Possible Side Effects & Safety of ADZENYS XR-ODT?

What are the possible side effects of ADZENYS XR-ODT?²⁸

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

Reference 28: ADZENYS XR-ODT® Prescribing Information, Neos Therapeutics, Inc, Denver, CO. September 2025. https://adzenysxrodt.com/wp-content/uploads/2025/11/N01666_Adzenys_Digitial-PI.pdf

The most common side effects of ADZENYS XR-ODT²⁹

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

Reference 29: ADZENYS XR-ODT® Prescribing Information, Neos Therapeutics, Inc, Denver, CO. September 2025. https://adzenysxrodt.com/wp-content/uploads/2025/11/N01666_Adzenys_Digitial-PI.pdf

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 threateningCall 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.

Important Safety Information

Indication

ADZENYS XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Limitations of Use

The use of ADZENYS XR-ODT is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage.

WARNING: ABUSE, MISUSE, AND ADDICTION

ADZENYS XR-ODT 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 ADZENYS XR-ODT, can result in overdose and death, and this risk is increased with higher doses of unapproved methods of administration, such as snorting or injection.

Before prescribing ADZENYS XR-ODT, 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 ADZENYS XR-ODT treatment, reassess each patient’s risk for abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Contraindications

In patients known to be hypersensitive to amphetamine, or other components of ADZENYS XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products.
Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.

Warnings and Precautions

Abuse, Misuse, and Addiction: ADZENYS XR-ODT has a high potential for abuse and misuse. The use of ADZENYS XR-ODT exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. ADZENYS XR-ODT can be diverted for non-medical use into illicit channels or distribution. Misuse and abuse of CNS stimulants, including ADZENYS XR-ODT, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing ADZENYS XR-ODT, 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 ADZENYS XR-ODT in a safe place, preferably locked, and instruct patients not to give ADZENYS XR-ODT to anyone else. Throughout ADZENYS XR-ODT treatment, reassess each patient’s risk for abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Risks to Patients with Serious Cardiac Disease: Sudden death has occurred in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosages. Avoid ADZENYS XR-ODT use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
Increased Blood Pressure and Heart Rate: CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 bpm). Some patients may have larger increases. Monitor all ADZENYS XR-ODT-treated patients for potential tachycardia and hypertension.
Psychiatric Adverse Reactions: Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating ADZENYS XR-ODT treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms CNS stimulants, at the recommended dosage, may cause psychotic or manic symptoms (e.g. hallucinations, delusional thinking or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing ADZENYS XR-ODT.
Long-Term Suppression of Growth in Pediatric Patients: ADZENYS XR-ODT is not approved for use and is not recommended in pediatric patients below 6 years of age. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in ADZENYS XR-ODT-treated pediatric patients treated with CNS stimulants. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.
Peripheral Vasculopathy, Including Raynaud’s Phenomenon: CNS stimulants, including ADZENYS XR-ODT, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during ADZENYS XR-ODT treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for ADZENYS XR-ODT-treated patients who develop signs or symptoms of peripheral vasculopathy.
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: 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. Before initiating ADZENYS XR-ODT, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor ADZENYS XR-ODT-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.
Potential for Overdose Due to Medication Errors: Medication errors, including substitution and dispensing errors, between ADZENYS XR-ODT and other amphetamine products could occur, leading to possible overdosage. To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles.

Adverse Reactions

Common side effects of ADZENYS XR-ODT in children 6 to 12 years of age also include:
- Abdominal pain
- Fever
- Infection
- Accidental injury
- Asthenia
- Loss of appetite
- Vomiting
- Nausea
- Dyspepsia
- Insomnia
- Emotional lability
- Nervousness
- Dizziness
- Weight loss

Common side effects of ADZENYS XR-ODT in children 13 to 17 years of age also include:
- Abdominal pain
- Loss of appetite
- Insomnia
- Weight loss

Common side effects of ADZENYS XR-ODT in adults also include:
- Headache
- Loss of appetite
- Insomnia
- Dizziness
- Urinary tract infection
- Asthenia
- Nausea
- Agitation
- Tachycardia
- Dry mouth
- Diarrhea
- Anxiety
- Weight loss

To report SUSPECTED ADVERSE REACTIONS, contact Neos Therapeutics, Inc. at 1-888-319-1789 or http://www.adzenysxrodt.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Monoamine Inhibitors (MAOI): MAOI antidepressants slow amphetamines effect on the release of norepinephrine and other monoamine from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Do not administer ADZENYS XR-ODT during or within 14 days following administration of MAOI.
Serotonergic Drugs: The concomitant use of ADZENYS XR-ODT and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during ADZENYS XR-ODT initiation or dosage increase. If serotonin syndrome occurs, discontinue ADZENYS XR-ODT and the concomitant serotonergic drug(s).
Alkalinizing Agents: Increase blood levels and potentiate the action of amphetamine. Co-administration of ADZENYS XR-ODT and gastrointestinal alkalinizing agents should be avoided.
Acidifying Agents: Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response.
Tricyclic Antidepressants: May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response.

Pregnancy and Lactation

Available data from epidemiologic studies and postmarketing reports on the use of amphetamine in pregnant women over decades of use have not identified a drug-associated risk of major birth defects or miscarriage. Neonates exposed to amphetamine in utero are at risk for withdrawal symptoms following delivery. Adverse pregnancy outcomes include premature delivery and low birth weight have been seen in infants born to mothers taking amphetamines during pregnancy. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness.
There are no reports of adverse effects on the breastfed infant. Long-term neurodevelopment effects on infants from amphetamine exposure are unknown. It is possible that large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established. Because of the potential for serious adverse reactions in nursing infants, advise patients that breastfeeding is not recommended during treatment with ADZENYS XR-ODT.

Pediatric Use

The safety and effectiveness of ADZENYS XR-ODT have not been established in pediatric patients below the age of 6 years.
In studies evaluating extended-release amphetamine products, patients 4 to <6 years of age had higher systemic amphetamine exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had higher incidence of adverse reactions, including weight loss.

Please click here for Full Prescribing Information.

What are the possible side effects of ADZENYS XR-ODT?28

The most common side effects of ADZENYS XR-ODT29