Cyclophosphamide
Nitrogen Mustard Analogues
Sold as PROCYTOX
- Drug class
- Nitrogen Mustard Analogues
- Availability
- Prescription only
- Routes
- Intravenous, Oral
- Markets covered
- 3
- Products on record
- 48
- FDA reports (12 mo)
- 12,480
Overview
Plain-language summary, compiled from the cited regulatory records
Cyclophosphamide is an alkylating drug [1]. It belongs to the drug class of Nitrogen Mustard Analogues [1].
Cyclophosphamide is approved for the treatment of various malignant diseases in adults and pediatric patients. These include certain types of lymphomas such as Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, and Burkitt’s lymphoma. It is also indicated for multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, and retinoblastoma [1]. Additionally, it is approved for the treatment of breast carcinoma [1]. Cyclophosphamide is also indicated for minimal change nephrotic syndrome in pediatric patients with biopsy-proven minimal change disease [1].
In the past 12 months, there have been 12,480 adverse event reports associated with cyclophosphamide [2]. The most frequently reported adverse events include off-label use, febrile neutropenia, drug ineffective, neutropenia, and myelosuppression [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 29 | May 15, 2026 |
| CA Canada | Health Canada | 15 | November 6, 2025 |
| US United States | FDA | 4 | August 7, 2025 |
GBUnited Kingdom· MHRA
29 products
Uses
Cyclophosphamide is used in combination with chemotherapy regimens or alone, depending on the indication. Cyclophosphamide is indicated in the treatment of: • Chronic Lymphocytic Leukemia (CLL) • Acute Lymphocytic Leukemia (ALL) • As conditioning for a bone marrow transplantation, in the treatment of Acute Lymphocytic Leukemia, Chronic myelogenous leukaemia and Acute myelogenous leukaemia in combination with whole body irradiation or busulfan.
• Hodgkin’s disease, Non-Hodgkin’s lymphoma and Multiple Myeloma. • Metastatic ovarian and breast, carcinoma • Adjuvant treatment of breast carcinoma • Ewing’s sarcoma • Small cell lung cancer • Advances or metastatic neuroblastoma, • Life-threatening autoimmune diseases: severe progressive forms of lupus nephritis and Wegener’s granulomatosis.
How to take
Cyclophosphamide should only be used by clinicians experienced in the use of cancer chemotherapy. Cyclophosphamide should only be administered where there are facilities for monitoring of clinical, biochemical and haematological parameters before, during, and after administration and under the supervision of an oncology specialist.
Posology Dosage must be individualised. Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient's general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy- free intervals may be necessary. Use of haematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis-stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
Prior, during or immediately after the administration, adequate amounts of fluid should be ingested or infused to force diuresis in order to reduce the risk of urinary tract toxicity. Therefore, Cyclophosphamide should be administered in the morning.
See section
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
The frequency listing of adverse reactions reported below are derived from clinical trials and from post marketing experience.
The frequency of adverse reactions is defined using the following convention:
Very common (>1/10), common (> 1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (> 1/10,000 to <1/1,000), Very rare (< 1/10,000) not known.
Infections and infestations Common :
Infections1 Uncommon : Pneumonia2, sepsis1 Neoplasms, benign and malignant and unspecified (including cysts and polyps) Rare : Acute leukemia3, myelodysplastic syndrome, secondary malignancies, bladder cancer, ureteric cancer Very rare : Tumour lysis syndrome Not known : Non-Hodgkin's lymphoma, sarcoma, renal cell carcinoma, renal pelvis cancer, thyroid cancer Blood and lymphatic system disorders Very common : Myelosuppression4, leukopenia, neutropenia Common : Febrile neutropenia Uncommon : Thrombocytopenia, anaemia Very rare : Disseminated intravascular coagulation, Haemolytic uremic syndrome Not known : Agranulocytosis, Lymphopenia, Haemoglobin decreased Immune system disorders Very common : Immunosuppression Uncommon : Anaphylactic/ Anaphylactoid reaction, hypersensitivity reaction Very rare : Anaphylactic shock Endocrine disorders Rare : SIADH (syndrome of inappropriate antidiuretic hormone secretion) Not known : Water intoxication Metabolism and nutrition disorders Uncommon : Anorexia Rare : Dehydration Very rare : Hyponatremia Not known : Blood glucose increased, Blood glucose decreased Psychiatric disorders Very rare : Confusional state Nervous system disorders Uncommon : Peripheral neuropathy, polyneuropathy, neuralgia Rare : Convulsion, dizziness Very rare : Dysgeusia, hypogeusia, paresthesia Not known : Neurotoxicity5, Reversible posterior leukoencephalopathy syndrome6, encephalopathy Eye disorders Rare : Blurred vision Very rare : Visual impairment, conjunctivitis, eye oedema7 Not known : Lacrimation increased Ear and labyrinth disorders Uncommon : Deafness Not known : Tinnitus Cardiac disorders Uncommon : Heart failure8, cardiomyopathy, myocarditis, tachycardia Rare : Ventricular arrhythmia, arrhythmia, supraventricular arrhythmia Very rare : Ventricular fibrillation, angina, myocardial infarction, pericarditis, atrial fibrillation, Not known : Ventricular tachycardia, cardiogenic shock, pericardial effusion, palpitations, bradycardia, electrocardiogram QT prolonged Vascular disorders Uncommon : Flushing Rare : Haemorrhage Very rare : Thromboembolism, hypertension, hypotension Not known : Pulmonary embolism, venous thrombosis, vasculitis, peripheral ischemia.
