83/100 · Critical
Manufactured by Bayer HealthCare Pharmaceuticals Inc.
High Safety Concerns with Ciprofloxacin, Particularly for Serious Reactions
205,746 FDA adverse event reports analyzed
Last updated: 2026-05-12
CIPROFLOXACIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare Pharmaceuticals Inc.. Based on analysis of 205,746 FDA adverse event reports, CIPROFLOXACIN has a safety score of 83 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 CIPROFLOXACIN include DRUG HYPERSENSITIVITY, PAIN, FATIGUE, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CIPROFLOXACIN.
Ciprofloxacin has a safety concern score of 83 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 205,746 adverse event reports for this medication, which is primarily manufactured by Bayer Healthcare Pharmaceuticals Inc..
The most commonly reported adverse events include Drug Hypersensitivity, Pain, Fatigue. Of classified reports, 83.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ciprofloxacin reports show a high frequency of serious adverse events, particularly kidney and respiratory issues.
The drug is frequently reported to cause kidney injury and respiratory distress, indicating potential organ toxicity. A significant number of reports involve drug interactions and off-label use, suggesting caution is needed.
Patients taking Ciprofloxacin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ciprofloxacin can interact with various drugs, including warfarin and nonsteroidal anti-inflammatory drugs (NSAIDs), and should be used with caution. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ciprofloxacin received a safety concern score of 83/100 (high concern). This is based on a 83.2% serious event ratio across 89,390 classified reports. The score accounts for 205,746 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: 47,040, Male: 34,300, Unknown: 317. The most frequently reported age groups are age 65 (1,804 reports), age 67 (1,412 reports), age 66 (1,368 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 89,390 classified reports for CIPROFLOXACIN:
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.
Ciprofloxacin can interact with various drugs, including warfarin and nonsteroidal anti-inflammatory drugs (NSAIDs), and should be used with caution.
If you are taking Ciprofloxacin, here are important things to know. The most commonly reported side effects include drug hypersensitivity, pain, fatigue, 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 inform their healthcare provider of all current medications to avoid potential drug interactions. Use Ciprofloxacin only for approved indications and follow prescribed dosages. 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 has issued warnings regarding the use of fluoroquinolones like Ciprofloxacin due to the risk of severe side effects, particularly in older adults.
The FDA has received approximately 205,746 adverse event reports associated with Ciprofloxacin. 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 Ciprofloxacin include Drug Hypersensitivity, Pain, Fatigue, Diarrhoea, Nausea. By volume, the top reported reactions are: Drug Hypersensitivity (5,673 reports), Pain (5,585 reports), Fatigue (5,502 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ciprofloxacin.
Out of 89,390 classified reports, 74,347 (83.2%) were classified as serious and 15,043 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 Ciprofloxacin break down by patient sex as follows: Female: 47,040, Male: 34,300, Unknown: 317. 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 Ciprofloxacin adverse events are: age 65: 1,804 reports, age 67: 1,412 reports, age 66: 1,368 reports, age 69: 1,351 reports, age 62: 1,341 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 Ciprofloxacin adverse event reports is Bayer Healthcare 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 Ciprofloxacin include: Arthralgia, Drug Ineffective, Acute Kidney Injury, Chronic Kidney Disease, Dyspnoea. 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 Ciprofloxacin 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.
Ciprofloxacin has a safety concern score of 83 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. Ciprofloxacin reports show a high frequency of serious adverse events, particularly kidney and respiratory issues.
Key safety signals identified in Ciprofloxacin's adverse event data include: Acute and chronic kidney injury are among the most common serious reactions.. Respiratory issues such as dyspnea and pneumonia are also frequently reported.. Drug interactions and off-label use are significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ciprofloxacin can interact with various drugs, including warfarin and nonsteroidal anti-inflammatory drugs (NSAIDs), and should be used with caution. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ciprofloxacin.
Patients should inform their healthcare provider of all current medications to avoid potential drug interactions. Use Ciprofloxacin only for approved indications and follow prescribed dosages.
Ciprofloxacin has 205,746 adverse event reports on file with the FDA. The drug is frequently reported to cause kidney injury and respiratory distress, indicating potential organ toxicity. The volume of reports for Ciprofloxacin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings regarding the use of fluoroquinolones like Ciprofloxacin due to the risk of severe side effects, particularly in older adults. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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