Evigrade

Rabeprazole

AEMPS

Proton pump inhibitor (PPI)

ATC code: A02BC04

Updated · Methodology

Indications

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

PPI for NSAID gastric prophylaxis in low-risk patients

Not recommended

Rabeprazole is prescribed for gastric protection to healthy people without diagnosed GERD or peptic ulcer, including for single NSAID or antibiotic courses. 2022 and 2022 confine PPIs to patients with GI-bleed risk factors. Systematic low-risk-population use increases fracture, hypomagnesemia, B12-deficiency, CDI and acid-rebound risk.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A benzimidazole that covalently binds gastric parietal cell H+/K+-ATPase. Compared with other PPIs, faster onset (1 hour vs 2–3 with omeprazole), stable pharmacokinetics in CYP2C19 slow and rapid metabolizers (metabolized largely non-enzymatically). Fewer clopidogrel interactions than omeprazole.

Safety

Contraindications

  • Rabeprazole or other PPI hypersensitivity
  • Concomitant rilpivirine
  • Pregnancy – with caution

Serious adverse effects

  • Hypomagnesemia
  • Vitamin B12 deficiency
  • Osteoporosis and fractures (long-term)
  • C. difficile infection
  • Acute interstitial nephritis
  • Subacute cutaneous lupus erythematosus

Common adverse effects

  • Headache
  • Diarrhea or constipation
  • Nausea
  • Abdominal pain
  • Flatulence
  • Skin rash

Pregnancy: can you take Rabeprazole?

AEMPS summary of product characteristics (section 4.6): there are no data on the safety of rabeprazole in pregnant women. Reproduction studies in rats and rabbits found no fetal harm from rabeprazole sodium, although low feto-placental transfer occurs in rats. Rabeprazole is contraindicated during pregnancy.

Breastfeeding: can you take Rabeprazole?

Compatible with breastfeeding.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take 30 minutes before meals. Do not chew or break – the enteric coating protects the drug from gastric acid. Long-term use over 1 year is associated with vitamin B12, magnesium deficiency, and osteoporosis. Review need annually.
Label mentions18 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • «No se recomienda la co-administración de atazanavir con Rabeprazol Tecnigen (ver sección 4.5).»

    AEMPS, section 4.4 · Open on CIMA

  • «DRUG INTERACTIONS: Intervention: Rilpivirine-containing products: Concomitant use with Rabeprazole Sodium delayed-release tablets is contraindicated [see Contraindications (4) ] . See prescribing…»

    FDA, section 7 · Open on DailyMed

  • ModerateDigoxin
    «DRUG INTERACTIONS: Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin.»

    FDA, section 7 · Open on DailyMed

  • ModerateItraconazole
    «Rabeprazol sódico produce una intensa y prolongada inhibición de la secreción de ácido gástrico. Se podría producir una interacción con compuestos cuya absorción depende del pH. La administración…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateKetoconazole
    «Rabeprazol sódico produce una intensa y prolongada inhibición de la secreción de ácido gástrico. Se podría producir una interacción con compuestos cuya absorción depende del pH. La administración…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateMethotrexate
    «DRUG INTERACTIONS: Intervention: A temporary withdrawal of Rabeprazole Sodium delayed-release tablets may be considered in some patients receiving high dose methotrexate administration.»

    FDA, section 7 · Open on DailyMed

  • «DRUG INTERACTIONS: Intervention: Mycophenolate mofetil (MMF): Co-administration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the…»

    FDA, section 7 · Open on DailyMed

  • ModerateTacrolimus
    «DRUG INTERACTIONS: Intervention: Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing…»

    FDA, section 7 · Open on DailyMed

  • ModerateWarfarin
    «DRUG INTERACTIONS: Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.»

    FDA, section 7 · Open on DailyMed

  • antiácidosclass named in the label
    «En ensayos clínicos se han administrado antiácidos concomitantemente con Rabeprazol Tecnigen sin que se haya observado interacción alguna con antiácidos líquidos en un ensayo específico de…»

    AEMPS, section 4.5 · Open on CIMA

  • «DRUG INTERACTIONS: Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole)»

    FDA, section 7 · Open on DailyMed

  • «DRUG INTERACTIONS: Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole)»

    FDA, section 7 · Open on DailyMed

  • «La co-administración de atazanavir 300 mg/ritonavir 100 mg con omeprazol (40 mg una vez al día) o atazanavir 400 mg con lansoprazol (60 mg una vez al día) a voluntarios sanos dio como resultado una…»

    AEMPS, section 4.5 · Open on CIMA

  • «La co-administración de atazanavir 300 mg/ritonavir 100 mg con omeprazol (40 mg una vez al día) o atazanavir 400 mg con lansoprazol (60 mg una vez al día) a voluntarios sanos dio como resultado una…»

    AEMPS, section 4.5 · Open on CIMA

  • «La co-administración de atazanavir 300 mg/ritonavir 100 mg con omeprazol (40 mg una vez al día) o atazanavir 400 mg con lansoprazol (60 mg una vez al día) a voluntarios sanos dio como resultado una…»

    AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

  • «Pharmacokinetic Drug Interactions: Rabeprazole 29% 19%»

    FDA, section 7 · Open on DailyMed

  • «Medicamentos para los trans tornos relacionados con la acidez: Antiácidos (aluminio, calcio, magnesio o bicarbonato de sodio), Antagonistas del receptor-H2 (p.ej., cimetidina, ranitidina)…»

    AEMPS, section 4.5 · Open on CIMA

  • «Medicamentos metabolizados por el citocromo P450: En las personas que son metabolizadores lentos de CYP2C19, los niveles plasmáticos de sertralina se aumentan aproximadamente en un 50% en comparación…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Rabeprazole used for?

Rabeprazole is evaluated for the following indications with varying evidence strength: Gastroesophageal reflux disease (evidence tier A), Peptic ulcer disease (evidence tier A), PPI for NSAID gastric prophylaxis in low-risk patients (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Rabeprazole?

Common side effects of Rabeprazole (≥ 1 in 100): Headache, Diarrhea or constipation, Nausea, Abdominal pain, Flatulence, Skin rash. See the Safety section for uncommon and serious reactions.

Is Rabeprazole safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there are no data on the safety of rabeprazole in pregnant women. Reproduction studies in rats and rabbits found no fetal harm from rabeprazole sodium, although low feto-placental transfer occurs in rats. Rabeprazole is contraindicated during pregnancy.

Is Rabeprazole compatible with breastfeeding?

Compatible with breastfeeding.

Who should not take Rabeprazole?

Rabeprazole is contraindicated in: Rabeprazole or other PPI hypersensitivity; Concomitant rilpivirine; Pregnancy – with caution. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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