Respiratory, thoracic and mediastinal disorders8, 9 Very rare :
Acute respiratory distress syndrome (ARDS), chronic pulmonary interstitial fibrosis, pulmonary oedema, bronchospasm, dyspnoea, hypoxia, cough Not known : Pulmonary veno-occlusive disease, alveolitis allergic, pneumonitis, nasal congestion, oropharyngeal pain, rhinorrhoea, sneezing, Obliterative bronchiolitis, Pleural effusion Gastrointestinal disorders Common : Mucosal inflammation Very rare : Haemorrhagic enterocolitis, acute pancreatitis, ascites, stomatitis, diarrhoea, vomiting, constipation, nausea Not known : Gastrointestinal haemorrhage, Cecitis, colitis, enteritis, abdominal pain, inflammation of parotid salivary glands Hepatobiliary disorders Common : Hepatic function abnormal Rare : Hepatitis Very rare : Veno-occlusive liver disease, hepatomegaly, Jaundice Not known : Cholestatic hepatitis, hepatotoxicity10 Skin and subcutaneous tissue disorders Very common : Alopecia11, Rare : Rash, Dermatitis, Nail discolouration, Skin discolouration12 Very rare : Stevens-Johnson syndrome, toxic epidermal necrolysis, radiation erythaema, pruritus (including inflammatory itching) Not known : Erythema multiforme, palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome), urticaria, erythema, facial swelling, hyperhidrosis Musculoskeletal and connective tissue disorders Very rare : Rhabdomyolysis, cramps Not known : Scleroderma, muscle spasms, myalgia, arthralgia Renal and urinary tract disorders Very common : Cystitis, microhaematuria Common : Haemorrhagic cystitis, macrohematuria Very rare : Sub urethral haemorrhage, bladder wall oedema, fibrosis and bladder sclerosis, renal failure, renal impairment, blood creatinine increased, Renal tubular necrosis.
Not known :
Renal tubular disorder, nephropathy toxic, haemorrhagic urethritis, bladder contracture, nephrogenic diabetes insipidus, atypical urinary bladder epithelial cells, blood urea nitrogen increased Pregnancy, puerperium and perinatal conditions Not known : Premature labour Reproductive system and breast disorders Common : Impairment of spermatogenesis Uncommon : Ovulation disorder (rarely irreversible) Rare : Amenorrhea13, azoospermia/asperima13, oligospermia13 Not known : Infertility, ovarian failure, oligomenorrhea, testicular atrophy, Congenital, familial and genetic disorders Not Known : Intra-uterine death, foetal malformation, foetal growth retardation, foetal toxicity, Carcinogenic effect on offspring General disorders and administrative site conditions Very common : Fever Common : Chills, asthenia, malaise, Rare : Chest pain Very rare : Headache, pain, multiorgan failure, injection/infusion site reactions (thrombosis, necrosis, phlebitis, inflammation, pain, swelling, erythema) Investigations Uncommon : Blood lactate dehydrogenase increased, C-reactive protein increased, ECG changes, decreased left ventricle ejection fraction (LVEF), Lower levels of female sex hormones Very rare : Weight gain Not known : Blood oestrogen level decreased, Blood gonadotropin level increased 1An increased risk for and severity of pneumonias (including fatal outcomes), other bacterial, fungal, viral, protozoal, and parasitic infections; reactivation of latent infections, including viral hepatitis, tuberculosis, JC virus with progressive multifocal leukoencephalopathy (including fatal outcomes), pneumocystis jiroveci, herpes zoster, […]
4 It is within the responsibility of the physician to decide on the use of Cyclophosphamide according to the operative treatment guidelines.
The doses below can be regarded as general guidelines:
Hematologic and solid tumours • For daily treatment: 3 - 6 mg/kg body weight (= 120 - 240 mg/m2 body surface area), injected intravenously • For the intermittent treatment: 10 - 15 mg/kg body weight (= 400 - 600 mg/m2 body surface area), injected intravenously, with therapy-free intervals of 2 to 5 days • For high-dose intermittent treatment: 20 - 40 mg/kg body weight (= 800 - 1600 mg/m2 body surface area), injected intravenously, with therapy-free intervals of 21 to 28 days.
As preparation for a bone marrow transplantation 2 days 60 mg/kg or 4 days 50 mg/kg body weight injected intravenously. 5). Autoimmune diseases Per month 500 – 1000 mg/m2 body surface area. Patients with Hepatic Impairment Severe hepatic impairment may be associated with a decreased activation of cyclophosphamide.
This may alter the effectiveness of the Cyclophosphamide treatment and should be considered when selecting the dose and estimating response to the medicinal product. 4). The dose must be reduced in patients with severe hepatic impairment.
086 mmol/l). Patients with Renal Impairment In patients with renal impairment, particularly in patients with severe impairment, decreased renal excretion may result in increased plasma levels of cyclophosphamide and its metabolites.
This may result in increased toxicity and should be considered when determining the dosage in such patients. 4). A dose reduction of 50% for a glomerular filtration rate below 10 mL/minute is recommended. Cyclophosphamide and its metabolites are dialyzable, although there may be differences in clearance depending upon the dialysis system being used.
In patients requiring dialysis, consistent interval between dialysis cycles and Cyclophosphamide administration should be considered. 4. Elderly patients In elderly patients, monitoring for toxicities and the need for dose adjustment should reflect the higher frequency of decreased hepatic, renal or cardiac function, or other organ function and concomitant diseases or other drug therapy in this population.
Paediatric population Cyclophosphamide has been administered to children. The safety profile of cyclophosphamide in paediatric patients is similar to that of the adult population. Dose modification due to myelosuppression A leukocyte and platelet count should be regularly performed during treatment with cyclophosphamide.
It is recommended to adjust the dose, if required, if signs of myelosuppression become evident. Please refer to the table below. Urinary sediment should also be checked regularly for the presence of erythrocytes. Leukocyte count [μl] Platelet count [μl] Dosage >4000 >100 000 100% of the planned dose 2500 - 4000 50 000 - 100 000 50% of the planned dose <2500 <50 000 Omit until values normalise or decide individually In combination therapy further dose reductions may have to be considered.
