Diclofenac

DRUG INFORMATION

  ADULT
    - 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
    - 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

  CHILD
    - 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

  RENAL IMPAIRMENT
    - ( 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
    - 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
    - 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

  HEPATIC IMPAIRMENT
    - 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
    - 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
    - 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

  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 'pregnancy',
      retrieved 2026-08-29
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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