About the shortage of methylphenidate hydrochloride products

Summary

• The supply of most methylphenidate hydrochloride products has resumed.
• The shortage of Rubifen LA capsules has been extended until September 2026.
• The approvals we granted for the supply of overseas-registered methylphenidate modified-release products during the shortage have now lapsed. 

During 2024 to 2025, pharmaceutical companies (the sponsors) Janssen-Cilag, Novartis and AFT Pharmaceuticals notified us about shortages of their methylphenidate modified-release products. 

Methylphenidate hydrochloride products are used to treat attention deficit hyperactivity disorder (ADHD). 

Some of these shortages were due to an increasing global demand for methylphenidate products and affected multiple countries. The shortages of most methylphenidate products have now resolved, and the overall supply continues to improve and stabilise. You can check the current and anticipated shortage status of these products in the table below.

The TGA’s response to these shortages

Our role in medicine shortages is to reduce the impact on patients where possible. To assist patients during the shortage, we approved the supply of multiple strengths of overseas-registered methylphenidate modified-release products under section 19A of the Therapeutic Goods Act 1989. As supply has improved and Australian-registered products are now available, these approvals have now lapsed.

Other actions we implemented to mitigate the impact of these shortages:

• worked with sponsors to minimise the impact on patients, prescribers and pharmacies by closely monitoring the supply of all products and updating this page with new information as soon as it becomes available
• met with medical colleges, health professional organisations and peak body groups to develop clinical management advice about alternatives during the shortage (see below)
• communicated updates on this webpage and also the Medicine shortage reports database- external site- external site. 

We convened a Medicine Shortage Action Group (MSAG) with the following health professional groups and peak body groups for input to help us manage the shortage:

• ADHD Foundation
• Advanced Pharmacy Australia (AdPhA)
• Australian Medical Association (AMA)
• Australasian Society for Developmental Paediatrics (ASDP)
• Australasian ADHD Professionals Association (AADPA)
• National Aboriginal Community Controlled Health Organisation (NACCHO)
• Pharmaceutical Society of Australia (PSA)
• Royal Australian and New Zealand College of Psychiatrists (RANZCP)
• Royal Australian College of General Practitioners (RACGP)
• Royal Australasian College of Physicians (RACP)
• Pharmacy Guild of Australia.

Information for patients

The supply of most methylphenidate hydrochloride products has resumed and continues to improve and stabilise. We continue to monitor the supply of these products closely. 

During the shortage, we approved access to several overseas-registered methylphenidate modified-release products in multiple strengths to help with supply. As supply of Australian-registered products has now resumed, the approvals allowing supply of these products have lapsed. 

Information for pharmacists and prescribers

The supply of most methylphenidate hydrochloride products has resumed and continues to improve and stabilise. We continue to monitor the supply of these products closely. 

You can check this webpage and the Medicine Shortage Reports Database- external site for the most up-to-date information. 

During the shortage, we approved the supply of multiple strengths of overseas-registered methylphenidate modified-release products under section 19A of the Therapeutic Goods Act 1989 to minimise the impact of these shortages. As supply of the Australian-registered products has now resumed, the approvals allowing the supply of these products have lapsed.

General information

Please note that the dates given for these shortages may change and we encourage you to check the Medicine Shortage Reports Database for updates about the supply of methylphenidate products.

While we can work with pharmaceutical companies to communicate information about medicine shortages to health professionals and patients, we cannot compel companies to increase supply or apply to have their products subsidised on the PBS.

While we can suggest approaches to manage the supply of medicines during shortages, we do not have the power to regulate the clinical decisions of health professionals.

We will continue to monitor the supply of methylphenidate-containing products and work with the suppliers and relevant health professionals to update this advice if needed.

Please also know that there is always someone to talk to about mental health and behavioural concerns. If you or someone close to you is experiencing an emergency, or is at immediate risk of harm, call triple zero (000). To talk to someone now, call Beyond Blue on 1300 22 4636 or Lifeline on 13 11 14. 

The HealthDirect website has a full list of mental health resources at www.healthdirect.gov.au/mental-health-resources.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to our monitoring of these products.

We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.