Ketoprofen

DRUG INFORMATION

  ADULT
    - Individual patients may show a better response to 300 mg of Ketoprofen Capsules,
      USP daily as compared to 200 mg, although in well-controlled clinical trials
      patients on 300 mg did not show greater mean effectiveness.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'dosage and
      administration', retrieved 2026-08-29
    - When treating patients with 300 mg/day, the physician should observe sufficient
      increased clinical benefit to offset potential increased risk.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'dosage and
      administration', retrieved 2026-08-29
    - In patients with mildly impaired renal function, the maximum recommended total
      daily dose of Ketoprofen Capsules, USP is 150 mg.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness in pediatric patients below the age of 18 have not been
      established.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'pediatric use',
      retrieved 2026-08-29
    - Carefully consider the potential benefits and risks of Ketoprofen Capsules, USP
      and other treatment options before deciding to use Ketoprofen Capsules, USP. Use
      the lowest effective dose for the shortest duration consistent with individual
      patient treatment goals (see WARNINGS ). After observing the response to initial
      therapy with Ketoprofen Capsules, USP, the dose and frequency should be adjusted
      to suit an individual patient's needs.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - In patients with a more severe renal impairment (GFR less than 25 mL/min/1.73 m2
      or end-stage renal impairment), the maximum total daily dose of Ketoprofen
      Capsules, USP should not exceed 100 mg.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'dosage and
      administration', retrieved 2026-08-29
    - Pregnancy Risk Summary Use of NSAIDs, including Ketoprofen Capsules, USP, 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 ketoprofen (Ketoprofen), section 'warnings and cautions',
      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 ketoprofen (Ketoprofen), section 'warnings and cautions',
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - A smaller dose should be utilized initially in small individuals, in debilitated
      or elderly patients, or in patients with renal or liver disease (see PRECAUTIONS
      ).
      Source: US FDA label for ketoprofen (Ketoprofen), section 'dosage and
      administration', retrieved 2026-08-29
    - If clinical signs and symptoms consistent with liver disease develop, or if
      systemic manifestations occur (e.g., eosinophilia, rash, etc.), Ketoprofen
      Capsules, USP should be discontinued.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'warnings and cautions',
      retrieved 2026-08-29
    - In patients with chronic liver disease with reduced serum albumin levels,
      ketoprofen’s pharmacokinetics are altered (see CLINICAL PHARMACOLOGY ).
      Source: US FDA label for ketoprofen (Ketoprofen), section 'warnings and cautions',
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Use of NSAIDs, including Ketoprofen Capsules, USP, 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 ketoprofen (Ketoprofen), section 'pregnancy', retrieved
      2026-08-29
    - Because of these risks, limit dose and duration of Ketoprofen Capsules, USP use
      between about 20 and 30 weeks of gestation, and avoid Ketoprofen Capsules, USP use
      at about 30 weeks of gestation and later in pregnancy [see WARNINGS ; Fetal
      Toxicity].
      Source: US FDA label for ketoprofen (Ketoprofen), section 'pregnancy', retrieved
      2026-08-29
    - Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including Ketoprofen
      Capsules, USP, 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 ketoprofen (Ketoprofen), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - It is not known whether this drug is excreted in human milk.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'nursing mothers',
      retrieved 2026-08-29
    - Data on secretion in human milk after ingestion of ketoprofen do not exist.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'nursing mothers',
      retrieved 2026-08-29
    - In rats, ketoprofen at doses of 9 mg/kg (54 mg/m2/day; approximately 0.3 times the
      maximum human therapeutic dose) did not affect perinatal development.
      Source: US FDA label for ketoprofen (Ketoprofen), section 'nursing mothers',
      retrieved 2026-08-29