Vyvanse (lisdexamfetamine dimesilate)

Summary

Our investigation into reported concerns about Vyvanse’s potential lack of effectiveness, quality and safety found no issues of concern.

Vyvanse (lisdexamfetamine dimesilate) is used for the treatment of attention deficit hyperactivity disorder (ADHD), and moderate to severe binge eating disorder in adults when nonpharmacological treatment is unsuccessful or unavailable.

Approved therapeutic indications and other information to support safe and quality use of Vyvanse are outlined in the Australian Product Information (PI).

We began an investigation in March 2025 following an unexpected increase in the number of adverse event reports for Vyvanse, including concerns about lack of effectiveness, quality and safety. The increased reporting started in March 2025 and appeared to be stimulated by social media commentary.

Our testing found that all batches tested were compliant with expected strengths and quality.

What health professionals should do

Be alert to these issues and the potential for patients to raise their concerns.

Advise patients that our testing found no issues with quality, safety or effectiveness.

Background

Our review of the case reports found that most of the reported adverse event terms were already listed in the Australian PI.

Of the terms not listed in the Australian PI, some were related to a typographical error on the label, some were related to the underlying condition (ADHD), and some were concerns about lack of effectiveness.

The concern for lack of effectiveness was referred to TGA laboratories for further testing. No other safety signals were identified from the adverse event reports.

We published a Product Alert on 3 April 2025 covering multiple batches and pack sizes of Vyvanse, detailing the two minor typographical errors on the Vyvanse packaging. The alert informed patients and carers that the typographical errors did not impact the quality of the Vyvanse capsules or patient safety. It advised patients to continue taking Vyvanse as prescribed and to speak to a health professional about any concerns. 

Our laboratory reports can be accessed here.

Vyvanse is only PBS listed for ADHD (authority required).

Adverse events reported to us

A search of the TGA Database of Adverse Event Notifications (DAEN) retrieved 382 adverse event reports for Vyvanse from 1 January 2025 to 31 August 2025. 

The most reported adverse event terms included drug ineffective (190 cases), anxiety (100 cases), product label issue (94 cases), therapeutic response decreased (78 cases), insomnia (70 cases), condition aggravated (65 cases), disturbance in attention (62 cases), therapeutic product effect decreased (56 cases), fatigue (54 cases) and irritability (47 cases). 
 

The monthly number of all Vyvanse adverse event reports received peaked at 150 in April 2025 (75 reported as ‘drug ineffective’) and has been decreasing since then with 24 total reports in August 2025 (15 reported as ‘drug ineffective’).