SITAFLOXACIN: 80 Adverse Event Reports & Safety Profile
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80
Total FAERS Reports
18 (22.5%)
Deaths Reported
26
Hospitalizations
80
As Primary/Secondary Suspect
4
Life-Threatening
First Report: 20140407 · Latest Report: 20230101
What Are the Most Common SITAFLOXACIN Side Effects?
#1 Most Reported
Pneumatosis intestinalis
19 reports (23.8%)
#2 Most Reported
Off label use
11 reports (13.8%)
#3 Most Reported
Drug ineffective
11 reports (13.8%)
All SITAFLOXACIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pneumatosis intestinalis | 19 | 23.8% | 0 | 2 |
| Drug ineffective | 11 | 13.8% | 5 | 7 |
| Off label use | 11 | 13.8% | 6 | 3 |
| Treatment failure | 8 | 10.0% | 0 | 0 |
| Product use in unapproved indication | 7 | 8.8% | 0 | 0 |
| Disease progression | 6 | 7.5% | 1 | 0 |
| Diarrhoea | 5 | 6.3% | 0 | 2 |
| Drug-induced liver injury | 5 | 6.3% | 0 | 2 |
| Drug resistance | 5 | 6.3% | 1 | 1 |
| Liver disorder | 5 | 6.3% | 0 | 0 |
Who Reports SITAFLOXACIN Side Effects? Age & Gender Data
Gender: 64.8% female, 35.2% male. Average age: 62.1 years. Most reports from: JP. View detailed demographics →
Is SITAFLOXACIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 3 | 0 | 1 |
| 2015 | 6 | 1 | 3 |
| 2017 | 3 | 0 | 2 |
| 2018 | 2 | 1 | 2 |
| 2019 | 3 | 0 | 2 |
| 2020 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 1 |
What Is SITAFLOXACIN Used For?
| Indication | Reports |
|---|---|
| Mycobacterium avium complex infection | 24 |
| Product used for unknown indication | 9 |
| Mycobacterium abscessus infection | 7 |
| Lung disorder | 5 |
| Mycoplasma genitalium infection | 5 |
Official FDA Label for SITAFLOXACIN
Official prescribing information from the FDA-approved drug label.