{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "methylphenidate",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.2 ) Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      },
      {
        "text": "Doses above 60 mg daily are not recommended.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      },
      {
        "text": "Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for methylphenidate hydrochloride extended-release capsules use [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9 )]. 2.2 General Dosing Information The recommended starting dose for methylphenidate hydrochloride extended-release capsules is 20 mg once daily.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of methylphenidate hydrochloride extended-release capsules for the treatment of ADHD have been established in pediatric patients 6 to 12 years. The safety and effectiveness of methylphenidate hydrochloride extended-release capsules in pediatric patients less than 6 years have not been established. The long- term efficacy of methylphenidate in pediatric patients has not been established.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      },
      {
        "text": "The doses at which these findings were observed are at least 4 times the MRHD of 60 mg/day given to children on a mg/m 2 basis.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      },
      {
        "text": "In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10).",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.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 methylphenidate (Methylphenidate Hydrochloride (LA)), retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": false
      }
    ],
    "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 methylphenidate (Methylphenidate Hydrochloride (LA)), retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      },
      {
        "text": "There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations) .",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      },
      {
        "text": "No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.7.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      },
      {
        "text": "There are no reports of adverse effects on the breastfed infant and no effects on milk production.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      },
      {
        "text": "Long-term neurodevelopmental effects on infants from stimulant exposure are unknown.",
        "source": "US FDA label for methylphenidate (Methylphenidate Hydrochloride (LA)), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/methylphenidate.json",
        "verbatim": true
      }
    ]
  }
}