Adzenys XR-ODT (Amphetamine) - Oral

Warning:

This medication has a boxed warning (the Food and Drug Administration's [FDA] strictest warning label) due to its high potential for abuse and dependence.

What Is Adzenys XR-ODT?

Adzenys XR-ODT (amphetamine) is a controlled prescription medication that treats attention deficit hyperactivity disorder (ADHD). Adzenys XR-ODT is a brain stimulant thought to work by raising naturally occurring brain chemicals—dopamine and norepinephrine.

This medication contains amphetamine, which has a high potential for abuse and dependence. For this reason, Adzenys XR-ODT is classified as a controlled substance, meaning the federal government tightly regulates its handling, storage, and distribution requirements.

Adzenys XR-ODT is available in an extended-release orally disintegrating tablet (ODT) that easily dissolves when placed on the tongue.

Drug Facts

Generic Name: Amphetamine

Brand Name(s): Adzenys XR-ODT, Dyanavel XR, Evekeo, Evekeo ODT

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Central nervous system agent

Available Generically: No

Controlled Substance: Schedule II

Active Ingredient: Amphetamine

Dosage Form(s): Tablet

What Is Adzenys XR-ODT Used For?

The Food and Drug Administration (FDA) approved Adzenys XR-ODT to treat ADHD for people 6 years and older.

ADHD affects more than 6 million children in the United States. Two-thirds of these children will continue to experience ADHD symptoms as adults. People with ADHD tend to have difficulties paying attention and controlling behaviors due to being distracted, hyperactivity, impulsiveness, or having a combination of these symptoms.

This medication is a controlled substance, meaning it has a high potential for abuse and dependence. Because of this, there are limitations on if you can have refills for this medication and how long a pharmacy can fill it after your healthcare provider prescribes it.

How to Take Adzenys XR-ODT

Use dry hands to peel the backing of the blister. Then, remove the Adzenys XR-ODT tablet from the blister pack without pushing the tablet through the foil. However, don’t remove the medication from the blister pack until immediately before you are ready to take it.

To take Adzenys XR-ODT, place the tablet on your tongue and allow the tablet to dissolve before swallowing with no need for water. Take this medication with or without food in the morning. Don’t chew or crush the Adzenys XR-ODT tablet.

Storage

Adzenys XR-ODT is a controlled medication. Therefore, your healthcare provider will not give you refills on the same paper or electronic prescription. You and your healthcare provider will regularly be in touch for a new Adzenys XR-ODT prescription to give to the pharmacy.

When you pick up Adzenys XR-ODT from the pharmacy, store the medication at room temperature—which is between 68 F to 77 F—with a safe range of 59 F to 86 F. Since Adzenys XR-ODT is a controlled prescription, store the medication in a locked cabinet or a similar safe place.

When traveling with Adzenys XR-ODT, place the blister packs of medication in a sturdy, plastic travel case. You can ask for additional cases from the manufacturer Neo Therapeutics by phone at 1-855-298-8246.

To bring Adzenys XR-ODT into and out of certain countries, talk with your healthcare provider to get a document of medical necessity on a letter with an official letterhead. Also, consider making a copy of your prescription.

How Long Does Adzenys XR-ODT Take to Work?

People with ADHD tend to notice symptom improvement right away. However, the effects of Adzenys XR-ODT vary person-to-person.

What Are the Side Effects of Adzenys XR-ODT?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Children usually experience some of the following common side effects:

Except for fever and rapid mood changes, adults typically experience some of the common side effects similar to children—in addition to the following side effects:

Severe Side Effects

Seek medical attention if you’re experiencing the following serious side effects:

  • Fast heartbeat
  • Heart attack
  • High blood pressure
  • New or worsening mood condition
  • Numbness, pain, skin color changes, or temperature sensitivity in fingers or toes
  • Serotonin syndrome with possible symptoms of seizures, sweating, and tremors
  • Stroke
  • Weight loss and slow growth in children

Long-Term Side Effects

Long-term treatment with Adzenys XR-ODT might lead to tolerance. Over time, the medication might not work as well as it used to.

Abruptly stopping Adzenys XR-ODT after taking it at high doses for long periods, however, may lead to the following discontinuation (withdrawal) symptoms:

Tell your healthcare provider if you experience the following:

  • Current or past medical history of alcohol or other substance use disorder (SUD)
  • Tolerance
  • Withdrawal symptoms

Long-term use of Adzenys XR-ODT in children might lead to weight loss and a slow growth rate. The healthcare provider may closely monitor your child’s height and weight.

