Brivaracetam Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 1, 2024.

Applies to brivaracetam: intravenous solution.

Other dosage forms:

• oral solution, oral tablet

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for 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, or angry, getting upset easily, restless, or if you 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 cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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 sex organs, 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 interrupt or stop receiving this medicine without checking first with your doctor. 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 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 or nurse immediately if any of the following side effects occur while taking brivaracetam:

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:

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

• Common (1% to 10%): Influenza^[Ref]

See also:

Further information

Brivaracetam 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.

Medical Disclaimer