Method of administration Cyclophosphamide is inert until activated by enzymes in the liver. However, as with all cytotoxic agents, it is recommended that reconstitution should be performed by trained personnel, in a designated area.
Precaution to be taken before handling or administering the product Those handling the preparation should wear protective gloves. Care should be taken to avoid splashing material into the eyes. The material should not be handled by women who are pregnant or who are breast-feeding.
The choice of solvent for reconstituting Cyclophosphamide depends on the route of administration to be used.
Infusion:
Intravenous administration should preferably be conducted as an infusion. 9% sterile sodium chloride solution or 5% glucose solution. 6. 9% sterile sodium chloride solution. 9% sterile sodium chloride solution is suitable for bolus injection.
Cyclophosphamide reconstituted in water is hypotonic and should not be injected directly. 6. g. facial swelling, headache, nasal congestion, scalp burning), cyclophosphamide should be injected or infused very slowly. Duration of the infusion (ranging from 30 minutes to 2 hours) should be appropriate for the volume and type of carrier fluid to be infused.
Before intravenous use, the substance must be completely dissolved. Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
1; • acute infections; • bone marrow aplasia or bone marrow depression prior to treatment; • urinary tract infection; • acute urothelial toxicity following cytotoxic chemotherapy or radiation therapy; • urinary outflow obstruction.
6) Cyclophosphamide should not be used in the management of non-malignant disease, except for […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
1; • acute infections; • bone marrow aplasia or bone marrow depression prior to treatment; • urinary tract infection; • acute urothelial toxicity following cytotoxic chemotherapy or radiation therapy; • urinary outflow obstruction.
6) Cyclophosphamide should not be used in the management of non-malignant disease, except for immunosuppression in life-threatening situations.
This is not medical advice. Consult a qualified healthcare professional.
CACanada· Health Canada
15 products
Uses
Cyclophosphamide for Injection, used alone or as a component of combination therapy is indicated in adults for: A: Frequently responsive myeloproliferative and lymphoproliferative disorders 1. Malignant lymphomas (See also 4 DOSAGE AND ADMINISTRATION) a) Hodgkin's disease [Cotswold stages II & III (massive mediastinal disease) and IIIA1,2 - IV E] Non-Hodgkin's lymphomas (Working Formulation.
Low Grade A,B,C; Intermediate Grade D,E,F,G; High Grade H,I,J) b) Follicular lymphoma (B,C,D) c) Lymphocytic lymphoma (A,B,E; mixed histiocytic, C,F) ** Note: Type A, small diffuse and well differentiated malignant lymphocytic lymphoma is consistent with chronic lymphocytic leukemia, to be considered a heterogenous group of chronic B-cell disorders.
d) Diffuse histiocytic lymphoma (G,H) e) Lymphoblastic lymphoma (I) f) Burkitt's lymphoma (J) 2. Multiple Myelomas (Myeloma stages II, IIIA, IIIB) (See also 4 DOSAGE AND ADMINISTRATION) 3. Leukemias (See also 4 DOSAGE AND ADMINISTRATION) a) Chronic Lymphocytic Leukemia (CLL) (Rai Stages II, III, IV) (Binet Stages B, C) NOTE: Chronic lymphocytic leukemias are considered to be a heterogenous group of chronic B-cell disorders.
b) Chronic Myelogenous Leukemia (CML) (Ineffective in acute blastic crises) c) Acute Myelogenous Leukemia (AML) (M0-M7) (Also called acute nonlymphocytic leukemia) Acute Myelomonocytic Leukemia (AMML) (Type M4) PrCyclophosphamide for Injection Page 5 of 59 Protected B / Protégé B 4.
Mycosis Fungoides (Advanced disease) (Stages III, IVA, IVB) (See also 4 DOSAGE AND ADMINISTRATION) B: Frequently responsive solid malignancies (See also 4 DOSAGE AND ADMINISTRATION) 1. Neuroblastoma (in patients with disseminated disease, Stage IV) 2.
Carcinoma of the Breast (Stages II-IV) 3. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): In elderly patients, monitoring for toxicities and the need for dose adjustment should reflect the higher frequency of decreased hepatic, renal, cardiac, or other organ function, and concomitant diseases or other drug therapy in this population.
How to take
) a) Hodgkin's disease [Cotswold stages II & III (massive mediastinal disease) and IIIA1,2 - IV E] Non-Hodgkin's lymphomas (Working Formulation. Low Grade A,B,C; Intermediate Grade D,E,F,G; High Grade H,I,J) b) Follicular lymphoma (B,C,D) c) Lymphocytic lymphoma (A,B,E; mixed histiocytic, C,F) ** Note: Type A, small diffuse and well differentiated malignant lymphocytic lymphoma is consistent with chronic lymphocytic leukemia, to be considered a heterogenous group of chronic B-cell disorders.
d) Diffuse histiocytic lymphoma (G,H) e) Lymphoblastic lymphoma (I) f) Burkitt's lymphoma (J) 2. Multiple Myelomas (Myeloma stages II, IIIA, IIIB) (See also 4 DOSAGE AND ADMINISTRATION) 3. Leukemias (See also 4 DOSAGE AND ADMINISTRATION) a) Chronic Lymphocytic Leukemia (CLL) (Rai Stages II, III, IV) (Binet Stages B, C) NOTE: Chronic lymphocytic leukemias are considered to be a heterogenous group of chronic B-cell disorders.
b) Chronic Myelogenous Leukemia (CML) (Ineffective in acute blastic crises) c) Acute Myelogenous Leukemia (AML) (M0-M7) (Also called acute nonlymphocytic leukemia) Acute Myelomonocytic Leukemia (AMML) (Type M4) PrCyclophosphamide for Injection Page 5 of 59 Protected B / Protégé B 4.
