Brivaracetam

The precise mechanism by which brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.

• Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.ICD-10: G40.909

• Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam tablets (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4) ] . Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam.contraindicated

Adults (16 Years and Older ): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day). (2.1) Pediatric Patients (1 Month to less than 16 Years): The recommended dosage is based on body weight and is administered orally twice daily (2.1) Hepatic Impairment: Dose adjustment is recommended for all stages of hepatic impairment. (2.5) 2.1 Dosage Information Monotherapy or Adjunctive Therapy The recommended dosage for patients 1 month of age and older is included in Table 1. In pediatric patients weighing less than 50 kg, the recommended dosing regimen is dependent upon body weight. When initiating treatment, gradual dose escalation is not required. Dosage should be adjusted based on clinical response and tolerability.

Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation. (5.1) Neurological Adverse Reactions: Monitor for somnolence and fatigue, and advise patients not to drive or operate machinery until they have gained sufficient experience on brivaracetam. (5.2) Psychiatric Adverse Reactions: Behavioral reactions including psychotic symptoms, irritability, depression, aggressive behavior, and anxiety; monitor patients for symptoms. (5.3) Hypersensitivity: Bronchospasm and Angioedema: Advise patients to seek immediate medical care. Discontinue and do not restart brivaracetam if hypersensitivity occurs. (5.4) Serious Dermatologic Reactions: Discontinue brivaracetam unless an alternative etiology is established ( 5.5 ) Withdrawal of Antiepileptic Drugs: Brivaracetam should be gradually withdrawn. ( 5.6 ) 5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including brivaracetam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.

The following serious adverse reactions are described elsewhere in labeling: Suicidal Behavior and Ideation [ see Warnings and Precautions (5.1)] Neurological Adverse Reactions [see Warnings and Precautions (5.2)] Psychiatric Adverse Reactions [see Warnings and Precautions (5.3)] Hypersensitivity: Bronchospasm and Angioedema [see Warnings and Precautions (5.4)] Serious Dermatologic Reactions [see Warnings and Precautions (5.5) ] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions (5.6) ] Adults: Most common adverse reactions (at least 5% for brivaracetam and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea/vomiting. (6.1) Pediatric Patients: Most common adverse reactions are similar to those seen in adult patients. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In all controlled and uncontrolled trials performed in adult epilepsy patients, brivaracetam was administered as adjunctive therapy to 2437 patients. Of these patients, 1929 were treated for at least 6 months, 1500 for at least 12 months, 1056 for at least 24 months, and 758 for at least 36 months.

Pregnancy: Based on animal data, may cause fetal harm. (8.1) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as brivaracetam, during pregnancy. Encourage patients who are taking brivaracetam during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with brivaracetam use during pregnancy. In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Metabolism

Brivaracetam tablets, oral solution, and injection can be used interchangeably. Brivaracetam exhibits linear and time-independent pharmacokinetics at the approved doses.

There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness were reported in a patient taking a single dose of 1400 mg (14 times the highest recommended single dose) of brivaracetam. The following adverse reactions were reported with brivaracetam overdose: vertigo, balance disorder, fatigue, nausea, diplopia, anxiety, and bradycardia. In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions. There is no specific antidote for overdose with brivaracetam. In the event of overdose, standard medical practice for the management of any overdose should be used. An adequate airway, oxygenation, and ventilation should be ensured; monitoring of cardiac rate and rhythm and vital signs is recommended. A certified poison control center should be contacted for updated information on the management of overdose with brivaracetam. There are no data on the removal of brivaracetam using hemodialysis, but because less than 10% of brivaracetam is excreted in urine, hemodialysis is not expected to enhance brivaracetam clearance.

• Feb 18, 2016NDANDA205836Ucb Inc
• Feb 18, 2016NDANDA205837Ucb Inc
• Feb 18, 2016NDANDA205838Ucb Inc
• Jun 9, 2022ANDAANDA214748Sunshine
• Oct 3, 2022ANDAANDA214501Zydus Pharms
• Jan 6, 2023ANDAANDA214848Aurobindo Pharma Ltd
• Nov 13, 2025ANDAANDA214921Msn
• Feb 19, 2026ANDAANDA214922Msn

1. 1Seizure3,062—
2. 2Off Label Use1,088—
3. 3Drug Ineffective924—
4. 4Fatigue543—
5. 5Therapy Interrupted480—
6. 6Somnolence470—
7. 7Overdose452—
8. 8Dizziness447—
9. 9Product Availability Issue368—
10. 10Fall349—
11. 11Generalised Tonic-clonic Seizure324—
12. 12Product Dose Omission Issue299—
13. 13Epilepsy292—
14. 14Product Use Issue291—
15. 15Headache290—

The 10 most recently updated of 58 ClinicalTrials.gov registrations naming Brivaracetam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Tolerability and Activity of Brivaracetam (BRV) in Patients With Diffuse Gliomas
  Terminated · Early phase 1 · Interventional · 3 enrolled · University of Rochester
  NCT05029960updated 2026-06-03
• Compassionate Use Program With Brivaracetam for the Treatment of Patients With Epilepsy
  No longer available · Expanded access · UCB Biopharma SRL
  NCT03532516updated 2026-06-01
• Long-term Safety and Efficacy of Adjunctive Brivaracetam in Chinese Patients With Uncontrolled Focal Epilepsy
  Completed · Phase 3 · Interventional · 141 enrolled · Jiangxi Qingfeng Pharmaceutical Co. Ltd.
  NCT07563634updated 2026-05-04
• A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
  Recruiting · Phase 3 · Interventional · 120 enrolled · UCB Biopharma SRL
  NCT06315322updated 2026-04-13
• Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
  Completed · Phase 3 · Interventional · 44 enrolled · University of Minnesota
  NCT05639946updated 2026-03-18
• A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
  Active not recruiting · Phase 3 · Interventional · 153 enrolled · UCB Biopharma SRL
  NCT04666610updated 2026-03-13
• Epileptic Hippocampus in Alzheimer's Disease
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 25 enrolled · University of California, Los Angeles
  NCT05899764updated 2026-01-27
• A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
  Completed · Phase 3 · Interventional · 84 enrolled · UCB Biopharma SRL
  NCT05109234updated 2025-10-22
• Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
  Completed · Phase 3 · Interventional · 257 enrolled · UCB Pharma SA
  NCT01364597updated 2025-10-20
• Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
  Completed · Phase 1 · Phase 2 · Interventional · 24 enrolled · University of Minnesota
  NCT04379011updated 2025-10-14

CPIC-curated drug–gene pairs for Brivaracetam. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2C19CPIC B (provisional)ClinPGx 3FDA label: Actionable PGx

Frequently asked questions

How does Brivaracetam work?

The precise mechanism by which brivaracetam exerts its anticonvulsant activity is not known. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.

What is Brivaracetam used for?

According to FDA labeling, Brivaracetam carries indications including: Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Brivaracetam?

Brivaracetam is classified as Other antiepileptics, Epoxide Hydrolase Inhibitors, Central Nervous System Depression.

What are the brand names for Brivaracetam?

Brivaracetam is marketed under brand names including Briviact.

What are the contraindications for Brivaracetam?

Brivaracetam labeling lists contraindications including: Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam tablets (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4) ] . Hypersensitivity to brivaracetam or any of the inactive ingredients in brivaracetam.. Always consult the full prescribing information and a clinician.