85/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
Levofloxacin Adverse Events: High Seriousness and Diverse Reactions
112,219 FDA adverse event reports analyzed
Last updated: 2026-05-12
LEVOFLOXACIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 112,219 FDA adverse event reports, LEVOFLOXACIN has a safety score of 85 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 LEVOFLOXACIN include OFF LABEL USE, DRUG INEFFECTIVE, DYSPNOEA, PNEUMONIA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LEVOFLOXACIN.
Levofloxacin has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 112,219 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Dyspnoea. Of classified reports, 88.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Levofloxacin reports show a high percentage of serious adverse events (88.1%).
The most common reactions include kidney injury, respiratory issues, and gastrointestinal symptoms. Drug interactions and hyper-sensitivity reactions are also frequently reported.
Patients taking Levofloxacin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Levofloxacin can interact with various drugs, leading to increased toxicity or reduced efficacy. Patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Levofloxacin received a safety concern score of 85/100 (high concern). This is based on a 88.1% serious event ratio across 58,022 classified reports. The score accounts for 112,219 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: 26,292, Male: 24,963, Unknown: 227. The most frequently reported age groups are age 77 (1,281 reports), age 65 (1,201 reports), age 67 (1,069 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 58,022 classified reports for LEVOFLOXACIN:
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.
Levofloxacin can interact with various drugs, leading to increased toxicity or reduced efficacy. Patients should inform their healthcare provider of all medications they are taking.
If you are taking Levofloxacin, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, dyspnoea, pneumonia, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Inform your healthcare provider about any pre-existing conditions, especially kidney or liver disease. Report any unusual symptoms to your doctor immediately. 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 closely monitors levofloxacin safety. Healthcare providers should follow guidelines and consider alternative antibiotics for patients with a history of adverse reactions.
The FDA has received approximately 112,219 adverse event reports associated with Levofloxacin. 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 Levofloxacin include Off Label Use, Drug Ineffective, Dyspnoea, Pneumonia, Nausea. By volume, the top reported reactions are: Off Label Use (3,120 reports), Drug Ineffective (2,964 reports), Dyspnoea (2,947 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Levofloxacin.
Out of 58,022 classified reports, 51,134 (88.1%) were classified as serious and 6,888 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 Levofloxacin break down by patient sex as follows: Female: 26,292, Male: 24,963, Unknown: 227. 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 Levofloxacin adverse events are: age 77: 1,281 reports, age 65: 1,201 reports, age 67: 1,069 reports, age 72: 1,041 reports, age 60: 1,029 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 Levofloxacin adverse event reports is Ani Pharmaceuticals, 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 Levofloxacin include: Pyrexia, Fatigue, Acute Kidney Injury, Diarrhoea, Pain. 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 Levofloxacin 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.
Levofloxacin has a safety concern score of 85 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. Levofloxacin reports show a high percentage of serious adverse events (88.1%).
Key safety signals identified in Levofloxacin's adverse event data include: Acute kidney injury and chronic kidney disease are significant safety signals.. Respiratory failure and pneumonia are critical adverse events.. Drug hypersensitivity and tendon disorders are also key safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Levofloxacin can interact with various drugs, leading to increased toxicity or reduced efficacy. Patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Levofloxacin.
Inform your healthcare provider about any pre-existing conditions, especially kidney or liver disease. Report any unusual symptoms to your doctor immediately.
Levofloxacin has 112,219 adverse event reports on file with the FDA. The most common reactions include kidney injury, respiratory issues, and gastrointestinal symptoms. The volume of reports for Levofloxacin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors levofloxacin safety. Healthcare providers should follow guidelines and consider alternative antibiotics for patients with a history of adverse reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by ANI Pharmaceuticals, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with LEVOFLOXACIN:
Drugs related to LEVOFLOXACIN based on therapeutic use, drug class, or shared indications: