INDICATIONS AND LIMITATIONS OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult and pediatric patients 6 and older, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
- Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
Warnings and Precautions
- Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
- CNS stimulants cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
- Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD (monitor weight and height). Treatment may need to be interrupted in pediatric patients not growing or gaining weight as expected. Vyvanse is not approved for use in pediatric patients below 6 years of age.
- CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
Adverse Reactions
- Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
- Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
- Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.
Pregnancy and Lactation
Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.
Other Considerations
- Safety and effectiveness in patients <18 years with B.E.D. have not been established.

Please click here for Full Prescribing Information.

INDICATION AND LIMITATIONS OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 and older. Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
- Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
Warnings and Precautions
- Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
- CNS stimulants cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
- Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients (monitor weight and height). Treatment may need to be interrupted in patients not growing or gaining weight as expected. Vyvanse is not approved for use in pediatric patients below 6 years of age.
- CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
Adverse Reactions
- Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
- Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
- Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
Pregnancy and Lactation

Please click here for Full Prescribing Information.

INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
- Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
Warnings and Precautions
- Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
- CNS stimulants cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
- Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
Adverse Reactions
- The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.
Pregnancy and Lactation
Other Considerations
- Safety and effectiveness in patients <18 years with B.E.D. have not been established.

Please click here for Full Prescribing Information.

VYVANSE and the VYVANSE logo are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited. ©2022 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved. 1-877-TAKEDA-7 (1-877-825-3327).

All content of this website, including text, images, graphics, sound files, and their arrangement, is copyrighted and owned by Takeda Pharmaceuticals U.S.A., Inc. and is protected by international copyright laws. All other intellectual property rights are reserved. The content may not be copied for commercial use or, distribution, nor may these objects be downloaded, modified, or posted to other sites. This site is intended solely for US residents and is governed solely by US laws and government regulations. Please see our Terms of Use for more information. While Takeda makes reasonable efforts to include accurate, up-to-date information on this site, Takeda makes no warranties or representations as to its accuracy. Takeda assumes no liability for any errors or omissions in the content of this site. The information on this site is not intended to make a diagnosis or to take the place of talking to a US healthcare professional.

US-LIS-1285v1.0 10/22

Keep in touch

INDICATIONS AND LIMITATIONS OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in ages 6+ and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Pediatric patients with ADHD <6 years of age experienced more long-term weight loss than patients 6+ years. It is not for weight loss or to treat obesity. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. Click here for FULL SAFETY INFORMATION.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE: CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. Click here for FULL SAFETY INFORMATION.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

Go Back

INDICATIONS AND LIMITATIONS OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult and pediatric patients 6 and older, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
- Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
Warnings and Precautions
- Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
- CNS stimulants cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
- Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD (monitor weight and height). Treatment may need to be interrupted in pediatric patients not growing or gaining weight as expected. Vyvanse is not approved for use in pediatric patients below 6 years of age.
- CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
Adverse Reactions
- Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
- Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
- Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.
Pregnancy and Lactation
Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.
Other Considerations
- Safety and effectiveness in patients <18 years with B.E.D. have not been established.

Please click here for Full Prescribing Information.

Keep in touch

INDICATION AND LIMITATIONS OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in ages 6+. Pediatric patients with ADHD <6 years of age experienced more long-term weight loss than patients 6+ years. It is not for weight loss or to treat obesity. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. Click here for FULL SAFETY INFORMATION.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE: CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. Click here for FULL SAFETY INFORMATION.

INDICATION AND IMPORTANT SAFETY INFORMATION

Go Back

INDICATION AND LIMITATIONS OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 and older. Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
- Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
Warnings and Precautions
- Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
- CNS stimulants cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
- Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients (monitor weight and height). Treatment may need to be interrupted in patients not growing or gaining weight as expected. Vyvanse is not approved for use in pediatric patients below 6 years of age.
- CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
Adverse Reactions
- Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
- Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
- Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
Pregnancy and Lactation
Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.

Please click here for Full Prescribing Information.

Keep in touch

INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. It is not for weight loss or to treat obesity. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. Click here for FULL SAFETY INFORMATION.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE: CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. Click here for FULL SAFETY INFORMATION.

INDICATION AND IMPORTANT SAFETY INFORMATION

Go Back

INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
- Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.
Warnings and Precautions
- Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
- CNS stimulants cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
- Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
Adverse Reactions
- The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.
Pregnancy and Lactation
Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.

Other Considerations
- Safety and effectiveness in patients <18 years with B.E.D. have not been established.

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