Summary

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

Applies to brivaracetam: oral solution, oral tablet. Other dosage forms:

• intravenous solution

Serious side effects of Brivaracetam

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
• deep or fast breathing with dizziness
• dizziness or lightheadedness
• double vision
• drowsiness
• dry mouth
• general feeling of discomfort or illness
• irregular heartbeat
• irritability
• nausea
• numbness of feet, hands, and around mouth
• 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
• uncontrolled eye movements
• unsteadiness, trembling, or other problems with muscle control or coordination

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 genitals
• noisy breathing
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose

Other side effects of Brivaracetam

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
• 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

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]

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, dysgeusia^[Ref]

Psychiatric

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

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

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

Common (1% to 10%): Decreased WBC

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