About the shortage of methylphenidate hydrochloride products

Summary

• The shortages of most methylphenidate modified-release products have resolved, including Concerta modified-release tablets and Ritalin LA modified-release capsules.
• The shortages of all strengths of Rubifen LA capsules are expected to resolve by the end of June 2026. 

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 also 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; some of these overseas-registered alternatives are registered on the PBS- external site- external site. 

Approvals for overseas-registered methylphenidate modified-release capsule products remain in place until the end of April 2026. 

Please check the Section 19A approvals database for more information on all current and past section 19A approvals.

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.

Clinical guidance from the Medicine Shortage Action Group

The members of the Methylphenidate MSAG agreed to the following approach for health professionals to utilise when prescribing ADHD medicines during the methylphenidate shortages:

• Consider the ongoing shortages when prescribing methylphenidate products.
• Consider the availability of other ADHD medicines when there is a need to change to an alternative.
• Where possible, switch within the same stimulant class first before considering a change of class; cross-class switching requires new titration.
• Inform patients that supply of the various methylphenidate products is expected to be limited throughout 2025 and 2026 at different times, and discuss alternative treatments when they are unable to access their usual medicine.

The Australasian ADHD Professionals Association developed clinical guidelines about managing the ADHD medicine shortages. The guidelines include information for bridging with methylphenidate IR or switching from methylphenidate to either lisdexamfetamine or dexamfetamine IR during the shortages. Go to: ADHD Medication Shortage Clinical Guidance for Healthcare Professionals- external site to access these resources.

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. Details of these approvals are available on the Section 19A approvals database. The overseas-registered alternatives are also subsidised on the PBS- external site. 

If your pharmacist offers you an overseas-registered alternative medicine, they should explain any differences between the products.

Please note that certain medicines a pharmacist can substitute may cost you more and, in some cases, you may require a new prescription. The pharmacist will tell you if this applies to you.

The Australasian ADHD Professionals Association has developed resources to support patients, families and educators during these shortages. You can access these at: Free Resources for Families, Educators, & Adults Navigating ADHD Medication Shortages- external site.

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. Overseas-registered methylphenidate modified-release capsules remain approved under section 19A until the end of April 2026. Please see the Section 19A approvals database for information about currently approved overseas-registered section 19A products.

Patients may require a new prescription from their prescriber to access an overseas-registered alternative, subsidised on the PBS- external site.

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.