This site is intended for US health care professionals only.


This site is intended for US healthcare professionals only.


  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, 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.
Full Safety Information Below

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.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/High Potential for Abuse and Dependence1

Advise patients that Vyvanse is a controlled substance and it can be abused and lead to dependence and not to give Vyvanse to anyone else [see Drug Abuse and Dependence (9.1, 9.2, and 9.3)]. Advise patients to store Vyvanse in a safe place, preferably locked, to prevent abuse. Advise patients to dispose of remaining, unused, or expired Vyvanse by a medicine take-back program.

Serious Cardiovascular Risks1

Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with Vyvanse use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Hypertension and Tachycardia1

Instruct patients that Vyvanse can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects.

Psychiatric Risks1

Advise patients that Vyvanse at recommended doses may cause psychotic or manic symptoms even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Impairment in Ability to Operate Machinery or Vehicles1

Advise patients that Vyvanse may impair their ability to engage in potentially dangerous activities such as operating machinery or vehicles. Instruct patients to find out how Vyvanse will affect them before engaging in potentially dangerous activities [see Adverse Reactions (6.1, 6.2)].

Circulation Problems in Fingers and Toes (Peripheral Vasculopathy, including Raynaud's Phenomenon)1

Instruct patients beginning treatment with Vyvanse about the risk of peripheral vasculopathy, including Raynaud's Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Vyvanse. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

Serotonin Syndrome1

Caution patients about the risk of serotonin syndrome with concomitant use of VYVANSE and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications (4), Warnings and Precautions (5.7) and Drug Interactions (7.1)]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.

Concomitant Medications1

Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1)].


Advise patients of the potential fetal effects from the use of Vyvanse during pregnancy. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Vyvanse. [see Use in Specific Populations (8.1)].


Advise women not to breastfeed if they are taking Vyvanse. [see Use in Specific Populations (8.1)].

These highlights do not include all the information needed to use Vyvanse appropriately. See Full Prescribing Information.


All content of this Web site including text, images, graphics, sound files, and their arrangements, belongs to Shire and is protected by international copyrights 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 online privacy policy for more information. While Shire US Inc. makes reasonable efforts to include accurate, up-to-date information on the site, Shire US Inc. makes no warranties or representations as to its accuracy. Shire US Inc. assumes no liability for any errors or omissions in the content of the site.

S38425  04/18

You are about to leave

Please be advised that Shire has no control over the content or presentation of the site you are about to view.

Cancel Continue