Applies to cyclophosphamide: capsule, powder for solution, solution, tablet.

Serious side effects of Cyclophosphamide

Along with its needed effects, cyclophosphamide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cyclophosphamide:

More common

• Cough or hoarseness
• fever or chills
• lower back or side pain
• missing menstrual periods
• painful or difficult urination

With high doses and/or long-term treatment

• Blood in the urine
• dizziness, confusion, or agitation
• fast heartbeat
• joint pain
• shortness of breath
• swelling of the feet or lower legs
• unusual tiredness or weakness

Less common

• Black, tarry stools
• pinpoint red spots on the skin
• unusual bleeding or bruising

Rare

• Frequent urination
• redness, swelling, or pain at the injection site
• sores in the mouth and on the lips
• sudden shortness of breath
• unusual thirst
• yellow eyes or skin

Other side effects of Cyclophosphamide

Some side effects of cyclophosphamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Darkening of the skin and fingernails
• loss of appetite
• nausea or vomiting

Less common

• Diarrhea
• flushing or redness of the face
• headache
• increased sweating
• skin rash, hives, or itching
• stomach pain
• swollen lips

For Healthcare Professionals

Applies to cyclophosphamide: intravenous powder for injection, intravenous solution, oral capsule, oral tablet.

Hematologic

Very common (10% or more): Myelosuppression (e.g., bone marrow failure, pancytopenia, neutropenia, agranulocytosis, granulocytopenia, thrombocytopenia [complicated by bleeding], leukopenia, anemia)

Common (1% to 10%): Febrile neutropenia

Uncommon (0.1% to 1%): Thrombocytopenia, anemia

Rare (0.01% to 0.1%): Hemorrhage

Very rare (less than 0.01%): Disseminated intravascular coagulation, hemolytic uremic syndrome, thromboembolism

Frequency not reported: Agranulocytosis, lymphopenia, hemoglobin decreased^[Ref]

Gastrointestinal

Common (1% to 10%): Mucosal inflammation

Very rare (less than 0.01%): Enterocolitis hemorrhagic, acute pancreatitis, ascites, stomatitis, diarrhea, vomiting, constipation, nausea

Frequency not reported: Abdominal pain, parotid gland inflammation, GI hemorrhage, cecitis, colitis, enteritis^[Ref]

Dermatologic

Very common (10% or more): Alopecia

Rare (0.01% to 0.1%): Rash, dermatitis, nail discoloration, skin discoloration (palms and heels)

Very rare (less than 0.01%): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), radiation erythema, pruritus (including itching due to inflammation)

Frequency not reported: Erythema multiforme, palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome), urticaria, erythema, facial swelling, hyperhidrosis, scleroderma^[Ref]

Genitourinary

Very common (10% or more): Cystitis, microhematuria

Common (1% to 10%): Impairment of spermatogenesis

Uncommon (0.1% to 1%): Ovulation disorder (rarely irreversible)

Rare (0.01% to 0.1%): Amenorrhea, azoospermia/asperima, oligospermia, oligospermia, lower levels of female sex hormones, blood estrogen level decreased, blood gonadotropin level increased

Very rare (less than 0.01%): Suburethral hemorrhage, bladder wall edema, bladder fibrosis and sclerosis, atypical urinary bladder epithelial cells

Frequency not reported: Infertility, ovarian failure, oligomenorrhea, testicular atrophy^[Ref]

Respiratory

Uncommon (0.1% to 1%): Pneumonia (sometimes fatal)

Very rare (less than 0.01%): Acute respiratory distress syndrome (ARDS), chronic pulmonary interstitial fibrosis, pulmonary edema, bronchospasm, dyspnea, hypoxia, cough

Frequency not reported: Nasal congestion, oropharyngeal pain, rhinorrhea, pulmonary venoocclusive disease, obliterative bronchiolitis, alveolitis allergic,^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Cardiomyopathy, myocarditis, heart failure (sometimes fatal), tachycardia, flushing, ECG changes, decreased LVEF

