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Molecule

Perampanel

Noncompetitive AMPA Glutamate Receptor Antagonist
Available on requestControlled substanceNeurology
Presentations
14
Brands
1
Manufacturers
1
Available from stock
0

Perampanel is a noncompetitive AMPA glutamate receptor antagonist indicated for treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older, among other approved uses. MedsAcross supplies Perampanel for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Noncompetitive AMPA Glutamate Receptor Antagonist, AMPA Receptor Antagonists, Cytochrome P450 2C8 Inhibitors, Cytochrome P450 3A4 Inhibitors, UGT1A9 Inhibitors, UGT2B7 Inhibitors
ATC classification
N03AX22 Perampanel · Anticonvulsant agent, subgroup N03AX
US FDA first approval
22 October 2012
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Oral suspension
Identifiers
UNII H821664NPKRxCUI 1356552CAS 380917-97-5DrugBank DB08883Q868658

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

FYCOMPA, 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. Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older

Source: US FDA prescribing information

How it works

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. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown.

Source: US FDA prescribing information

Dosing overview

Dosing in the absence of moderate or strong CYP3A4 inducers Starting dose: 2 mg once daily orally at bedtime. May increase dose based on clinical response and tolerability by increments of 2 mg once daily no more frequently than at weekly intervals. Recommended maintenance dose in monotherapy or adjunctive therapy for partial-onset seizures: 8 mg to 12 mg once daily at bedtime. Recommended maintenance dose in adjunctive therapy for primary generalized tonic-clonic seizures: 8 mg once daily at bedtime. Measure oral suspension using provided adaptor and dosing syringe. Dosing in the presence of concomitant moderate or strong CYP3A4 inducers: see section

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (serious psychiatric and behavioral reactions): Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA. Suicidal Behavior and Ideation: Monitor for suicidal thoughts or behavior. Neurologic Effects: Monitor for dizziness, gait disturbance, somnolence, and fatigue. Patients should use caution when driving or operating machinery. Falls: Monitor for falls and injuries. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology. Withdrawal of Antiepileptic Drugs: In patients with epilepsy, there may be an increase in seizure frequency

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described below and elsewhere in the labeling: Serious Psychiatric and Behavioral Reactions Suicidal Behavior and Ideation Neurologic Effects Falls Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity 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

Source: US FDA prescribing information

Interactions

Contraceptives: 12 mg once daily may decrease the effectiveness of hormonal contraceptives containing levonorgestrel. Moderate and Strong CYP3A4 Inducers (including carbamazepine, oxcarbazepine, and phenytoin): increase clearance of perampanel and decrease perampanel plasma concentrations. When moderate or strong CYP3A4 inducers are introduced or withdrawn, monitor patients closely. Dose adjustment of FYCOMPA may be necessary

Source: US FDA prescribing information

Storage

Storage Tablets: store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Oral Suspension: Do not store above 30°C (86°F). Do not freeze.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

14 presentations of Perampanel, sorted by availability.

MedicineManufacturerRegisterAvailability
Perampanel 10 mg tabletOralGeneric name—US FDAAvailable on request
Perampanel 12 mg tabletOralGeneric name—US FDAAvailable on request
Perampanel 2 mg tabletOralGeneric name—US FDAAvailable on request
Perampanel 4 mg tabletOralGeneric name—US FDAAvailable on request
Perampanel 6 mg tabletOralGeneric name—US FDAAvailable on request
Perampanel 8 mg tabletOralGeneric name—US FDAAvailable on request
Fycompa 10 mg tabletOralCatalyst PharmaceuticalsUS FDAAvailable on request
Fycompa 12 mg tabletOralCatalyst PharmaceuticalsUS FDAAvailable on request
Fycompa 2 mg tabletOralCatalyst PharmaceuticalsUS FDAAvailable on request
Fycompa 4 mg tabletOralCatalyst PharmaceuticalsUS FDAAvailable on request
Fycompa 6 mg tabletOralCatalyst PharmaceuticalsUS FDAAvailable on request
Fycompa 8 mg tabletOralCatalyst PharmaceuticalsUS FDAAvailable on request
Fycompa 0.5 mg/mL oral suspensionOralCatalyst PharmaceuticalsUS FDAAvailable on request
Perampanel 0.5 mg/mL oral suspensionOralGeneric name—US FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 22 October 2012Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Perampanel in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Perampanel available for export from India?

Yes, on request. MedsAcross lists 14 presentations of Perampanel and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Perampanel have?

The catalogue lists 1 brand names for Perampanel, including Fycompa.

Is Perampanel approved by the US FDA?

Yes. The US FDA first approved Perampanel on 22 October 2012, according to Drugs@FDA.

Is Perampanel authorised in the European Union?

Yes. Perampanel has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Perampanel need cold chain shipping?

No listed presentation of Perampanel is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Perampanel in?

Perampanel is classified under ATC code N03AX22 (Perampanel).

References

  1. Fycompa prescribing information (Catalyst Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 5 January 2024
  2. Fycompa: European public assessment report (EPAR). European Medicines Agency. Retrieved 10 July 2026

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