Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

VYVANSE (NDA-208510)

(LISDEXAMFETAMINE DIMESYLATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/23/2026 (SUPPL-9)

Approved Drug Label (PDF)

7 Drug Interactions

7.2 Interference with Laboratory Test

Newly added subsection:

Allow for an adequate washout period between administration of VYVANSE and radioactive diagnostic agents used for dopamine transporter (DAT) visualization. VYVANSE can interfere with the test results of a radioactive diagnostic agent (ioflupane I-123) that is used for DAT visualization by binding and internalization of the DAT, which may result in lower DAT in the striatum. This may lead to false-positive diagnostic results.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined

…

Who should not take VYVANSE?

Do not take VYVANSE if you or your child are:

…

Your healthcare provider may tell you to stop taking VYVANSE for a short time before you get certain imaging tests because VYVANSE may impact the results of some tests.

…

What are the possible side effects of VYVANSE? VYVANSE may cause serious side effects, including:

See “What is the most important information I should know about VYVANSE?”
Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with VYVANSE. VYVANSE treatment may be stopped if your child is not growing or gaining weight as expected.

…

How should I store VYVANSE?

Store VYVANSE in a safe place (like a locked cabinet) at room temperature between 68°F to 77°F (20°C to 25°C).
Keep the container tightly closed and protect VYVANSE from light.

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Concomitant Medications

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 patient or caregiver of steps to take with VYVANSE when a laboratory imaging procedure is ordered [see Drug Interactions (7.2)].

…

09/23/2025 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Long-Term Suppression of Growth in Pediatric Patients

Additions and/or revisions underlined:

VYVANSE is not approved for use and is not recommended in pediatric patients below 6 years of age [see Use in Specific Populations (8.4)].

…

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of VYVANSE have not been established in pediatric patients below the age of 6 years.

…

10/13/2023 (SUPPL-7)

Approved Drug Label (PDF)

Boxed Warning

Additions and/or revisions underlined:

VYVANSE has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including VYVANSE, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing VYVANSE, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout VYVANSE treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)].

5 Warnings and Precautions

5.1 Abuse, Misuse, and Addiction

Additions and/or revisions underlined:

VYVANSE has a high potential for abuse and misuse. The use of VYVANSE exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. VYVANSE can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2 )]. Misuse and abuse of CNS stimulants, including VYVANSE, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing VYVANSE, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store VYVANSE in a safe place, preferably locked, and instruct patients to not give VYVANSE to anyone else. Throughout VYVANSE treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

5.8 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

New subsection added:

CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6.2)].

Before initiating VYVANSE, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor VYVANSE-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

6 Adverse Reactions

Additions and/or revisions underlined:

The following adverse reactions are discussed in greater detail in other sections of the labeling:

…

Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2, 9.3)]

…

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.8)]

6.2 Postmarketing Experience

Additions and/or revisions underlined

… These events are as follows: cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, motor and verbal tics, bruxism, depression, dermatillomania, alopecia, aggression, Stevens-Johnson Syndrome, chest pain, angioedema, urticaria, seizures, libido changes, frequent or prolonged erections, constipation, rhabdomyolysis, and intestinal ischemia.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Additions and/or revisions underlined

…

Abuse, Misuse, and Addiction

Educate patients and their families about the risks of abuse, misuse, and addiction of VYVANSE, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store VYVANSE in a safe place, preferably locked, and instruct patients to not give VYVANSE to anyone else.

…

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with VYVANSE. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.8)].

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVANSE during pregnancy [see Use in Specific Populations (8.1)].

…

MEDICATION GUIDE

Medication Guide has undergone extensive changes; please refer to label.

02/25/2022 (SUPPL-5)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

Additions underlined

… and intestinal ischemia.

11/02/2021 (SUPPL-4)

Approved Drug Label (PDF)

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

What is VYVANSE?

‘VYVANSE is not for use in children under 6 years of age with ADHD.’ replaces ‘It is not known if VYVANSE is safe and effective for use in children with ADHS under 6 years of age or for use in children with BED.’

‘VYVANSE is not for weight loss. It is not known if VYVANSE is safe and effective for the treatment of obesity. It is not known if VYVANSE is safe and effective for use in children with BED’ replaces ‘VYVANSE is not for weight loss. It is not known if VYVANSE is safe and effective for the treatment of obesity.’

07/29/2021 (SUPPL-3)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 Suppression of Growth

Additions underlined

…

Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. VYVANSE is not approved for use in pediatric patients below 6 years of age [see Use in Specific Populations (8.4)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions underlined

…

Attention Deficit Hyperactivity Disorder

…

Adverse Reactions Occurring at an Incidence of greater than or equal to 5% or More Among VYVANSE Treated Patients with ADHD in Clinical Trials

The most common adverse reactions (incidence greater than or equal to 5% and at a rate at least twice placebo) reported in pediatric patients ages 6 to 17 years, and/or adults were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.

…

Weight Loss and Slowing Growth Rate in Pediatric Patients with ADHD

…

Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients ages 7 to 13 years (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. In a controlled trial of amphetamine (d- to l-enantiomer ratio of 3:1) in pediatric patients ages 13 to 17 years, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 pounds and -2.8 pounds, respectively, for patients receiving 10 mg and 20 mg of amphetamine. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment [see Warnings and Precautions (5.5)].

