{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "albendazole",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "DOSAGE & ADMINISTRATION Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg).",
        "source": "US FDA label for albendazole (Albendazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      },
      {
        "text": "DOSAGE & ADMINISTRATION Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole Tablets should be taken with food. ( 2 ) Hydatid disease: 28‑day cycle followed by 14‑day albendazole‑free interval for a total of 3 cycles. ( 2 ) Neurocysticercosis: 8 to 30 days. ( 2 ) See additional important information in the Full Prescribing Information.",
        "source": "US FDA label for albendazole (Albendazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of Albendazole Tablets in children appears to be similar to that in adults.",
        "source": "US FDA label for albendazole (Albendazole), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      },
      {
        "text": "DOSAGE & ADMINISTRATION Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole Tablets should be taken with food. ( 2 ) Hydatid disease: 28‑day cycle followed by 14‑day albendazole‑free interval for a total of 3 cycles. ( 2 ) Neurocysticercosis: 8 to 30 days. ( 2 ) See additional important information in the Full Prescribing Information.",
        "source": "US FDA label for albendazole (Albendazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      },
      {
        "text": "DOSAGE & ADMINISTRATION Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg).",
        "source": "US FDA label for albendazole (Albendazole), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.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 albendazole (Albendazole), retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts.",
        "source": "US FDA label for albendazole (Albendazole), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      },
      {
        "text": "There have also been case reports of acute liver failure of uncertain causality and hepatitis [ see Adverse Reactions ( 6 ) ].",
        "source": "US FDA label for albendazole (Albendazole), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Based on findings from animal reproduction studies, Albendazole Tablets may cause fetal harm when administered to a pregnant woman.",
        "source": "US FDA label for albendazole (Albendazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      },
      {
        "text": "However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1 st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for albendazole (Albendazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      },
      {
        "text": "In animal reproductive studies, oral administration of albendazole during the period of organogenesis caused embryotoxicity and skeletal malformations in pregnant rats (at doses of 0.10 times and 0.32 times the maximum recommended human dose based on body surface area in mg/m 2 ) and pregnant rabbits (at doses of 0.60 times the maximum recommended human dose based on body surface area in mg/m 2 ).",
        "source": "US FDA label for albendazole (Albendazole), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating Albendazole Tablets.",
        "source": "US FDA label for albendazole (Albendazole), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      },
      {
        "text": "Contraception Females Albendazole Tablets may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )].",
        "source": "US FDA label for albendazole (Albendazole), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      },
      {
        "text": "Advise females of reproductive potential to use effective contraception during treatment with Albendazole Tablets and for 3 days after the final dose.",
        "source": "US FDA label for albendazole (Albendazole), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/albendazole.json",
        "verbatim": true
      }
    ]
  }
}