Omeprazole
Regulatory sources consulted
- openfda-label-ca200f16-7b7e-4b33-964b-e2ccfc62f0f4
- aemps-spc-64004
- ansm-rcp-69816753
- PubMed PMID:39466269 ↗
- PubMed PMID:36065676 ↗
- PubMed PMID:37330988 ↗
- PubMed PMID:35652564 ↗
- PubMed PMID:36142643 ↗
- CredibleMeds.org
- OpenFDA · A02BC01
- RxNorm rxcui 7646 ↗
Approved indications
- Treatment of peptic ulcer disease, including healing of gastric and duodenal ulcers.
- Eradication of Helicobacter pylori in combination with appropriate antibiotics in patients with H. pylori-associated ulcers.
- Treatment of gastroesophageal reflux disease (GERD).
- Treatment of frequent heartburn (occurs 2 or more days a week) in its OTC formulation.
- Management of high-output stoma (off-label use with limited evidence). · off-label
Contraindications
Absolute
- Hypersensitivity to omeprazole or other substituted benzimidazoles.
- Concomitant use with nelfinavir.
Clinical warnings
- Major warning · In the presence of alarm symptoms (e.g., weight loss, recurrent vomiting, dysphagia), malignancy should be excluded as treatment may mask symptoms and delay diagnosis. — ANSM RCP
- Long-term treatment can cause hypomagnesemia, which can be serious. Monitoring magnesium levels should be considered. — ANSM RCP
- Major warning · Acute tubulointerstitial nephritis (TIN) has been observed in patients taking omeprazole. It may progress to renal failure. — ANSM RCP
- PPI use may slightly increase the risk of gastrointestinal infections such as Salmonella, Campylobacter, and Clostridium difficile. — ANSM RCP
- Long-term use has been associated with an increased risk of osteoporotic fractures. — PMID:36142643
Drug interactions
- HighClopidogrelB01AC04
Mechanism: Omeprazole, as a moderate CYP2C19 inhibitor, reduces the conversion of clopidogrel to its active metabolite, decreasing its antiplatelet effect.
Recommendation: Concomitant use is discouraged. If a PPI is required, consider alternatives with less CYP2C19 inhibition (e.g., pantoprazole).
PMID:36065676ANSM RCP
- ModerateMethotrexateL01BA01
Mechanism: PPIs can inhibit renal tubular secretion of methotrexate, potentially leading to increased plasma concentrations and toxicity.
Recommendation: Consider temporary withdrawal of omeprazole before high-dose methotrexate administration. Monitor methotrexate levels and renal function.
EMA SPC
- HighNelfinavirJ05AE04
Mechanism: Co-administration significantly reduces nelfinavir plasma concentrations (AUC decreased by ~40%), leading to a loss of antiviral efficacy.
Recommendation: Concomitant use of omeprazole and nelfinavir is contraindicated.
ANSM RCP
Adverse events
Common (≥1%)
headache · abdominal pain · constipation · diarrhea · flatulence · nausea · vomiting
Rare but serious
severe cutaneous adverse reactions (SCARs: SJS, TEN, DRESS, AGEP) · acute tubulointerstitial nephritis · hypomagnesemia · subacute cutaneous lupus erythematosus · rhabdomyolysis · pancytopenia
Pregnancy and lactation
FDA category: Not Assigned
Epidemiological data show no increased risk of malformations with omeprazole use during pregnancy. It is excreted in breast milk but is not likely to affect the child at therapeutic doses.
Recent literature (PubMed)
Revisión que destaca el papel central de los bloqueadores de ácido como el omeprazol en la curación de úlceras pépticas (80-100% en 4 semanas) y en los regímenes de erradicación de H. pylori para prevenir la recurrencia.
Revisión de farmacología clínica que subraya la interacción farmacocinética clave entre clopidogrel y omeprazol, donde la inhibición de CYP2C19 por omeprazol conduce a un efecto antiplaquetario atenuado.
Revisión sobre los mecanismos de la hipomagnesemia inducida por IBP. La evidencia apunta a una absorción intestinal de magnesio alterada debido al aumento del pH luminal y a cambios en el microbioma intestinal.
Revisión narrativa que discute la asociación sustancial, aunque basada en estudios observacionales, entre el uso a largo plazo de IBP y un mayor riesgo de fracturas osteoporóticas, a pesar de la falta de efectos consistentes sobre la densidad mineral ósea.
Metaanálisis que evaluó el uso de omeprazol para estomas de alto débito. No se encontró una diferencia significativa en la reducción del débito en comparación con el control, destacando la debilidad de la evidencia actual para este uso off-label.