{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "vonoprazan",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Recommended Dosage : Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up to 6 months.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease: 10 mg once daily for 4 weeks.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of VOQUEZNA have not been established in pediatric patients.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Recommended Dosage : Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks. ( 2.1 ) Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up to 6 months. ( 2.1 ) Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease: 10 mg once daily for 4 weeks. ( 2.1 ) Treatment of H. pylori Infection: see full prescribing information.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Table 4: Recommended VOQUEZNA Dosage in Patients with Hepatic Impairment: Treatment of H. pylori Infection Classification Recommended Dosage Child-Pugh Class A 20 mg twice daily Child-Pugh Class B Use is not recommended Child-Pugh Class C Use is not recommended 2.4 Administration Instructions Take VOQUEZNA with or without food [see Clinical Pharmacology (12.3) ] .",
        "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 vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Also refer to the amoxicillin and clarithromycin full prescribing information. 2.2 Recommended Dosage in Patients with Renal Impairment Healing of Erosive Esophagitis The recommended dosage of VOQUEZNA in adult patients with renal impairment is described in Table 1 below [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .",
        "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 vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Treatment of H. pylori Infection The recommended dosage of VOQUEZNA in adult patients with renal impairment is described in Table 2 below [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ].",
        "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 vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Table 2: Recommended VOQUEZNA Dosage in Patients with Renal Impairment: Treatment of H. pylori Infection Also refer to the Dosage and Administration section of the amoxicillin and clarithromycin prescribing information for dosage recommendations in patients with renal impairment.",
        "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 vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "( 2.1 ) See also full prescribing information for the recommended dosage by indication for patients with renal or hepatic impairment.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Estimated GFR Recommended Dosage 30 mL/minute or greater 20 mg twice daily Less than 30 mL/minute Use is not recommended 2.3 Recommended Dosage in Patients with Hepatic Impairment Healing of Erosive Esophagitis The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is described in Table 3 below [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] .",
        "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 vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Treatment of H. pylori Infection The recommended dosage of VOQUEZNA in adult patients with hepatic impairment is described in Table 4 below [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].",
        "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 vonoprazan (VOQUEZNA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA during pregnancy.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Healthcare providers are encouraged to register patients by calling 1-866-609-1612 or visiting https://voqueznapregnancyregistry.com/ .",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary There are no adequate and well-controlled studies of vonoprazan in pregnant women.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "In a pre- and postnatal development (PPND) study, pups from dams orally administered vonoprazan during organogenesis and through lactation exhibited liver discoloration, which, in follow-up mechanistic animal studies, was associated with necrosis, fibrosis, and hemorrhage at a dose approximately 22-times the MRHD, based on AUC comparisons that were likely attributable to exposure during lactation [see Use in Specific Populations (8.2) ] .",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "In a PPND study, pregnant female rats were orally administered vonoprazan at doses of 1, 3, 10, or 100 mg/kg/day (0.01-, 0.18-, 1.1-, 22-times the MRHD based on AUC comparison) from GD 6 to lactation day (LD) 21.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      },
      {
        "text": "Decreased body weight gain and food consumption were present in dams at the highest dose during lactation.",
        "source": "US FDA label for vonoprazan (VOQUEZNA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/vonoprazan.json",
        "verbatim": true
      }
    ]
  }
}