Pharmacologic class (EPC) · 2 drug pages
Quinolone antimicrobial: adverse event reports filed with FDA
3,483 reports list a drug in this class as a suspect or interacting product, 2004–2026.
- 3,483
- reports across the class
- 0% of all reports
- 149
- reports, 12 months to June 2026
- 153 in the 12 months before
- 88%
- marked serious by the reporter
- 57.4% across all reports
- 2
- drugs with a page
- brand and generic names counted separately
Quinolone antimicrobial is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 3,483 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.
149 reports arrived in the 12 months to June 2026, close to the 153 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 88% of the class's reports are marked serious, 7.1% record death among the outcomes and 41.2% record hospitalisation, as reported.
Across the class the reactions recorded most often are drug ineffective (4.7%), arthralgia (4.5%) and hypoglycaemia (4.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.
The members table is 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."
Drugs in the class
| Drug | Name type | Reports | Latest 12 months | Marked serious | Top term recorded |
|---|---|---|---|---|---|
| Ofloxacin | generic | 2,713 | 124 | 88.3% | Arthralgia |
| Gatifloxacin | generic | 770 | 25 | 86.9% | Hypoglycaemia |
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."
Reports by month, five years
FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
Reactions recorded across the class
share of class reports recording the termmedian drug in the class
- Drug ineffectivethe medicine did not work as expected4.7%163
- Arthralgiajoint pain4.5%156
- Hypoglycaemialow blood sugar4.3%151
- Drug interactionan interaction between medicines3.6%127
- Headachehead pain3.3%116
- Tendonitisinflammation of a tendon3.2%112
- Anxietyanxiety3.2%110
- Painpain, site not specified3.1%107
- Fatiguetiredness3%103
- Myalgiamuscle pain3%103
- Diarrhoealoose or frequent stools2.9%102
- Insomniadifficulty sleeping2.9%100
- Tendon pain2.8%99
- Nauseafeeling sick2.8%97
- Paraesthesiatingling or pins and needles2.8%96
- Dyspnoeashortness of breath2.7%93
- Anaphylactic reactiona severe, sudden allergic reaction2.6%91
- Rashskin rash2.6%91
- Confusional stateconfusion2.5%88
- Off label useused for a purpose or in a way not on the label2.5%88
- Condition aggravatedthe condition being treated got worse2.5%87
- Hyperglycaemiahigh blood sugar2.5%87
- Dizzinesslight-headedness or unsteadiness2.5%86
- Pyrexiafever2.4%85
- Drug intolerancethe medicine was not tolerated2.4%82
Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.
Outcomes, patients and reporters
Outcomes recorded
Patient age
Who reported
Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.
Questions about Quinolone antimicrobial reports
Which drugs are in the Quinolone antimicrobial class on this site?
Ofloxacin and Gatifloxacin. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.
How many reports does the class have?
3,483 reports through June 2026, 149 of them in the latest 12 months. A report listing two drugs of the class counts once for each.
What reactions are recorded most often?
drug ineffective (4.7%), arthralgia (4.5%), hypoglycaemia (4.3%), drug interaction (3.6%) and headache (3.3%).
Can the members table be used to rank the drugs?
No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.
How do I report an adverse event?
Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.