · Latest Report: 20240216

What Are the Most Common ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE Side Effects?

#1 Most Reported
Drug ineffective
105 reports (29.7%)
#2 Most Reported
Headache
77 reports (21.8%)
#3 Most Reported
Off label use
75 reports (21.2%)

All ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 105 29.8% 5 43
Headache 77 21.8% 1 49
Off label use 75 21.3% 6 21
Dyspnoea 67 19.0% 3 43
Diarrhoea 65 18.4% 3 24
Nausea 64 18.1% 3 8
Arthralgia 57 16.2% 3 21
Fatigue 55 15.6% 5 19
Pain 53 15.0% 5 29
Hypertension 40 11.3% 5 39
Therapeutic product effect incomplete 40 11.3% 2 36
Abdominal discomfort 39 11.1% 1 10
Back pain 37 10.5% 5 15
Hyperhidrosis 37 10.5% 0 0
Product use in unapproved indication 36 10.2% 1 7
Blood test abnormal 35 9.9% 0 25
Abdominal pain upper 34 9.6% 1 14
Malaise 34 9.6% 5 24
Anxiety 33 9.4% 1 23
Cough 33 9.4% 0 19

Who Reports ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE Side Effects? Age & Gender Data

Gender: 62.6% female, 37.4% male. Average age: 57.3 years. Most reports from: CA. View detailed demographics →

Is ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 0
2008 3 2 2
2010 1 0 0
2011 1 1 1
2012 1 1 0
2013 2 2 0
2014 1 0 1
2015 4 2 2
2016 1 1 0
2017 2 2 0
2018 11 1 0
2019 3 0 2
2020 5 0 5
2021 8 0 2
2022 11 0 0
2023 36 0 8
2024 7 0 5

View full timeline →

What Is ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE Used For?

IndicationReports
Product used for unknown indication 190
Gastrooesophageal reflux disease 61
Migraine 14
Helicobacter infection 13
Reflux laryngitis 10
Dyspepsia 6
Somatic symptom disorder 6
Ulcer 6
Rheumatoid arthritis 5
Somatic dysfunction 5

ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs Alternatives: Which Is Safer?

ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESOMEPRAZOLE\NAPROXEN ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTAZOLAM ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTRADIOL ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTRADIOL CYPIONATE ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTRADIOL\LEVONORGESTREL ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTRADIOL\NORETHINDRONE ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTRADIOL\NORETHINDRONE\RELUGOLIX ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTRADIOL\PROGESTERONE ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTRAMUSTINE ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE vs ESTRING

Official FDA Label for ESOMEPRAZOLE\ESOMEPRAZOLE\ESOMEPRAZOLE

Official prescribing information from the FDA-approved drug label.