Perampanel
Fycompa · ATC code N03AX22
Brand names: Fycompa, Fypalan, Perampanel Ratiopharm, Perampanel Ratiopharm®, Fylepsia, Perampanel Al, Perampanel Doc, Perampanel Elpen, Perampanel Stada, Perampanel Vivanta, Pilesia
- Key facts
- Active substance
- Perampanel
- Drug class
- Anticonvulsant agent
- ATC code
- N03AX22
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Fycompa 2 mg film-coated tablets / Fycompa 4 mg film-coated tablets / Fycompa 6 mg film-coated tablets · Fycompa 0.5 mg/ml oral suspension
- Marketing authorisation holder
- Eisai GmbH
- Information as of
- 2026-10-27
Key facts
Perampanel is an antiepileptic (AMPA receptor antagonist) used as adjunctive treatment of partial-onset and primary generalised tonic-clonic seizures.
What it is used for
- Adjunctive treatment of partial-onset seizures with or without secondary generalisation from 4 years of age
- Adjunctive treatment of primary generalised tonic-clonic seizures in idiopathic generalised epilepsy from 7 years of age
Dosing
- Once daily at bedtime; titrated to individual response and tolerability
- Adults/adolescents 12 years and older and children ≥ 30 kg: start 2 mg/day, increase by 2 mg; maintenance 4 – 8 mg/day, maximum 12 mg/day
- Children 20 - < 30 kg: start 1 mg/day, maintenance 4 – 6 mg/day, maximum 8 mg/day; children < 20 kg: maintenance 2 – 4 mg/day, maximum 6 mg/day
- Titration no more often than every 2 weeks, or weekly with co-medication that shortens the half-life
- Mild/moderate hepatic impairment: start 2 mg, increase no faster than every 2 weeks, max 8 mg
- Not recommended in moderate/severe renal impairment, haemodialysis or severe hepatic impairment
Contraindications
- Hypersensitivity to the active substance or any excipient
Important warnings
- Suicidal ideation and behaviour: monitoring of children, adolescents and adults
- Severe cutaneous reactions (DRESS, SJS), possibly fatal; withdraw immediately and never restart
- Absence and myoclonic seizures should be monitored
- Psychiatric events such as aggression, anger and psychosis may occur
- Hepatotoxicity has been reported
Side effects
- Most common reasons for discontinuation: dizziness and somnolence
- Others: ataxia, dysarthria, balance disorder, irritability, diplopia, blurred vision, vertigo, nausea, fatigue, gait disturbance
- Psychiatric: aggression, anger, anxiety, confusional state, suicidal ideation, hallucinations
Interactions
- At 12 mg/day, progestative hormonal contraceptives may be less effective; additional non-hormonal contraception
- Enzyme-inducing antiepileptics and other CYP450 inducers/inhibitors alter perampanel levels; dose adjustment may be needed
Pregnancy and breastfeeding
- Not recommended during pregnancy; in women of childbearing potential without contraception only if clearly necessary
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- FycompaEisai GmbH · EMEA/H/C/002434
Source: European Medicines Agency (EMA), product information
Austria
- FypalanG.L. Pharma Gmbh · 1 register entry
- Perampanel RatiopharmRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
- Perampanel Ratiopharm®Ratiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- FylepsiaElpen Pharmaceutical Co. Inc. · 1 register entry
- FypalanG.L. Pharma Gmbh · 1 register entry
- Perampanel AlAliud Pharma Gmbh · 1 register entry
- Perampanel DocDoc Generici S.R.L. · 1 register entry
- Perampanel ElpenElpen Pharmaceutical Co. Inc. · 1 register entry
- Perampanel RatiopharmRatiopharm Gmbh · 1 register entry
- Perampanel StadaStadapharm Gmbh · 1 register entry
- Perampanel VivantaVivanta Generics S.R.O. · 1 register entry
- PilesiaFarmitalia S.R.L. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Brand names in 16 more European countries
- Cyprus
- Fylepsia
- Czechia
- Fypalan, Perampanel Orion, Perampanel Teva
- Denmark
- Perampanel Orion, Perampanel Vivanta
- Finland
- Perampanel Orion
- France
- Perampanel Teva
- Greece
- Fylepsia, Perampanel Win Medica
- Iceland
- Fycompa
- Italy
- Fypalan, Perampanel Doc, Perampanel Eg, Perampanel Teva, Pilesia
- Liechtenstein
- Fycompa
- Netherlands
- Fypalan, Perampanel Sandoz, Perampanel Sandoztten, Perampanel Teva
- Norway
- Fycompa, Perampanel Orion, Perampanel Vivanta
- Poland
- Fypalan, Perampanel Orion
- Portugal
- Perampanel Teva
- Slovakia
- Fypalan
- Spain
- Perampanel Cinfa, Perampanel Combix, Perampanel Elpen, Perampanel Swanpond Investments, Perampanel Teva, Perampanel Vivanta, Priaxal
- Sweden
- Perampanel Orion, Perampanel Vivanta
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- European Medicines Agency. Fycompa – EPAR, Product Information (OF THE TEXT {MM/YYYY} Detailed information on this medicinal). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/fycompa-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- Wikidata (CC0): ATC N03AX.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.