Deutetrabenazine Side Effects
Applies to deutetrabenazine: oral tablet, oral tablet extended release.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet; tablet, extended release)
Depression and Suicidality in Patients with Huntington's Disease. Deutetrabenazine extended release tablets and deutetrabenazine tablets can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington disease.
Anyone considering the use of deutetrabenazine extended release tablets or deutetrabenazine tablets 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 extended release tablets and deutetrabenazine tablets are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.
Precautions
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to allow for changes in the dose.
Deutetrabenazine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed, especially if they have a condition called Huntington's disease. If you or your caregiver notice any of these side effects, tell your doctor right away.
Do not take this medicine if you are also taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within 14 days of each other. If you have questions, check with your doctor.
Do not take this medicine if you are also taking reserpine (Serpalan® or Renese®-R). Wait at least 20 days after stopping reserpine before starting deutetrabenazine. If you have questions, check with your doctor.
Do not take this medicine if you are also taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®). If your doctor plans to switch your treatment from tetrabenazine to deutetrabenazine, take your first dose of deutetrabenazine one day after your last dose of tetrabenazine. If you have questions, check with your doctor.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
Check with your doctor right away if you have an inability to sit still, need to keep moving, or restlessness. These could be symptoms of a movement disorder called akathisia.
This medicine may cause parkinsonism (a movement disorder). Check with your doctor right away if you have difficulty swallowing, loss of balance control, mask-like face, shuffling walk, slowed movements, slurred speech, stiffness of the arms and legs, tic-like or jerky movements of the head, face, mouth, and neck, or trembling and shaking of the fingers and hands.
This medicine may cause drowsiness, trouble with thinking, or trouble with controlling movements. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If the problem continues or worsens, check with your doctor.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, barbiturates or medicine for seizures, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you Stop taking deutetrabenazine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of deutetrabenazine
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 side effects
- 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 side effects
- 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
Other side effects of deutetrabenazine
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 side effects
- bruising
- large, flat, blue patches on the skin
Less common side effects
- muscle aches
- sore throat
- stuffy or runny nose
For healthcare professionals
Applies to deutetrabenazine: oral tablet, oral tablet extended release.
General adverse events
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]
See also:
Xenazine
Xenazine (tetrabenazine) is used to treat Huntington's chorea (uncontrolled muscle ...
Ingrezza
Ingrezza (valbenazine) is used to treat tardive dyskinesia (TD) and chorea associated with ...
Austedo
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Gocovri
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Symmetrel
Symmetrel is used for extrapyramidal reaction, parkinson's disease
Valbenazine
Valbenazine (Ingrezza) is used to treat tardive dyskinesia (TD) and chorea associated with ...
Tetrabenazine
Tetrabenazine tablets are used to treat involuntary movements (chorea) caused by Huntington's ...
Vitamin e
Vitamin E is an antioxidant that occurs naturally in some foods and is used to treat or prevent ...
Pyridoxine
Pyridoxine systemic is used for anemia, dietary supplementation, drug induced vitamin/mineral ...
Amantadine
Easy-to-read patient leaflet for amantadine. Includes indications, proper use, special ...
References
1. (2017) "Product Information. Austedo (deutetrabenazine)." Teva Pharmaceuticals USA
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Further information
Deutetrabenazine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.