{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "diclofenac",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "For relief of the pain of osteoarthritis (OA) of the knee(s), the recommended dose is 40 mg of diclofenac sodium (2 pump actuations) on each painful knee, 2 times a day.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. The recommended dose is 2 pump actuations on each painful knee, 2 times a day. ( 2 ) Apply diclofenac sodium topical solution, to clean, dry skin. ( 2.1 ) Dispense 40 mg (2 pump actuations) directly onto the knee or first into the hand and then onto the knee. Spread evenly around front, back and sides of the knee.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 8.3 ) 8.1 Pregnancy Risk Summary Use of NSAIDs, including diclofenac sodium topical solution, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), diclofenac sodium topical solution should be discontinued immediately.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Use of NSAIDs, including diclofenac sodium topical solution, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "Because of these risks, limit dose and duration of diclofenac sodium topical solution use between about 20 and 30 weeks of gestation, and avoid diclofenac sodium topical solution use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data) .",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including diclofenac sodium topical solution, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "In a study in which pregnant rats were orally administered 2 or 4 mg/kg diclofenac (0.12 and 0.24 times the MRHD, respectively, based on BSA comparison) from Gestation Day 15 through Lactation Day 21, significant maternal toxicity (peritonitis, mortality) was noted.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "In published studies, diclofenac administration to pregnant rats prolonged gestation and produced liver toxicity and neuronal loss in offspring (1 mg/kg, IP; 0.06 times the MRHD based on BSA comparison), impaired nephrogenesis in the kidney (3.6 mg/kg, IP; 0.2 times the MRHD based on BSA comparison), and caused adverse effects on the developing testes (6.1 mg/kg, oral; 0.4 times the MRHD based on BSA comparison).",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for diclofenac sodium topical solution and any potential adverse effects on the breastfed infant from the diclofenac sodium topical solution or from the underlying maternal condition.",
        "source": "US FDA label for diclofenac (Diclofenac sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diclofenac.json",
        "verbatim": true
      }
    ]
  }
}