85/100 · Critical
Manufactured by Alembic Pharmaceuticals Inc.
High Safety Concerns with Cyclophosphamide Injection, Solution
284,200 FDA adverse event reports analyzed
Last updated: 2026-05-12
CYCLOPHOSPHAMIDE INJECTION, SOLUTION is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Alembic Pharmaceuticals Inc.. Based on analysis of 284,200 FDA adverse event reports, CYCLOPHOSPHAMIDE INJECTION, SOLUTION 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 CYCLOPHOSPHAMIDE INJECTION, SOLUTION include OFF LABEL USE, FEBRILE NEUTROPENIA, NEUTROPENIA, DRUG INEFFECTIVE, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CYCLOPHOSPHAMIDE INJECTION, SOLUTION.
Cyclophosphamide Injection, Solution 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 284,200 adverse event reports for this medication, which is primarily manufactured by Alembic Pharmaceuticals Inc..
The most commonly reported adverse events include Off Label Use, Febrile Neutropenia, Neutropenia. Of classified reports, 96.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Severe and life-threatening reactions such as sepsis, pneumonia, and respiratory failure are common.
Neutropenia and thrombocytopenia are frequent, leading to increased risk of infections and bleeding. Significant drug ineffectiveness and disease progression reports indicate limited efficacy in some cases.
Patients taking Cyclophosphamide Injection, Solution should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cyclophosphamide can cause severe bone marrow suppression, leading to neutropenia, thrombocytopenia, and anemia. It may also interact with other hematopoietic suppressants, increasing the risk of severe adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cyclophosphamide Injection, Solution received a safety concern score of 85/100 (high concern). This is based on a 96.2% serious event ratio across 168,880 classified reports. The score accounts for 284,200 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: 74,263, Male: 62,143, Unknown: 1,336. The most frequently reported age groups are age 60 (2,827 reports), age 65 (2,741 reports), age 62 (2,668 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 168,880 classified reports for CYCLOPHOSPHAMIDE INJECTION, SOLUTION:
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.
Cyclophosphamide can cause severe bone marrow suppression, leading to neutropenia, thrombocytopenia, and anemia. It may also interact with other hematopoietic suppressants, increasing the risk of severe adverse events.
If you are taking Cyclophosphamide Injection, Solution, here are important things to know. The most commonly reported side effects include off label use, febrile neutropenia, neutropenia, drug ineffective, pyrexia. 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 signs of infection, such as fever, chills, or respiratory symptoms, to their healthcare provider immediately. Monitor blood counts regularly to detect hematological toxicity early. 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 Cyclophosphamide for safety, particularly for severe infections and hematological toxicity. Healthcare providers should be vigilant and consider alternative treatments if adverse events occur.
The FDA has received approximately 284,200 adverse event reports associated with Cyclophosphamide Injection, Solution. 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 Cyclophosphamide Injection, Solution include Off Label Use, Febrile Neutropenia, Neutropenia, Drug Ineffective, Pyrexia. By volume, the top reported reactions are: Off Label Use (15,422 reports), Febrile Neutropenia (13,977 reports), Neutropenia (10,160 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cyclophosphamide Injection, Solution.
Out of 168,880 classified reports, 162,467 (96.2%) were classified as serious and 6,413 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 Cyclophosphamide Injection, Solution break down by patient sex as follows: Female: 74,263, Male: 62,143, Unknown: 1,336. 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 Cyclophosphamide Injection, Solution adverse events are: age 60: 2,827 reports, age 65: 2,741 reports, age 62: 2,668 reports, age 66: 2,666 reports, age 64: 2,606 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 Cyclophosphamide Injection, Solution adverse event reports is Alembic 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 Cyclophosphamide Injection, Solution include: Disease Progression, Pneumonia, Product Use In Unapproved Indication, Thrombocytopenia, Nausea. 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 Cyclophosphamide Injection, Solution 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.
Cyclophosphamide Injection, Solution 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. Severe and life-threatening reactions such as sepsis, pneumonia, and respiratory failure are common.
Key safety signals identified in Cyclophosphamide Injection, Solution's adverse event data include: Frequent reports of severe infections (pneumonia, sepsis, and respiratory failure). High incidence of hematological toxicity (neutropenia, thrombocytopenia, anemia). Common occurrence of drug ineffectiveness and disease progression. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cyclophosphamide can cause severe bone marrow suppression, leading to neutropenia, thrombocytopenia, and anemia. It may also interact with other hematopoietic suppressants, increasing the risk of severe adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cyclophosphamide Injection, Solution.
Patients should report any signs of infection, such as fever, chills, or respiratory symptoms, to their healthcare provider immediately. Monitor blood counts regularly to detect hematological toxicity early.
Cyclophosphamide Injection, Solution has 284,200 adverse event reports on file with the FDA. Neutropenia and thrombocytopenia are frequent, leading to increased risk of infections and bleeding. The volume of reports for Cyclophosphamide Injection, Solution reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Cyclophosphamide for safety, particularly for severe infections and hematological toxicity. Healthcare providers should be vigilant and consider alternative treatments if adverse events occur. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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