Rare (0.01% to 0.1%): Ventricular arrhythmia, supraventricular arrhythmia, chest pain

Very rare (less than 0.01%): Ventricular fibrillation, angina, myocardial infarction, pericarditis, atrial fibrillation, hypertension, hypotension

Frequency not reported: Ventricular tachycardia, cardiogenic shock, pericardial effusion, bradycardia, palpitation, electrocardiogram QT prolonged, pulmonary embolism, venous thrombosis, vasculitis, peripheral ischemia^[Ref]

Endocrine

Rare (0.01% to 0.1%): Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Frequency not reported: Water intoxication^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reaction, anaphylactic/anaphylactoid reaction

Very rare (less than 0.01%): Anaphylactic shock^[Ref]

Oncologic

Rare (0.01% to 0.1%): Acute leukemia (e.g., acute myeloid leukemia, acute promyelocytic leukemia), myelodysplastic syndrome, secondary malignancies, bladder cancer, ureteric cancer

Very rare (less than 0.01%): Tumor lysis syndrome

Frequency not reported: Non-Hodgkin's lymphoma, sarcoma, renal cell carcinoma, renal pelvis cancer, thyroid cancer^[Ref]

Nervous system

Rare (0.01% to 0.1%): Convulsion, dizziness

Very rare (less than 0.01%): Dysgeusia, hypogeusia, paresthesia

Frequency not reported: Neurotoxicity (e.g., myelopathy, peripheral neuropathy, polyneuropathy, neuralgia, dysesthesia, hypoesthesia, paresthesia, tremor, hypogeusia, parosmia), reversible posterior leukoencephalopathy syndrome (e.g., headache, altered mental functioning, seizures, abnormal vision from blurriness to vision loss), encephalopathy^[Ref]

Musculoskeletal

Very rare (less than 0.01%): Rhabdomyolysis, cramps

Frequency not reported: Muscle spasms, myalgia, arthralgia^[Ref]

Local

Very rare (less than 0.01%): Injection site reactions (e.g., thrombosis, necrosis, phlebitis, inflammation, pain, swelling, erythema)

Ocular

Rare (0.01% to 0.1%): Blurred vision, visual impairment

Very rare (less than 0.01%): Conjunctivitis, eye edema (usually from hypersensitivity), lacrimation increased

Frequency not reported: Blurred vision, vision loss^[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, blood lactate dehydrogenase increased, C-reactive protein increased

Rare (0.01% to 0.1%): Dehydration

Very rare (less than 0.01%): Hyponatremia, weight gain

Frequency not reported: Hyperglycemia, hypoglycemia^[Ref]

Psychiatric

Common (1% to 10%): Chills, asthenia, malaise

Very rare (less than 0.01%): Confusion^[Ref]

Hepatic

Common (1% to 10%): Hepatic function abnormal

Rare (0.01% to 0.1%): Hepatitis

Very rare (less than 0.01%): Venoocclusive liver disease, hepatomegaly, jaundice

Frequency not reported: Cholestatic hepatitis, hepatotoxicity (e.g., hepatic failure, hepatic encephalopathy, ascites, hepatomegaly, jaundice, blood bilirubin increased, hepatic enzymes increased [e.g., ASAT, ALAT, ALP, gamma-GT])^[Ref]

Other

Very common (10% or more): Fever

Uncommon (0.1% to 1%): Deafness

Very rare (less than 0.01%): Multiorgan failure

Frequency not reported: Tinnitus, premature labor, intrauterine death, fetal malformation, fetal growth retardation, fetal damage, carcinogenic effect on offspring^[Ref]

Renal

Very rare (less than 0.01%): Renal impairment, blood creatinine increased, renal tubular necrosis

Frequency not reported: Renal tubular disorder, toxic nephropathy, hemorrhagic urethritis, bladder contracture, nephrogenic diabetes insipidus, blood urea nitrogen increased^[Ref]