{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "estradiol",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Start therapy with estradiol transdermal system 0.0375 mg/day applied to the skin twice weekly for the treatment of moderate to severe vasomotor symptoms due to menopause or moderate to severe symptoms of vulvar and vaginal atrophy symptoms due to menopause.",
        "source": "US FDA label for estradiol (Estradiol), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      },
      {
        "text": "Dosage adjustment should be guided by the clinical response (2.1 , 2.2 , 2.3) Start therapy with estradiol transdermal system 0.025 mg/day for the prevention of postmenopausal osteoporosis (2.4) Place estradiol transdermal system on a clean, dry area of the lower abdomen or buttocks.",
        "source": "US FDA label for estradiol (Estradiol), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      },
      {
        "text": "Do not apply estradiol transdermal system to the breasts (2.5) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Start therapy with estradiol transdermal system 0.0375 mg per day applied to the skin twice weekly.",
        "source": "US FDA label for estradiol (Estradiol), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Estradiol transdermal system is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population. If estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration.",
        "source": "US FDA label for estradiol (Estradiol), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Monitor any woman with a condition(s) that might predispose her to fluid retention, such as cardiac or renal impairment.",
        "source": "US FDA label for estradiol (Estradiol), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Discontinue estradiol transdermal system if pancreatitis occurs. 5.10 Hepatic Impairment and/or Past History of Cholestatic Jaundice Estrogens may be poorly metabolized in women with hepatic impairment.",
        "source": "US FDA label for estradiol (Estradiol), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Estradiol transdermal system is not indicated for use in pregnancy.",
        "source": "US FDA label for estradiol (Estradiol), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      },
      {
        "text": "There are no data with the use of estradiol transdermal system in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy.",
        "source": "US FDA label for estradiol (Estradiol), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      },
      {
        "text": "In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.",
        "source": "US FDA label for estradiol (Estradiol), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Estrogens are present in human milk and can reduce milk production in breast-feeding women.",
        "source": "US FDA label for estradiol (Estradiol), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      },
      {
        "text": "This reduction can occur at any time but is less likely to occur once breast-feeding is well-established.",
        "source": "US FDA label for estradiol (Estradiol), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for estradiol transdermal system and any potential adverse effects on the breastfed child from estradiol transdermal system or from the underlying maternal condition.",
        "source": "US FDA label for estradiol (Estradiol), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/estradiol.json",
        "verbatim": true
      }
    ]
  }
}