Adzenys XR-ODT Side effects

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Did you have any side effects with this medicine?

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

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

Stop using Adzenys XR-ODT and call your doctor at once if you have:

  • chest pain, trouble breathing, feeling like you might pass out;

  • fast heartbeats, rapid breathing;

  • confusion, unusual thoughts, paranoia, hallucinations (seeing or hearing things that are not real);

  • new behavior problems, aggression, anger, feeling irritable;

  • numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;

  • changes in your vision; or

  • unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine).

Adzenys XR-ODT can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Adzenys XR-ODT side effects may include:

  • stomach pain, nausea, vomiting, loss of appetite;

  • diarrhea, constipation;

  • weight loss;

  • mood changes, feeling restless or nervous, sleep problems (insomnia);

  • dry mouth, unusual or unpleasant taste in the mouth;

  • runny nose, nosebleeds;

  • increased heart rate;

  • headache, dizziness;

  • itching; or

  • impotence, sexual problems.

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.

Side effects of Adzenys XR-ODT in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Drug Dependence
  • Hypersensitivity to Adzenys XR-ODT, or other components of Adzenys XR-ODT
  • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors
  • Serious Cardiovascular Reactions
  • Blood Pressure and Heart Rate Increases
  • Psychiatric Adverse Reactions
  • Long-Term Suppression of Growth
  • Peripheral Vasculopathy, including Raynaud's phenomenon

6.1 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 Adzenys XR-ODT 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 Adzenys XR-ODT 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 Adzenys XR-ODT in Pediatric Patients with ADHD

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

Table 1. Common adverse reactions occurring in ≥2% of Subjects on Adzenys XR-ODT and greater than Placebo during the double blind phase.
Preferred Term Adzenys XR-ODT

(N=52)

Placebo

(N=48)

Respiratory, thoracic and mediastinal disorders
Epistaxis 3.8% 0%
Rhinitis allergic 3.8% 0%
Gastrointestinal disorders
Abdominal pain upper 3.8% 2.1%

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of other Adzenys XR-ODT 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.

Endocrine: frequent or prolonged erections.

Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.

Psychiatric Disorders: dermatillomania.

What is the most important information I should know about Adzenys XR-ODT?

  • Tell your doctor or dentist that you take Adzenys XR-ODT before you receive any medical or dental care, emergency care, or surgery.
  • Adzenys XR-ODT may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Adzenys XR-ODT with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious heart problem, talk with your doctor about other therapies to treat your condition.
  • Adzenys XR-ODT may cause sleeplessness. Do not take Adzenys XR-ODT near your bedtime unless your doctor tells you otherwise.
  • Adzenys XR-ODT may cause circulation problems in the hands and feet. Tell your doctor if you have any numbness, pain, tingling, cold feeling, or skin color change (eg, from pale to blue or red) in your hands or feet. Call your doctor right away if you have any unexplained sores or wounds on your fingers or toes.
  • Adzenys XR-ODT may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Adzenys XR-ODT.
  • You may need to have some heart tests before starting Adzenys XR-ODT. Discuss any questions or concerns with your doctor.
  • Check your blood pressure and heart rate as your doctor has told you. Discuss any questions or concerns with your doctor.
  • Lab tests may be performed while you use Adzenys XR-ODT. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Adzenys XR-ODT should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
  • Adzenys XR-ODT may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Adzenys XR-ODT.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Adzenys XR-ODT while you are pregnant. Adzenys XR-ODT is found in breast milk. Do not breast-feed while taking Adzenys XR-ODT.

When used for long periods of time or at high doses, Adzenys XR-ODT may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Adzenys XR-ODT stops working well. Do not take more than prescribed.

Some people who use Adzenys XR-ODT for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Adzenys XR-ODT, you may experience WITHDRAWAL symptoms. These may include severe fatigue and drowsiness.

Adzenys XR-ODT contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Adzenys XR-ODT is contraindicated in patients:

  • With known hypersensitivity to Adzenys XR-ODT, or other components of Adzenys XR-ODT. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other Adzenys XR-ODT products.
  • Receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MOAI (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.

References

  1. DailyMed. "AMPHETAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DTP/NCI. "AMPHETAMINE: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Amphetamine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Adzenys XR-ODT are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Adzenys XR-ODT. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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