The lisdexamfetamine label: a boxed warning on misuse and addiction, and approval for binge eating disorder too
Vyvanse is a Schedule II stimulant approved for ADHD from age 6 and for moderate to severe binge eating disorder in adults. Its boxed warning covers abuse, misuse and addiction. It is not for weight loss.
Reasonable evidence with real limitations. how we score evidence
Caveat on this rating: Risk statements without per-person probabilities; the 0.1 percent psychosis figure is from short-term pooled trials.
The FDA-approved label for lisdexamfetamine (Vyvanse), read for its two approved uses and its main warnings.
Significant findings
VYVANSE is indicated for "Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older" and "Moderate to severe binge eating disorder (BED) in adults". The label adds: "VYVANSE is not indicated for weight loss." It is a prodrug of amphetamine, a Schedule II controlled substance.
The boxed warning: "VYVANSE has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including VYVANSE, can result in overdose and death". Prescribers are told to assess each patient's risk before and throughout treatment.
Other warnings: avoid with serious heart disease (5.2); monitor blood pressure and pulse (5.3); psychiatric reactions (5.4), including that stimulants "may cause psychotic or manic symptoms" in people with no such history, which in a pooled analysis of short-term trials "occurred in approximately 0.1% of CNS stimulant-treated patients compared to 0% of placebo-treated" patients; growth suppression in children (5.5); Raynaud's phenomenon (5.6); serotonin syndrome with serotonergic drugs (5.7); tics (5.8).
For binge eating disorder, two 12-week trials (374 and 350 adults) found greater reductions in binge days per week than placebo, by 1.35 and 1.66 days, from baselines of about 4.7 binge days.
The other direction
The binge eating trials also report a phase 2 study in which 30 mg "was not statistically different from placebo", while 50 and 70 mg were. The 0.1 percent psychosis figure is from short-term trials; longer-term and real-world rates are not given. A label lists risks without saying how likely they are for a given person.
What this does not show
It does not support use for weight loss, and it does not compare Vyvanse with other ADHD medicines. It is not a reason to start, stop or change a dose.
Worth asking
How will we check, over time, that the benefit is still worth the risks on this label?
Source
VYVANSE (lisdexamfetamine dimesylate) capsules and chewable tablets: FDA-approved prescribing information, Boxed Warning, Indications, Warnings 5.1 to 5.8, Clinical Studies 14.2 — Takeda Pharmaceuticals America, Inc.; US Food and Drug Administration (2026)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- Industry funded
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published October 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "moderate evidence". Reasonable evidence with real limitations. It scores 57 out of 100 on our published rubric. One caveat travels with that badge: Risk statements without per-person probabilities; the 0.1 percent psychosis figure is from short-term pooled trials. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
VYVANSE (lisdexamfetamine dimesylate) capsules and chewable tablets: FDA-approved prescribing information, Boxed Warning, Indications, Warnings 5.1 to 5.8, Clinical Studies 14.2 — Takeda Pharmaceuticals America, Inc.; US Food and Drug Administration (2026). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: Industry funded. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is lisdexamfetamine (Vyvanse), vyvanse FDA approved?
Yes — this medication carries FDA approval. Approval is always for a specific indication, not for every use it is prescribed for.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.