Briviact Side Effects
Generic name: brivaracetam
Note: This document provides detailed information about Briviact Side Effects associated with brivaracetam. Some dosage forms listed on this page may not apply specifically to the brand name Briviact.
Applies to brivaracetam: oral solution, oral tablet.
Other dosage forms:
Precautions
It is very important that your doctor check your or your child's progress at regular visits, especially for the first few months you are taking this medicine to allow for a change in the dose and to check for any unwanted effects.
Brivaracetam may cause changes in mood or behavior, problems with coordination, or unusual tiredness or weakness. Tell your doctor right away if you start to feel depressed, anxious, angry, getting upset easily, restless, or have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you, especially if they are new or getting worse quickly.
This medicine may make you dizzy, drowsy, tired, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause serious allergic reactions, including bronchospasm and angioedema. Tell your doctor if you have difficulty in breathing or swallowing, a fever, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, nausea, reddening of the skin, especially around the ears, swelling of the eyes, face, or inside of the nose, or unusual tiredness or weakness.
Do not stop using brivaracetam (the active ingredient contained in Briviact) without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
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 Briviact
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 side effects
- 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 side effects
- 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 Briviact
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 side effects
- difficulty having a bowel movement
- vomiting
For healthcare professionals
Applies to brivaracetam: intravenous solution, oral liquid, oral tablet.
General adverse events
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, dysgeusia[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, 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
- 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
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2016) "Product Information. Briviact (brivaracetam)." UCB Pharma Inc
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Further information
Briviact 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.