Vyvanse Side Effects

Please note - some side effects for Vyvanse may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Vyvanse - for the Consumer

Vyvanse

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vyvanse:

Constipation; decreased appetite; diarrhea; dizziness; dry mouth; headache; increased sweating; mild irritability, nervousness, or restlessness; nausea; trouble sleeping; unpleasant taste; upper stomach pain; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Vyvanse:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; blurred vision or other vision changes; change in sexual ability or desire; chest pain; fainting; fast or irregular heartbeat; fever; hallucinations; new or worsening mental or mood changes; seizures; severe or persistent headache; severe or persistent irritability, nervousness, or restlessness; shortness of breath; tremor; uncontrolled speech or muscle movements (eg, tics); unusual weakness or tiredness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Vyvanse Side Effects - for the Professional

Vyvanse

Clinical Studies Experience

The premarketing development program for Vyvanse included exposures in a total of 995 participants in clinical trials (348 pediatric patients aged 6 to 12 years, 233 adolescent patients aged 13 to 17 years, 358 adult patients and 56 healthy adult subjects). Of these, 348 pediatric (aged 6 to 12) patients were evaluated in two controlled clinical studies (one parallel-group and one crossover), one open-label extension study, and one single-dose clinical pharmacology study, 233 adolescent (aged 13 to 17) patients were evaluated in one controlled clinical study, and 358 adult patients were evaluated in one controlled clinical study and one open-label extension study. The information included in this section is based on data from the 4-week parallel-group controlled clinical studies in pediatric and adult patients with ADHD. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized reactions categories. In the tables and listings that follow, MedDRA terminology has been used to classify reported adverse reactions.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced a treatment-emergent adverse reaction of the type listed at least once.

Adverse Reactions Associated with Discontinuation of Treatment in Clinical Trials

In the controlled pediatric (aged 6 to 12) trial, 9% (20/218) of Vyvanse-treated patients discontinued due to adverse reactions compared to 1% (1/72) who received placebo. The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, and rash (2/218 each; 1%).

In the controlled adolescent (aged 13 to 17) trial, 4% (10/233) of Vyvanse-treated patients discontinued due to adverse events compared to 1% (1/77) who received placebo. The most frequent adverse reactions leading to discontinuation and considered to be drug-related were irritability (3/233; 1%), decreased appetite (2/233; 1%), and insomnia (2/233; 1%).

In the controlled adult trial, 6% (21/358) of Vyvanse-treated patients discontinued due to adverse events compared to 2% (1/62) who received placebo. The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%).

Adverse Reactions Occurring at an Incidence of 2% or More Among Vyvanse Treated Patients in Clinical Trials

Adverse reactions reported in the controlled trials in pediatric (aged 6 to 17 years) and adult patients treated with Vyvanse or placebo are presented in Tables 1, 2, and 3 below. The prescriber should be aware that these figures cannot be used to predict the incidence of adverse reactions in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatment uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse reaction incidence rate in the population studied.

Pediatric

Table 1 Adverse Reactions Reported by 2% or More of Children (Aged 6 to 12 Years) Taking Vyvanse in a 4-Week Clinical Trial

Body System	Preferred Term	Vyvanse (n=218)	Placebo (n=72)
Gastrointestinal Disorders	Abdominal Pain Upper	12%	6%
	Vomiting	9%	4%
	Nausea	6%	3%
	Dry Mouth	5%	0%
General Disorder and Administration Site Conditions	Pyrexia	2%	1%
Investigations	Weight Decreased	9%	1%
Metabolism and Nutrition	Decreased Appetite	39%	4%
Nervous System Disorders	Dizziness	5%	0%
	Somnolence	2%	1%
Psychiatric Disorders	Insomniaa	23%	3%
	Irritability	10%	0%
	Affect lability	3%	0%
	Tic	2%	0%
Skin and Subcutaneous Tissue Disorders	Rash	3%	0%

a Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia.

Note: This table includes those reactions for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo.

Table 2 Adverse Reactions Reported by 2% or More of Adolescent (Aged 13 to 17 Years) Patients Taking Vyvanse in a 4-Week Clinical Trial

Body System	Preferred Term	Vyvanse (n=233)	Placebo (n=77)
b Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia. Note: This table includes those reactions for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo.
Gastrointestinal Disorders	Dry Mouth	4%	1%
Investigations	Weight Decreased	9%	0%
Metabolism and Nutrition	Decreased Appetite	34%	3%
Psychiatric Disorders	Insomniab	13%	4%

Adult

Table 3 Adverse Reactions Reported by 2% or More of Adult Patients Taking Vyvanse in a 4-Week Clinical Trial

