{ "schema_version": 1, "kind": "drug_profile", "generic": "rabeprazole", "review_status": "reviewed", "origin": "openfda", "sections": { "adult": [ { "text": "For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabeprazole Sodium Delayed-Release Tablets may be considered. 2.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults The recommended adult oral dose is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily [ see Indications and Usage (1.2) ].", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "The recommended adolescent dosing is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily for 8 weeks. 2.4 Healing of Duodenal Ulcers in Adults The recommended adult oral dose is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily after the morning meal for a period up to four weeks [ see Indications and Usage (1.4) ].", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "Rabeprazole Sodium Delayed-Release Tablet 20 mg Twice Daily for 7 Days Amoxicillin 1000 mg Twice Daily for 7 Days Clarithromycin 500 mg Twice Daily for 7 Days 2.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults The dosage of Rabeprazole Sodium Delayed-Release Tablets in patients with pathologic hypersecretory conditions varies with the individual patient.", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true } ], "child": [ { "text": "The recommended adolescent dosing is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily for 8 weeks. 2.4 Healing of Duodenal Ulcers in Adults The recommended adult oral dose is one Rabeprazole Sodium 20 mg Delayed-Release Tablet to be taken once daily after the morning meal for a period up to four weeks [ see Indications and Usage (1.4) ].", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "Some patients with Zollinger-Ellison syndrome have been treated continuously with Rabeprazole Sodium Delayed-Release Tablets for up to one year. 2.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older The recommended oral dose for adolescents 12 years of age and older is one 20 mg Delayed-Release Tablet once daily for up to 8 weeks [ see Use in Specific Populations (8.4) and Clinical Studies (14.7) ].", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true } ], "renal": [ { "text": "No kidney-impairment dose in this label. Not a statement that none is needed.", "source": "Read and found silent: the US FDA label for rabeprazole (Rabeprazole Sodium), retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": false } ], "hepatic": [ { "text": "Some patients with Zollinger-Ellison syndrome have been treated continuously with Rabeprazole Sodium Delayed-Release Tablets for up to one year. 2.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older The recommended oral dose for adolescents 12 years of age and older is one 20 mg Delayed-Release Tablet once daily for up to 8 weeks [ see Use in Specific Populations (8.4) and Clinical Studies (14.7) ].", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination.", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients. 2.10 Administration Recommendations TABLE 2 Administration Recommendations Formulation Population Instructions Delayed-Release Tablet Adults and adolescents 12 years of age and older Swallow tablets whole.", "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for rabeprazole (Rabeprazole Sodium), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true } ], "pregnancy": [ { "text": "Pregnancy Category B Risk Summary There are no adequate and well-controlled studies with Rabeprazole Sodium Delayed-Release Tablets in pregnant women.", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "No evidence of teratogenicity was seen in animal reproduction studies with rabeprazole at 13 and 8 times the human exposure at the recommended dose for GERD, in rats and rabbits, respectively.", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true } ], "lactation": [ { "text": "It is not known if Rabeprazole Sodium Delayed-Release Tablets is excreted in human milk; however, rabeprazole is present in rat milk.", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'nursing mothers', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "Because many drugs are excreted in milk, caution should be exercised when Rabeprazole Sodium Delayed-Release Tablets is administered to a nursing woman.", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'nursing mothers', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true }, { "text": "Administration of rabeprazole to rats in late gestation and during lactation at an oral dose of 400 mg/kg/day (about 195-times the human oral dose based on mg/m 2 ) resulted in decreases in body weight gain of the pups. 8.3 Nursing Mothers It is not known if Rabeprazole Sodium Delayed-Release Tablets is excreted in human milk; however, rabeprazole is present in rat milk.", "source": "US FDA label for rabeprazole (Rabeprazole Sodium), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/rabeprazole.json", "verbatim": true } ] }, "verdicts": { "pregnancy": { "level": "caution", "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.", "set_by": "Set from the label's own words, not from a reading of them: 'should be used during pregnancy only if'." } } }