Drug Safety Information for GABITRIL (Tiagabine hydrochloride)

Safety-related Labeling Changes for GABITRIL (TIAGABINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for GABITRIL* (Tiagabine hydrochloride)

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 GABITRIL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Convulsion	213
2	Dizziness*	91
3	Confusional state*	90
4	Drug ineffective	87
5	Loss of consciousness	80
6	Tremor*	69
7	Anxiety	67
8	Completed suicide	66
9	Nausea	64
10	Headache	61
11	Fall	61
12	Insomnia	61
13	Drug interaction	58
14	Pain	58
15	Depression*	55
16	Fatigue	54
17	Diabetes mellitus	52
18	Vomiting	52
19	Overdose	50
20	Agitation	48

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	307
2	Convulsion	279
3	Neuralgia*	196
4	Insomnia*	187
5	Anxiety*	159
6	Epilepsy	144
7	Generalised anxiety disorder*	134
8	Bipolar disorder	107
9	Complex partial seizures	94
10	Psychogenic pain disorder	85

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

Types of Adverse Events for GABITRIL

Total Reports Filed with FDA: 7508

Number of FDA Adverse Event Reports by Patient Age for GABITRIL

Total Reports Filed with FDA: 7508*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tiagabine hydrochloride (Gabitril)

Charts are based on 7508 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.