Possible Side Effects & Safety of ADZENYS XR-ODT?

What are the possible side effects of ADZENYS XR-ODT?

ADZENYS XR-ODT can cause serious side effects, including:

Abuse, Misuse, and Addiction
Heart-related problems
Mental (psychiatric) problems
Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon)
Symptoms of serotonin syndrome
Slowing of growth (height and weight)
New or worsening tics or worsening Tourette’s syndrome

The most common side effects of ADZENYS XR-ODT

Common side effects of ADZENYS XR-ODT in children 6 to 12 years of age also include:

stomach pain
nausea
nervousness
vomiting
extreme mood change
fever

Common side effects of ADZENYS XR-ODT in children 13 to 17 years of age also include:

stomach pain
weight loss

Common side effects of ADZENYS XR-ODT in adults also include:

dry mouth
fast heart beat
nausea
urinary tract infections
dizziness
weight loss
weakness
restlessness
headache
diarrhea
anxiety

Talk to your healthcare provider if you or your child have side effects that are bothersome or do not go away.

These are not all the possible side effects ADZENYS XR-ODT.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088

What is the most important information I should know about ADZENYS XR-ODT?

ADZENYS XR-ODT is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). ADZENYS XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

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

ADZENYS XR-ODT is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep ADZENYS XR-ODT in a safe place to prevent it from theft. Never give your ADZENYS XR-ODT to anyone else, because it may harm them. Selling or giving away ADZENYS XR-ODT may harm others and is against the law.

ADZENYS XR-ODT may cause serious side effects, including:

Abuse, misuse, and addiction. ADZENYS XR-ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of ADZENYS XR-ODT, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of ADZENYS XR-ODT or when it is used in ways that are not approved, such as snorting or injection.

Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with ADZENYS XR-ODT and will monitor you or your child. ADZENYS XR-ODT may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
Do not give ADZENYS XR-ODT to anyone else. See “What is ADZENYS XR-ODT?” for more information.
Keep ADZENYS XR-ODT in a safe place and properly dispose of any unused medicine. See “How should I store ADZENYS XR-ODT?” for more information.
Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Risks for people with serious heart disease.

Sudden death has happened in people who have heart defects or other serious heart disease.
Your healthcare provider should check you or your child carefully for heart problems before starting ADZENYS XR-ODT. Tell your healthcare provider if you or your child has 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 while taking ADZENYS XR-ODT.

Increased blood pressure and heart rate.

Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with ADZENYS XR-ODT.

Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems
new or worse bipolar illness
new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) 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 your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking ADZENYS XR-ODT, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:

fingers or toes may feel numb, cool, painful
fingers or toes may change from pale, to blue, to red

Tell your healthcare provider if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your healthcare provider right away if you have or your child has any unexplained wounds appearing on fingers or toes while taking ADZENYS XR-ODT.

Symptoms of Serotonin Syndrome:

Which may happen when ADZENYS XR-ODT is taken with certain other medicines and may be life threatening
Call your doctor or go to the nearest hospital emergency room if you have any of the following symptoms: status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Slowing of growth (height and weight) in children.

Children should have their height and weight checked often during treatment with ADZENYS XR-ODT.
Your healthcare provider may stop your child’s ADZENYS XR-ODT treatment if they are not growing or gaining weight as expected

Pregnant or Plans to Become Pregnant

It is not known if ADZENYS XR-ODT will harm your unborn baby.
Notify your healthcare provider if you or your child become pregnant or intend to become pregnant during treatment. Healthcare providers can advise you or your child of the potential fetal effects from the use of ADZENYS XR-ODT during pregnancy.

Breastfeeding, or Plans to Breastfeed

If you or your child is breastfeeding or plan to breastfeed. ADZENYS XR-ODT passes into breast milk. You should not breastfeed while you are taking ADZENYS XR-ODT.

Other Medications

Tell your healthcare provider about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements. ADZENYS XR-ODT 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 ADZENYS XR-ODT.
Your healthcare provider will decide whether ADZENYS XR-ODT can be taken with other medicines.
Especially tell your healthcare provider if you or your child takes:
- anti-depression medicines including MAOIs
Know the medicines that you or your child take. Keep a list of your medicines with you to show your healthcare provider and pharmacist.

