Naproxen

DRUG INFORMATION

  ADULT
    - (2.1) Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen
      delayed-release tablets 375 mg or 500 mg Twice daily To maintain the integrity of
      the enteric coating, the naproxen delayed-release tablet should not be broken,
      crushed or chewed during ingestion.
      Source: US FDA label for naproxen (Naproxen), section 'dosage and administration',
      retrieved 2026-08-29
    - In patients who tolerate lower doses well, the dose may be increased to naproxen
      1500 mg/day for up to 6 months.
      Source: US FDA label for naproxen (Naproxen), section 'dosage and administration',
      retrieved 2026-08-29
    - Table 1: Recommended dosages for Naproxen delayed-release tablets Naproxen
      delayed-release tablets 375 mg or 500 mg Twice daily Twice daily During long-term
      administration, the dose of naproxen may be adjusted up or down depending on the
      clinical response of the patient.
      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 naproxen (Naproxen),
      section 'dosage and administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients below the age of 2 years have not
      been established. Pediatric dosing recommendations for polyarticular juvenile
      idiopathic arthritis are based on well-controlled studies [ see Dosage and
      Administration (2) ].
      Source: US FDA label for naproxen (Naproxen), section 'pediatric use', retrieved
      2026-08-29
    - Use the lowest effective dosage for shortest duration consistent with individual
      patient treatment goals. (2.1) Rheumatoid Arthritis, Osteoarthritis, and
      Ankylosing Spondylitis Naproxen delayed-release tablets 375 mg or 500 mg Twice
      daily To maintain the integrity of the enteric coating, the naproxen delayed-
      release tablet should not be broken, crushed or chewed during ingestion.
      Source: US FDA label for naproxen (Naproxen), section 'dosage and administration',
      retrieved 2026-08-29
    - There are no adequate effectiveness or dose-response data for other pediatric
      conditions, but the experience in polyarticular juvenile idiopathic arthritis and
      other use experience have established that single doses of 2.5 to 5 mg/kg as
      naproxen suspension, with total daily dose not exceeding 15 mg/kg/day, are well
      tolerated in pediatric patients over 2 years of age.
      Source: US FDA label for naproxen (Naproxen), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - (8.3) Renal Impairment: Naproxen-containing products are not recommended for use
      in patients with moderate to severe and severe renal impairment (creatinine
      clearance <30 mL/min).
      Source: US FDA label for naproxen (Naproxen), section 'use in specific
      populations', retrieved 2026-08-29
    - (8.7) 8.1 Pregnancy Risk Summary Use of NSAIDs, including naproxen delayed-release
      tablets, 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 naproxen (Naproxen), 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 naproxen (Naproxen), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Geriatric patients may be at a greater risk for the development of a form of renal
      toxicity precipitated by reduced prostaglandin formation during administration of
      nonsteroidal anti-inflammatory drugs [ see Warnings and Precautions (5.6) ]. 8.6
      Hepatic Impairment Caution is advised when high doses are required and some
      adjustment of dosage may be required in these patients.
      Source: US FDA label for naproxen (Naproxen), section 'use in specific
      populations', retrieved 2026-08-29
    - Discontinue if abnormal liver tests persist or worsen or if clinical signs and
      symptoms of liver disease develop.
      Source: US FDA label for naproxen (Naproxen), section 'warnings and cautions',
      retrieved 2026-08-29
    - (5.5) Renal Toxicity: Monitor renal function in patients with renal or hepatic
      impairment, heart failure, dehydration, or hypovolemia.
      Source: US FDA label for naproxen (Naproxen), section 'warnings and cautions',
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Use of NSAIDs, including naproxen delayed-release tablets, 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 naproxen (Naproxen), section 'pregnancy', retrieved
      2026-08-29
    - Because of these risks, limit dose and duration of naproxen delayed-release
      tablets use between about 20 and 30 weeks of gestation, and avoid naproxen
      delayed-release tablets use at about 30 weeks of gestation and later in pregnancy
      (see CLINICAL CONSIDERATIONS , DATA ).
      Source: US FDA label for naproxen (Naproxen), section 'pregnancy', retrieved
      2026-08-29
    - Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including naproxen
      delayed-release tablets, 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 naproxen (Naproxen), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Infertility Females Based on the mechanism of action, the use of prostaglandin-
      mediated NSAIDs, including naproxen delayed-release tablets, may delay or prevent
      rupture of ovarian follicles, which has been associated with reversible
      infertility in some women.
      Source: US FDA label for naproxen (Naproxen), section 'nursing mothers', retrieved
      2026-08-29
    - Published animal studies have shown that administration of prostaglandin synthesis
      inhibitors has the potential to disrupt prostaglandin- mediated follicular rupture
      required for ovulation.
      Source: US FDA label for naproxen (Naproxen), section 'nursing mothers', retrieved
      2026-08-29
    - Small studies in women treated with NSAIDs have also shown a reversible delay in
      ovulation.
      Source: US FDA label for naproxen (Naproxen), section 'nursing mothers', retrieved
      2026-08-29