Mycosis Fungoides (Advanced disease) (Stages III, IVA, IVB) (See also 4 DOSAGE AND ADMINISTRATION) B: Frequently responsive solid malignancies (See also 4 DOSAGE AND ADMINISTRATION) 1. Neuroblastoma (in patients with disseminated disease, Stage IV) 2.
Carcinoma of the Breast (Stages II-IV) 3. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): In elderly patients, monitoring for toxicities and the need for dose adjustment should reflect the higher frequency of decreased hepatic, renal, cardiac, or other organ function, and concomitant diseases or other drug therapy in this population.
2 CONTRAINDICATIONS Cyclophosphamide is contraindicated in: • Patients who are hypersensitive to this drug or its metabolites, alone or as part of combination chemotherapy or to any ingredient in the formulation, including any non-medical ingredient, or component of the container.
For a complete listing, See
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
1 Adverse Reaction Overview Increased risk for and severity of pneumonias (including fatal outcomes), reactivation of latent infections, malignant and benign neoplasms, progression of underlying malignancies (including fatal outcomes), different degrees of myelosuppression (sometimes with life threatening infections), leucopenia, anemia, thrombocytopenia, fulminating anaphylaxis (with fatal outcome), hypersensitivity reactions, syndrome of inappropriate antidiuretic hormone secretion, tumor lysis syndrome, hematuria, confusion, neurotoxicity (both the central and peripheral nervous system), cardiotoxicity (with fatal outcomes), hearing disorders, arterial and venous occlusive disorders with and without embolization, gastrointestinal hemorrhages, acute pancreatitis, hepatotoxicity, hepatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, skin eruption, hemorrhagic cystitis, rhabdomyolysis, sterility in both sexes, fetal malformation and toxicity (including intra-uterine death), multiorgan failure, general physical deterioration, increased lactate dehydrogenase and C-reactive protein.
NOTE:
Many side effects of cancer chemotherapy are unavoidable, since they represent the drug's pharmacologic action. Leukopenia and thrombocytopenia are used as guidelines, among others, to aid in individual dosage titration. 2 Clinical Trial Adverse Reactions The list of adverse reactions to cyclophosphamide in this document is based on postmarketing data.
5 Post-Market Adverse Reactions The following is a summary of adverse reactions reported with cyclophosphamide either alone or in combination with other chemotherapeutic agents in the post marketing experience, listed by MedDRA system Organ Class (SOC), then by Preferred Term in order of severity, where feasible.
In the case of a polychemotherapy regimen, the adverse reaction profile of each drug component should be reviewed.
INFECTIONS AND INFESTATIONS:
The following manifestations have been associated with myelosuppression and immunosuppression caused by cyclophosphamide: increased risk for and severity of pneumonias (including fatal outcomes), other bacterial, fungal, viral, protozoal, parasitic infections; reactivation of latent infections, including viral hepatitis, tuberculosis, JC virus with progressive multifocal leukoencephalopathy (including fatal outcomes), Pneumocystis jiroveci, herpes zoster, Strongyloides, Sepsis and Septic shock (including fatal outcomes) NEOPLASMS, BENIGN AND MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS): Acute leukemia (Acute myeloid leukemia, Acute promyelocytic leukemia), Myelodysplastic syndrome, Lymphoma (Non-Hodgkin’s lymphoma), Sarcomas, Renal cell carcinoma, Renal pelvis cancer, Bladder cancer, Ureteric cancer, Thyroid cancer, Treatment related PrCyclophosphamide for Injection Page 34 of 59 Protected B / Protégé B secondary malignancy, Carcinogenic effect in offspring, Tumor lysis syndrome.
Additionally, progression of underlying malignancies, including fatal outcomes, have been reported.
BLOOD AND LYMPHATIC SYSTEM DISORDERS:
Myelosuppression manifested as Bone marrow failure, Pancytopenia, Neutropenia, Agranulocytosis, Granulocytopenia, Thrombocytopenia (complicated by bleeding), Leukopenia, Anemia; Febrile neutropenia, Lymphopenia, Disseminated intravascular coagulation, Hemolytic uremic syndrome (with thrombotic microangiopathy), Hemoglobin decreased IMMUNE SYSTEM DISORDERS: Immunosuppression, Anaphylactic shock, Anaphylactic / Anaphylactoid reaction (including fatal outcomes), Hypersensitivity reaction ENDOCRINE DISORDERS: Water intoxication, Syndrome of inappropriate antidiuretic hormone secretion (SIADH) with fatal outcomes.
METABOLISM AND NUTRITION DISORDERS:
Hyponatremia with fatal outcomes, Fluid retention, Anorexia, Blood glucose increased, Blood glucose decreased, tumor lysis manifested by hyperkalemia, hyperuricemia PSYCHIATRIC DISORDERS: Confusional state NERVOUS SYSTEM DISORDERS: Encephalopathy, Convulsion, Dizziness, Neurotoxicity has been reported and manifested as Reversible posterior leukoencephalopathy syndrome, Myelopathy, Peripheral neuropathy, Polyneuropathy, Neuralgia, Dysesthesia, Hypoesthesia, Paresthesia, Tremor, Dysgeusia, Hypogeusia, Parosmia EYE DISORDERS: Blurring of Vision, Myopia, Visual impairment, Conjunctivitis, Lacrimation increased EAR AND LABYRINTH DISORDERS: Deafness, Hearing impaired, Tinnitus CARDIAC DISORDERS: Cardiac arrest, Ventricular fibrillation, Ventricular tachycardia, Cardiogenic shock, Pericardial effusion (progressing to cardiac tamponade), Myocardial hemorrhage, Myocardial infarction, Cardiac failure congestive (including fatal outcomes), Cardiac failure (including fatal outcomes), Left ventricular failure, Left ventricular dysfunction, Cardiomyopathy, Myocarditis, Pericarditis, Carditis, Atrial fibrillation, Supraventricular arrhythmia, Ventricular arrhythmia, Bradycardia, Tachycardia, Palpitations, Electrocardiogram QT prolonged, Ejection fraction decreased PrCyclophosphamide for Injection Page 35 of 59 Protected B / Protégé B VASCULAR DISORDERS: Pulmonary embolism, Venous thrombosis, Vasculitis, Peripheral ischemia, Hypertension, Hypotension, Flushing, Hot flush, Blood pressure decreased.
RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS:
Pulmonary veno-occlusive disease, Acute respiratory distress syndrome, Interstitial lung disease as manifested by Pulmonary fibrosis, Respiratory failure (including fatal outcomes), Obliterative bronchiolitis, Organizing pneumonia, Alveolitis allergic, Pneumonitis; Respiratory distress, Pulmonary hypertension, Pulmonary edema, Pleural effusion, Bronchospasm, Dyspnea, Hypoxia, Cough, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Rhinorrhea, Sneezing GASTROINTESTINAL DISORDERS: Enterocolitis hemorrhagic, Gastrointestinal hemorrhage, Acute pancreatitis, Colitis, Enteritis, Cecitis, Mucosal ulceration, Stomatitis, Diarrhea, Vomiting, Constipation (sometimes severe), Nausea, […]
General Risk factors for cyclophosphamide toxicities and their sequelae described here and in other sections may constitute contraindications if cyclophosphamide is not used for the treatment of a life-threatening condition. In such situations, individual assessment of risk and expected benefits is necessary.
Prior to initiating treatment with Cyclophosphamide for Injection, it is necessary to exclude or correct any electrolyte imbalances. PrCyclophosphamide for Injection Page 25 of 59 Protected B / Protégé B Each individual component of a cyclophosphamide-containing poly-chemotherapy regimen must have its precaution profile reviewed.
Since cyclophosphamide is highly toxic with a relatively low therapeutic index, and a therapeutic response is not likely to occur without some evidence of toxicity, the drug must only be used under constant supervision of the attending physician.
Alopecia occurs commonly in patients treated with even low doses of cyclophosphamide. With large parenteral doses, considerable hair loss (5-30%, with possible total alopecia) is to be expected. The hair can be expected to grow back after or even during continued treatment; it may, however be different in texture and / or colour.
If a patient who is to undergo surgery is receiving cyclophosphamide or has been treated with cyclophosphamide within 10 days of general anesthesia, the anesthetist should be so advised prior to surgery (See also 9 Drug-Drug Interactions section).
In case of accidental paravenous administration of cyclophosphamide, the infusion should be stopped immediately, the extravascular cyclophosphamide solution should be aspirated with the cannula in place, and other measures should be instituted as appropriate.
Carcinogenesis and Mutagenesis As with cytotoxic therapy in general, treatment with cyclophosphamide involves the risk of secondary tumours and their precursors as late sequelae. The risk of developing urinary tract cancer as well as myelodysplastic alterations partly progressing to acute leukemias, or non-malignant disease in which immune processes are believed to be involved pathologically is increased.
Other malignancies reported after use of cyclophosphamide or regimens with cyclophosphamide include lymphoma, thyroid cancer, and sarcomas. In some cases, the second malignancy developed several years after cyclophosphamide treatment had been discontinued.
Malignancy has also been reported after in utero exposure. Urinary bladder malignancies have usually occurred in patients who previously had hemorrhagic cystitis. Animal studies demonstrate that the risk of bladder cancer can be markedly reduced by an adequate administration of mesna.
Cardiovascular Myocarditis and myopericarditis, which may be accompanied by significant pericardial effusion and cardiac tamponade, have been reported with cyclophosphamide therapy and have led to severe, sometimes fatal congestive heart failure.
Histopathologic examination has primarily shown hemorrhagic myocarditis. Hemopericardium has occurred secondary to hemorrhagic myocarditis and myocardial necrosis. PrCyclophosphamide for Injection Page 26 of 59 Protected B / Protégé B Acute cardiac toxicity has been reported with a single dose of less than 20 mg/kg cyclophosphamide.
Following exposure to treatment regimens that included cyclophosphamide, supraventricular arrhythmias (including atrial fibrillation and flutter) as well as ventricular arrhythmias (including severe QT prolongation associated with ventricular tachyarrhythmia) have been reported in patients with and without other signs of cardiotoxicity.
The risk of cyclophosphamide cardiotoxicity may be increased following high doses of cyclophosphamide, in patients with advanced age, and in patients with previous radiation treatment of the cardiac region and/or previous or concomitant treatment with other cardiotoxic agents.
Particular caution is necessary in patients with risk factors for cardiotoxicity and in patients with pre-existing cardiac disease. Driving and Operating Machinery Due to potential adverse effects of cyclophosphamide such as dizziness, blurred vision, visual impairment, nausea and vomiting which could be symptoms of vasomotor ataxia, caution should be advised when driving or operating machinery.
5 mg of ethanol anhydrous. The alcohol content in a dose of cyclophosphamide regimen may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized, including high-risk groups such as patients with hepatic impairment or epilepsy.
Some medications, such as CNS depressants, pain relievers and sleep aids may interact with the alcohol in the cyclophosphamide infusion and exacerbate depression or worsen the intoxicating effects. Product may also interact with the other alcohol containing chemotherapy drugs which could be administered concomitantly with cyclophosphamide.
Patients are advised to avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after the infusion of Cyclophosphamide for Injection. Health care professionals should consider the alcohol content of Cyclophosphamide for Injection when prescribing or administering the drug to patients when using it in conjunction with other medications.
