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Brivaracetam Side Effects

In Summary

Commonly reported side effects of brivaracetam include: acute psychosis, dizziness, drowsiness, equilibrium disturbance, fatigue, sedated state, abnormal behavior, abnormal gait, aggressive behavior, agitation, anxiety, apathy, asthenia, ataxia, depressed mood, depression, hallucination, hypersomnia, lacrimation, lethargy, nervousness, nystagmus, paranoia, psychomotor agitation, vertigo, irritability, emotional lability, malaise, and restlessness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to brivaracetam: oral solution, oral tablet

Other dosage forms:

Along with its needed effects, brivaracetam 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 brivaracetam:

More Common

  • Anxiety
  • changes in behavior
  • chest pain or discomfort
  • dizziness or lightheadedness
  • double vision
  • drowsiness
  • dry mouth
  • general feeling of discomfort or illness
  • hyperventilation
  • irregular heartbeats
  • irritability
  • nausea
  • restlessness
  • seeing double
  • sensation of spinning
  • sleepiness or unusual drowsiness
  • thoughts of killing oneself
  • trouble sleeping
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • unusually deep sleep
  • unusually long duration of sleep

Less Common

  • Shakiness and unsteady walk
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • uncontrolled eye movements

Incidence Not Known

  • Cough
  • difficulty breathing or swallowing
  • fever
  • hives
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • reddening of the skin, especially around the ears
  • swelling of the eyes, face, or inside of the nose

Some side effects of brivaracetam 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:

Less Common

  • Difficulty having a bowel movement (stool)
  • vomiting

For Healthcare Professionals

Applies to brivaracetam: intravenous solution, oral liquid, oral tablet

General

The more commonly reported adverse events have included somnolence/sedation, dizziness, fatigue, and nausea/vomiting.

Nervous system

Very common (10% or more): Somnolence/sedation (up to 27%), dizziness and disturbances in gait and coordination (up to 16%); fatigue-related adverse reactions (i.e., fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy)

Common (1% to 10%): Cerebellar coordination and balance disturbances, convulsion, vertigo[Ref]

This drug causes dose-dependent increases in somnolence and fatigue-related adverse reactions (i.e., fatigue, asthenia, malaise, hypersomnia, sedation, and lethargy). In clinical trials, somnolence and fatigue-related adverse reactions were reported in 25%, 20%, 26%, and 27% of patients receiving at least 50 mg/day, 50 mg/day, 100 mg/day, and 200 mg/day, respectively. Adverse reactions related to dizziness, gait and coordination disturbances including vertigo, ataxia, nystagmus occurred in 16% of patients.[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, insomnia, irritability

Uncommon (0.1% to 1%): Suicidal ideation, psychotic disorder, aggression, agitation[Ref]

Psychiatric adverse events have been commonly reported. During clinical trials, approximately 13% of patients (compared to 8% on placebo) reported psychiatric events which included irritability, anxiety, nervousness, aggression, belligerence, anger, agitation, restlessness, depression, depressed mood, tearfulness, apathy, altered mood, mood swings, affect lability, psychomotor hyperactivity, abnormal behavior, adjustment disorder, psychotic disorder, hallucinations, paranoia, acute psychosis and psychotic behavior. A total of 1.7% of adult patients discontinued treatment because of psychiatric reactions (compared to 1.3% of placebo). In pediatric trials, psychiatric events were generally similar.[Ref]

Local

Common (1% to 10%): Infusion site pain

Hypersensitivity

Frequency not reported: Hypersensitivity, bronchospasm, angioedema

Metabolic

Common (1% to 10%): Decreased appetite, decreased weight[Ref]

Hematologic

Common (1% to 10%): Decreased WBC

Uncommon (0.1% to 1%): Neutropenia[Ref]

In clinical trials, at least 1.8% of patients had at least 1 clinically significant decreased WBC (compared to 1.1% of placebo).[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, constipation[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infections, cough[Ref]

Immunologic

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

References

1. "Product Information. Briviact (brivaracetam)." UCB Pharma Inc, Smyrna, GA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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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