Cyclophosphamide (Cyclophosphamide) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Information on adverse reactions associated with the use of cyclophosphamide is arranged according to body system affected or type of reaction. The adverse reactions are listed in order of decreasing incidence. The most serious adverse reactions are described in the WARNINGS section.

Reproductive System

See WARNINGS: Carcinogenesis, Mutagenesis, and Impairment of Fertility

Digestive System

Nausea and vomiting commonly occur with cyclophosphamide therapy. Anorexia and, less frequently, abdominal discomfort or pain and diarrhea may occur. There are isolated reports of hemorrhagic colitis, oral mucosal ulceration and jaundice occurring during therapy. These adverse drug effects generally remit when cyclophosphamide treatment is stopped.

Skin and Its Structures

Alopecia occurs commonly in patients treated with cyclophosphamide. The hair can be expected to grow back after treatment with the drug or even during continued drug treatment, though it may be different in texture or color. Skin rash occurs occasionally in patients receiving the drug. Pigmentation of the skin and changes in nails can occur. Very rare reports of Stevens-Johnson syndrome and toxic epidermal necrolysis have been received during postmarketing surveillance; due to the nature of spontaneous adverse event reporting, a definitive causal relationship to cyclophosphamide has not been established.

Hematopoietic System

Leukopenia occurs in patients treated with cyclophosphamide, is related to the dose of drug, and can be used as a dosage guide. Leukopenia of less than 2000 cells/mm³ develops commonly in patients treated with an initial loading dose of the drug, and less frequently in patients maintained on smaller doses. The degree of neutropenia is particularly important because it correlates with a reduction in resistance to infections. Fever without documented infection has been reported in neutropenic patients.

Thrombocytopenia or anemia develop occasionally in patients treated with cyclophosphamide. These hematologic effects usually can be reversed by reducing the drug dose or by interrupting treatment. Recovery from leukopenia usually begins in 7 to 10 days after cessation of therapy.

Urinary System

See WARNINGS: Urinary System for information on cystitis and urinary bladder fibrosis.

Hemorrhagic ureteritis and renal tubular necrosis have been reported to occur in patients treated with cyclophosphamide. Such lesions usually resolve following cessation of therapy.

Infections

See WARNINGS: Infections for information on reduced host resistance to infections.

Carcinogenesis

See WARNINGS: Carcinogenesis, Mutagenesis, and Impairment of Fertility

Respiratory System

Interstitial pneumonitis has been reported as part of the postmarketing experience. Interstitial pulmonary fibrosis has been reported in patients receiving high doses of cyclophosphamide over a prolonged period.

Other

Anaphylactic reactions have been reported; death has also been reported in association with this event. Possible cross-sensitivity with other alkylating agents has been reported. SIADH (syndrome of inappropriate ADH secretion) has been reported with the use of cyclophosphamide. Malaise and asthenia have been reported as part of the postmarketing experience.

REPORTS OF SUSPECTED CYCLOPHOSPHAMIDE SIDE EFFECTS / ADVERSE REACTIONS

Possible Cyclophosphamide side effects / adverse reactions in 88 year old female

Reported by a physician from United States on 2011-10-03

Patient: 88 year old female

Reactions: Death, Neutropenia

Adverse event resulted in: death

Suspect drug(s):
Cyclophosphamide
    Indication: Acquired Haemophilia

Rituximab
    Indication: Acquired Haemophilia

Possible Cyclophosphamide side effects / adverse reactions in 82 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2011-10-03

Patient: 82 year old female

Reactions: Febrile Neutropenia

Adverse event resulted in: death

Suspect drug(s):
Cyclophosphamide
    Dosage: cycle 2

Rituximab

Doxorubicin Hydrochloride
    Dosage: cycle 1

Vincristine
    Indication: non-Hodgkin's Lymphoma

Rituximab
    Indication: non-Hodgkin's Lymphoma

Prednisone
    Dosage: cycle 2
    Indication: non-Hodgkin's Lymphoma

Doxorubicin Hydrochloride
    Dosage: cycle 1

Doxorubicin Hydrochloride
    Dosage: cycle 2

Cyclophosphamide
    Indication: non-Hodgkin's Lymphoma

Vincristine
    Dosage: cycle 2

Prednisone

Doxorubicin Hydrochloride
    Dosage: cycle 2

Doxorubicin Hydrochloride
    Dosage: cycle 2

Doxorubicin Hydrochloride
    Dosage: cycle 1
    Indication: non-Hodgkin's Lymphoma

Possible Cyclophosphamide side effects / adverse reactions in 6 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-03

Patient: 6 year old female weighing 18.0 kg (39.6 pounds)

Reactions: Urinary Tract Infection, Pain, Febrile Neutropenia, Idiopathic Pneumonia Syndrome, Periorbital Oedema, Mucosal Inflammation, Cardio-Respiratory Arrest, Metapneumovirus Infection, Fungal Infection, Posterior Reversible Encephalopathy Syndrome, Deep Vein Thrombosis

Adverse event resulted in: death, life threatening event

Suspect drug(s):
Busulfan
    Administration route: Oral
    Indication: Bone Marrow Failure
    Start date: 2010-11-08
    End date: 2010-11-11

Cyclophosphamide
    Indication: Bone Marrow Failure
    Start date: 2010-11-12
    End date: 2010-11-15

Methotrexate
    Indication: Graft Versus Host Disease
    Start date: 2010-11-21
    End date: 2010-11-24

Other drugs received by patient: Mycophenolate Mofetil; Pentamidine; Ciprofloxacin; Foscarnet Sodium; Ganciclovir; Immune Globulin NOS; Infliximab; Voriconazole; Mesna; Tacrolimus; Calcium Gluconate; Ceftriaxone; Rituximab; Vitamin K TAB; Acyclovir; Alemtuzumab; Basiliximab; Dalteparin Sodium; Dapsone; Lansoprazole; Ondansetron; Phenytoin; Amphotericin B; Posaconazole; Valganciclovir; Interferon Gamma-1B; Oseltamivir; Allopurinol; Caspofungin Acetate; Cyclosporine; Itraconazole; Ribavirin