Drug Safety Information for FACTIVE (Gemifloxacin mesylate)

Safety-related Labeling Changes for FACTIVE (GEMIFLOXACIN MESYLATE) Rx Drug: FDA Link

Risk of mitral and aortic regurgitation Evaluating

Adverse Drug Reactions for FACTIVE* (Gemifloxacin mesylate)

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 FACTIVE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Rash*	420
2	Rash generalised	270
3	Urticaria	83
4	Rash erythematous	45
5	Dyspnoea	45
6	Drug ineffective	45
7	Nausea	45
8	Diarrhoea	43
9	Rash maculo-papular	42
10	Pruritus	38
11	Rash pruritic	33
12	Dizziness	28
13	Headache	27
14	Vomiting	25
15	Rash papular	24
16	Swelling face	24
17	Pyrexia	23
18	Insomnia	21
19	Anaphylactic reaction	21
20	Pain	20

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

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

	Reason	# of FDA Reports
1	Respiratory tract infection bacterial	1681
2	Bronchitis	195
3	Sinusitis*	150
4	Product used for unknown indication	78
5	Pneumonia*	61
6	Respiratory tract infection	58
7	Upper respiratory tract infection	50
8	Lobar pneumonia	23
9	Urinary tract infection	21
10	Ear infection	18

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

Types of Adverse Events for FACTIVE

Total Reports Filed with FDA: 3146

Number of FDA Adverse Event Reports by Patient Age for FACTIVE

Total Reports Filed with FDA: 3146*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Gemifloxacin mesylate (Gemifloxacin, Factive)

Charts are based on 3146 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.