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    HomeMedication GuideEsomeprazole Safety
    Proton pump inhibitor

    Esomeprazole: What to Know Before You Take It

    Also sold as Nexium

    What Esomeprazole Is Used For

    Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

    Warnings

    Warnings Allergy alert : Do not use if you are allergic to esomeprazole. Esomeprazole may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away.

    Most-Reported Side Effects

    Based on 233,118 reports in the FDA Adverse Event Reporting System (FAERS). Reports do not prove the drug caused the effect.

    chronic kidney disease35,582acute kidney injury20,444renal failure16,270drug ineffective14,285nausea13,453gastrooesophageal reflux disease11,960diarrhoea11,177drug dose omission11,126pain10,713end stage renal disease10,298malaise9,980fatigue9,904

    Explore full Esomeprazole safety data in our free FDA Safety Explorer

    FDA Recalls (12)

    Class IIOngoingMay 13, 2025

    Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

    Recalling firm: Zydus Pharmaceuticals (USA) Inc

    Class IIOngoingMay 13, 2025

    Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

    Recalling firm: Zydus Pharmaceuticals (USA) Inc

    Class IIIOngoingNov 14, 2024

    Labeling: Not Elsewhere Classified - Wrong NDC number

    Recalling firm: Zydus Pharmaceuticals (USA) Inc

    Class IIITerminatedOct 23, 2023

    Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).

    Recalling firm: Glenmark Pharmaceuticals Inc., USA

    Class IIITerminatedJun 21, 2022

    Superpotent Drug: Out of specification for assay at the 12-month timepoint.

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Class IIITerminatedJun 21, 2022

    Superpotent Drug: Out of specification for assay at the 12-month timepoint.

    Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

    Class IITerminatedDec 17, 2020

    Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

    Recalling firm: CIPLA

    Class IITerminatedDec 17, 2020

    Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

    Recalling firm: CIPLA

    Class IITerminatedDec 17, 2020

    Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

    Recalling firm: CIPLA

    Class IIITerminatedApr 24, 2020

    Discoloration: product contains brown pellets

    Recalling firm: Dr. Reddy's Laboratories, Inc.

    Class IIITerminatedFeb 6, 2019

    Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

    Recalling firm: Dr. Reddy's Laboratories, Inc.

    Class IIITerminatedJul 2, 2012

    Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.

    Recalling firm: ASTRA ZENECA Lp

    This information is educational — not medical advice.

    This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

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