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

Abuse and Dependence

ADZENYS XR-ODT, other amphetamine containing medicines, and methylphenidates have a high chance for abuse and can cause physical and psychological dependence. Your doctor should check you or your child for signs of abuse and dependence before and during treatment with Adzenys XR-ODT.

• Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
• Your doctor can tell you more about the differences between physical and psychological dependence and drug addiction.

Heart-related Problems, Including:

• sudden death in patients who have heart problems or heart defects
• sudden death, stroke and heart attack in adults
• increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Adzenys XR-ODT. Your doctor should check you or your child’s blood pressure and heart rate regularly during treatment with Adzenys XR-ODT.

Call your doctor right away 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.

Mental (Psychiatric) Problems, Including:

• 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 doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor 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, and/or change color from pale, to blue, to red

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

Call your doctor 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: agitation, hallucinations, coma or other changes in mental status, problems controlling your movements or muscle twitching, fast heartbeat, high or low blood pressure, sweating or fever, muscle stiffness or tightness, nausea, vomiting or diarrhea.sudden death in patients who have heart problems or heart defects

Slowing of Growth (Height and Weight)

• Your child should have his or her height and weight checked often while taking Adzenys XR-ODT.
• Treatment may be stopped if your child is not gaining weight or height.

Pregnant or Plans to Become Pregnant

• It is not known if Adzenys XR-ODT will harm the unborn baby.
• If your child becomes pregnant during treatment with Adzenys XR-ODT, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants.

Breastfeeding, or Plans to Breastfeed

• You or your child should not breastfeed while taking either Adzenys XR-ODT

Other Medications

• Tell your doctor if you or your child takes any other medications, 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.

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