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What the label lists and what reports show

Cyclophosphamide side effects

Cyclophosphamide's FDA label: “The most common adverse reactions were neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea.” FAERS holds 176,005 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (14,530 reports).

  • Generic listed

Check it at the source: the cyclophosphamide FDA label on DailyMed (effective January 19, 2026, Amneal Pharmaceuticals LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions were neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea.

From the label: adverse reactions, continued

The following adverse reactions are discussed in more detail in other sections of the labeling. Hypersensitivity [see Contraindications (4) ] Myelosuppression, Immunosuppression, Bone Marrow Failure, and Infections [see Warnings and Precautions (5.1) ] Urinary Tract and Renal Toxicity [see Warnings and Precautions (5.2) ] Cardiotoxicity [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] Secondary Malignancies [see Warnings and Precautions (5.5) ] Veno-occlusive Liver Disease [see Warnings and Precautions (5.6) ] Infertility [ see Warnings and Precautions (5.8 ) and Use in Specific Populations (8.3 , 8.4) ] Impaired Wound Healing [see Warnings and Precautions (5.9) ] Hyponatremia [see Warnings and Precautions (5.10) ] Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials and Post-marketing Experience The following adverse reactions associated with the use of cyclophosphamide were identified in clinical studies or post-marketing reports. …

Source: FDA drug label, Amneal Pharmaceuticals LLC, effective January 19, 2026 (SPL set 520bfe39-dfd5-4a20-9a37-80078afded0d), via openFDA; the full label on DailyMed

What do FAERS reports show?

176,005 reports list cyclophosphamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 35,641 are coded as a death and 63,677 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)16,346
  • Febrile Neutropenia (named in the label)14,530
  • Neutropenia (named in the label)10,581
  • Drug Ineffective (a use or a product term, not a reaction)10,572
  • Pyrexia (named in the label)9,242
  • Disease Progression (a use or a product term, not a reaction)8,095
  • Pneumonia (named in the label)6,668
  • Thrombocytopenia (named in the label)6,523
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)6,513
  • Nausea (named in the label)6,251
  • Anaemia (named in the label)6,148
  • Sepsis (named in the label)5,729
  • Diarrhoea (named in the label)5,488
  • Death (an outcome recorded in the report)5,220
  • Vomiting (named in the label)4,910
  • Infection (named in the label)4,649
  • Myelosuppression (named in the label)4,374
  • Pancytopenia4,315
  • White Blood Cell Count Decreased4,251
  • Fatigue (named in the label)4,227
  • Dyspnoea3,811
  • Cytokine Release Syndrome3,746
  • Mucosal Inflammation (named in the label)3,570
  • Neuropathy Peripheral3,476
  • Platelet Count Decreased3,163

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Cyclophosphamide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions