Change to methotrexate pack sizes due to safety concerns

Published in NPS RADAR

Date published: About this date

Clinical content may change after this date. This information is not intended as a substitute for medical advice from a qualified health professional. Health professionals should rely on their own expertise and enquiries when providing medical advice or treatment.

From 1 April 2008 a smaller pack size of methotrexate 10 mg tablets (15 tablets with maximum of 1 repeat) was made available on the PBS as an unrestricted benefit. The new PBS listing is to help reduce the chance of accidental overdose and potentially fatal toxicity.1 As a result of this change, the currently listed larger pack size of methotrexate 10 mg tablets (50 tablets with a maximum of 2 repeats) has received a restricted benefit listing, for patients requiring doses exceeding 20 mg weekly.1

Methotrexate can cause severe toxicity and death when the recommended dosage (dose and/or dose frequency) is exceeded.2

When prescribing or dispensing methotrexate to patients or carers:

  • stress the importance of taking methotrexate only as prescribed
  • provide clear written and verbal instructions to ensure the dosage regimen is understood (for example, the Methoblastin consumer medicine information [CMI] leaflet contains instructions about safe use and may be a useful counselling aid)
  • for weekly regimens agree on a specific day of the week for taking methotrexate (preferably one of significance for the individual) and make sure once-weekly dosing is not confused with once-daily dosing.2–4
  • emphasise the importance of regular monitoring (blood tests)
  • warn about possible signs and symptoms of toxicity and explain what to do if these develop.3


  1. Australian Government Department of Health and Ageing. Positive recommendations made by the PBAC — March 2008. (accessed 4 July 2008).
  2. Adverse Drug Reactions Advisory Committee (ADRAC). Methotrexate — name the day. Australian Adverse Drugs Reaction Bulletin 1998;17. (accessed 4 July 2008).
  3. New South Wales Government Department of Health. Methotrexate — safe use of oral methotrexate. 2005. (accessed 4 July 2008).
  4. Kanagarajah S. Perils and pitfalls of methotrexate prescription. Australian Prescriber 2000;23.