{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "citalopram",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Use another citalopram product for initial dosage titration or dosages other than 30 mg once daily.",
        "source": "US FDA label for citalopram (citalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Recommended dosage of Citalopram Capsules is 30 mg once daily.",
        "source": "US FDA label for citalopram (citalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Citalopram dosages above 40 mg once daily are not recommended due to the risk of QT prolongation.",
        "source": "US FDA label for citalopram (citalopram), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of citalopram have not been established in pediatric patients. Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with other another formulation of citalopram, and the data were not sufficient to support use in pediatric patients. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warnings and Precautions ( 5.1 )] .",
        "source": "US FDA label for citalopram (citalopram), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.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 citalopram (citalopram), retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "( 8.5 ) Hepatic Impairment: Not recommended.",
        "source": "US FDA label for citalopram (citalopram), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      },
      {
        "text": "SSRIs, including citalopram, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions ( 5.9 )] . 8.6 Hepatic Impairment Citalopram Capsules is not recommended in patients with hepatic impairment.",
        "source": "US FDA label for citalopram (citalopram), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      },
      {
        "text": "Avoid use of Citalopram Capsules in CYP2C19 poor metabolizers, patients receiving concomitant cimetidine or another CYP2C19 inhibitor, patients with hepatic impairment, and patients who are greater than 60 years of age, because Citalopram Capsules are only available in a 30 mg dose strength and dosage adjustments are not possible [see Drug Interactions ( 7 ), Use in Specific Populations ( 8.5 , 8.6 ), Clinical Pharmacology ( 12.3 )] .",
        "source": "US FDA label for citalopram (citalopram), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.",
        "source": "US FDA label for citalopram (citalopram), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      },
      {
        "text": "Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.",
        "source": "US FDA label for citalopram (citalopram), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( 5.4 ) and Clinical Considerations] .",
        "source": "US FDA label for citalopram (citalopram), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Citalopram was administered orally to pregnant rats during late gestation and lactation periods at doses of 4.8, 12.8, and 32 mg/kg/day, which are approximately 1, 3, and 8 times the MRHD of 40 mg, based on mg/m 2 body surface area.",
        "source": "US FDA label for citalopram (citalopram), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      },
      {
        "text": "In a separate study, similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, which is approximately 6 times the MRHD.",
        "source": "US FDA label for citalopram (citalopram), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      },
      {
        "text": "A NOAEL was not determined in that study. 8.2 Lactation Risk Summary Data from the published literature report the presence of citalopram in human milk at relative infant doses ranging between 0.7 to 9.4% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.78 to 4.3.",
        "source": "US FDA label for citalopram (citalopram), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/citalopram.json",
        "verbatim": true
      }
    ]
  }
}