ATC codes: L04AX03
Rheumatoid arthritis, serology unspecified ICD11 code: FA20.Z
Medicine type
Chemical agent
List type
Complementary (EML)
Oral > Solid > tablet: 2.5 mg (as sodium salt)
EML status history
First added in 1997 (TRS 882)
Changed in 2003 (TRS 920)
Changed in 2011 (TRS 965)
Changed in 2023 (TRS 1049)
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend the inclusion of sub-cutaneous injection formulations of methotrexate on the EML and EMLc for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and arthritic psoriasis and Crohn disease in patients not responding to maximum tolerable doses of oral methotrexate. The Committee noted that methotrexate is one of the mainstays of treatment for these conditions, but that data on clinical efficacy and safety of subcutaneous methotrexate compared to oral or intramuscular formulations are limited and are based mostly on studies in patients with rheumatoid arthritis. Overall, the Committee considered the possible benefits of subcutaneous compared to oral methotrexate were unclear, and with limited available evidence suggesting only modest benefits in a small proportion of patients, at a considerably higher price.