Esomeprazole
/api/v1/drug/esomeprazoleMechanism of action
Sourced from openFDAMechanism-of-action classes: Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors.
Indications
Sourced from openFDA- 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
Dosage & administration
Sourced from openFDADirections • adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • may take 1 to 4 days for full effect 14-Day Course of Treatment • swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
Warnings & precautions
Sourced from openFDAAllergy 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. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Approval history
Sourced from openFDA- Feb 20, 2001NDANDA021153Astrazeneca
- Oct 20, 2006NDANDA021957Astrazeneca
- Feb 27, 2008NDANDA022101Astrazeneca
- Aug 6, 2013NDANDA202342Belcher
- Mar 28, 2014NDANDA204655Astrazeneca Lp
- Aug 3, 2015ANDAANDA078936Mylan
- Sep 25, 2015ANDAANDA078279Dr Reddys
- Nov 23, 2015NDANDA207920Astrazeneca Lp
FAERS reports
- 1Chronic Kidney Disease35,58215%
- 2Acute Kidney Injury20,4448.8%
- 3Renal Failure16,2747.0%
- 4Drug Ineffective14,2856.1%
- 5Nausea13,4585.8%
- 6Gastrooesophageal Reflux Disease11,9615.1%
- 7Diarrhoea11,1764.8%
- 8Drug Dose Omission11,1264.8%
- 9Pain10,7104.6%
- 10End Stage Renal Disease10,2984.4%
- 11Malaise9,9774.3%
- 12Fatigue9,9054.2%
- 13Headache9,5354.1%
- 14Renal Injury9,5294.1%
- 15Off Label Use9,5144.1%
Literature
Recent PubMed references pinned to Esomeprazole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Impact of different domperidone dosages on reflux esophagitis treated with esomeprazole: a randomized controlled trial.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2026 · Niu W, Bao M, Zhao Y, et al.PMID 42271600DOI 10.1093/dote/doag053
- Gender Differences in the Effects of Esomeprazole on Ethanol-Induced Acute Gastric Injury in Mice.Frontiers in bioscience (Landmark edition) · 2026 · Yi ZH, Wu Y, Yu Y, et al.PMID 42052825DOI 10.31083/FBL49148
- Esomeprazole Decreases Soluble Fms-like Tyrosine Kinase-1 in Preeclamptic Pregnancy in Rats.International journal of molecular sciences · 2026 · da Silva MLS, Toghi CJ, da Silva AAF, et al.PMID 41977292DOI 10.3390/ijms27073105
- Development of a Biorelevant Dissolution Test Using Bicarbonate Buffer and Apex Vessel to Predict Clinical Bioequivalence.Chemical & pharmaceutical bulletin · 2026 · Fushimi M, Nakamichi K, Nakatani M, et al.PMID 41621953DOI 10.1248/cpb.c25-00583
- Fourteen-and Ten-Day Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for Helicobacter pylori Eradication-A Noninferiority, Multicenter, Randomized Controlled Trial.Journal of gastroenterology and hepatology · 2026 · Fan Y, Li C, Zhang W, et al.PMID 41371765DOI 10.1111/jgh.70180
- Chemical stability of esomeprazole in biorelevant bicarbonate buffer and an exploratory study for specific degradation products.Journal of pharmaceutical and biomedical analysis · 2026 · Takasusuki A, Takayama T, Inoue K, et al.PMID 41371047DOI 10.1016/j.jpba.2025.117305
- Development of a Sustainable One-Pot Process for Esomeprazole Production via Enantioselective Iron Catalysis.Chemical & pharmaceutical bulletin · 2025 · Nishiguchi S, Sukegawa J, Onai T, et al.PMID 41285457DOI 10.1248/cpb.c25-00470
- A Chrono-Prolific Controlled Release Tripartite Tablet: Case Study of Paracetamol, Diclofenac Sodium and Esomeprazole Magnesium Trihydrate.AAPS PharmSciTech · 2025 · Mazarura KR, Kumar P, van Eyk A, et al.PMID 41199089DOI 10.1208/s12249-025-03231-3
Clinical trials
The 10 most recently updated of 564 ClinicalTrials.gov registrations naming Esomeprazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric BypassRecruiting · Phase 4 · Interventional · 50 enrolled · Prof Urs ZinggNCT05320796updated 2026-06-09
- Vonoprazan High-Dose Dual VS Levofloxacin ConcomitantNot yet recruiting · Phase 4 · Interventional · 150 enrolled · Damascus HospitalNCT07624422updated 2026-06-03
- A Multiple Dose Study of LY3502970 in Healthy ParticipantsCompleted · Phase 1 · Interventional · 26 enrolled · Eli Lilly and CompanyNCT05051566updated 2026-05-29
- Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux DiseaseNot yet recruiting · Phase 4 · Interventional · 800 enrolled · University of MonsNCT07611162updated 2026-05-28
- The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter PyloriNot yet recruiting · Phase 3 · Interventional · 556 enrolled · Xuanzhu Biopharmaceutical Co., Ltd.NCT07606833updated 2026-05-26
- Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal RefluxCompleted · Interventional · 30 enrolled · University Hospital, BordeauxNCT01854970updated 2026-05-14
- Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori InfectionEnrolling by invitation · Interventional · 66 enrolled · Akil Al IslamNCT07010744updated 2026-05-07
- Comparison of Esomeprazole Versus Vonoprazan in Gastroesophageal Reflux DiseaseCompleted · Interventional · 824 enrolled · Muhammad Aamir LatifNCT07563491updated 2026-05-04
- Keverprazan Combined With Amoxicillin for the Treatment of Helicobacter PyloriCompleted · Interventional · 264 enrolled · Key Laboratory for Gastrointestinal Diseases of Gansu ProvinceNCT06851468updated 2026-04-29
- Tegoprazan-containing Sequential for H. PyloriRecruiting · Interventional · 400 enrolled · Seoul National University Bundang HospitalNCT06382493updated 2026-04-28
Pharmacogenomics
CPIC-curated drug–gene pairs for Esomeprazole. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.
- CYP2C19CPIC CClinPGx 3FDA label: No Clinical PGx
Structural analogs
Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.
Frequently asked questions
- How does Esomeprazole work?
- Mechanism-of-action classes: Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors.
- What is Esomeprazole used for?
- According to FDA labeling, Esomeprazole carries indications including: 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. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Esomeprazole?
- Esomeprazole is classified as Proton pump inhibitors, Proton Pump Inhibitor, Cytochrome P450 2C19 Inhibitors, Proton Pump Inhibitors, Inhibition Gastric Acid Secretion.
- What are the brand names for Esomeprazole?
- Esomeprazole is marketed under brand names including Nexium, Vimovo.
esomeprazole is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.