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Xenazine Side Effects

Generic Name: tetrabenazine

Please note - some side effects for Xenazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Xenazine - for the Consumer

Xenazine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xenazine:

Decreased appetite; dizziness; drowsiness; nausea; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Xenazine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; fast or irregular heartbeat; fever; increased sweating; increased or unusual coughing; new or worsening muscle problems (eg, body stiffness, tremor or shaking, trouble moving or keeping your balance, unsteadiness); new or unusual involuntary muscle movements of the face, mouth, jaws, or tongue (eg, fast eye blinking, lip smacking, mouth puckering or chewing movements, puffing of cheeks, sticking out of the tongue); new or worsening mental or mood problems (eg, agitation or aggressiveness, anxiety, confusion, depression or sadness, panic attack, restlessness, or unusual behavior changes); persistent trouble sleeping; severe nausea or vomiting; severe or persistent dizziness; shortness of breath; suicidal thoughts or actions; trouble speaking or swallowing; trouble urinating; unusual bruising or bleeding; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Xenazine Side Effects - for the Professional

Xenazine

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

Commonly Observed Adverse Reactions in Controlled Clinical Trials

The most common adverse reactions from Table 1 occurring in over 10% of Xenazine-treated patients, and at least 5% greater than placebo, were sedation/somnolence (31%), fatigue (22%), insomnia (22%), depression (19%), akathisia (19%), and nausea (13%).

Clinical Studies 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 practice.

During its development, Xenazine was administered to 773 unique subjects and patients. The conditions and duration of exposure to Xenazine varied greatly, and included single and multiple dose clinical pharmacology studies in healthy volunteers (n=259) and open-label (n=529) and double-blind studies (n=84) in patients.

In a randomized, 12-week, placebo-controlled clinical trial of HD subjects, adverse reactions (ARs) were more common in the Xenazine group than in the placebo group. Forty-nine of 54 (91%) patients who received Xenazine experienced one or more ARs at any time during the study. The ARs most commonly reported (over 10%, and at least 5% greater than placebo) were sedation/somnolence (31% vs. 3% on placebo), fatigue (22% vs. 13% on placebo), insomnia (22% vs. 0% on placebo), depression (19% vs. 0% on placebo), akathisia (19% vs. 0% on placebo), and nausea (13% vs. 7% on placebo).

Adverse Reactions Occurring in ≥4% Patients

The number and percentage of the most commonly reported AEs that occurred at any time during the study in ≥4% of Xenazine-treated patients, and with a greater frequency than in placebo-treated patients, are presented in Table 1 in decreasing order of frequency within body systems for the Xenazine group.

Table 1. Treatment Emergent Adverse Reactions in Patients Treated with Xenazine and with a Greater Frequency than Placebo in the 12-Week, Double-Blind, Placebo-Controlled Trial of Xenazine
Body System AE Term Xenazine
n = 54
n (%)		 Placebo
n = 30
n (%)
PSYCHIATRIC DISORDERS Sedation/somnolence 17 (31%) 1 (3%)
Insomnia 12 (22%) -
Depression 10 (19%) -
Anxiety/anxiety aggravated 8 (15%) 1 (3%)
Irritability 5 (9%) 1 (3%)
Appetite decreased 2 (4%) -
Obsessive reaction 2 (4%) -
CENTRAL & PERIPHERAL NERVOUS SYSTEM Akathisia 10 (19%) -
Balance difficulty 5 (9%) -
Parkinsonism/bradykinesia 5 (9%) -
Dizziness 2 (4%) -
Dysarthria 2 (4%) -
Gait unsteady 2 (4%) -
Headache 2 (4%) 1 (3%)
GASTROINTESTINAL SYSTEM DISORDERS Nausea 7 (13%) 2 (7%)
Vomiting 3 (6%) 1 (3%)

BODY AS A WHOLE – GENERAL		 Fatigue 12 (22%) 4 (13%)
Fall 8 (15%) 4 (13%)
Laceration (head) 3 (6%) -
Ecchymosis 3 (6%) -
RESPIRATORY SYSTEM DISORDERS Upper respiratory tract infection 6 (11%) 2 (7%)
Shortness of breath 2 (4%) -
Bronchitis 2 (4%) -
URINARY SYSTEM DISORDERS Dysuria 2 (4%) -

Dose escalation was discontinued or dosage of study drug was reduced because of one or more ARs in 28 of 54 (52%) patients randomized to Xenazine. These ARs consisted of sedation (15), akathisia (7), parkinsonism (4), depression (3), anxiety (2), fatigue (1) and diarrhea (1). Some patients had more than one AR and are, therefore, counted more than once.

Adverse Reactions Due to Extrapyramidal Symptoms (EPS)

The following table describes the incidence of events considered to be extrapyramidal adverse reactions.

Table 2. Treatment Emergent EPS in Patients Treated with Xenazine occurring with a Greater Frequency than Placebo in the 12-Week, Double-Blind, Placebo-Controlled Trial of Xenazine
Event Patients (%) reporting event
Xenazine
n = 54		 Placebo
n = 30
*
Patients with the following adverse event preferred terms were counted in this category: akathisia, hyperkinesia, restlessness.
†
Patients with the following adverse event preferred terms were counted in this category: bradykinesia, parkinsonism, extrapyramidal disorder, hypertonia.
Akathisia * 10 (19%) 0
Extrapyramidal event † 8 (15%) 0
Any extrapyramidal event 18 (33%) 0

Patients may have had events in more than one category.

Laboratory Tests

No clinically significant changes in laboratory parameters were reported in clinical trials with Xenazine. In controlled clinical trials, Xenazine caused a small mean increase in alanine aminotransferase (ALT) and aspartate aminotransferase (AST), laboratory values as compared to placebo.

Vital Signs

In controlled clinical trials, Xenazine did not affect blood pressure, pulse, and body weight. Orthostatic blood pressure was not consistently measured in the Xenazine clinical trials.

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Side Effects by Body System - for Healthcare Professionals

Psychiatric

Psychiatric side effects have included sedation, somnolence, insomnia, depression, anxiety, irritability, and obsessive reaction.

Nervous system

Nervous system side effects have included akathisia, balance difficulty, Parkinsonism, bradykinesia, dizziness, dysarthria, and unsteady gait.

Other

Other side effects have included fatigue, falls, and ecchymosis.

Respiratory

Respiratory side effects have included upper respiratory tract infection, shortness of breath, and bronchitis.

Genitourinary

Genitourinary side effects have included dysuria.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.

Cardiovascular

Cardiovascular side effects have included hypotension.

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More Xenazine resources

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