{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "escitalopram",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Indication Recommended Dose MDD in Adolescents ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Adults ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults ( 2.2 ) Initial: 10 mg once daily Recommended: 10 mg once daily • No additional benefits seen at 20 mg/day dose ( 2.1 ).",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "A flexible-dose trial of escitalopram tablets (10 to 20 mg/day) demonstrated the effectiveness of escitalopram oxalate [ see Clinical Studies ( 14.1 ) ].",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "If the dose is increased to 20 mg, this should occur after a minimum of three weeks.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Escitalopram tablets should be administered once daily, in the morning or evening, with or without food. Escitalopram tablets should generally be administered once daily, morning or evening with or without food ( 2.1 , 2.2 ).",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "Indication Recommended Dose MDD in Adolescents ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Adults ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults ( 2.2 ) Initial: 10 mg once daily Recommended: 10 mg once daily • No additional benefits seen at 20 mg/day dose ( 2.1 ).",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "Use caution in patients with severe renal impairment ( 2.3 ). • Discontinuing escitalopram tablets: A gradual dose reduction is recommended ( 2.4 ). 2.1 Major Depressive Disorder Initial Treatment Adolescents The recommended dose of escitalopram tablet is 10 mg once daily.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Indication Recommended Dose MDD in Adolescents ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Adults ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults ( 2.2 ) Initial: 10 mg once daily Recommended: 10 mg once daily • No additional benefits seen at 20 mg/day dose ( 2.1 ).",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "Use caution in patients with severe renal impairment ( 2.3 ). • Discontinuing escitalopram tablets: A gradual dose reduction is recommended ( 2.4 ). 2.1 Major Depressive Disorder Initial Treatment Adolescents The recommended dose of escitalopram tablet is 10 mg once daily.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "No dosage adjustment is necessary for patients with mild or moderate renal impairment.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Indication Recommended Dose MDD in Adolescents ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Adults ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults ( 2.2 ) Initial: 10 mg once daily Recommended: 10 mg once daily • No additional benefits seen at 20 mg/day dose ( 2.1 ).",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "The physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. 2.3 Special Populations 10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "In subjects with hepatic impairment, clearance of racemic citalopram was decreased and plasma concentrations were increased.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "In a rat embryo/fetal development study, oral administration of escitalopram (56, 112, or 150 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased fetal body weight and associated delays in ossification at the two higher doses (approximately ≥ 56 times the maximum recommended human dose [MRHD] of 20 mg/day on a body surface area [mg/m 2 ] basis).",
        "source": "US FDA label for escitalopram (Escitalopram), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "Maternal toxicity (clinical signs and decreased body weight gain and food consumption), mild at 56 mg/kg/day, was present at all dose levels.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "The developmental no-effect dose of 56 mg/kg/day is approximately 28 times the MRHD on a mg/m 2 basis.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Escitalopram is excreted in human breast milk.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "Limited data from women taking 10 to 20 mg escitalopram showed that exclusively breast-fed infants receive approximately 3.9% of the maternal weight-adjusted dose of escitalopram and 1.7% of the maternal weight-adjusted dose of desmethylcitalopram.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      },
      {
        "text": "There were two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in association with breastfeeding from a racemic citalopram-treated mother; in one case, the infant was reported to recover completely upon discontinuation of racemic citalopram by its mother and, in the second case, no follow-up information was available.",
        "source": "US FDA label for escitalopram (Escitalopram), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/escitalopram.json",
        "verbatim": true
      }
    ]
  }
}