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
1Rash*420
2Rash generalised270
3Urticaria83
4Rash erythematous45
5Dyspnoea45
6Drug ineffective45
7Nausea45
8Diarrhoea43
9Rash maculo-papular42
10Pruritus38
11Rash pruritic33
12Dizziness28
13Headache27
14Vomiting25
15Rash papular24
16Swelling face24
17Pyrexia23
18Insomnia21
19Anaphylactic reaction21
20Pain20

* 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
1Respiratory tract infection bacterial1681
2Bronchitis195
3Sinusitis*150
4Product used for unknown indication78
5Pneumonia*61
6Respiratory tract infection58
7Upper respiratory tract infection50
8Lobar pneumonia23
9Urinary tract infection21
10Ear infection18

*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.

Click to go back to search results and FACTIVE Reviews and Review Summary .

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.

Visit   DrugInformer.com more on FACTIVE's side effects.