Drug Safety Information for FYCOMPA (Perampanel)

Safety-related Labeling Changes for FYCOMPA (PERAMPANEL) Rx Drug: FDA Link

Required post-approval safety study:

A pharmacokinetic study in pediatric patients with partial-onset seizures aged 1 month to < 24 months. At least 2 maintenance dose levels of FYCOMPA (perampanel) should be evaluated to characterize pharmacokinetic parameters following multiple administration of oral perampanel. Pharmacokinetic data can be obtained and analyzed using either conventional pharmacokinetics methods with intensive sampling or using a population PK approach by collecting sparse samples. Subjects should be balanced among age cohorts. Effort should also be made to balance the gender distributions within each age cohort. Due Date: 2022-03-31

Original FDA Drug Approval Date for FYCOMPA: 2012-10-22

Adverse Drug Reactions for FYCOMPA* (Perampanel)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with FYCOMPA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Convulsion	47
2	Aggression	46
3	Dizziness	43
4	Drug interaction	21
5	Status epilepticus	20
6	Suicidal ideation	19
7	Fall	19
8	Somnolence	18
9	Balance disorder	18
10	Drug ineffective	17
11	Irritability	17
12	Suicide attempt	16
13	Fatigue	15
14	Abnormal behaviour	14
15	Depressed mood	14
16	Hallucination	14
17	Gait disturbance	14
18	Psychotic disorder	14
19	Intentional overdose	14
20	Confusional state	13

* This side effect also appears in "Top 10 Side Effects of FYCOMPA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking FYCOMPA
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Epilepsy	402
2	Product used for unknown indication	236
3	Partial seizures	152
4	Convulsion	66
5	Pruritus	60
6	Grand mal convulsion	27
7	Complex partial seizures	23
8	Lennox-gastaut syndrome	18
9	Temporal lobe epilepsy	10
10	Frontal lobe epilepsy	9

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for FYCOMPA

Total Reports Filed with FDA: 1129

Number of FDA Adverse Event Reports by Patient Age for FYCOMPA

Total Reports Filed with FDA: 1129*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Perampanel (Fycompa)

Charts are based on 1129 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.