Vyvanselisdexamfetamine
According to the FDA label: Lisdexamfetamine dimesylate capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1) ] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2) ] . Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4) ] .
32,167 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Vyvanse in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 4,564 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Fatigue 1,991 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 1,986 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Anxiety 1,752 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Headache 1,708 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →- Product Availability Issue 1,564 reports
Nausea 1,506 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Insomnia 1,455 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Depression 1,344 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Feeling Abnormal 1,344 reports
A general report that the person did not feel like themselves, without a more specific description.
Full definition in the glossary →Product Use Issue 1,303 reports
A general report that there was some problem in how the medication was used.
Full definition in the glossary →Disturbance in Attention 1,224 reports
Difficulty concentrating or staying focused.
Full definition in the glossary →No Adverse Event 1,191 reports
A report that was filed but did not actually describe any adverse event. This is a record-keeping category.
Full definition in the glossary →Product Quality Issue 1,170 reports
A report of a possible problem with the medication's quality, such as appearance, packaging, or condition. This is a quality-tracking category.
Full definition in the glossary →Intentional Overdose 1,126 reports
A report that a person deliberately took more of a medication than prescribed. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 16,326 |
| Male | 11,111 |
| Unknown | 319 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 5,628 |
| 18-34 | 4,759 |
| 35-49 | 3,614 |
| 50-64 | 2,071 |
| 65-74 | 397 |
| 75+ | 38 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Vyvanse. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 19,171 |
| Other Serious | 10,159 |
| Hospitalization | 3,812 |
| Disability | 704 |
| Life-Threatening | 459 |
| Death | 289 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Vyvanse. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2007 | 300 |
| 2008 | 974 |
| 2009 | 1,147 |
| 2010 | 431 |
| 2011 | 377 |
| 2012 | 415 |
| 2013 | 502 |
| 2014 | 1,419 |
| 2015 | 2,219 |
| 2016 | 3,132 |
| 2017 | 1,872 |
| 2018 | 1,904 |
| 2019 | 1,777 |
| 2020 | 1,804 |
| 2021 | 1,697 |
| 2022 | 2,501 |
| 2023 | 3,166 |
| 2024 | 3,254 |
| 2025 | 2,675 |
| 2026 (partial) | 601 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Vyvanse
In FDA adverse event reports that mention Vyvanse, these medications appeared most often in the same report.
- Dextroamphetamine Dextroamphetamine Saccharate Amphetamine And Amphetamine Aspartate (2,905 reports)
- Oxybate (2,888 reports)
- Ergocalciferol (2,040 reports)
- Dextroamphetamine Saccharate Amphetamine Aspartate Dextroamphetamine And Amphetamine (1,982 reports)
- Methylphenidate (1,707 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026