Dyanavel XR

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/19/2021
Dyanavel XR Side Effects Center

What Is Dyanavel XR?

Dyanavel XR (amphetamine) extended-release oral suspension is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

What Are Side Effects of Dyanavel XR?

Common side effects of Dyanavel XR include:

Dosage for Dyanavel XR

In children 6 years of age and older, the recommended starting dose of Dyanavel XR is 2.5 mg or 5 mg once daily in the morning.

What Drugs, Substances, or Supplements Interact with Dyanavel XR?

Dyanavel XR may interact with monoamine oxidase inhibitors (MAOIs), alkalinizing agents (e.g., sodium bicarbonate, acetazolamide, some thiazides), acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, methenamine salts), tricyclic antidepressants, or proton pump inhibitors (PPIs). Tell your doctor all medications and supplements you or your child use.

Dyanavel XR During Pregnancy and Breastfeeding

Dyanavel XR is not recommended for use during pregnancy; it may harm a fetus. Breastfeeding is not recommended while using Dyanavel XR. Withdrawal symptoms may occur if you suddenly stop taking Dyanavel XR.

Additional Information

Our Dyanavel XR (amphetamine) extended-release oral suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

ADHD Symptoms in Children See Slideshow
Dyanavel XR Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
  • signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
  • signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
  • a seizure (convulsions);
  • muscle twitches (tics);
  • pain or burning when you urinate; or
  • changes in your vision.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Amphetamine can affect growth. Tell your doctor if your child is not growing at a normal rate.

Common side effects may include:

  • increased heart rate;
  • mood changes, anxiety, feeling restless or nervous;
  • trouble sleeping;
  • dry mouth, stomach pain, nausea, vomiting, diarrhea, constipation;
  • loss of appetite, weight loss;
  • painful urination;
  • sexual problems, impotence;
  • headache, dizziness;
  • fever, weakness; or
  • itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Dyanavel XR (Amphetamine Extended-release Oral Suspension)

QUESTION

The abbreviated term ADHD denotes the condition commonly known as: See Answer
Dyanavel XR Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Drug Dependence [see BOXED WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
  • Hypersensitivity to amphetamine, or other components of DYANAVEL XR [see CONTRAINDICATIONS]
  • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
  • Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
  • Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
  • Peripheral Vasculopathy, including Raynaud's phenomenon [see WARNINGS AND PRECAUTIONS]
  • Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trials Experience With Other Amphetamine Products In Pediatric Patients And Adults With ADHD

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea.

Eye Disorders: Vision blurred, mydriasis.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, changes in libido.

Skin: Alopecia.

Clinical Trials Experience With DYANAVEL XR In Pediatric Patients With ADHD

There is limited experience with DYANAVEL XR in controlled trials. Based on this limited experience, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis, allergic rhinitis and upper abdominal pain.

Table 1: Common adverse reactions occurring in ≥2% of Subjects on DYANAVEL XR and greater than Placebo during the double blind phase.

Preferred TermDYANAVEL XR
(N=52)
Placebo
(N=48)
Respiratory, thoracic and mediastinal disorders
Epistaxis3.8%0%
Rhinitis allergic3.8%0%
Gastrointestinal disorders
Abdominal pain upper3.8%2.1%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of other amphetamine products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergic: urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.

Cardiovascular: palpitations, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, aggression, anger, logorrhea, and paresthesia (including formication).

Endocrine: impotence, changes in libido, frequent or prolonged erections.

Eye Disorders: vision blurred, mydriasis

Gastrointestinal: unpleasant taste, constipation, other gastrointestinal disturbances.

Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.

Psychiatric Disorders: dermatillomania, bruxism.

Skin: alopecia

Vascular Disorders: Raynaud's phenomenon

Read the entire FDA prescribing information for Dyanavel XR (Amphetamine Extended-release Oral Suspension)

© Dyanavel XR Patient Information is supplied by Cerner Multum, Inc. and Dyanavel XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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