Endocrine and Metabolism Cyclophosphamide has been shown to be more toxic in adrenalectomized dogs. Dose adjustments of Cyclophosphamide for Injection may be necessary for adrenalectomized patients. PrCyclophosphamide for Injection Page 27 of 59 Protected B / Protégé B Gastrointestinal Administration of cyclophosphamide may cause nausea and vomiting.
Current guidelines on the use of antiemetics for prevention and amelioration of nausea and vomiting should be considered. Alcohol consumption may increase cyclophosphamide-induced vomiting and nausea. Administration of cyclophosphamide may cause stomatitis […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
Cyclophosphamide is contraindicated in: • Patients who are hypersensitive to this drug or its metabolites, alone or as part of combination chemotherapy or to any ingredient in the formulation, including any non-medical ingredient, or component of the container.
For a complete listing, See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with urinary outflow obstructions • Patients with severe myelosuppression • Patients with severe renal impairment • Patients with severe hepatic impairment • Patients with an active infection, particularly varicella zoster infection • Patients with severe immunosuppression • Pediatric population (<18 years of age) • Pregnant women • Breast feeding women PrCyclophosphamide for Injection Page 6 of 59 Protected B / Protégé B • Asian patients with ALDH2 mutation In combined chemotherapy regimen, the contraindications for each individual drug must be identified.
This is not medical advice. Consult a qualified healthcare professional.
Brands in Canada (1)
USUnited States· FDA
4 products
Uses
1 INDICATIONS AND USAGE Cyclophosphamide 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 Malignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma multiple myeloma leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) mycosis fungoides (advanced disease) neuroblastoma (disseminated disease) adenocarcinoma of the ovary retinoblastoma carcinoma of the breast Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.
How to take
1 ). 2 ) Intravenous: Initial course for patients with no hematologic deficiency: 40 mg per kg to 50 mg per kg in divided doses over 2 to 5 days. Other regimens include 10 mg per kg to 15 mg per kg given every 7 to 10 days or 3 mg per kg to 5 mg per kg twice weekly.
1 Important Administration Instructions During or immediately after the administration of Cyclophosphamide Injection, adequate amounts of fluid should be ingested or infused to force diuresis in order to reduce the risk of urinary tract toxicity.
Therefore, Cyclophosphamide Injection should be administered in the morning. 2 Recommended Dosage for Malignant Diseases Adults and Pediatric Patients Intravenous Use When used as the only oncolytic drug therapy, the recommended dosage for the initial course of Cyclophosphamide Injection for patients with no hematologic deficiency is 40 mg per kg to 50 mg per kg given intravenously in divided doses over a period of 2 to 5 days.
Other intravenous regimens include 10mg per kg to 15 mg per kg given every 7 to 10 days or 3 mg per kg to 5 mg per kg twice weekly. Adjust the dosage of Cyclophosphamide Injection based on the specific regimen administered, response to treatment, myelosuppression or other adverse reactions, and patient risk factors [see Warnings and Precautions ( 5 ) ] .
3 Preparation, Handling and Administration Cyclophosphamide Injection is a hazardous drug. Follow applicable special handling and disposal procedures 1 . Caution should be exercised when handling and preparing Cyclophosphamide Injection.
To minimize the risk of dermal exposure, always wear gloves when handling vials containing Cyclophosphamide Injection. Cyclophosphamide Injection Intravenous Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Cyclophosphamide does not contain any antimicrobial preservative and thus care must be taken to assure the sterility of prepared solutions. Use aseptic technique. For Direct Intravenous Injection Aseptically withdraw the prescribed dose from the vial.
9% Sodium Chloride Injection, USP For Intravenous Infusion Aseptically withdraw the prescribed dose from the vial. , facial swelling, headache, nasal congestion, scalp burning), Cyclophosphamide Injection should be injected or infused very slowly.
Duration of the infusion also should be appropriate for the volume and type of carrier fluid to be infused. 9% Sodium chloride Injection, USP up to 24 hours up to 6 days Storage of Undiluted Cyclophosphamide Solution: After first use, store partially used multiple-dose vial in the original carton at 2°C to 8°C (36ºF to 46°F) for up to 28 days.
Discard unused portion after 28 days.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 12,480 reports total. [4]
- Off Label Use 1,637
- Febrile Neutropenia 1,067
- Drug Ineffective 911
- Neutropenia 767
- Myelosuppression 717
- Pyrexia 560
- Disease Progression 524
- Thrombocytopenia 502
- Anaemia 482
- Pneumonia 474
- Cytokine Release Syndrome 463
- Nausea 447
Side effects & warnings
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. 11) ] Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc. gov/medwatch. 1 Clinical Trials and Postmarketing Experience The following adverse reactions associated with the use of cyclophosphamide were identified in clinical studies or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions were neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea.
Cardiac: cardiac arrest, ventricular fibrillation, ventricular tachycardia, cardiogenic shock, pericardial effusion (progressing to cardiac tamponade), myocardial hemorrhage, myocardial infarction, cardiac failure (including fatal outcomes), cardiomyopathy, myocarditis, pericarditis, carditis, atrial fibrillation, supraventricular arrhythmia, ventricular arrhythmia, bradycardia, tachycardia, palpitations, QT prolongation.
Congenital, Familial and Genetic: intra-uterine death, fetal malformation, fetal growth retardation, fetal toxicity (including myelosuppression, gastroenteritis). Ear and Labyrinth: deafness, hearing impaired, tinnitus. Endocrine: water intoxication.
Eye: visual impairment, conjunctivitis, lacrimation. Gastrointestinal: gastrointestinal hemorrhage, acute pancreatitis, colitis, enteritis, cecitis, stomatitis, constipation, parotid gland inflammation, nausea, vomiting, diarrhea. General Disorders and Administrative Site Conditions: multiorgan failure, general physical deterioration, influenza-like illness, injection/infusion site reactions (thrombosis, necrosis, phlebitis, inflammation, pain, swelling, erythema), pyrexia, edema, chest pain, mucosal inflammation, asthenia, pain, chills, fatigue, malaise, headache febrile neutropenia.