Report Side Effects

Adzenys XR-ODT may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Adzenys XR-ODT Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For ADHD:
    • For oral dosage form (extended-release oral disintegrating tablets):
      • Adzenys XR-ODT®:
        • Adults—12.5 milligrams (mg) once a day, in the morning.
        • Children 13 to 17 years of age and older—At first, 6.3 mg once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 12.5 mg per day.
        • Children 6 to 12 years of age—At first, 6.3 mg once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 18.8 mg per day.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
      • Evekeo ODT®:
        • Children 6 to 17 years of age—At first, 5 milligrams (mg) 1 or 2 times a day, in the morning. You may add another dose after 4 to 6 hours. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
        • Children 3 to 5 years of age—At first, 2.5 mg once a day, in the morning. You may add another dose after 4 to 6 hours. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
        • Children younger than 3 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (extended-release tablets):
      • Adults and children 6 years of age and older—At first, 2.5 or 5 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (extended-release suspension):
      • Adzenys ER™:
        • Adults—12.5 milligrams (mg) (10 mL) once a day, in the morning.
        • Children 13 to 17 years of age and older—At first, 6.3 mg (5 mL) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 12.5 mg (10 mL) per day.
        • Children 6 to 12 years of age—At first, 6.3 mg (5 mL) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 18.8 mg (15 mL) per day.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
      • Dyanavel® XR:
        • Adults and children 6 years of age and older—At first, 2.5 or 5 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults and children 6 years of age and older—At first, 5 milligrams (mg) 1 or 2 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
      • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may increase your dose as needed.
      • Children younger than 3 years of age—Use is not recommended.
  • For narcolepsy:
    • For oral dosage form (tablets):
      • Adults and children 12 years of age and older—At first, 10 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children 6 to 11 years of age—At first, 5 mg once a day, in the morning. Your doctor may increase your dose as needed.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For weight loss:
    • For oral dosage form (tablets):
      • Adults and children 12 years of age and older—5 to 10 milligrams (mg) per day, taken 30 to 60 minutes before each meal. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 12 years of age—Use is not recommended.

Modifications

There is little effectiveness and safety data about Adzenys XR-ODT in pregnant people. Therefore, the effects on the unborn baby are unknown.

As for breastfeeding, limited evidence suggests that negative effects are unlikely in nursing babies. However, high doses of Adzenys XR-ODT might negatively affect milk supply. So, you may decide to avoid this medication if you are breastfeeding.

Please discuss with your healthcare provider to help you weigh the benefits and risks of taking this medication during your pregnancy or while nursing.

Missed Dose

If you ever miss a dose of Adzenys XR-ODT, just wait until your next scheduled dose. To prevent sleeping troubles, don’t try to take it too late during the day or too close to bedtime. Don’t try to double up and take more than one dose at a time. 

If you have any questions, please talk with your healthcare provider.

Overdose: What Happens If I Take Too Much Adzenys XR-ODT?

If you accidentally took too many doses of Adzenys XR-ODT at one time, seek immediate medical attention or call the Poison Control Center at 1-800-222-1222.

Symptoms of an overdose vary by person but may include the following:

What Happens If I Overdose on Adzenys XR-ODT

If you think you or someone else may have overdosed on Adzenys XR-ODT, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Adzenys XR-ODT, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly. Blood and blood pressure tests may be needed to check for unwanted effects. Your doctor may occasionally stop treatment to check symptoms of ADHD.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]), within the past 14 days.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may be:

  • A strong desire or need to continue using the medicine.
  • A need to increase the dose to receive the same effects.
  • Withdrawal effects after stopping the medicine including agitation, generalized slowing of mental and physical activity, increased appetite, trouble sleeping, unable to sleep, unpleasant dreams, unusual tiredness or weakness, or unusually deep sleep or long duration of sleep.

This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, fast or uneven heartbeat, trouble breathing, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

Symptoms of an overdose include: aggressive, angry, confusion, dark-colored urine, fever, muscle cramps, spasms, pains, or stiffness, panic state, restlessness, seeing, hearing, or feeling things that are not there, shakiness in the legs, arms, hands, or feet, trembling or shaking of hands or feet. Call your doctor right away if you notice these symptoms.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you or your child have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Avoid drinking alcohol while using this medicine.

