# Naproxen ```text 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 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)