Body System	Preferred Term	Vyvanse (n=358)	Placebo (n=62)
Gastrointestinal Disorders	Dry Mouth	26%	3%
	Diarrhea	7%	0%
	Nausea	7%	0%
General Disorder and Administration Site Conditions	Feeling Jittery	4%	0%
Investigations	Blood Pressure Increased	3%	0%
	Heart Rate Increased	2%	0%
Metabolism and Nutrition Disorders	Decreased Appetite	27%	3%
	Anorexia	5%	0%
Nervous System Disorders	Tremor	2%	0%
Psychiatric Disorders	Insomniac	27%	8%
	Anxiety	6%	0%
	Agitation	3%	0%
	Restlessness	3%	0%
Respiratory, Thoracic, and Mediastinal Disorders	Dyspnea	2%	0%
Skin and Subcutaneous Tissue Disorders	Hyperhidrosis	3%	0%

c Insomnia includes the following preferred terms reported in the study: Initial Insomnia, Insomnia, Middle Insomnia.

Note: This table includes those events for which the incidence in patients taking Vyvanse is at least twice the incidence in patients taking placebo.

In addition, adverse reactions observed at a rate of less than 2% included decreased libido and erectile dysfunction.

Vital Signs

Weight Loss - In the controlled adult trial, mean weight loss after 4 weeks of therapy was 2.8 lbs, 3.1 lbs, and 4.3 lbs, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of Vyvanse, respectively, compared to a mean weight gain of 0.5 lbs for patients receiving placebo.

Postmarketing Reports

The following adverse reactions have been identified during post approval use of Vyvanse. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac Disorders - Palpitation

Eye Disorders - Vision blurred, mydriasis, diplopia

General Disorders and Administration Site Conditions - Fatigue

Hepatobiliary Disorders - Eosinophilic Hepatitis

Immune System Disorders - Anaphylactic reaction, hypersensitivity

Nervous System Disorders - Somnolence, seizure, dyskinesia

Psychiatric Disorder - Psychotic episodes, mania, hallucination, depression, aggression, dysphoria, euphoria, logorrhoea, dermatillomania

Skin and Subcutaneous Tissue Disorder - Stevens-Johnson Syndrome, angioedema, urticaria

Adverse Reactions Associated with the Use of Amphetamine

Cardiovascular

Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System

Psychotic episodes at recommended doses, overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, depression, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome, seizures, stroke.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic

Urticaria, rashes, and hypersensitivity reactions, including angioedema and anaphylaxis. Serious skin reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported.

Endocrine

Impotence, changes in libido.

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Side Effects by Body System - for Healthcare Professionals

General

All side effects listed, unless otherwise noted, were reported in pediatric patients.

Other

Other side effects have included decreased appetite (39%), headache, and pyrexia (2%).

Gastrointestinal

Gastrointestinal side effects have included upper abdominal pain (12%), dry mouth (5%), nausea (6%), and vomiting (9%). Gastrointestinal side effects associated with amphetamine or lisdexamfetamine have included dryness of mouth, unpleasant taste, diarrhea, and constipation.

Metabolic

Metabolic side effects have included weight loss.

Nervous system

Nervous system side effects have included insomnia (19%), dizziness (5%), initial insomnia (4%), and somnolence (2%). Nervous system side effects associated with the use of recommended doses of amphetamine or lisdexamfetamine have included dyskinesia and seizures. Postmarketing reports have included psychotic episodes, mania, hallucination, and aggression.

Psychiatric

Psychiatric side effects have included irritability (10%), affect lability (3%), and tic (2%). Psychiatric side effects associated with the use of recommended doses of amphetamine or lisdexamfetamine have included overstimulation, restlessness, euphoria, dysphoria, depression, tremor, and exacerbation of motor and phonic tics and Tourette syndrome. Postmarketing reports have included dermatillomania.

Dermatologic

Dermatological side effects have included rash (3%). Dermatological side effects associated with amphetamine or lisdexamfetamine have included serious skin rashes, Stevens Johnson Syndrome, and toxic epidermal necrolysis.

Cardiovascular

Cardiovascular side effects associated with amphetamine or lisdexamfetamine have included palpitations, tachycardia, increased blood pressure, sudden death, stroke, and myocardial infarction. Cardiomyopathy has been associated with chronic amphetamine use.

Hypersensitivity

Hypersensitivity reactions associated with amphetamine or lisdexamfetamine have included urticaria, angioedema, anaphylaxis, Stevens Johnson Syndrome, and toxic epidermal necrolysis.

Genitourinary

Genitourinary side effects associated with amphetamine or lisdexamfetamine have included decreased libido (less than 2%), erectile dysfunction (less than 2%), impotence, and changes in libido.

Ocular

Ocular side effects including blurred vision have been reported.

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