85/100 · Critical
Manufactured by Amneal Pharmaceuticals NY LLC
High Safety Concerns with Ciprofolxacin Based on Adverse Event Reports
160,448 FDA adverse event reports analyzed
Last updated: 2026-05-12
CIPROFOLXACIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. Based on analysis of 160,448 FDA adverse event reports, CIPROFOLXACIN 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 CIPROFOLXACIN include FATIGUE, ACUTE KIDNEY INJURY, PAIN, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CIPROFOLXACIN.
Ciprofolxacin 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 160,448 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Ny Llc.
The most commonly reported adverse events include Fatigue, Acute Kidney Injury, Pain. Of classified reports, 88.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events such as acute kidney injury and renal failure are frequently reported.
A wide range of reactions, including neurological and gastrointestinal issues, are observed. Drug interactions and ineffective drug performance are also significant concerns.
Patients taking Ciprofolxacin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ciprofolxacin has been associated with drug interactions and ineffective drug performance, requiring careful monitoring and potential dose adjustments. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ciprofolxacin received a safety concern score of 85/100 (high concern). This is based on a 88.3% serious event ratio across 69,499 classified reports. The score accounts for 160,448 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: 35,039, Male: 28,131, Unknown: 275. The most frequently reported age groups are age 65 (1,506 reports), age 67 (1,130 reports), age 66 (1,102 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 69,499 classified reports for CIPROFOLXACIN:
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.
Ciprofolxacin has been associated with drug interactions and ineffective drug performance, requiring careful monitoring and potential dose adjustments.
If you are taking Ciprofolxacin, here are important things to know. The most commonly reported side effects include fatigue, acute kidney injury, pain, diarrhoea, nausea. 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 new or worsening symptoms to their healthcare provider immediately. Avoid using Ciprofolxacin for off-label indications unless specifically prescribed by a healthcare provider. 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 should continue to monitor the safety profile of Ciprofolxacin, especially for patients with pre-existing kidney conditions or those taking other medications.
The FDA has received approximately 160,448 adverse event reports associated with Ciprofolxacin. 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 Ciprofolxacin include Fatigue, Acute Kidney Injury, Pain, Diarrhoea, Nausea. By volume, the top reported reactions are: Fatigue (4,225 reports), Acute Kidney Injury (4,106 reports), Pain (4,103 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ciprofolxacin.
Out of 69,499 classified reports, 61,362 (88.3%) were classified as serious and 8,137 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 Ciprofolxacin break down by patient sex as follows: Female: 35,039, Male: 28,131, Unknown: 275. 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 Ciprofolxacin adverse events are: age 65: 1,506 reports, age 67: 1,130 reports, age 66: 1,102 reports, age 69: 1,092 reports, age 62: 1,091 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 Ciprofolxacin adverse event reports is Amneal Pharmaceuticals Ny Llc. 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 Ciprofolxacin include: Arthralgia, Chronic Kidney Disease, Drug Ineffective, Drug Hypersensitivity, Off Label Use. 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 Ciprofolxacin 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.
Ciprofolxacin 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. Serious adverse events such as acute kidney injury and renal failure are frequently reported.
Key safety signals identified in Ciprofolxacin's adverse event data include: Acute kidney injury and renal failure are among the most serious reported reactions.. A high number of reports indicate drug ineffectiveness and hyper-sensitivity.. Multiple neurological symptoms, including dizziness and confusion, are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ciprofolxacin has been associated with drug interactions and ineffective drug performance, requiring careful monitoring and potential dose adjustments. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ciprofolxacin.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Avoid using Ciprofolxacin for off-label indications unless specifically prescribed by a healthcare provider.
Ciprofolxacin has 160,448 adverse event reports on file with the FDA. A wide range of reactions, including neurological and gastrointestinal issues, are observed. The volume of reports for Ciprofolxacin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should continue to monitor the safety profile of Ciprofolxacin, especially for patients with pre-existing kidney conditions or those taking other medications. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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