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

What should I avoid while taking ADZENYS XR-ODT?

Drinking alcohol

Common Side Effects For ADZENYS XR-ODT Include:

Common side effects of ADZENYS XR-ODT in children 6 to 12 years of age also include:

stomach pain
nausea
nervousness
vomiting
extreme mood change
fever

Common side effects of ADZENYS XR-ODT in children 13 to 17 years of age also include:

stomach pain
weight loss

Common side effects of ADZENYS XR-ODT, in adults also include:

dry mouth
fast heart beat
nausea
urinary tract infections
dizziness
weight loss
weakness
restlessness
headache
diarrhea
anxiety

Talk to your healthcare provider if you or your child have side effects that are bothersome or do not go away.

These are not all the possible side effects ADZENYS XR-ODT.

For additional safety information, click here for Medication Guide and Full Prescribing Information and discuss with our healthcare provider.

Keep ADZENYS XR-ODT and all medicines out of the reach of children.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

Consumer Important Safety Information

Most Important Information About ADZENYS XR-ODT:

Abuse, misuse, and addiction. ADZENYS XR-ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of ADZENYS XR-ODT, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of ADZENYS XR-ODT or when it is used in ways that are not approved, such as snorting or injection.

ADZENYS XR-ODT may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
Do not give ADZENYS XR-ODT to anyone else.
Keep ADZENYS XR-ODT in a safe place and properly dispose of any unused medicine.

Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting ADZENYS XR-ODT. Tell your healthcare provider if you or your child has 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 while taking ADZENYS XR-ODT.
Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with ADZENYS XR-ODT.
Mental (Psychiatric) problems: 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 your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking ADZENYS XR-ODT, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What is ADZENYS XR-ODT: ADZENYS XR-ODT is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ADZENYS XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. It is not known if ADZENYS XR-ODT is safe and effective in children under 6 years of age. ADZENYS XR-ODT is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep ADZENYS XR-ODT in a safe place to prevent it from theft. Never give your ADZENYS XR-ODT to anyone else because it may harm them. Selling or giving away ADZENYS XR-ODT may harm others and is against the law.

Who Should Not Take ADZENYS XR-ODT: ADZENYS XR-ODT should not be taken if you or your child:

Are allergic to amphetamine, or any of the ingredients in ADZENYS XR-ODT
Are taking or have taken within the past 14 days an anti-depression medicine called monoamine oxidase inhibitor or MAOI

What Should I Tell My Healthcare Provider Before Taking ADZENYS XR-ODT?

All health conditions (or family history) of heart problems or high blood pressure; mental problems; circulation problems; kidney problems; if you, your child, or family member have or had repeated movements or sounds (tics) or Tourette’s syndrome; if you or your child are pregnant or plan to become pregnant; or if you or your child is breastfeeding or plan to breastfeed.
All medications that you or your child takes.
Any anti-depression medicines including MAOIs
Do not start any new medicine while taking ADZENYS XR-ODT without talking to your healthcare provider first.

Avoid drinking alcohol while taking ADZENYS XR-ODT.

The most common side effects of ADZENYS XR-ODT include decreased appetite and problems sleeping. ADZENYS XR-ODT can cause serious side effects, including:

Slowing growth (height and weight) in children. Children should have their height and weight checked often during treatment with ADZENYS XR-ODT.
Circulation problems in fingers and toes. [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers and toes may feel numb, cool, painful and/or change from pale to blue or red. Call your healthcare provider right away if you or your child have any unexplained wounds appearing on fingers or toes while taking ADZENYS XR-ODT.
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 ADZENYS XR-ODT.
Common side effects of ADZENYS XR-ODT in children 6 to 12 years of age also include: stomach pain, extreme mood change, vomiting, nervousness, nausea, and fever.
Common side effects of ADZENYS XR-ODT in children 13 to 17 years of age also include: stomach pain and weight loss.
Common side effects of ADZENYS XR-ODT in adults also include: dry mouth, headache, weight loss, nausea, anxiety, restlessness, dizziness, fast heartbeat, diarrhea, weakness, and urinary tract infections

These are not all the possible side effects of ADZENYS XR-ODT.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please click here for Full Medication Guide.