Drug Safety Information for FELBATOL (Felbamate)

Adverse Drug Reactions for FELBATOL* (Felbamate)

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 FELBATOL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Convulsion	150
2	Drug ineffective	48
3	Vomiting	27
4	Condition aggravated	27
5	Somnolence	26
6	Product substitution issue	19
7	Grand mal convulsion	17
8	Fatigue	16
9	Diarrhoea	16
10	Weight decreased	16
11	Asthenia	16
12	Fall	16
13	Dizziness	15
14	Nausea	15
15	Aggression	15
16	Drug dose omission	15
17	Pyrexia	14
18	Drug interaction	13
19	Decreased appetite	13
20	Incorrect dose administered	13

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	311
2	Epilepsy	297
3	Convulsion*	171
4	Lennox-gastaut syndrome	90
5	Grand mal convulsion	47
6	Partial seizures	44
7	Complex partial seizures	32
8	Status epilepticus	29
9	Myoclonic epilepsy	25
10	Carbon monoxide poisoning	19

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

Types of Adverse Events for FELBATOL

Total Reports Filed with FDA: 1815

Number of FDA Adverse Event Reports by Patient Age for FELBATOL

Total Reports Filed with FDA: 1815*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Felbamate (Taloxa, Felbatol, Felbamate)

Charts are based on 1815 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.