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 shortage of all strengths of Teva-XR modified-release tablets has resolved.
• There is limited supply of Ritalin LA and Rubifen LA capsules; most products will be in shortage until the end of December 2025 (see table below for dates for individual brands and strengths)
• Substitute overseas-registered methylphenidate modified-release tablets and capsules in multiple strengths have been approved; some are subsidised on the Pharmaceutical Benefits Scheme (PBS)
• Clinical guidelines are available for prescribers to use during the shortages (see below)  

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- external site (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. 

During the anticipated shortage period, the sponsors of these methylphenidate products will continue to receive supply but there may be periods when the supply is limited or some products are unavailable.   

Other medicines approved to treat ADHD are available. 

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 have 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. 

The availability of overseas-registered section 19A products may fluctuate, please get in touch with the approval holders of the relevant products for availability and ordering information. 

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

• working with wholesalers to distribute stock fairly when it is available
• 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 have 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.  

Methylphenidate hydrochloride products will continue to be available during the shortage but there may be periods when supply is limited or some products are unavailable. Your pharmacist can tell you about the best way to get your medicine during these shortages. 

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

We understand it can be frustrating when you are unable to get your preferred brand of a 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 about this.

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

Methylphenidate products will continue to be available during the shortage but there may be periods when the supply is limited and some products are unavailable. Please check stock availability at wholesalers when dispensing these medicines for your patients.

We have also approved the supply of multiple strengths of overseas-registered methylphenidate modified-release products to minimise the impact of these shortages. You can order these alternative products and supply them to patients using existing prescriptions. If a new prescription is required, please inform the patient to see their prescriber.

You can call the approval holders, Phero Pharma on (02) 9420 9199, Medsurge Healthcare on 1300 788 261, Pharmacor on 1300 138 805 or Arrotex Pharmaceuticals on 1800 195 055, for details about ordering these products. Go to our Section 19A approvals database for more information. Some of these overseas-registered alternatives are subsidised on the PBS. 

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

Information for prescribers

Methylphenidate products will continue to be available during the shortage but there will be periods when the supply is limited and some products are unavailable. 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 have approved access to several strengths of overseas-registered methylphenidate modified-release products. Pharmacists can order these alternative products and supply them using existing prescriptions. Further details are available on our Section 19A approvals database.  

Please also note that:

• only some of the overseas-registered alternatives we have approved are subsidised on the PBS; your patient may require a new prescription for a PBS-subsidised medicine
• 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, and to consider the availability of other ADHD medicines when there is a need to change to an alternative: 

• Current shortages are affecting most brands of methylphenidate MR and there is limited supply (please see table above).
• Methylphenidate IR, dexamfetamine IR and lisdexamfetamine are available.

As outlined above, you should inform patients that supply of the various methylphenidate medicines is expected to be limited during 2025 and 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.