Drugs › Quinolone antimicrobial
Generic name
Gatifloxacin: adverse event reports filed with FDA
770 reports list it as a suspect or interacting product, 2004–2026. Class: Quinolone antimicrobial. Also reported as Gatifloxacin Tabs, Gatifloxacin 400mg.
- 770
- reports as suspect product
- 0% of all reports · about 34 a year
- 25
- reports, 12 months to June 2026
- 4 in the 12 months before
- 86.9%
- marked serious by the reporter
- 88% across the class
- 3%
- record death among outcomes, as reported
- 23 reports · not verified by FDA
770 adverse event reports received by FDA list gatifloxacin, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 741 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 25 reports listed it, up 525% from 4 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 34 reports a year and 0% of the 20,646,523 reports in the database, and 22.1% of the reports for the quinolone antimicrobial class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are hypoglycaemia (18.1%), hyperglycaemia (10.8%) and anaphylactic reaction (10%). A report can list several reactions, so shares add to more than 100%; 224 different terms appear across these reports. Hypoglycaemia is recorded in 18.1% of these reports, a larger share than in the median quinolone antimicrobial drug (9.3%).
86.9% of the reports are marked serious by the reporter (88% across the class); 3% record death among the outcomes and 43.5% record hospitalisation, as reported. 45.1% of the reports came from pharmacists, and the largest patient age group is 75 and over (30.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Gatifloxacin reports recording the termmedian drug in quinolone antimicrobial
- Hypoglycaemialow blood sugar18.1%139
- Hyperglycaemiahigh blood sugar10.8%83
- Anaphylactic reactiona severe, sudden allergic reaction10%77
- Drug intolerancethe medicine was not tolerated9.4%72
- Diarrhoealoose or frequent stools5.5%42
- Blood glucose increasedraised blood sugar reading4.4%34
- Rashskin rash3.8%29
- Dizzinesslight-headedness or unsteadiness3.5%27
- Drug ineffectivethe medicine did not work as expected3.5%27
- Blood glucose decreasedlow blood sugar reading3.4%26
- Clostridium colitis2.6%20
- Drug interactionan interaction between medicines2.6%20
- Electrocardiogram QT prolongeda QT prolongation on the ECG2.6%20
- Confusional stateconfusion2.5%19
- Nauseafeeling sick2.1%16
- Convulsion1.8%14
- International normalised ratio increasedblood clotting slower than intended (raised INR)1.8%14
- Renal failure acute1.8%14
- Mental status changes1.7%13
- Astheniaweakness or lack of energy1.6%12
- Dyspnoeashortness of breath1.6%12
- Loss of consciousnesspassing out1.6%12
- Vomitingbeing sick1.6%12
- Blood creatinine increasedraised creatinine, a kidney test1.4%11
- Pneumonialung infection1.4%11
- Anaphylactic shocka severe allergic reaction with collapse1.3%10
- Coma1.3%10
- Drug hypersensitivityan allergic-type reaction to a medicine1.3%10
- Pruritusitching1.3%10
Top 30 of 224 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the quinolone antimicrobial class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 3,483 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 31.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Urinary tract infection | 89 | 11.6% |
| Pneumonia | 78 | 10.1% |
| Bronchitis | 21 | 2.7% |
| Infection | 21 | 2.7% |
| Cellulitis | 9 | 1.2% |
| Sinusitis | 9 | 1.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 770 reports.
In context
| Measure | Gatifloxacin | Quinolone antimicrobial | All reports |
|---|---|---|---|
| Reports as suspect product | 770 | 3,483 | 20,646,523 |
| Share of that pool | — | 22.1% | 0% |
| Reports, latest 12 months | 25 | — | 1,332,454 |
| Marked serious | 86.9% | 88% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 30 | 71 | 91 |
| Hospitalisation recorded, per 1,000 reports | 435 | 412 | 213 |
| Consumer-filed share | 4.8% | 18.7% | 45.8% |
| Top term, share of reports | Hypoglycaemia 18.1% | median 9.3% | 0.2% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the quinolone antimicrobial class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Ofloxacin | generic | 2,713 | 124 | 88.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Gatifloxacin reports
How many adverse event reports has FDA received for Gatifloxacin?
770 reports list Gatifloxacin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 25 of them arrived in the latest 12 months. Another 741 list it only as a concomitant medication.
What reactions are recorded in Gatifloxacin reports?
hypoglycaemia (18.1%), hyperglycaemia (10.8%), anaphylactic reaction (10%), drug intolerance (9.4%) and diarrhoea (5.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Gatifloxacin was responsible.
How serious are the reports?
86.9% are marked serious by the reporter. Among the outcomes recorded, 3% of reports include death and 43.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
pharmacist (45.1%), other health professional (23%) and physician (20.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Gatifloxacin rising?
25 reports in the 12 months to June 2026, up 525% from 4 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Gatifloxacin was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Gatifloxacin?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Gatifloxacin as a suspect or interacting product; reports listing it only as a concomitant medication (741) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.