Use with medications that increase stomach or urine alkalinity, including sodium bicarbonate, acetazolamide, and some thiazide diuretics (water pill) should be avoided. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal (eg, St. John's wort) or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

What Are Reasons I Shouldn’t Take Adzenys XR-ODT?

If you have the following heart conditions, you may need not be able to take Adzenys XR-ODT:

These heart conditions raise the risk of heart attack, stroke, and sudden death with Adzenys XR-ODT. Also, taking Adzenys XR-ODT is not advisable if you have taken a monoamine oxidase inhibitor (MAOI) medication within the last 14 days—due to a higher risk of a rare and severe side effect called serotonin syndrome.

What Other Medications Interact With Adzenys XR-ODT?

Due to potential drug interactions, use caution with medications that make your urine acidic or basic.

Medications that make your urine more acidic lower the amount of Adzenys XR-ODT in your body, which may reduce its effectiveness. Some of these medications include acetazolamide and certain thiazides.

Other medications that interact with Adzenys XR-ODT include:

  • Ascorbic acid: Absorbic acid decreases serum concentrations of amphetamine in the body.
  • Reserpine: Amphetamine and reserpine have competing mechanisms of action, which can raise blood pressure.
  • Glutamic acid HCl: This medication decreases amphetamine concentrations in the body.
  • Guanethidine: Taking guanethidine with Adzenys XR-ODT can increase the risk of arrhythmias.
  • MAO inhibitors, such as Emsam and Zelapar (selegiline) and isocarboxazid: Avoid taking Adzenys XR-ODT with MAO inhibitors or within 14 days of administration.
  • Serotonergic drugs, including selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, triptans, and St. John's wort: These medications can increase the risk of serotonin syndrome.
  • Tricyclic antidepressants, such as Norpramin and Pertofrane (desipramine) and protriptyline: Your healthcare provider may monitor the use of Adzenys XR-ODT with these medications and adjust or change your therapy if necessary.

This is not a complete list of possible drug interactions. Before starting Adzenys XR-ODT, tell your healthcare team about all the medications, including prescription and over-the-counter, vitamins, and herbal supplements you are taking. Let your healthcare provider know about any medication changes.

What Medications Are Similar?

There are many brain stimulants used to treat ADHD. Some other orally-disintegrating tablet forms are Cotempla XR-ODT (methylphenidate) and Evekeo ODT (amphetamine).

Compared with Adzenys XR-ODT, Cotempla XR-ODT and Evekeo ODT are only approved for children. However, Adzenys XR-ODT can be used in both children and adults.

Some people with ADHD might take multiple brain stimulants. For example, they may take an extended-release form every morning and an immediate-release version in the afternoon as needed, based on activities. Since the best treatment plan varies person-to-person, talk with your healthcare provider to help you determine whether one or a combination of medications will be better for you.

Frequently Asked Questions

  • Where is Adzenys XR-ODT available?

    Adzenys XR-ODT is available as a prescription from your healthcare provider. Many retail pharmacies can carry or order this medication for you.

  • How much does Adzenys XR-ODT cost?

    Adzenys XR-ODT is a brand-name medication. It will likely cost more than a generic medication would. If cost is a concern, Neos Therapeutics may help you find a partner pharmacy. You can download a savings coupon to use at your local pharmacy if there isn't a partner pharmacy near you.

  • How long do I need to take Adzenys XR-ODT?

    The duration of treatment varies by person. Talk with your healthcare provider. They will discuss the benefits and risks of stopping Adzenys XR-ODT.

  • Can I drink alcohol with Adzenys XR-ODT?

    It is not recommended to combine Adzenys XR-ODT and alcohol.

How Can I Stay Healthy While Taking Adzenys XR-ODT?

Living with ADHD can be overwhelming. Consider working with your healthcare provider to find the best treatment plan for you and to make any necessary adjustments based on your symptoms and side effects. Reaching out to a counselor may help you with coping strategies for ADHD symptoms.

If you are a parent or caretaker of a child with ADHD, also consider helpguide.org for potentially useful tips to assist you in helping your child.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

5 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Adzenys XR-ODT label.

  2. Centers for Disease Control and Prevention. Attention-Deficit/Hyperactivity Disorder (ADHD). Data and statistics about ADHD.

  3. National Center for Biotechnology Information. Drugs and Lactation Database (LactMed) [Internet]. Amphetamine.

  4. Food and Drug Administration. Evekeo ODT label.

  5. Food and Drug Administration. Cotempla XR-ODT label.