72/100 · Elevated
Manufactured by Takeda Pharmaceuticals America, Inc.
Lisdexamfetamine Dimesylate Reports Show Significant Safety Concerns
65,887 FDA adverse event reports analyzed
Last updated: 2026-05-12
LISDEXAMFETAMINE DIMESYLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 65,887 FDA adverse event reports, LISDEXAMFETAMINE DIMESYLATE has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for LISDEXAMFETAMINE DIMESYLATE include DRUG INEFFECTIVE, OFF LABEL USE, FATIGUE, ANXIETY, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LISDEXAMFETAMINE DIMESYLATE.
Lisdexamfetamine Dimesylate has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 65,887 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Fatigue. Of classified reports, 40.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A high percentage of reports (40.1%) describe serious adverse events, including intentional overdose and suicidal ideation.
The most common reactions include fatigue, anxiety, and headache, indicating a broad range of potential side effects. There are significant reports of drug ineffectiveness and off-label use, suggesting issues with product efficacy and misuse. A notable number of reports involve product availability and use issues, indicating potential supply and usage problems.
Patients taking Lisdexamfetamine Dimesylate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Warnings include the risk of intentional overdose and suicidal ideation, and the drug should be used with caution, especially in patients with a history of mental health issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lisdexamfetamine Dimesylate received a safety concern score of 72/100 (elevated concern). This is based on a 40.1% serious event ratio across 31,487 classified reports. The score accounts for 65,887 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 15,979, Male: 10,970, Unknown: 319. The most frequently reported age groups are age 14 (527 reports), age 15 (507 reports), age 16 (497 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 31,487 classified reports for LISDEXAMFETAMINE DIMESYLATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Warnings include the risk of intentional overdose and suicidal ideation, and the drug should be used with caution, especially in patients with a history of mental health issues.
If you are taking Lisdexamfetamine Dimesylate, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, fatigue, anxiety, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any serious adverse events to their healthcare provider immediately. Healthcare providers should carefully monitor patients for signs of suicidal ideation and intentional overdose. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of lisdexamfetamine dimesylate, and healthcare providers should be vigilant about potential serious adverse events and ensure proper patient management.
The FDA has received approximately 65,887 adverse event reports associated with Lisdexamfetamine Dimesylate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Lisdexamfetamine Dimesylate include Drug Ineffective, Off Label Use, Fatigue, Anxiety, Headache. By volume, the top reported reactions are: Drug Ineffective (4,466 reports), Off Label Use (1,949 reports), Fatigue (1,929 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lisdexamfetamine Dimesylate.
Out of 31,487 classified reports, 12,620 (40.1%) were classified as serious and 18,867 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Lisdexamfetamine Dimesylate break down by patient sex as follows: Female: 15,979, Male: 10,970, Unknown: 319. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Lisdexamfetamine Dimesylate adverse events are: age 14: 527 reports, age 15: 507 reports, age 16: 497 reports, age 17: 480 reports, age 9: 471 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Lisdexamfetamine Dimesylate adverse event reports is Takeda Pharmaceuticals America, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Lisdexamfetamine Dimesylate include: Product Availability Issue, Nausea, Insomnia, Feeling Abnormal, Depression. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Lisdexamfetamine Dimesylate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Lisdexamfetamine Dimesylate has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. A high percentage of reports (40.1%) describe serious adverse events, including intentional overdose and suicidal ideation.
Key safety signals identified in Lisdexamfetamine Dimesylate's adverse event data include: Intentional overdose and suicidal ideation are among the most serious adverse events reported.. Drug ineffectiveness and off-label use are frequent, indicating potential misuse or lack of efficacy.. Product availability and use issues are common, suggesting supply chain and usage problems.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Warnings include the risk of intentional overdose and suicidal ideation, and the drug should be used with caution, especially in patients with a history of mental health issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lisdexamfetamine Dimesylate.
Patients should report any serious adverse events to their healthcare provider immediately. Healthcare providers should carefully monitor patients for signs of suicidal ideation and intentional overdose.
Lisdexamfetamine Dimesylate has 65,887 adverse event reports on file with the FDA. The most common reactions include fatigue, anxiety, and headache, indicating a broad range of potential side effects. The volume of reports for Lisdexamfetamine Dimesylate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of lisdexamfetamine dimesylate, and healthcare providers should be vigilant about potential serious adverse events and ensure proper patient management. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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