About the shortage of methylphenidate hydrochloride modified-release tablets

Pharmaceutical company Janssen-Cilag has notified us about the following current and anticipated shortages of their Concerta (methylphenidate hydrochloride) modified-release tablet products (see table below). 

The other supplier of modified-release methylphenidate hydrochloride tablets, Teva Pharma Australia, has also reported shortages for all strengths until the end of 2025 (see table below).

These shortages are due to manufacturing issues and are affecting multiple countries. 

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

We understand how crucial it is for patients and their caregivers to have consistent access to methylphenidate modified release tablets. We acknowledge the concerns and difficulties caused by shortages of this medicine, especially due to the specific requirements for prescribing and dispensing it. 

We are working with the pharmaceutical companies to minimise the impact on patients, prescribers and pharmacies by closely monitoring the supply of all strengths and updating this page with new information as soon as it becomes available. 

Other forms of methylphenidate medicines, such as immediate-release tablets and modified-release capsules, remain available. Other medicines approved to treat ADHD are also 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. 

We have approved the supply of overseas-registered alternatives to Concerta under section 19A of the Therapeutic Goods Act 1989 to reduce the impact of these shortages. Go to the Section 19A approvals database for up-to-date information about these alternative products (search by the active ingredient ‘methylphenidate’).

You can go to the Medicine Shortage Reports Database- external site (search for ‘methylphenidate’) for the most up-to-date information. 

Information for patients

We understand how crucial it is for patients and their caregivers to have consistent access to methylphenidate. We acknowledge the concerns and difficulties caused by shortages of this medicine, particularly due to the specific requirements for prescribing and dispensing it. 

Your pharmacist can tell you about the best way to get your medicines during these shortages. To help with supply, we have approved access to several overseas-registered strengths of Concerta modified-release tablets. Your pharmacist can order these alternative products by contacting the approval holder, Medsurge. Further information is available on the Section 19A approvals database.

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 a Section 19A medicine, they should explain any differences between the products.

Please note that certain medicines a pharmacist can substitute may cost you more. 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. 

Information for pharmacists

We have approved the supply of multiple strengths of overseas-registered Concerta methylphenidate modified-release products. You can order these alternative products and supply them to patients using existing prescriptions. 

Please call the approval holder Medsurge Healthcare on 1300 788 261, for details about ordering these products. Further details are available on our Section 19A approvals database. 

Section 19A-approved Concerta tablets are not PBS-subsidised. Please advise patients to contact their doctor if their prescribed medicine is unavailable and substitutable alternatives are either inappropriate or unavailable.

Information for prescribers

Your patients may want to discuss ongoing treatment options while Concerta and Methylphenidate-Teva modified-release tablets are unavailable.

Pharmacists, patients and carers may contact you to authorise alternative strengths or formulations of methylphenidate modified-release substitute medicines to treat their condition. We acknowledge the difficulties involved in the prescribing of controlled drugs 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. 

Please refer to this webpage and the Medicine Shortage Reports Database for the most up-to-date information. 

We have approved access to several overseas-registered strengths of Concerta methylphenidate modified-release tablets. 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:

• section 19A-approved Concerta medicines are not PBS-subsidised and your patient may prefer a new prescription for a medicine that is 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.

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 extended-release products.

Please also keep in mind that we can work with pharmaceutical companies to communicate information about medicine shortages to health professionals and patients, but 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.