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Deutetrabenazine Side Effects

In Summary

Commonly reported side effects of deutetrabenazine include: drowsiness. Other side effects include: depression, agitation, akathisia, fatigue, and restlessness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to deutetrabenazine: oral tablet

Oral route(Tablet)

Depression and Suicidality in Patients with Huntington's DiseaseDeutetrabenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington disease. Anyone considering the use of deutetrabenazine must balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician.Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington’s disease. Deutetrabenazine is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression .

Along with its needed effects, deutetrabenazine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking deutetrabenazine:

More Common

  • Body aches or pain
  • chills
  • diarrhea
  • difficulty with breathing
  • difficulty with swallowing
  • discouragement
  • drowsiness
  • dry mouth
  • fear
  • feeling sad or empty
  • fever
  • headache
  • inability to sit still
  • irritability
  • lack of appetite
  • loss of balance control
  • loss of interest or pleasure
  • mask-like face
  • need to keep moving
  • nervousness
  • relaxed and calm feeling
  • restlessness
  • shuffling walk
  • sleepiness or unusual drowsiness
  • slow movement or reflexes
  • slurred speech
  • stiffness of the arms and legs
  • tic-like (jerky) movements of the head, face, mouth, and neck
  • tiredness
  • trembling and shaking of the fingers and hands
  • trouble concentrating
  • trouble sleeping
  • trouble with balance
  • unusual tiredness or weakness

Less Common

  • Agitation
  • dizziness
  • problems passing stools

Get emergency help immediately if any of the following symptoms of overdose occur while taking deutetrabenazine:

Symptoms of Overdose

  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fixed position of the eye
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • mood or mental changes
  • nausea
  • seeing, hearing, or feeling things that are not there
  • shakiness in the legs, arms, hands, or feet
  • sticking out of the tongue
  • sweating
  • trembling or shaking of the hands or feet
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions
  • vomiting

Some side effects of deutetrabenazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Bruising
  • large, flat, blue patches on the skin

Less Common

For Healthcare Professionals

Applies to deutetrabenazine: oral tablet

General

The most common adverse reactions occurring in greater than 8% were somnolence, diarrhea, dry mouth, and fatigue.[Ref]

Nervous system

Very common (10% or more): Sedation/somnolence (11%)

Common (1% to 10%): Dizziness[Ref]

Dermatologic

Common (1% to 10%): Contusion[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dry mouth, constipation[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, depression, suicidal ideation, akathisia/agitation/restlessness[Ref]

References

1. "Product Information. Austedo (deutetrabenazine)." Teva Pharmaceuticals USA, North Wales, PA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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