Safety & Side Effects | DYANAVEL® XR (amphetamine)

Find important information about side effects

DYANAVEL XR is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep DYANAVEL XR in a safe place to prevent abuse and misuse. Never give your DYANAVEL XR to anyone else, because it may cause death or harm them. Selling or giving away DYANAVEL XR may harm others and is against the law.

Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting, treatment with DYANAVEL XR and will monitor you or your child during treatment.
Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

DYANAVEL XR should not be taken if you or your child are allergic to amphetamine, or any of the ingredients in DYANAVEL XR, or are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.

The following have been reported with the use of amphetamine and other stimulant medicines:

Heart-related problems:
- Sudden death in patients who have heart problems or heart defects
- Stroke and heart attack in adults
- Increased blood pressure and heart rate
- Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with DYANAVEL XR
Mental (psychiatric) problems:
- New or worse behavior and thought problems
- New or worse bipolar illness
- May cause new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon):
- Fingers or toes may feel numb, cool, painful, or may change color from pale, to blue, to red

Call your healthcare provider right away if you or your child have any:

Heart-related symptoms such as chest pain, shortness of breath, or fainting
New or worsening mental (psychiatric) symptoms or new manic symptoms
Signs of unexplained wounds appearing on fingers or toes while taking DYANAVEL XR
Symptoms of serotonin syndrome:
- Agitation, hallucinations, coma, or changes in mental status; problems controlling movements or muscle twitching, stiffness, or tightness; fast heartbeat; sweating or fever; nausea, vomiting or diarrhea. Call your doctor or go to the emergency room if symptoms occur. Serotonin syndrome may occur if DYANAVEL XR is taken with certain medicines and may be life-threatening
Slowing of growth (height and weight) in children:
- Your child should have his or her height and weight checked often while taking DYANAVEL XR for Attention Deficit Hyperactivity Disorder (ADHD). The doctor may stop treatment if a problem is found during these check-ups.
New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment.

DYANAVEL XR should not be taken if you or your child:

Are allergic to amphetamine, or any of the ingredients in DYANAVEL XR. See the end of the Medication Guide for a complete list of ingredients in DYANAVEL XR
Are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor, or MAOI

DYANAVEL XR may not be right for you or your child. Before starting DYANAVEL XR tell your or your child’s healthcare provider about all health conditions (or a family history of) including:

Heart problems, heart defects, high blood pressure
Mental problems including psychosis, mania, bipolar illness, or depression
Repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome
Circulation problems in fingers and toes
Are pregnant or plan to become pregnant. It is not known if DYANAVEL XR will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
You or your child should not breastfeed during treatment with DYANAVEL XR. Tell your doctor if you are breastfeeding or plan to breastfeed

Tell your healthcare provider about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. DYANAVEL XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking DYANAVEL XR.

Your healthcare provider will decide whether DYANAVEL XR can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes:

Antidepression medicines including MAOIs
Cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your healthcare provider and pharmacist.

Do not start any new medicine while taking DYANAVEL XR without talking to your healthcare provider first.

Children should have their height and weight checked often. If a problem is found, your healthcare provider may ask you to stop taking DYANAVEL XR
In case of poisoning, immediately call 1-800-222-1222, or go to the nearest hospital emergency room
If you miss a dose of DYANAVEL XR, be sure to speak with your healthcare provider

The most common side effects of DYANAVEL XR include decreased appetite, trouble sleeping, nausea, stomach pain, weight loss, dizziness, mood swings, fast heart beat, dry mouth, restlessness. These are not all the possible side effects of DYANAVEL XR

Call your healthcare provider for medical advice about side effects.

You may report adverse events related to Tris Pharma products by calling 1-732-940-0358 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. The FDA has established a reporting service known as MedWatch, where healthcare professionals and consumers can report serious problems they suspect may be associated with the drugs and medical devices they prescribe, dispense, or use. Visit MedWatch or call 1-800-FDA-1088.

For more information about the possible side effects of DYANAVEL XR, see full Prescribing Information.

FDA, Food and Drug Administration.

See DYANAVEL XR Liquid dosing & administration information.

Learn about DYANAVEL XR study results

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Important Safety Information & Approved Use

DYANAVEL^® XR (amphetamine) is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep DYANAVEL XR in a safe place to prevent abuse and misuse. Never give your DYANAVEL XR to anyone else because it may cause death or harm them. Selling or giving away DYANAVEL XR may harm others and is against the law.

– Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with DYANAVEL XR and will monitor you or your child during treatment.

– Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol prescription medicines, or street drugs.

DYANAVEL XR should not be taken if you or your child are allergic to amphetamine or any of the ingredients in DYANAVEL XR or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI including the antibiotic linezolid and the intravenous medicine methylene blue.

DYANAVEL XR can cause serious side effects including:

Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Before starting DYANAVEL XR, tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DYANAVEL XR.
Increase in blood pressure and heart rate.
Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with DYANAVEL XR.
Mental (psychiatric) problems, including new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms.
Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
Call the doctor right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with DYANAVEL XR.
New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with DYANAVEL XR.
Serotonin Syndrome. This problem may happen when DYANAVEL XR is taken with certain other medicines and may be life-threatening. Stop taking DYANAVEL XR and call your healthcare provider or go to the nearest hospital emergency room if you get symptoms such as agitation, hallucinations, coma, or other changes in mental status; fast heartbeat; sweating or fever; nausea, vomiting, diarrhea; high or low blood pressure; problems controlling movements or muscle twitching; muscle stiffness or tightness.
Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with DYANAVEL XR. Your healthcare provider may stop your child’s DYANAVEL XR treatment if they are not growing or gaining weight as expected.
It is not known if DYANAVEL XR will harm the unborn baby. There is a pregnancy registry for females who are exposed to DYANAVEL XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to DYANAVEL XR and their baby. If you or your child becomes pregnant during treatment with DYANAVEL XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
DYANAVEL XR passes into breast milk. You or your child should not breastfeed during treatment with DYANAVEL XR. Tell your doctor if you are breastfeeding or plan to breastfeed.
The most common side effects of amphetamine products include:

– dry mouth

– decreased appetite

– weight loss

– stomach pain

– nausea

– trouble sleeping

– restlessness

– extreme mood changes

– dizziness

– increased heart rate

Talk to your doctor if you or your child have any side effects that bother you or do not go away.
Avoid drinking alcohol while taking DYANAVEL XR.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

APPROVED USE

DYANAVEL XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.

Please see Full Prescribing Information, including Boxed Warning about Abuse, Misuse and Addiction and Medication Guide.