Tablet
- Strengths
- 2, 4, 6, 8, 10, 12 mg
- Product note
- Fycompa / generic.
Perampanel
Fycompa
DailyMed-verified antiseizure indications
Indication / use
- Label / evidence summary
- Fycompa: focal-onset seizures with or without secondary generalization from age 4 years; adjunctive treatment of primary generalized tonic-clonic seizures from age 12 years.
- Role
- Maintenance
- Class
- Noncompetitive postsynaptic AMPA-receptor antagonism
Indications checked 26 September 2026. Product, route, age, and treatment-role limits apply. A DailyMed listing alone does not establish FDA approval.
- Fycompa tablet/suspension U.S. label
Focal seizures · 4 years and older · Maintenance - Fycompa tablet/suspension U.S. label
Generalized tonic-clonic seizures · 12 years and older · MaintenanceAdjunctive.
Formulations & strengths
U.S. products unless another country is named. Strengths are per unit or stated volume.
Oral suspension
- Strengths
- 0.5 mg/mL (2.5 mg/5 mL)
- Product note
- Shake; confirm concentration before calculating volume.
Brand & formulation labels
Each link names the product and formulation it covers. Archived labels do not establish current availability.
Dosing & administration
- Adult / product-specific schedule
- Without moderate/strong CYP3A4 inducers: start 2 mg nightly; increase 2 mg no more often than weekly. Focal maintenance usually 8–12 mg nightly (some respond to 4 mg); PGTC 8 mg nightly, up to 12 mg if needed. With moderate/strong CYP3A4 inducers: start 4 mg nightly and follow the inducer-specific schedule.
- Pediatric
- Focal ≥4 years; adjunctive PGTC ≥12 years. Same fixed-dose, co-medication-specific titration as adults. Hepatic/renal impairment and older age modify the schedule.
- Titration / repeat dosing
- Start 2 mg once nightly; increase by 2 mg no more often than weekly (often every 2 weeks for tolerability) to 4–8 mg/day; may increase to 12 mg/day. With enzyme inducers, consider 4 mg start.
Dose adjustment & concentrations
- Renal impairment
- Not recommended in severe renal impairment or hemodialysis.
- Hepatic impairment
- Maximum 6 mg/day in mild and 4 mg/day in moderate impairment; not recommended in severe impairment.
- Serum reference information
- No established therapeutic range; concentration–response is variable
Safety
- Boxed warning
- Boxed warning: serious psychiatric and behavioral reactions, including aggression, hostility, irritability, anger and homicidal ideation/threats. Monitor closely during titration and at higher doses; evaluate new or worsening symptoms promptly.
- Contraindications
- None listed in the linked U.S. label; serious psychiatric warnings still apply.
- Serious precautions & monitoring
- Boxed warning for serious psychiatric and behavioral reactions. Very long half-life makes titration and washout slow.
Common / selected adverse effects
- Dizziness
- Somnolence
- Fatigue
- Irritability
- Falls
- Ataxia
Drug interactions: toxicity & clinical action
| Partner / combination | Clinical effect | Clinical action |
|---|---|---|
| Carbamazepine, oxcarbazepine or phenytoin | CYP3A induction lowers perampanel exposure; stopping an inducer can increase it. | Use inducer-specific starting regimen and monitor dizziness, falls and behavior after changes. |
| Alcohol / other CNS depressants | Greater impairment; alcohol may worsen anger/behavior effects. | Avoid alcohol and assess combined sedative burden. |
| Levonorgestrel contraception at perampanel 12 mg/day | Reduced levonorgestrel exposure. | Use additional nonhormonal contraception during treatment and for 1 month after stopping per label. |
Pregnancy & contraception
- Fetal / neonatal risk
- Human perampanel pregnancy data are inadequate. Developmental toxicity occurred in animal studies at clinically relevant doses.
- Contraception
- At 12 mg/day, perampanel lowers levonorgestrel exposure by about 40%. Use additional nonhormonal contraception during treatment and for one month after stopping, per the U.S. label.
Clinical evidence
Research summaries describe studied populations and outcomes; they do not add indications or constitute treatment recommendations.
Direct pivotal trial
Trial summary
- Study design / duration
- Three randomized, double-blind, placebo-controlled adjunctive focal-seizure trials used 6-week titration plus 13-week maintenance; a separate 17-week trial evaluated primary generalized tonic-clonic seizures.
- Primary endpoint
- No single pivotal endpoint is identified in the cited source.
- Results
- Three pivotal adjunctive focal-seizure trials showed median reductions of approximately 23–35% at 4–12 mg/day versus 10–21% with placebo. In primary generalized tonic-clonic seizures, median reduction was 76% versus 38% with placebo.
Trial publications
Mechanism of action
- Noncompetitively antagonizes postsynaptic AMPA-type ionotropic glutamate receptors, reducing excitatory neurotransmission.
- Acts at the receptor, rather than primarily reducing glutamate release. It is not an NMDA antagonist; the complete connection between receptor blockade and clinical efficacy remains incompletely defined.
Pharmacology
Adult values unless specified. Vd/F denotes apparent oral distribution volume.
Pharmacokinetics
- Bioavailability
- Rapid, essentially complete oral absorption; food slows the peak without changing overall exposure. Tablet and suspension exposure is comparable at steady state.
- Elimination half-life
- Approximately 105 hours without strong enzyme-inducing co-medication; steady state may take 2–3 weeks.
- Volume of distribution
- Approximately 77 L in healthy volunteers (TGA assessment).
- Active metabolite(s)
- No clinically established active metabolite contribution; individual circulating metabolites occur only in trace amounts.
- Active-metabolite half-life
- Not applicable — no clinically established active metabolite.
- Protein binding
- ~95%
- Metabolism / elimination
- Primarily CYP3A4/5 oxidation followed by glucuronidation
Enzyme-inducing ASMs can markedly shorten persistence and reduce exposure.
Molecular structure
NIH PubChem structure and record ↗
Product history
- Initial U.S. approval
- 2012
- Brands
- Fycompa
- Manufacturer / marketer
- Catalyst Pharmaceuticals (Fycompa, U.S.)
- Generic availability
- No widely marketed U.S. generic
- Related drugs
- Mechanistically distinct; the only marketed selective noncompetitive AMPA-receptor antagonist ASM.
Sources & review status
Representative sources are selected product labels, not an exhaustive list of generic manufacturers. Consult the exact product and formulation prescribed. Brand-name package inserts are linked separately.
Brand reference: Fycompa tablets / suspension ↗
Indications and DailyMed PDFs checked: 2026-09-26. Other profile sources reviewed: 2026-09-15 · label revision noted at that review: 6/2023. This is a draft reference; final review is pending.