76/100 · Elevated
Manufactured by Allergan, Inc.
Ofloxacin Adverse Events: High Seriousness and Diverse Reactions
11,897 FDA adverse event reports analyzed
Last updated: 2026-05-12
OFLOXACIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 11,897 FDA adverse event reports, OFLOXACIN has a safety score of 76 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for OFLOXACIN include DRUG INEFFECTIVE, EYE PAIN, OFF LABEL USE, HEADACHE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OFLOXACIN.
Ofloxacin has a safety concern score of 76 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 11,897 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Drug Ineffective, Eye Pain, Off Label Use. Of classified reports, 76.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A high percentage (76.2%) of reported adverse events are serious.
The most common reactions include eye pain, headache, and pain. Serious reactions such as acute kidney injury and renal failure are frequently reported.
Patients taking Ofloxacin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ofloxacin can cause drug interactions, particularly with other antibiotics, and warnings are issued for its use in patients with renal impairment. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ofloxacin received a safety concern score of 76/100 (high concern). This is based on a 76.2% serious event ratio across 7,061 classified reports. The score accounts for 11,897 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 3,528, Male: 2,984, Unknown: 28. The most frequently reported age groups are age 69 (160 reports), age 65 (130 reports), age 67 (126 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 7,061 classified reports for OFLOXACIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Ofloxacin can cause drug interactions, particularly with other antibiotics, and warnings are issued for its use in patients with renal impairment.
If you are taking Ofloxacin, here are important things to know. The most commonly reported side effects include drug ineffective, eye pain, off label use, headache, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any serious adverse events immediately to their healthcare provider. Follow prescribed dosages and do not use the drug for unapproved indications. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of Ofloxacin and has not issued any major safety alerts, but healthcare providers should be vigilant about serious adverse events.
The FDA has received approximately 11,897 adverse event reports associated with Ofloxacin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Ofloxacin include Drug Ineffective, Eye Pain, Off Label Use, Headache, Pain. By volume, the top reported reactions are: Drug Ineffective (345 reports), Eye Pain (345 reports), Off Label Use (306 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ofloxacin.
Out of 7,061 classified reports, 5,383 (76.2%) were classified as serious and 1,678 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Ofloxacin break down by patient sex as follows: Female: 3,528, Male: 2,984, Unknown: 28. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Ofloxacin adverse events are: age 69: 160 reports, age 65: 130 reports, age 67: 126 reports, age 70: 116 reports, age 75: 114 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Ofloxacin adverse event reports is Allergan, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Ofloxacin include: Fatigue, Nausea, Arthralgia, Diarrhoea, Acute Kidney Injury. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Ofloxacin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Ofloxacin has a safety concern score of 76 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. A high percentage (76.2%) of reported adverse events are serious.
Key safety signals identified in Ofloxacin's adverse event data include: Acute kidney injury and renal failure are key safety signals.. Eye pain and irritation are significant visual safety signals.. Serious adverse events like sepsis and toxic epidermal necrolysis are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ofloxacin can cause drug interactions, particularly with other antibiotics, and warnings are issued for its use in patients with renal impairment. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ofloxacin.
Patients should report any serious adverse events immediately to their healthcare provider. Follow prescribed dosages and do not use the drug for unapproved indications.
Ofloxacin has 11,897 adverse event reports on file with the FDA. The most common reactions include eye pain, headache, and pain. The volume of reports for Ofloxacin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Ofloxacin and has not issued any major safety alerts, but healthcare providers should be vigilant about serious adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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