{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "acyclovir",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "ZOVIRAX Cream should be applied 5 times per day for 4 days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis, i.e. during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults. • Apply 5 times a day for 4 days. ( 2 ) • Administer immediately following the onset of cold sore lesions. ( 2 )",
        "source": "US FDA label for acyclovir (Zovirax), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "An open-label, uncontrolled trial with ZOVIRAX Cream was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.",
        "source": "US FDA label for acyclovir (Zovirax), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": true
      },
      {
        "text": "ZOVIRAX Cream should be applied 5 times per day for 4 days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis, i.e. during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults. • Apply 5 times a day for 4 days. ( 2 ) • Administer immediately following the onset of cold sore lesions. ( 2 )",
        "source": "US FDA label for acyclovir (Zovirax), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.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 acyclovir (Zovirax), retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.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 acyclovir (Zovirax), retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the ZOVIRAX Cream [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for acyclovir (Zovirax), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": true
      },
      {
        "text": "Experience with topical acyclovir use in pregnant women over several decades, based on published literature including observational studies, has not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",
        "source": "US FDA label for acyclovir (Zovirax), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": true
      },
      {
        "text": "Animal reproduction studies with systemic exposure of acyclovir have been conducted.",
        "source": "US FDA label for acyclovir (Zovirax), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "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. 8.2 Lactation Risk Summary Acyclovir is minimally absorbed systemically following topical route of administration, and breastfeeding is not expected to result in exposure of the child to ZOVIRAX Cream [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for acyclovir (Zovirax), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": true
      },
      {
        "text": "There are no data on the effects of ZOVIRAX on the breastfed infant or on milk production.",
        "source": "US FDA label for acyclovir (Zovirax), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZOVIRAX Cream and any potential adverse effects on the breastfed child from ZOVIRAX Cream or from the underlying maternal condition. 8.4 Pediatric Use An open-label, uncontrolled trial with ZOVIRAX Cream was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis.",
        "source": "US FDA label for acyclovir (Zovirax), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/acyclovir.json",
        "verbatim": true
      }
    ]
  }
}