MajorDrugs for peptic ulcer and GORD. Proton pump inhibitors×Antimetabolites, folic acid analogues
Updated · Methodology
Mechanism
Proton pump inhibitors block the renal BCRP transporter and reduce methotrexate clearance. At high oncologic doses, risk of delayed elimination and severe toxicity.
Symptoms
Mouth ulcers (mucositis), nausea, diarrhoea, hair loss. Blood counts fall: leukocytes, platelets, erythrocytes. Severe cases: fatal pancytopenia, nephrotoxicity.
Management
With high-dose (oncology) methotrexate, the Spanish label requires avoiding proton pump inhibitors, especially in renal impairment. Withhold esomeprazole for the course and use an H2-receptor antagonist such as famotidine for gastric protection. With low-dose methotrexate (rheumatology, psoriasis) the combination is possible, but the labels warn about methotrexate accumulation, so monitor blood counts, creatinine and signs of toxicity such as mouth ulcers and diarrhoea, with extra care in reduced kidney function.
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Sources
- FDA: Methotrexate Sodium Tablets prescribing information (2016)– ; DailyMed setid 8f1260de-b60c-4f0e-8af6-0e957b0a281b
- AEMPS: Ficha técnica Metotrexato Accord 100 mg/ml concentrado para solución para perfusión (2025)– AEMPS, CIMA, nº registro 79440, revisión 01/2025, secciones 4.4 y 4.5
- AEMPS: Ficha técnica Bertanel 20 mg/1 ml solución inyectable en jeringa precargada (metotrexato) (2026)– AEMPS, CIMA, nº registro 70999, revisión 09/2026, sección 4.5
- FDA: Methotrexate Injection – Prescribing Information (2026)– FDA, DailyMed SPL, Accord Healthcare, раздел 7.1
- AEMPS: Ficha técnica Nexium Mups 20 mg comprimidos gastrorresistentes (esomeprazol) (2025)– AEMPS, CIMA, nº registro 63436, revisión 05/2025, sección 4.5