Hematologic: myelosuppression, bone marrow failure, disseminated intravascular coagulation and hemolytic uremic syndrome (with thrombotic microangiopathy). Hepatic: veno-occlusive liver disease, cholestatic hepatitis, cytolytic hepatitis, hepatitis, cholestasis; hepatotoxicity with hepatic failure, hepatic encephalopathy, ascites, hepatomegaly, blood bilirubin increased, hepatic function abnormal, hepatic enzymes increased.
Immune: immunosuppression, anaphylactic shock and hypersensitivity reaction.
Infections:
The following manifestations have been associated with myelosuppression and immunosuppression caused by cyclophosphamide: increased risk for and severity of pneumonias (including fatal outcomes), other bacterial, fungal, viral, protozoal and, parasitic infections; reactivation of latent infections, (including viral hepatitis, tuberculosis), Pneumocystis jiroveci , herpes zoster, Strongyloides , sepsis and septic shock.
Investigations: blood lactate dehydrogenase increased, C-reactive protein increased. Metabolism and Nutrition: hyponatremia, fluid retention, blood glucose increased, blood glucose decreased. Musculoskeletal and Connective Tissue: rhabdomyolysis, scleroderma, muscle spasms, myalgia, arthralgia.
Neoplasms: acute leukemia, myelodysplastic syndrome, lymphoma, sarcomas, renal cell carcinoma, renal pelvis cancer, bladder cancer, ureteric cancer, thyroid cancer. Nervous System: encephalopathy, convulsion, dizziness, neurotoxicity has been reported and manifested as reversible posterior leukoencephalopathy syndrome, myelopathy, peripheral neuropathy, polyneuropathy, neuralgia, dysesthesia, hypoesthesia, paresthesia, tremor, dysgeusia, hypogeusia, parosmia.
Pregnancy: premature labor. Psychiatric: confusional state. Renal and Urinary: renal failure, renal tubular disorder, renal impairment, nephropathy toxic, hemorrhagic cystitis, bladder necrosis, cystitis ulcerative, bladder contracture, hematuria, nephrogenic diabetes insipidus, atypical urinary bladder epithelial cells.
Reproductive System: infertility, ovarian failure, ovarian disorder, amenorrhea, oligomenorrhea, testicular atrophy, azoospermia, oligospermia. Respiratory: pulmonary veno-occlusive disease, acute respiratory distress syndrome, interstitial lung disease as manifested by respiratory failure (including fatal outcomes), obliterative bronchiolitis, organizing pneumonia, alveolitis allergic, pneumonitis, pulmonary hemorrhage; respiratory distress, pulmonary hypertension, pulmonary edema, pleural effusion, bronchospasm, dyspnea, hypoxia, cough, nasal congestion, nasal discomfort, oropharyngeal pain, rhinorrhea.
Skin and Subcutaneous Tissue: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, palmar-plantar erythrodysesthesia syndrome, radiation recall dermatitis, toxic skin eruption, urticaria, dermatitis, blister, pruritus, erythema, nail disorder, facial swelling, hyperhidrosis alopecia.
Tumor lysis syndrome: like other cytotoxic drugs, cyclophosphamide may induce tumor-lysis syndrome and hyperuricemia in patients with rapidly growing tumors. Vascular: pulmonary embolism, venous thrombosis, vasculitis, peripheral ischemia, hypertension, hypotension, flushing, hot flush.
5 WARNINGS AND PRECAUTIONS Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections - Severe immunosuppression may lead to serious and sometimes fatal infections. Close hematological monitoring is required. 1 ) Urinary Tract and Renal Toxicity - Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria can occur.
Urotoxicity can be fatal. Exclude or correct any urinary tract obstructions prior to treatment. 2 ) Cardiotoxicity - Myocarditis, myopericarditis, pericardial effusion, arrhythmias and congestive heart failure, which may be fatal, have been reported.
Monitor patients, especially those with risk factors for cardio toxicity or pre-existing cardiac disease. 3 ) Pulmonary Toxicity - Pneumonitis, pulmonary fibrosis and pulmonary veno-occlusive disease leading to respiratory failure may occur.
Monitor patients for signs and symptoms of pulmonary toxicity. 5 ) Veno-occlusive Liver Disease - Fatal outcome can occur. 6 ) Alcohol Content - The alcohol content in a dose of Cyclophosphamide Injection may affect the central nervous system.
This may include impairment of a patient's ability to drive or use machines immediately after infusion. 7 ) Embryo-Fetal Toxicity - Can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception.
1 Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections Cyclophosphamide can cause myelosuppression (leukopenia, neutropenia, thrombocytopenia and anemia), bone marrow failure, and severe immunosuppression which may lead to serious and sometimes fatal infections, including sepsis and septic shock.
1 ) ]. Antimicrobial prophylaxis may be indicated in certain cases of neutropenia at the discretion of the managing physician. In case of neutropenic fever, antibiotic therapy is indicated. Antimycotics and/or antivirals may also be indicated.
Monitoring of complete blood counts is essential during cyclophosphamide treatment so that the dose can be adjusted, if needed. Cyclophosphamide should not be administered to patients with neutrophils ≤1,500/mm 3 and platelets < 50,000/mm 3 .
Cyclophosphamide treatment may not be indicated, or should be interrupted, or the dose reduced, in patients who have or who develop a serious infection. G-CSF may be administered to reduce the risks of neutropenia complications associated with cyclophosphamide use.
Primary and secondary prophylaxis with G-CSF should be considered in all patients considered to be at increased risk for neutropenia complications. The nadirs of the reduction in leukocyte count and thrombocyte count are usually reached in weeks 1 and 2 of treatment.
