65/100 · Elevated
Manufactured by Takeda Pharmaceuticals America, Inc.
Amphetamine-Based Stimulants: Common Adverse Events and Safety Concerns
80,937 FDA adverse event reports analyzed
Last updated: 2026-05-12
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 80,937 FDA adverse event reports, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE include DRUG INEFFECTIVE, FATIGUE, NAUSEA, HEADACHE, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE.
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 80,937 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 43.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and nausea are the most common adverse events reported.
Serious adverse events, such as suicidal ideation and seizures, are concerning. The drug is associated with a range of psychological and neurological effects. Weight changes and gastrointestinal issues are also frequently reported. Adverse events related to drug misuse and incorrect dosing are prevalent.
Patients taking Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and misuse are common, with warnings against off-label use and incorrect dosing. Patients should avoid alcohol and other stimulants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate received a safety concern score of 65/100 (elevated concern). This is based on a 43.5% serious event ratio across 39,815 classified reports. The score accounts for 80,937 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: 26,252, Male: 10,619, Unknown: 314. The most frequently reported age groups are age 35 (528 reports), age 31 (493 reports), age 36 (493 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 39,815 classified reports for DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE:
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.
Drug interactions and misuse are common, with warnings against off-label use and incorrect dosing. Patients should avoid alcohol and other stimulants.
If you are taking Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, headache, anxiety. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosing instructions strictly to avoid adverse events. Report any serious side effects immediately to healthcare providers. Do not use the drug for off-label purposes or at higher doses than prescribed. 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 closely monitors these drugs due to their potential for abuse and serious adverse events. Regular medical follow-ups are recommended.
The FDA has received approximately 80,937 adverse event reports associated with Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate. 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 Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate include Drug Ineffective, Fatigue, Nausea, Headache, Anxiety. By volume, the top reported reactions are: Drug Ineffective (4,588 reports), Fatigue (3,117 reports), Nausea (2,816 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate.
Out of 39,815 classified reports, 17,328 (43.5%) were classified as serious and 22,487 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 Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate break down by patient sex as follows: Female: 26,252, Male: 10,619, Unknown: 314. 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 Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate adverse events are: age 35: 528 reports, age 31: 493 reports, age 36: 493 reports, age 33: 484 reports, age 34: 484 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 Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate 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 Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate include: Depression, Feeling Abnormal, Pain, Dizziness, Somnolence. 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 Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate 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.
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate has a safety concern score of 65 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. Fatigue and nausea are the most common adverse events reported.
Key safety signals identified in Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate's adverse event data include: Suicidal ideation and depression are key psychological safety signals.. Seizures and hypertension indicate potential neurological and cardiovascular risks.. Weight changes and gastrointestinal issues suggest metabolic and digestive side effects.. Incorrect dosing and drug dependence highlight the importance of proper usage.. Product quality issues and availability concerns indicate supply chain and manufacturing risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and misuse are common, with warnings against off-label use and incorrect dosing. Patients should avoid alcohol and other stimulants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate.
Follow prescribed dosing instructions strictly to avoid adverse events. Report any serious side effects immediately to healthcare providers. Do not use the drug for off-label purposes or at higher doses than prescribed.
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate has 80,937 adverse event reports on file with the FDA. Serious adverse events, such as suicidal ideation and seizures, are concerning. The volume of reports for Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors these drugs due to their potential for abuse and serious adverse events. Regular medical follow-ups are recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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