{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "isotretinoin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.2 , 5.3 ) Recommended dosage for (2.2 ): o ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) o ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6 mg/kg/day of ABSORICA LD) in divided doses.",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      },
      {
        "text": "The recommended dosage of: ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 1).",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for isotretinoin (Absorica LD), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      },
      {
        "text": "ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks (see Table 2).",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for isotretinoin (Absorica LD), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of ABSORICA/ABSORICA LD for the treatment of severe recalcitrant nodular acne have been established in non-pregnant pediatric patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater who are unresponsive to conventional therapy, including systemic antibiotics .",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      },
      {
        "text": "Evaluations Prior To Prescribing and Use of ABSORICA/ABSORICA LD: In patients who can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and documentation that they are not pregnant. See the Full Prescribing Information for the detailed requirements prior to prescribing ABSORICA/ABSORICA LD ( 2.1 , 8.3 ) Complete the following laboratory tests in all patients: fasting lipid profile and liver function tests.",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 , 5.3 ) Recommended dosage for (2.2 ): o ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) o ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6 mg/kg/day of ABSORICA LD) in divided doses.",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.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 isotretinoin (Absorica LD), retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.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 isotretinoin (Absorica LD), retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that documents pregnancies in patients exposed to isotretinoin during pregnancy.",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      },
      {
        "text": "Report any suspected fetal exposure during or 1 month after ABSORICA/ABSORICA LD treatment immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet ( www.ipledgeprogram.com) .",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary ABSORICA/ABSORICA LD are contraindicated during pregnancy because isotretinoin can cause fetal harm when administered to a pregnant patient.",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "All patients who can become pregnant must comply with the iPLEDGE program requirements [see Warnings and Precautions (5.2) ].",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      },
      {
        "text": "Pregnancy Testing All patients who can get pregnant must comply with the iPLEDGE REMS requirements [see Warnings and Precautions ( 5.2 )] .",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      },
      {
        "text": "Pregnancy Testing In patients who can get pregnant, pregnancy testing is required prior to, during, and after ABSORICA/ABSORICA LD treatment.",
        "source": "US FDA label for isotretinoin (Absorica LD), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/isotretinoin.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated during pregnan'."
    }
  }
}