82/100 · Critical
Manufactured by Aurobindo Pharma Limited
Moxifloxacin Hydrochloride Adverse Events: High Serious Reaction Rate
70,429 FDA adverse event reports analyzed
Last updated: 2026-05-12
MOXIFLOXACIN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 70,429 FDA adverse event reports, MOXIFLOXACIN HYDROCHLORIDE has a safety score of 82 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 MOXIFLOXACIN HYDROCHLORIDE include OFF LABEL USE, DYSPNOEA, DRUG INEFFECTIVE, ASTHMA, DRUG HYPERSENSITIVITY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MOXIFLOXACIN HYDROCHLORIDE.
Moxifloxacin Hydrochloride has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 70,429 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Off Label Use, Dyspnoea, Drug Ineffective. Of classified reports, 85.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High rate of serious reactions, including respiratory and gastrointestinal issues.
Multiple reports of drug hypersensitivity and allergic reactions. Significant number of cardiovascular and neurological adverse events. Common occurrence of drug intolerance and ineffectiveness. A notable number of reports involving drug interactions and contraindications.
Patients taking Moxifloxacin Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Moxifloxacin Hydrochloride can cause serious adverse events and should be used with caution, especially in patients with pre-existing conditions or those taking other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Moxifloxacin Hydrochloride received a safety concern score of 82/100 (high concern). This is based on a 85.0% serious event ratio across 19,216 classified reports. The score accounts for 70,429 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: 9,800, Male: 7,192, Unknown: 27. The most frequently reported age groups are age 65 (977 reports), age 72 (441 reports), age 44 (366 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 19,216 classified reports for MOXIFLOXACIN HYDROCHLORIDE:
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.
Moxifloxacin Hydrochloride can cause serious adverse events and should be used with caution, especially in patients with pre-existing conditions or those taking other medications.
If you are taking Moxifloxacin Hydrochloride, here are important things to know. The most commonly reported side effects include off label use, dyspnoea, drug ineffective, asthma, drug hypersensitivity. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider before starting moxifloxacin hydrochloride, especially if you have a history of allergies or other medical conditions. Inform your doctor about all medications you are taking to avoid potential drug interactions. 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 Moxifloxacin Hydrochloride and has issued warnings regarding its use, particularly in certain patient populations and with specific drugs.
The FDA has received approximately 70,429 adverse event reports associated with Moxifloxacin Hydrochloride. 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 Moxifloxacin Hydrochloride include Off Label Use, Dyspnoea, Drug Ineffective, Asthma, Drug Hypersensitivity. By volume, the top reported reactions are: Off Label Use (2,277 reports), Dyspnoea (2,035 reports), Drug Ineffective (2,005 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Moxifloxacin Hydrochloride.
Out of 19,216 classified reports, 16,342 (85.0%) were classified as serious and 2,874 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 Moxifloxacin Hydrochloride break down by patient sex as follows: Female: 9,800, Male: 7,192, Unknown: 27. 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 Moxifloxacin Hydrochloride adverse events are: age 65: 977 reports, age 72: 441 reports, age 44: 366 reports, age 70: 351 reports, age 66: 340 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 Moxifloxacin Hydrochloride adverse event reports is Aurobindo Pharma Limited. 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 Moxifloxacin Hydrochloride include: Pneumonia, Vomiting, Pain, Wheezing, Rash. 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 Moxifloxacin Hydrochloride 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.
Moxifloxacin Hydrochloride has a safety concern score of 82 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. High rate of serious reactions, including respiratory and gastrointestinal issues.
Key safety signals identified in Moxifloxacin Hydrochloride's adverse event data include: High rate of serious reactions (85%). Multiple reports of drug hypersensitivity and allergic reactions. Significant cardiovascular and neurological adverse events. Common occurrence of drug intolerance and ineffectiveness. Reports of drug interactions and contraindications. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Moxifloxacin Hydrochloride can cause serious adverse events and should be used with caution, especially in patients with pre-existing conditions or those taking other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Moxifloxacin Hydrochloride.
Consult a healthcare provider before starting moxifloxacin hydrochloride, especially if you have a history of allergies or other medical conditions. Inform your doctor about all medications you are taking to avoid potential drug interactions.
Moxifloxacin Hydrochloride has 70,429 adverse event reports on file with the FDA. Multiple reports of drug hypersensitivity and allergic reactions. The volume of reports for Moxifloxacin Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Moxifloxacin Hydrochloride and has issued warnings regarding its use, particularly in certain patient populations and with specific drugs. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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