Perampanel

Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation.

• Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Perampanel tablets are indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Perampanel tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.ICD-10: G40.909

• None.contraindicated

Dosing in the absence of moderate or strong CYP3A4 inducers Starting dose: 2 mg once daily orally at bedtime ( 2.1 , 2.2 ) May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals ( 2.1 , 2.2 ) Recommended maintenance dose in monotherapy or adjunctive therapy for partial-onset seizures: 8 mg to 12 mg once daily at bedtime ( 2.1 ) Recommended maintenance dose in adjunctive therapy for primary generalized tonic-clonic seizures: 8 mg once daily at bedtime ( 2.2 ) Dosing in the presence of concomitant moderate or strong CYP3A4 inducers : see section 2.3 Specific Populations Mild and Moderate Hepatic Impairment: Maximum recommended daily dose is 6 mg (mild) and 4 mg (moderate) once daily at bedtime ( 2.4 ) Severe Hepatic Impairment: Not recommended ( 2.4 ) Severe Renal Impairment or on Hemodialysis: Not recommended ( 2.5 ) Elderly: Increase dose no more frequently than every 2 weeks ( 2.6 ) 2.1 Dosage for Partial-Onset Seizures Monotherapy or Adjunctive Therapy The recommended starting dosage of perampanel in adults and pediatric patients 4 years of age and older is 2 mg once daily taken orally at bedtime. Increase dosage no more frequently than at weekly intervals by increments of 2 mg once daily based on individual clinical response and tolerability. The recommended maintenance dose range is 8 mg to 12 mg once daily, although some patients may respond to a dose of 4 mg daily.

Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior ( 5.2 ) Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence, and fatigue ( 5.3 ) Patients should use caution when driving or operating machinery ( 5.3 ) Falls: Monitor for falls and injuries ( 5.4 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Discontinue if no alternate etiology ( 5.5 ) Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may be an increase in seizure frequency ( 5.6 ) 5.1 Serious Psychiatric and Behavioral Reactions In the controlled partial-onset seizure clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive perampanel at doses of 8 mg and 12 mg per day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. Perampanel-treated patients experienced more hostility- and aggression-related adverse reactions that were serious, severe, and led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients. In general, in placebo-controlled partial-onset seizure clinical trials, neuropsychiatric events were reported more frequently in patients being treated with perampanel than in patients taking placebo.

The following serious adverse reactions are described below and elsewhere in the labeling: Serious Psychiatric and Behavioral Reactions [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Neurologic Effects [see Warnings and Precautions (5.3) ] Falls [see Warnings and Precautions (5.4) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-866-923-4914 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 clinical practice. Partial-Onset Seizures Adult and Adolescent Patients (12 years of age and older) A total of 1,038 patients receiving perampanel (2 mg, 4 mg, 8 mg, or 12 mg once daily) constituted the safety population in the pooled analysis of the placebo-controlled trials (Studies 1, 2, and 3) in patients with partial-onset seizures. Approximately 51% of patients were female, and the mean age was 35 years.

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 perampanel, during pregnancy. Encourage women who are taking perampanel during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary There are no adequate data on the developmental risk associated with use in pregnant women. In animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [see Data ] . In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of perampanel (1 mg/kg/day, 3 mg/kg/day, or 10 mg/kg/day) to pregnant rats throughout organogenesis resulted in an increase in visceral abnormalities (diverticulum of the intestine) at all doses tested; maternal toxicity was observed at the mid and high doses.

Metabolism

Pharmacokinetics of perampanel are similar in healthy subjects, patients with partial-onset seizures, and patients with primary generalized tonic-clonic seizures. The half-life of perampanel is about 105 hours, so that steady state is reached in about 2 to 3 weeks.

The highest reported overdose of perampanel was 300 mg. Events reported after perampanel overdose include somnolence, stupor, coma, psychiatric or behavioral reactions, altered mental status, and dizziness or gait disturbances. There is no available specific antidote to the overdose reactions of perampanel. 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 rhythm and vital sign measurement is recommended. A certified poison control center should be contacted for updated information on the management of overdose with perampanel. Due to its long half-life, the reactions caused by perampanel could be prolonged.

• Oct 22, 2012NDANDA202834Catalyst Pharms
• Apr 29, 2016NDANDA208277Catalyst Pharms
• May 23, 2025ANDAANDA209801Teva Pharms Usa Inc
• Jul 11, 2025ANDAANDA218152Msn
• Nov 25, 2025ANDAANDA218178Msn
• Nov 25, 2025ANDAANDA209538Taro

1. 1Seizure1,12115%
2. 2Drug Ineffective1,07215%
3. 3Off Label Use77211%
4. 4Somnolence5006.8%
5. 5Aggression4916.7%
6. 6Dizziness3875.3%
7. 7Epilepsy3404.6%
8. 8Multiple-drug Resistance3264.4%
9. 9Status Epilepticus3254.4%
10. 10Drug Interaction3234.4%
11. 11Fatigue2994.1%
12. 12Irritability2423.3%
13. 13Condition Aggravated2283.1%
14. 14Fall2223.0%
15. 15Product Use In Unapproved Indication2183.0%

The 10 most recently updated of 106 ClinicalTrials.gov registrations naming Perampanel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
  Recruiting · Early phase 1 · Interventional · 36 enrolled · Aarhus University Hospital
  NCT07284069updated 2026-05-07
• Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
  Recruiting · Phase 1 · Interventional · 50 enrolled · Yale University
  NCT05915013updated 2026-05-06
• The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects
  Recruiting · Phase 2 · Interventional · 30 enrolled · Yale University
  NCT05786066updated 2026-05-06
• Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
  Recruiting · Phase 1 · Interventional · 70 enrolled · National Institute of Mental Health (NIMH)
  NCT03973268updated 2026-02-24
• Population Pharmacokinetics of Antiepileptic in Pediatrics
  Completed · Observational · 753 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT03196466updated 2025-11-20
• Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus
  Terminated · Phase 4 · Interventional · 1 enrolled · Wayne State University
  NCT05684978updated 2025-10-14
• A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
  Recruiting · Phase 2 · Interventional · 100 enrolled · Eisai Inc.
  NCT04015141updated 2025-10-09
• An Extended Access Program (EAP) for Perampanel
  No longer available · Expanded access · Eisai Inc.
  NCT02307578updated 2025-09-15
• Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations
  Completed · Phase 1 · Interventional · 26 enrolled · Aya Mohammed Abdel Magid Abdel Hamid
  NCT06969963updated 2025-08-20
• Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest
  Recruiting · Observational · 80 enrolled · University of Milano Bicocca
  NCT05756621updated 2025-07-29

Frequently asked questions

How does Perampanel work?

Perampanel is a non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal over excitation.

What is Perampanel used for?

According to FDA labeling, Perampanel carries indications including: Perampanel tablets, a non-competitive AMPA glutamate receptor antagonist, is indicated for: Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Perampanel tablets are indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Perampanel tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Perampanel?

Perampanel is classified as Other antiepileptics, Noncompetitive AMPA Glutamate Receptor Antagonist, AMPA Receptor Antagonists, Cytochrome P450 2C8 Inhibitors, Cytochrome P450 3A4 Inhibitors, UGT1A9 Inhibitors, UGT2B7 Inhibitors, Decreased Central Nervous System Glutamate Activity.

What are the brand names for Perampanel?

Perampanel is marketed under brand names including FYCOMPA.

What are the contraindications for Perampanel?

Perampanel labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.