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Brivaracetam Injection: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Controlled substance Schedule V
Strength:
50 mg/5 mL
Brand names:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Brivaracetam Injection

What is the most important information I should know about brivaracetam injection?

Brivaracetam injection is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep brivaracetam injection in a safe place to prevent misuse and abuse. Selling or giving away brivaracetam injection may harm others and is against the law.

Like other antiepileptic drugs, brivaracetam injection may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • new or worse depression
  • feeling agitated or restless
  • trouble sleeping (insomnia)
  • acting aggressive, feeling angry, or being violent
  • an extreme increase in activity and talking (mania) • attempts to commit suicide
  • new or worse anxiety
  • panic attacks
  • new or worse irritability
  • acting on dangerous impulses
  • other unusual changes in behavior or mood

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop brivaracetam injection without first talking to a healthcare provider.

  • Stopping brivaracetam injection suddenly can cause serious problems.
  • Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).

What is brivaracetam injection?

Brivaracetam injection is a prescription medicine used to treat partial-onset seizures in people 1 month of age and older.

It is not known if brivaracetam injection is safe and effective in children younger than 1 month of age.

Who should not take brivaracetam injection?

Do not take brivaracetam injection if you are allergic to brivaracetam or any of the ingredients in brivaracetam injection. See the end of this Medication Guide for a complete list of ingredients in brivaracetam injection.

What should I tell my healthcare provider before starting brivaracetam injection?

Before taking brivaracetam injection, tell your healthcare provider about all of your medical conditions, including if you:

  • have or had depression, mood problems, or suicidal thoughts or behavior.
  • have liver problems.
  • have abused or been dependent on prescription medicines, street drugs, or alcohol.

  • are pregnant or plan to become pregnant. It is not known if brivaracetam injection will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking brivaracetam injection. You and your healthcare provider will have to decide if you should take brivaracetam injection while you are pregnant. If you become pregnant while taking brivaracetam injection, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of brivaracetam injection and other antiepileptic medicines during pregnancy.

  • are breastfeeding or plan to breastfeed. Brivaracetam passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take brivaracetam injection.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Brivaracetam injection may affect the way other medicines work, and other medicines may affect how brivaracetam injection works. Do not start a new medicine without first talking with your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take brivaracetam injection?

  • Take brivaracetam injection exactly as your healthcare provider tells you.
  • Your healthcare provider will tell you how much brivaracetam injection to take and when to take it.
  • Your healthcare provider may change your dose if needed. Do not change your dose without talking to your healthcare provider.
  • Brivaracetam injection can be given to you by intravenous (IV) infusion into your vein, as prescribed by your healthcare provider.
  • If you take too much brivaracetam injection, call your Poison Control Center or go to the nearest emergency room right away.

What should I avoid while taking brivaracetam injection?

Do not drive or operate machinery until you know how brivaracetam injection affects you. Brivaracetam injection may cause drowsiness, tiredness, dizziness, and problems with your balance and coordination.

What are the possible side effects of brivaracetam injection?

Brivaracetam injection may cause serious side effects, including:

  • See “ What is the most important information I should know about brivaracetam injection?”
  • Nervous system problems.Drowsiness, tiredness, and dizziness are common with brivaracetam injection, but can be severe. See “ What should I avoid while taking brivaracetam injection?” Brivaracetam injection can also cause problems with balance and coordination.
  • Mental (psychiatric) symptoms.Brivaracetam injection can cause mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. Irritability and anxiety are common with brivaracetam injection, and can be severe. People who take brivaracetam injection can also get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs), and unusual behavior.
  • Serious allergic reactions.Stop taking brivaracetam injection and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:
  • swelling of your face, mouth, lips, gums, tongue, throat, or neck
  • trouble breathing
  • Serious skin rashes.Brivaracetam injection may cause a severe rash with blisters and peeling skin. This may occur around the mouth, nose, eyes, and genitals or over much of the body. A mild rash may become a serious reaction and may cause death. Call your healthcare provider right away if you have a rash, skin blisters, sores in the mouth, or hives. Do not stop taking brivaracetam injection without first talking to your healthcare provider.

The most common side effects of brivaracetam injection in adults include:

  • sleepiness
  • dizziness
  • feeling tired
  • nausea and vomiting

Side effects of brivaracetam injection in children 1 month to less than 16 years of age are similar to those seen in adults. These are not all the possible side effects of brivaracetam injection. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store brivaracetam injection?

  • Store brivaracetam injection at room temperature between 59°F to 86°F (15°C to 30°C).

Keep brivaracetam injection and all medicines out of the reach of children.

General information about the safe and effective use of brivaracetam injection.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use brivaracetam injection for a condition for which it was not prescribed. Do not give brivaracetam injection to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about brivaracetam injection. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about brivaracetam injection that is written for health professionals.

What are the ingredients in brivaracetam injection?

Active ingredient:brivaracetam

Inactive ingredients: sodium acetate trihydrate (2.7 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9 mg/mL), and water for injection.

For more information, call 1-855-839-8195.

Manufactured by:

Micro Labs Limited

Bangalore-560099, INDIA.

Manufactured for:

Micro Labs USA, Inc.

Somerset, NJ 08873

This Medication Guide has been approved by the U.S. Food and Drug Administration

Rev. 12/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 214880 · View the label on DailyMed

Revision date stated in the text: December 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Brivaracetam Injection

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule VSchedule V: low potential for abuse relative to Schedule IV.
Active ingredient Brivaracetam 50 mg/5 mL
Dosage form Injection
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) MICRO LABS
FDA approval ANDA 214880Abbreviated New Drug Application (ANDA) – generic drug Approved February 23, 2026
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 4 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg/5 mL – 5 ml in 1 vial / 10 in 1 carton NDC 42571-370-92

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.