Australia's pharmaceutical regulator is investigating an unprecedented surge in adverse event reports for Vyvanse, the country's most widely prescribed ADHD medication, as reports increased more than 15-fold in early 2025 compared to the previous year.
The Therapeutic Goods Administration (TGA) confirmed it is examining 330 suspected adverse event reports for lisdexamfetamine dimesilate (Vyvanse) submitted between January 1 and July 14, 2025, compared to just 21 reports for the entire previous year. The investigation includes independent laboratory testing and collaboration with manufacturer Takeda Pharmaceuticals Australia.
Social Media Amplifies Reporting Concerns
"Following social media commentary about this matter, there has been a recent increase in suspected adverse event reports submitted to the TGA regarding Vyvanse," the TGA stated. The agency noted that increased social media discussion typically stimulates adverse event reporting, independent of actual safety issues.
Associate Professor John Kramer, Chair of RACGP Specific Interests ADHD, described the situation as "particularly frustrating," noting it undermines confidence in an important alternative to methylphenidate during ongoing supply shortages. "It plays into a narrative where there's always people looking for a problem with any sort of drug," he said.
Google Trends data confirms heightened public interest in ADHD and Vyvanse searches in Australia, with numerous Reddit threads and ADHD influencers discussing side effects and encouraging followers to report adverse experiences.
Drug Inefficacy Leads Reported Issues
The most frequently reported adverse reaction was drug inefficacy, accounting for 165 of the reports, followed by anxiety, insomnia, condition aggravation, and attention disturbance. An additional 91 reports concerned product packaging issues.
Dr. Karuppiah Jagadheesan, spokesperson for the Royal Australian and New Zealand College of Psychiatrists, suggested the RANZCP's ADHD committee had questioned Vyvanse's effectiveness at current dosages for some patients, potentially explaining why ineffectiveness topped the adverse event list.
Associate Professor Kramer attributed many inefficacy reports to improper dose titration. "The advice from the experts with Vyvanse is that you've got to carefully titrate the dose upwards as long as it's tolerated, with no significant side effects, and then go one dose adjustment past the ideal one," he explained.
Packaging Errors Fuel Concerns
Two typographical errors in Vyvanse packaging earlier this year contributed to user concerns. The labeling incorrectly pluralized "capsule" to "capsules" and misspelled "pharmaceuticals" as "pharmaceutivals." While Takeda confirmed these errors "do not impact the medicine's safety or quality," Associate Professor Kramer noted they led some patients to believe the errors affected medication efficacy.
"That was enough to set off a certain amount of people, and then that feeds into social media, and then it generates its own momentum, and the facts don't get in the way," he said.
Prescription Volume Surge Coincides with Reports
The adverse event spike coincides with dramatic growth in ADHD medication prescribing. Vyvanse prescriptions nearly doubled from 958,831 in 2022 to more than 1.78 million in 2024, according to Pharmaceutical Benefits Scheme data.
The TGA noted that increased medication usage would normally result in higher adverse event reporting numbers. Between January 2015 and June 2025, the agency registered 754 adverse events for the three most common ADHD stimulants—methylphenidate, dexamphetamine, and lisdexamfetamine—with only Vyvanse's increase significant enough to constitute a safety signal.
Expert Reassurance on Safety Profile
Dr. Sarahn Lovett, vice president of the Australasian ADHD Professionals Association, emphasized that reported side effects were normal for all stimulants. "If Vyvanse was working for a patient, there was no reason to stop taking it," she said, while recommending patients experiencing side effects or ineffectiveness consult their prescribers.
However, Dr. Tim Jones, RACGP ADHD spokesperson, reported colleagues in public psychiatry were seeing more mental health admissions related to prescribed stimulants, often involving psychosis, anxiety, and insomnia episodes. "It's something that's certainly entering into serious territory for side effects," he noted.
Manufacturing and Quality Assurance
Speculation online suggested adverse events began after Vyvanse manufacturing moved to Germany in early 2024. Takeda confirmed the relocation was implemented to support increased demand but stated "there have been no changes to the formulation." The company maintains that manufacturing complies with Australia's Therapeutics Goods Act with strict quality controls in place.
The TGA confirmed no compliance signals were under investigation for facilities manufacturing Vyvanse, and that investigation outcomes would be communicated once completed, including any necessary regulatory actions.