Binge Eating Disorder

…

Adverse Reactions Occurring at an Incidence of 5% or More and At Least Twice Placebo Among VYVANSE Treated Patients with BED in Clinical Trials

The most common adverse reactions (incidence greater than or equal to 5% and at a rate at least twice placebo) reported in adults were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.

Adverse Reactions Occurring at an Incidence of 2% or More and At Least Twice Placebo Among VYVANSE Treated Patients with BED in Clinical Trials

Adverse reactions reported in the pooled controlled trials in adult patients (Study 11 and 12) treated with VYVANSE or placebo are presented in Table 4 below.

Please refer to label to view Table 4

8 Use in Specific Populations

8.1 Pregnancy

Additions underlined

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and researchprograms/pregnancyregistry/adhd- medications/.

…

8.4 Pediatric Use

Additions underlined

ADHD

Safety and effectiveness of VYVANSE have been established in pediatric patients with ADHD ages 6 to 17 years [see Dosage and Administration (2.3), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)].

Safety and effectiveness of VYVANSE have not been established in pediatric patients below the age of 6 years.

Safety and efficacy of VYVANSE were evaluated in a double-blind, randomized, parallel-group, placebo-controlled, fixed-dose study in pediatric patients ages 4 to 5 years with ADHD, followed by a 1-year open-label extension study. In these studies, patients experienced elevated rates of adverse reactions, including weight loss, decreased BMI, decreased appetite, insomnia, infections (upper respiratory and nasopharyngitis), irritability, and affect lability.

With the same VYVANSE dose, mean steady state exposure of dextroamphetamine was approximately 44% higher in pediatric patients ages 4 to 5 years compared to the pediatric patients ages 6 to 11 years.

…

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Extensive additions and/or revisions, please refer to label for complete information.

PATIENT COUNSELING INFORMATION

Additions underlined

…

Administration Instructions

Capsules: Advise patients to take the capsules whole or empty and mix the entire contents with yogurt, water, or orange juice. Advise patients to consume the mixture immediately and not to store for future use [see Dosage and Administration (2.2)].
Chewable tablets: Advise patients that chewable tablets must be chewed thoroughly before swallowing [see Dosage and Administration (2.2)].

07/31/2017 (SUPPL-2)

Approved Drug Label (PDF)

6 Adverse Reactions

Table 1 Adverse Reactions Reported by 2% of More of Children (Ages 6-12 years) with ADHD Taking VYVANSE and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 1)

Under the VYVANSE column, Insomnia changes from 23 to 22%

Anorexia added to table, 2% under VYVANSE column, and 0% under placebo column

Table 2 Adverse Reactions Reported by 2% or More of Adolescent (Ages 13 to 17 Years (Patients with ADHD Taking VYVANSE and at least Twice the Incidence of Patients Taking Placebo in a 4-Week Clinical Trial (Study 4)

Addition of Palpitations, Anorexia, and Tremor to table. All have 2% under VYVNASE column, and 0% under Placebo column.

Table 3 Adverse Reactions Reported by 2% or More of Adult Patients with ADHD Taking Vyvanse and at least Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 7)

Addition of Palpitations to table; 2% under VYVANSE column and 0% under Placebo column.

Binge Eating Disorder

Adverse Reactions Associated with Discontinuation of Treatment in BED Clinical Trials

… No single adverse reaction led to discontinuation in 1% or more of VYVANSE-treated patients. Less commonly reported adverse reactions (less than 1% or less than twice rate of placebo) included increased heart rate, headache, abdominal pain upper, dyspnea, rash, insomnia, irritability, feeling jittery and anxiety.

6.1 Clinical Trial Experience

Attention Deficit Hyperactivity Disorder

Adverse Reactions Associated with Discontinuation of Treatment in ADHD Clinical Trials

Additions and/or revisions underlined:

In the controlled trials in patients ages 6 to 12 years (Study 1), 8% (18/218) of VYVANSE-treated patients discontinued due to adverse reactions compared to 0% (0/72) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, decreased appetite and rash [2 instances for each adverse reactions, i.e., 2/218 (1%)]. Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included abdominal pain upper, dry mouth, weight decreased, dizziness, somnolence, logorrhea, chest pain, anger, and hypertension.

In the controlled trial in patients ages 13 to 17 years (Study 4), 3% (7/233) of VYVANSE –treated patients discontinued due to adverse reactions compared to 1% (7/233) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were decreased appetite (2/233; 1%) and insomnia (2/233; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included irritability, dermatillomania, mood swings, and dyspnea.

In the controlled adult trial (Study 7), 6% (21/358) of VYVANSE-treated patients discontinued due to adverse reactions compared to 2% (1/62) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (28/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included palpitations, diarrhea, nausea, decreased appetite, dizziness, agitation, depression, paranoia and restlessness.

Adverse Reactions Occurring at an Incidence of greater than or equal to 5% or More Among VYVANSE Treated Patients with ADHD in Clinical Trials

The most common adverse reactions (incidence …

6.2 Postmarketing Experience

Addition of chest pain to listing of adverse reactions identified during post approval use of VYVANSE.

05/19/2017 (SUPPL-1)

Approved Drug Label (PDF)

6 Adverse Reactions

6.2 Postmarketing Experience

(Additions and/or revisions are underlined)

…These events are as follows: palpitations, cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision, eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, tics, bruxism, depression, dermatillomania, alopecia,…