GEMIFLOXACIN: 97 Adverse Event Reports & Safety Profile
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97
Total FAERS Reports
3 (3.1%)
Deaths Reported
24
Hospitalizations
97
As Primary/Secondary Suspect
6
Life-Threatening
6
Disabilities
Apr 4, 2003
FDA Approved
Discontinued
Status
Yes
Generic Available
Active Ingredient: GEMIFLOXACIN MESYLATE · FDA Application: 021158 ·
First Report: 2007 · Latest Report: 20230513
What Are the Most Common GEMIFLOXACIN Side Effects?
#1 Most Reported
Rash
16 reports (16.5%)
#2 Most Reported
Hypersensitivity
14 reports (14.4%)
#3 Most Reported
Pruritus
13 reports (13.4%)
All GEMIFLOXACIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Rash | 16 | 16.5% | 0 | 6 |
| Hypersensitivity | 14 | 14.4% | 0 | 4 |
| Pruritus | 13 | 13.4% | 0 | 5 |
| Erythema | 11 | 11.3% | 0 | 6 |
| Off label use | 8 | 8.3% | 0 | 3 |
| Drug hypersensitivity | 7 | 7.2% | 0 | 0 |
| Rash generalised | 7 | 7.2% | 0 | 3 |
| Urticaria | 5 | 5.2% | 0 | 0 |
Who Reports GEMIFLOXACIN Side Effects? Age & Gender Data
Gender: 74.2% female, 25.8% male. Average age: 43.7 years. Most reports from: TR. View detailed demographics →
Is GEMIFLOXACIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 2 | 0 | 1 |
| 2008 | 2 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
| 2014 | 3 | 1 | 0 |
| 2015 | 12 | 0 | 3 |
| 2016 | 13 | 2 | 6 |
| 2017 | 5 | 0 | 3 |
| 2018 | 2 | 0 | 0 |
| 2019 | 3 | 0 | 0 |
| 2022 | 4 | 0 | 0 |
| 2023 | 9 | 0 | 4 |
What Is GEMIFLOXACIN Used For?
| Indication | Reports |
|---|---|
| Pneumonia | 16 |
| Sinusitis | 16 |
| Bronchitis | 9 |
| Product used for unknown indication | 8 |
Official FDA Label for GEMIFLOXACIN
Official prescribing information from the FDA-approved drug label.