Methotrexate

DRUG INFORMATION

  ADULT
    - ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) RA: Recommended starting dosage
      of 7.5 mg once weekly intramuscularly; adjust dose to achieve an optimal response.
      Source: US FDA label for methotrexate (Methotrexate), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.10 ) pJIA: Recommended starting dosage of 10 mg/m 2 once weekly subcutaneously
      or intramuscularly; adjust dose to achieve an optimal response.
      Source: US FDA label for methotrexate (Methotrexate), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.11 ) Psoriasis: Recommended dosage of 10 mg to 25 mg once weekly
      intramuscularly or intravenously; adjust dose to achieve optimal response.
      Source: US FDA label for methotrexate (Methotrexate), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of Methotrexate Injection in pediatric patients have
      been established for ALL, meningeal leukemia prophylaxis and treatment, non-
      Hodgkin lymphoma, osteosarcoma and in pJIA. Clinical studies evaluating the use of
      methotrexate in pediatric patients with pJIA demonstrated safety comparable to
      that observed in adults with RA [see Adverse Reactions ( 6.1 )] .
      Source: US FDA label for methotrexate (Methotrexate), section 'pediatric use',
      retrieved 2026-08-29
    - Verify pregnancy status in females of reproductive potential before starting
      Methotrexate Injection. ( 2.1 , 4 , 5.1 ) Neoplastic diseases: Refer to the
      prescribing information for disease specific dosing recommendations. Follow
      guidelines for high-dose regimens. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9
      ) RA: Recommended starting dosage of 7.5 mg once weekly intramuscularly; adjust
      dose to achieve an optimal response.
      Source: US FDA label for methotrexate (Methotrexate), section 'dosage and
      administration', retrieved 2026-08-29
    - In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels
      of benzyl alcohol and its metabolites in the blood and urine (blood levels of
      benzyl alcohol were 0.61 to 1.378 mmol/L).
      Source: US FDA label for methotrexate (Methotrexate), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Leukemia/Lymphoma Serious neurotoxicity, frequently manifested as generalized or
      focal seizures, has been reported with unexpectedly increased frequency among
      pediatric patients with acute lymphoblastic leukemia who were treated with
      intermediate-dose intravenous methotrexate (1 g/m 2 ) [see Warnings and
      Precautions ( 5.8 )] .
      Source: US FDA label for methotrexate (Methotrexate), section 'use in specific
      populations', retrieved 2026-08-29
    - Patients with renal impairment are at increased risk for methotrexate adverse
      reactions.
      Source: US FDA label for methotrexate (Methotrexate), section 'use in specific
      populations', retrieved 2026-08-29
    - Consider reducing the dose or discontinuing methotrexate injection in patients
      with renal impairment as appropriate. 8.7 Hepatic Impairment The pharmacokinetics
      and safety of methotrexate in patients with hepatic impairment is unknown.
      Source: US FDA label for methotrexate (Methotrexate), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Consider reducing the dose or discontinuing methotrexate injection in patients
      with renal impairment as appropriate. 8.7 Hepatic Impairment The pharmacokinetics
      and safety of methotrexate in patients with hepatic impairment is unknown.
      Source: US FDA label for methotrexate (Methotrexate), section 'use in specific
      populations', retrieved 2026-08-29
    - Patients with hepatic impairment may be at increased risk for methotrexate adverse
      reaction based on elimination characteristics of methotrexate [see Clinical
      Pharmacology ( 12.3 )] .
      Source: US FDA label for methotrexate (Methotrexate), section 'use in specific
      populations', retrieved 2026-08-29
    - Consider reducing the dose or discontinuing methotrexate injection in patients
      with hepatic impairment as appropriate [see Warnings and Precautions ( 5.7 )] .
      Source: US FDA label for methotrexate (Methotrexate), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY   [ AVOID ]
    The label says not to use it. Read the quote below before deciding.
    - Risk Summary Methotrexate Injection is contraindicated in pregnant women with non-
      neoplastic diseases.
      Source: US FDA label for methotrexate (Methotrexate), section 'pregnancy',
      retrieved 2026-08-29
    - Based on published reports and its mechanism of action, methotrexate can cause
      embryo-fetal toxicity and fetal death when administered to a pregnant woman [see
      Data and Clinical Pharmacology ( 12.1 )] .
      Source: US FDA label for methotrexate (Methotrexate), section 'pregnancy',
      retrieved 2026-08-29
    - There are no animal data that meet current standards for nonclinical developmental
      toxicity studies.
      Source: US FDA label for methotrexate (Methotrexate), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Methotrexate can cause malformations and fetal death at doses less than or equal
      to the recommended clinical doses [see Use in Specific Populations ( 8.1 )] .
      Source: US FDA label for methotrexate (Methotrexate), section 'nursing mothers',
      retrieved 2026-08-29
    - Pregnancy Testing Verify the pregnancy status of females of reproductive potential
      prior to initiating Methotrexate Injection [see Contraindications ( 4 ) and Use in
      Specific Populations ( 8.1 )] .
      Source: US FDA label for methotrexate (Methotrexate), section 'nursing mothers',
      retrieved 2026-08-29
    - Contraception Females Advise females of reproductive potential to use effective
      contraception during and for 6 months after the last dose of Methotrexate
      Injection therapy.
      Source: US FDA label for methotrexate (Methotrexate), section 'nursing mothers',
      retrieved 2026-08-29