Peripheral blood cell counts are expected to normalize after approximately 20 days. Bone marrow failure has been reported. Severe myelosuppression may be expected particularly in patients pretreated with and/or receiving concomitant chemotherapy and/or radiation therapy.
2 Urinary Tract and Renal Toxicity Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria have been reported with cyclophosphamide. Medical and/or surgical supportive treatment may be required to treat protracted cases of severe hemorrhagic cystitis.
Discontinue cyclophosphamide therapy in case of severe hemorrhagic cystitis. Urotoxicity (bladder ulceration, necrosis, fibrosis, contracture and secondary cancer) may require interruption of cyclophosphamide treatment or cystectomy.
Urotoxicity can be fatal. Urotoxicity can occur with short-term or long-term use of cyclophosphamide. Before starting treatment, exclude or correct any urinary tract obstructions [see Contraindications ( 4 ) ]. Urinary sediment should be checked regularly for the presence of erythrocytes and other signs of urotoxicity and/or nephrotoxicity.
Cyclophosphamide should be used with caution, if at all, in patients with active urinary tract infections. Aggressive hydration with forced diuresis and frequent bladder emptying can reduce the frequency and severity of bladder toxicity.
Mesna has been used to prevent severe bladder toxicity. 3 Cardiotoxicity Myocarditis, myopericarditis, pericardial effusion including cardiac tamponade, and congestive heart failure, which may be fatal, have been reported with cyclophosphamide therapy.
Supraventricular arrhythmias (including atrial fibrillation and flutter) and ventricular arrhythmias (including severe QT prolongation associated with ventricular tachyarrhythmia) have been reported after treatment with regimens that included cyclophosphamide.
The risk of cardiotoxicity may be increased with high doses of cyclophosphamide, in patients with advanced age, and in patients with previous radiation treatment to the cardiac region and/or previous or concomitant treatment with other cardiotoxic agents.
Particular caution is necessary in patients with risk factors for cardiotoxicity and in patients with preexisting cardiac disease. Monitor patients with risk factors for cardiotoxicity and with pre-existing cardiac disease. 4 Pulmonary Toxicity Pneumonitis, pulmonary fibrosis, pulmonary veno-occlusive disease and other forms of pulmonary toxicity leading to respiratory failure have been reported during and following treatment with cyclophosphamide.
Late onset pneumonitis (greater than 6 months after start of cyclophosphamide) appears to be associated with increased mortality. Pneumonitis may develop years after treatment with cyclophosphamide. Monitor patients for signs and symptoms of pulmonary toxicity.
1 ) ]. Secondary malignancies (urinary tract cancer, myelodysplasia, acute leukemias, lymphomas, thyroid cancer, and sarcomas) have been reported in patients treated with cyclophosphamide-containing regimens. The risk of bladder cancer may be reduced by prevention of hemorrhagic cystitis.
6 Veno-occlusive Liver Disease Veno-occlusive liver disease (VOD) including fatal outcome has been reported in patients receiving cyclophosphamide-containing regimens. A cytoreductive regimen in preparation for bone marrow transplantation that consists of cyclophosphamide in combination with whole-body irradiation, busulfan, or other agents has been identified as a major risk factor.
VOD has also been reported to develop gradually in patients receiving long-term low-dose immunosuppressive doses of cyclophosphamide. Other risk factors predisposing to the development of VOD include preexisting disturbances of hepatic function, previous radiation therapy of the abdomen, and a low performance status.
7 Alcohol Content The alcohol content in a dose of Cyclophosphamide Injection may affect the central nervous system and should be taken into account for patients in whom alcohol intake should be avoided or minimized. Consideration should be given to the alcohol content in Cyclophosphamide Injection on the ability to drive or use machines immediately after the infusion.
155 g/kg of ethanol. 625 grams of ethanol [see Description ( 11 ) ] . Other cyclophosphamide products may have a different amount of alcohol or no alcohol. 1 ) ] . Exposure to cyclophosphamide during pregnancy may cause birth defects, miscarriage, fetal growth retardation, and fetotoxic effects in the newborn.
Cyclophosphamide is teratogenic and embryo-fetal toxic in mice, rats, rabbits and monkeys. 1 ) ] . Verify the pregnancy status of females of reproductive potential prior to initiation of Cyclophosphamide Injection. Advise females of reproductive potential to use effective contraception during treatment with Cyclophosphamide Injection and for up to 1 year after completion of therapy.
3 ) ]. 9 Infertility Male and female reproductive function and fertility may be impaired in patients being treated with Cyclophosphamide Injection. Cyclophosphamide interferes with oogenesis and spermatogenesis. It may cause sterility in both sexes.
Development of sterility appears to depend on the dose of cyclophosphamide, duration of therapy, and the state of gonadal function at the time of treatment. Cyclophosphamide-induced sterility may be irreversible in some patients. 4 )].
10 Impairment of Wound Healing Cyclophosphamide may interfere with normal wound healing. 11 Hyponatremia Hyponatremia associated with increased total body water, acute water intoxication, and a syndrome resembling SIADH (syndrome of inappropriate secretion of antidiuretic hormone), which may be fatal, has been reported.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
4 CONTRAINDICATIONS Hypersensitivity Cyclophosphamide Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to cyclophosphamide, any of its metabolites, or to other components of the product.
Anaphylactic reactions including death have been reported with cyclophosphamide. Cross-sensitivity with other alkylating agents can occur. 2 ) ]. Hypersensitivity to cyclophosphamide ( 4 ) Urinary outflow obstruction ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
Drug interactions
Known interactions involving Cyclophosphamide. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 432. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL200751402 · revised May 1, 2026
- [2]Health Canada (DPD) · 02559994 · revised August 28, 2025
- [3]FDA DailyMed · 0afd2cc7-09e6-48… · revised August 7, 2025 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.