{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "levothyroxine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Levothyroxine Sodium Tablets Dosing Guidelines for Hypothyroidism in Adults* *Dosages greater than 200 mcg/day are seldom required.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      },
      {
        "text": "An inadequate response to daily dosages greater than 300 mcg/day is rare and may indicate poor compliance, malabsorption, drug interactions, or a combination of these factors [see Dosage and Administration (2.1) and Drug Interactions (7) ].",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      },
      {
        "text": "Patient Population Starting Dosage Dosage Titration Based on serum TSH or Free-T4 Adults diagnosed with hypothyroidism Full replacement dose is 1.6 mcg/kg/day.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Levothyroxine sodium is indicated in patients from birth to less than 17 years of age: • As a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. • As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      },
      {
        "text": "• Administer once daily, preferably on an empty stomach, one-half to one hour before breakfast with a full glass of water. (2.1) • Administer at least 4 hours before or after drugs that are known to interfere with absorption. (2.1) • Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      },
      {
        "text": "Important Administration Instructions Administer levothyroxine sodium tablets as a single daily dose, on an empty stomach, one-half to one hour before breakfast with a full glass of water to avoid choking or gagging [see Adverse Reactions (6) ]. Administer levothyroxine sodium tablets at least 4 hours before or after drugs known to interfere with levothyroxine sodium absorption [see Drug Interactions (7.1) ].",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.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 levothyroxine sodium (Levothyroxine sodium), retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, androgens, and corticosteroids decrease TBG concentration.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary The clinical experience, including data from postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported increased rates of major birth defects, miscarriages, or other adverse maternal or fetal outcomes.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      },
      {
        "text": "There are risks to the mother and fetus associated with untreated hypothyroidism in pregnancy.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      },
      {
        "text": "Since TSH levels may increase during pregnancy, TSH should be monitored and levothyroxine sodium dosage adjusted during pregnancy (see Clinical Considerations) .",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Published studies report that levothyroxine is present in human milk following the administration of oral levothyroxine.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      },
      {
        "text": "No adverse effects on the breastfed infant have been reported and there is no information on the effects of levothyroxine on milk production.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      },
      {
        "text": "Adequate levothyroxine treatment during lactation may normalize milk production in hypothyroid lactating mothers with low milk supply.",
        "source": "US FDA label for levothyroxine sodium (Levothyroxine sodium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/levothyroxine.json",
        "verbatim": true
      }
    ]
  }
}