{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "gabapentin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended dose is reached by upward titration over a period of approximately 3 days Dose should be adjusted in patients with reduced renal function ( 2.3 , 2.4 ) 2.1 Dosage for Postherpetic Neuralgia In adults with postherpetic neuralgia, gabapentin may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day).",
        "source": "US FDA label for gabapentin (Gabapentin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day).",
        "source": "US FDA label for gabapentin (Gabapentin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated. 2.2 Dosage for Epilepsy with Partial Onset Seizures Patients 12 Years of Age and Above The starting dose is 300 mg three times a day.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness of gabapentin in the management of postherpetic neuralgia in pediatric patients have not been established. Safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established [see Clinical Studies (14.2 )].",
        "source": "US FDA label for gabapentin (Gabapentin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated. 2.2 Dosage for Epilepsy with Partial Onset Seizures Patients 12 Years of Age and Above The starting dose is 300 mg three times a day.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "Pediatric Patients Age 3 to 11 Years The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "The maximum time interval between doses should not exceed 12 hours. 2.3 Dosage Adjustment in Patients with Renal Impairment Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication): TABLE 1.",
        "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 gabapentin (Gabapentin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "Creatinine clearance (CLCr) is difficult to measure in outpatients.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault: The use of gabapentin in patients less than 12 years of age with compromised renal function has not been studied.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for gabapentin (Gabapentin), retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as gabapentin, during pregnancy.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "Encourage women who are taking gabapentin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary The totality of available data from published prospective and retrospective cohort studies pertaining to gabapentin use during pregnancy has not indicated an increased risk of major birth defects or miscarriage.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Gabapentin is secreted in human milk following oral administration.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "The effects on the breastfed infant and on milk production are unknown.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin and any potential adverse effects on the breastfed infant from gabapentin or from the underlying maternal condition.",
        "source": "US FDA label for gabapentin (Gabapentin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/gabapentin.json",
        "verbatim": true
      }
    ]
  }
}