{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "alprazolam",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Generalized Anxiety Disorder : (2.1) Recommended starting oral dosage is 0.25 mg to 0.5 mg three times daily.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      },
      {
        "text": "Dosage may be increased, at intervals of every 3 to 4 days, to a maximum recommended daily dose of 4 mg, given in divided doses.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      },
      {
        "text": "Panic Disorder : Recommended starting oral dosage is 0.5 mg three times daily.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness of alprazolam have not been established in pediatric patients.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.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 alprazolam (Alprazolam), retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "( 2.3 , 5.2 ) See the Full Prescribing Information for the recommended dosage in geriatric patients, patients with hepatic impairment, and with use with ritonavir.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      },
      {
        "text": "If adverse reactions occur at the recommended starting dosage, the dosage may be reduced [see Use in Specific Populations ( 8.5 ), Clinical Pharmacology ( 12.3 )] . 2.5 Dosage Recommendations in Patients with Hepatic Impairment In patients with hepatic impairment, the recommended starting oral dosage of alprazolam tablets is 0.25 mg, given 2 or 3 times daily.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      },
      {
        "text": "Therefore, dosage reduction of alprazolam is recommended in geriatric patients [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )] . 8.6 Hepatic Impairment Patients with alcoholic liver disease exhibit a longer elimination half-life (19.7 hours), compared to healthy subjects (11.4 hours).",
        "source": "US FDA label for alprazolam (Alprazolam), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam, during pregnancy.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      },
      {
        "text": "Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions ( 5.8 ) and Clinical Considerations)] .",
        "source": "US FDA label for alprazolam (Alprazolam), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Lactation : Breastfeeding not recommended.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      },
      {
        "text": "In addition, the majority of recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco, and other medications, have not confirmed these findings. 8.2 Lactation Risk Summary Limited data from published literature reports the presence of alprazolam in human breast milk.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      },
      {
        "text": "There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk.",
        "source": "US FDA label for alprazolam (Alprazolam), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/alprazolam.json",
        "verbatim": true
      }
    ]
  }
}