About the shortage of methylphenidate hydrochloride products

Summary

• Australian-registered Concerta modified-release tablets are expected to be in shortage until the end of December 2026
• The supply of all strengths of Ritalin LA capsules has resumed.
• The shortages of all strengths of Rubifen LA capsules are expected to resolve by the end of June 2026 (see table below)
• Supply of Australian-registered methylphenidate modified-release tablet and capsule products has improved, and previous approvals for the supply of overseas-registered methylphenidate modified-release tablets have lapsed
• Overseas-registered methylphenidate modified-release capsule products remain approved and are subsidised on the Pharmaceutical Benefits Scheme (PBS)

Pharmaceutical companies (the sponsors) Janssen-Cilag, Novartis and AFT Pharmaceuticals have notified us about shortages of their methylphenidate modified-release products (see table below). 

Some of these shortages are due to an increasing global demand for methylphenidate products and are affecting multiple countries. However, the reason for the shortage of individual products can vary. Please check the Medicine Shortage Reports Database (search for ‘methylphenidate’) for more information and each product's current shortage status. 

You can also check the current and anticipated shortage status of these products in the table below.

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

We acknowledge the concerns and difficulties caused by shortages of these medicines, especially due to the specific requirements for prescribing and dispensing them. 

Currently, the supply of methylphenidate products is improving. However, there may be periods when the supply of some products is limited or when some products are unavailable.   

We urge patients who will be affected by these shortages to speak with their pharmacist about supply. They should also consult with their prescribers early about their treatment plan, as new prescriptions may be needed to access alternate treatments. 

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 this 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. Please note:

• Approvals of overseas-registered methylphenidate modified-release tablet formulations lapsed on 31 January 2026, as supply of the Australian-approved methylphenidate modified-release tablet products has stabilised.
• Approvals for overseas-registered methylphenidate modified-release capsule products remain in place. 

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

Other actions we are taking to mitigate the impact of these shortages include:

• working with the 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
• meeting with medical colleges, health professional organisations and peak body groups to develop clinical management advice about alternatives during the shortage (see below)
• communicating updates on this webpage and also the Medicine shortage reports database- 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 have agreed to the following approach for health professionals 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 has 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 to access these resources.

We will continue to update this webpage with any further recommendations from the Methylphenidate MSAG.

Information for patients

We understand how crucial it is for patients and their caregivers to have consistent access to their methylphenidate medicine.  

The supply of methylphenidate hydrochloride products is improving and most products that were in shortage have resumed supply (see table above). We continue to monitor the supply of these products closely. 

There may be periods when some brands are limited in supply or unavailable. Your pharmacist can tell you about the best way to get your medicine during these shortages. 

To help with supply, we approved access to several overseas-registered methylphenidate modified-release products in multiple strengths during the shortage. Your pharmacist can order the alternative products by contacting the approval holder, whose details are available on the Section 19A approvals database. The overseas-registered alternatives are also subsidised on the PBS. 

We understand it can be frustrating when you are unable to get your preferred brand of medicine, but using other brands, including overseas-registered products, may at times be unavoidable during these shortages. 

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.

If you are having difficulty getting your regular medicines, speak to your doctor about alternative options for your situation. 

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.

Information for pharmacists

The supply of methylphenidate products is improving, with supply having resumed for most (see table above). We continue to monitor the supply of these products closely. 

Products that remain in shortage may continue to be available but there may be periods when the supply of some products is limited or interrupted. Please check stock availability at wholesalers when dispensing these medicines for your patients.

We also 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. Approvals for overseas-registered modified-release tablet products lapsed on 31 January 2026, however, overseas-registered methylphenidate modified-release capsules remain approved under section 19A. Please see the Section 19A approvals database for information about currently approved overseas-registered section 19A products.

Pharmacists can continue to dispense remaining overseas-registered stock they had purchased while the product was approved, after the section 19A approval has ended. This stock can be dispensed to patients until it is used up or until it reaches its expiry date. These products will eventually be removed from the PBS, and it is important to review the list of Section 19A medicines subsidised by the Pharmaceutical Benefits Scheme at the time of supply.

The overseas-registered alternatives are subsidised on the PBS. If a new prescription is required, please inform the patient to see their prescriber. 

Please also advise patients to contact their doctor if their prescribed medicine is unavailable and substitutable alternatives are either inappropriate or unavailable. 

Information for prescribers

The supply of methylphenidate products is improving, with supply having resumed for most (see table above). Products that remain in shortage may continue to be available but there will be periods when the supply of some products is limited or interrupted. Your patients may want to discuss ongoing treatment options while methylphenidate products are in shortage.

Pharmacists, patients and carers may contact you to authorise use of alternative strengths or formulations of methylphenidate substitute medicines. We acknowledge the difficulties involved in the prescribing of controlled medicines and the extra administrative workload these shortages cause. We understand that knowing about shortages early enables you to review and change prescriptions and treatment for patients if needed. 

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

We approved access to several strengths of overseas-registered methylphenidate modified-release products. Some of these products remain available. Pharmacists can order these alternative products and supply them using existing prescriptions. Further details are available on our Section 19A approvals database. 

Please note that:

• your patient may require a new prescription to access an overseas-registered alternative, subsidised on the PBS
• pharmacists will advise patients to contact you if their prescribed medicine is unavailable and substitutable alternatives are either inappropriate or unavailable.

Please also note the advice from the Methylphenidate MSAG (see above) to consider the ongoing shortages when prescribing methylphenidate products. 

As outlined above, you should inform patients that the supply of some methylphenidate medicines may be limited throughout 2026, and discuss alternative treatments when they are unable to access their usual medicine.

The Australasian ADHD Professionals Association has developed comprehensive clinical guidance on managing patient treatment during the methylphenidate shortages. To access these resources, go to: ADHD Medication Shortage Clinical Guidance for Healthcare Professionals.

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.