72/100 · Elevated
Manufactured by Apotex Corp.
Cilostazol Adverse Events: High Serious Reaction Rate and Diverse Safety Profile
9,564 FDA adverse event reports analyzed
Last updated: 2026-05-12
CILOSTAZOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Apotex Corp.. Based on analysis of 9,564 FDA adverse event reports, CILOSTAZOL has a safety score of 72 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 CILOSTAZOL include DIARRHOEA, FALL, PNEUMONIA, DRUG INEFFECTIVE, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CILOSTAZOL.
Cilostazol has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 9,564 adverse event reports for this medication, which is primarily manufactured by Apotex Corp..
The most commonly reported adverse events include Diarrhoea, Fall, Pneumonia. Of classified reports, 81.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Cilostazol reports show a high serious reaction rate, with 81.9% of reactions being serious.
The most common reactions include gastrointestinal issues, respiratory problems, and cardiovascular events. Drug interactions and renal impairment are significant safety concerns.
Patients taking Cilostazol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cilostazol can cause renal impairment and drug interactions, which should be monitored, especially in patients with pre-existing renal conditions or taking other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cilostazol received a safety concern score of 72/100 (elevated concern). This is based on a 81.9% serious event ratio across 5,990 classified reports. The score accounts for 9,564 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 3,302, Female: 2,282, Unknown: 15. The most frequently reported age groups are age 77 (189 reports), age 72 (167 reports), age 80 (161 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 5,990 classified reports for CILOSTAZOL:
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.
Cilostazol can cause renal impairment and drug interactions, which should be monitored, especially in patients with pre-existing renal conditions or taking other medications.
If you are taking Cilostazol, here are important things to know. The most commonly reported side effects include diarrhoea, fall, pneumonia, drug ineffective, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of renal impairment, especially in elderly patients. Be cautious of potential drug interactions, particularly with other anticoagulants or antiplatelet agents. 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 cilostazol safety, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 9,564 adverse event reports associated with Cilostazol. 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 Cilostazol include Diarrhoea, Fall, Pneumonia, Drug Ineffective, Death. By volume, the top reported reactions are: Diarrhoea (303 reports), Fall (231 reports), Pneumonia (230 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cilostazol.
Out of 5,990 classified reports, 4,904 (81.9%) were classified as serious and 1,086 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 Cilostazol break down by patient sex as follows: Male: 3,302, Female: 2,282, Unknown: 15. 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 Cilostazol adverse events are: age 77: 189 reports, age 72: 167 reports, age 80: 161 reports, age 78: 160 reports, age 70: 151 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 Cilostazol adverse event reports is Apotex Corp.. 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 Cilostazol include: Dyspnoea, Nausea, Off Label Use, Anaemia, Asthenia. 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 Cilostazol 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.
Cilostazol has a safety concern score of 72 out of 100 (elevated 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. Cilostazol reports show a high serious reaction rate, with 81.9% of reactions being serious.
Key safety signals identified in Cilostazol's adverse event data include: High percentage of serious reactions (81.9%). Diverse range of reactions, including gastrointestinal, respiratory, and cardiovascular issues. Renal impairment and drug interactions are frequent. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cilostazol can cause renal impairment and drug interactions, which should be monitored, especially in patients with pre-existing renal conditions or taking other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cilostazol.
Monitor for signs of renal impairment, especially in elderly patients. Be cautious of potential drug interactions, particularly with other anticoagulants or antiplatelet agents.
Cilostazol has 9,564 adverse event reports on file with the FDA. The most common reactions include gastrointestinal issues, respiratory problems, and cardiovascular events. The volume of reports for Cilostazol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor cilostazol safety, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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