Cyclophosphamide
According to the FDA label: Cyclophosphamide for injection is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1 ) Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome…
172,254 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Cyclophosphamide in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Off Label Use 15,866 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Febrile Neutropenia 14,218 reports
A fever occurring together with a low level of neutrophils, a type of infection-fighting white blood cell. It is taken seriously because infection is harder to fight when these cells are low.
Full definition in the glossary →Neutropenia 10,338 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Drug Ineffective 10,333 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Pyrexia 9,064 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Disease Progression 7,923 reports
A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Full definition in the glossary →Pneumonia 6,512 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Product Use in Unapproved Indication 6,446 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Thrombocytopenia 6,349 reports
A low level of platelets, the blood cells that help with clotting.
Full definition in the glossary →Nausea 6,103 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Anaemia 5,981 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Sepsis 5,611 reports
A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Full definition in the glossary →Diarrhoea 5,386 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Death 5,152 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Vomiting 4,799 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 75,793 |
| Male | 63,364 |
| Unknown | 1,338 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 19,111 |
| 18-34 | 12,877 |
| 35-49 | 20,062 |
| 50-64 | 35,437 |
| 65-74 | 23,205 |
| 75+ | 10,715 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Cyclophosphamide. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 114,539 |
| Hospitalization | 62,340 |
| Death | 35,009 |
| Life-Threatening | 13,624 |
| Non-Serious | 6,556 |
| Disability | 2,741 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Cyclophosphamide. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 3 |
| 2004 | 1,542 |
| 2005 | 1,761 |
| 2006 | 1,662 |
| 2007 | 1,990 |
| 2008 | 2,643 |
| 2009 | 3,104 |
| 2010 | 3,472 |
| 2011 | 5,663 |
| 2012 | 5,199 |
| 2013 | 3,762 |
| 2014 | 4,002 |
| 2015 | 5,800 |
| 2016 | 5,817 |
| 2017 | 7,859 |
| 2018 | 11,663 |
| 2019 | 12,216 |
| 2020 | 12,583 |
| 2021 | 12,743 |
| 2022 | 15,796 |
| 2023 | 17,125 |
| 2024 | 17,166 |
| 2025 | 15,489 |
| 2026 (partial) | 3,194 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Cyclophosphamide
In FDA adverse event reports that mention Cyclophosphamide, these medications appeared most often in the same report.
- Doxorubicin (57,709 reports)
- Rituximab (51,230 reports)
- Prednisone (42,113 reports)
- Dexamethasone (36,325 reports)
- Etoposide (28,666 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026