pharmacopeia
GET
/api/v1/drug/omeprazole
2D structure
6-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole
SMILES CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C(N2)C=C(C=C3)OC
InChIKey SUBDBMMJDZJVOS-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors.

Cytochrome P450 2C19Proton Pump

Indications

Sourced from openFDA
  • Use(s) 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 openFDA

Directions for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush tablets 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. Heartburn in children may sometimes be caused by a serious condition.

Warnings & precautions

Sourced from openFDA

Allergy alert: do not use if you are allergic to omeprazole omeprazole 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 lightheadednes 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 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
  • Jun 20, 2003NDANDA021229Astrazeneca
  • Jun 15, 2004NDANDA021636Salix
  • Feb 27, 2006NDANDA021849Salix
  • Dec 4, 2007NDANDA022032Dexcel Pharma
  • Mar 20, 2008NDANDA022056Azurity
  • Dec 1, 2009NDANDA022281Riley Consumer
  • Jul 5, 2017NDANDA209400Dexcel
  • Nov 1, 2019NDANDA213004Talicia Holdings

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-01)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-10)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 10 mg (NDC 0781-2859-31)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-01)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-10)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-31)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 20 mg (NDC 0781-2868-92)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 40 mg (NDC 0781-2234-01)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 40 mg (NDC 0781-2234-10)To be discontinued
    Sponsor: Sandoz Inc.
    Updated
  • Omeprazole, Delayed Release Capsule, 40 mg (NDC 0781-2234-31)To be discontinued
    Sponsor: Sandoz Inc.
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
442,295 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Chronic Kidney Disease36,7908.3%
  2. 2Nausea26,6986.0%
  3. 3Fatigue25,8305.8%
  4. 4Diarrhoea25,2605.7%
  5. 5Acute Kidney Injury23,8565.4%
  6. 6Drug Ineffective22,8915.2%
  7. 7Dyspnoea20,8024.7%
  8. 8Pain20,1844.6%
  9. 9Headache19,1394.3%
  10. 10Renal Failure18,1874.1%
  11. 11Vomiting17,1653.9%
  12. 12Dizziness16,9333.8%
  13. 13Off Label Use15,9623.6%
  14. 14Malaise13,9123.1%
  15. 15Asthenia13,8983.1%

Literature

View JSON

Recent PubMed references pinned to Omeprazole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 1,017 ClinicalTrials.gov registrations naming Omeprazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

View JSON

CPIC-curated drug–gene pairs for Omeprazole. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Structural analogs

View JSON

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Omeprazole work?
Mechanism-of-action classes: Cytochrome P450 2C19 Inhibitors; Proton Pump Inhibitors.
What is Omeprazole used for?
According to FDA labeling, Omeprazole carries indications including: Use(s) 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 Omeprazole?
Omeprazole 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 Omeprazole?
Omeprazole is marketed under brand names including Gastrobim, Konvomep, Prilosec, Primeguard, Talicia, UlcerGard, Yosprala, Zegerid Reformulated Aug 2006.
Note. Data for omeprazole 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.

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