Adzenys ER

Last updated on RxList: 6/28/2021

What is Adzenys ER and how is it used?

Adzenys ER is a prescription medicine used to treat the symptoms of Narcolepsy, Obesity, and Attention Deficit Hyperactivity Disorder (ADHD). Adzenys ER may be used alone or with other medications.

Adzenys ER belongs to a class of drugs called Stimulants; ADHD Agents.

It is not known if Adzenys ER is safe and effective in children younger than 6 years of age.

What are the possible side effects of Adzenys ER?

Adzenys ER may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • coldness of your fingers or toes,
  • numbness or pain in your fingers or toes,
  • skin color changes of your fingers or toes,
  • unusual wounds on the fingers or toes,
  • mental, mood or behavioral changes,
  • agitation,
  • aggression,
  • mood swings,
  • depression,
  • abnormal thoughts,
  • thoughts of self-harm,
  • twitching,
  • shaking,
  • continuous chewing movements,
  • teeth grinding,
  • outbursts of words or sounds that are hard to control,
  • vision changes,
  • blurred vision,
  • changes in sexual ability or desire,
  • frequent or prolonged erections (in males),
  • fainting,
  • seizures,
  • severe headache,
  • fast, pounding, or irregular heartbeat,
  • chest, jaw, or left arm pain,
  • shortness of breath,
  • unusual sweating,
  • weakness on one side of the body,
  • trouble speaking,
  • sudden vision changes,
  • confusion,
  • hallucinations,
  • loss of coordination,
  • severe dizziness,
  • severe nausea,
  • vomiting,
  • diarrhea,
  • twitching muscles,
  • unusual agitation,
  • restlessness,
  • fever,
  • rash,
  • itching, and
  • severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Adzenys ER include:

  • loss of appetite,
  • weight loss,
  • dry mouth,
  • stomach upset,
  • nausea,
  • vomiting,
  • dizziness,
  • headache,
  • diarrhea,
  • fever,
  • nervousness, and
  • trouble sleeping

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Adzenys ER. For more information, ask your doctor or pharmacist.

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

WARNING

ABUSE AND DEPENDENCE

CNS stimulants, including ADZENYS ER, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy [see WARNINGS AND PRECAUTIONS and Drug Abuse And Dependence].

DESCRIPTION

ADZENYS ER (amphetamine) extended-release oral suspension contains a 3 to 1 ratio of d-to l-amphetamine, a central nervous system stimulant.

The labeled strength reflects the amount of amphetamine in ADZENYS ER whereas the strengths of the mixed salts of a single-entity amphetamine products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products.

Structural Formula

ADZENYS ER (amphetamine) Structural Formula Illustration

C9H13N     MW 135.21

ADZENYS ER is an extended-release oral suspension containing approximately equal amounts of immediate-release and delayed-release amphetamine.

ADZENYS ER also contains the following inactive ingredients: purified water, sorbitol, propylene glycol, xanthan gum, natural orange flavor, methacrylic acid and methyl methacrylate copolymer, sodium polystyrene sulfonate, vegetable oil, triethyl citrate, methylparaben, citric acid, sucralose, propylparaben, orange color (FD&C Yellow No. 6), and polyethylene glycol.