25/100 · Low Risk
Manufactured by Teva Pharmaceuticals USA, Inc.
Amphetamine-Based Stimulants: Common Adverse Reactions and Low Serious Event Rate
69,920 FDA adverse event reports analyzed
Last updated: 2026-05-12
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Teva Pharmaceuticals USA, Inc.. Based on analysis of 69,920 FDA adverse event reports, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE has a safety score of 25 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE 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 SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate has a safety concern score of 25 out of 100, placing it in the low concern category based on analysis of FDA adverse event data. The FDA has received approximately 69,920 adverse event reports for this medication, which is primarily manufactured by Teva Pharmaceuticals Usa, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 46.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most common reactions include fatigue, nausea, and headache.
Serious adverse events account for 46.4% of total reports, but the majority are non-serious. The drug is frequently reported to be ineffective or to cause weight changes. Insomnia and anxiety are also commonly reported. Pain and dizziness are frequently reported side effects.
Patients taking Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with monoamine oxidase inhibitors (MAOIs) are contraindicated, and caution is advised when co-administering with other stimulants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate received a safety concern score of 25/100 (low concern). This is based on a 46.4% serious event ratio across 33,885 classified reports. The score accounts for 69,920 total adverse event reports and 100 distinct reaction types. This relatively low score suggests a favorable safety profile in reported data.
Adverse event reports by sex: Female: 23,097, Male: 8,760, Unknown: 208. The most frequently reported age groups are age 35 (477 reports), age 32 (442 reports), age 33 (442 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 33,885 classified reports for DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE:
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.
Interactions with monoamine oxidase inhibitors (MAOIs) are contraindicated, and caution is advised when co-administering with other stimulants.
If you are taking Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate, 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. Patients should be closely monitored for signs of depression, anxiety, and suicidal ideation. Inform healthcare providers about any pre-existing conditions or medications to avoid potential interactions. 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 monitors these drugs closely, and any serious adverse events should be reported to the agency immediately.
The FDA has received approximately 69,920 adverse event reports associated with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate. 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate include Drug Ineffective, Fatigue, Nausea, Headache, Anxiety. By volume, the top reported reactions are: Drug Ineffective (3,221 reports), Fatigue (2,738 reports), Nausea (2,533 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate.
Out of 33,885 classified reports, 15,723 (46.4%) were classified as serious and 18,162 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate break down by patient sex as follows: Female: 23,097, Male: 8,760, Unknown: 208. 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate adverse events are: age 35: 477 reports, age 32: 442 reports, age 33: 442 reports, age 36: 438 reports, age 34: 429 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate adverse event reports is Teva Pharmaceuticals Usa, 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate has a safety concern score of 25 out of 100 (low 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. Most common reactions include fatigue, nausea, and headache.
Key safety signals identified in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate's adverse event data include: Frequent reports of drug ineffectiveness and weight changes suggest potential issues with efficacy and side effects.. High incidence of anxiety and depression signals a need for careful monitoring of mental health.. Reports of suicidal ideation and agitation highlight the importance of patient counseling and monitoring.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with monoamine oxidase inhibitors (MAOIs) are contraindicated, and caution is advised when co-administering with other stimulants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate.
Patients should be closely monitored for signs of depression, anxiety, and suicidal ideation. Inform healthcare providers about any pre-existing conditions or medications to avoid potential interactions.
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate has 69,920 adverse event reports on file with the FDA. Serious adverse events account for 46.4% of total reports, but the majority are non-serious. The volume of reports for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA monitors these drugs closely, and any serious adverse events should be reported to the agency immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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