Dexrazoxane


DB00380



General information:


Withdrawn ID: DB00380
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): V03AF02
Molecular Formula: C11H16N4O4
Molweight: 268.269



Withdrawal information:


Withdrawn due to drug safety reasons:No
First approved: 1995
First withdrawn: 2010
Last withdrawn: 2010



Side-effects:

Total reported cases (submitted by medical professionals) with Dexrazoxane as primary suspect: 145


Reported final outcomes:
Hospitalization (initial or prolonged): 53
Life-Threatening condition: 30
Death: 17
Disability: 1


Reported side-effects:

Side-effect Case number
Off label use147
Bone marrow failure45
Myelosuppression24
Febrile neutropenia24
Diarrhoea16
NAUSEA15
VOMITING10
Colitis10
Pyrexia9
Hypokalaemia8
SEPSIS7
PNEUMONIA7
ASPARTATE AMINOTRANSFERASE INCREASED7
Metabolic disorder6
Disseminated intravascular coagulation6
CONDITION AGGRAVATED6
Underdose5
Pancytopenia5
MUCOSAL INFLAMMATION5
INJECTION SITE PAIN5
DYSPNOEA5
Cardiac arrest5
URINARY RETENTION4
Respiratory failure4
OEDEMA PERIPHERAL4
NEUTROPENIA4
Neuropathy peripheral4
Gastrointestinal disorder4
Ejection fraction decreased4
DRUG INEFFECTIVE4
CONSTIPATION4
CELLULITIS4
Antithrombin III decreased4
Alanine aminotransferase increased4
Adverse event4
Abdominal pain upper4
WHITE BLOOD CELL COUNT DECREASED3
Renal impairment3
Overdose3
MALAISE3
Liver disorder3
INFUSION SITE PAIN3
INFUSION SITE EXTRAVASATION3
INFUSION RELATED REACTION3
Hypotension3
Herpes zoster3
Headache3
HAEMOPTYSIS3
ERYTHEMA3
Enterocolitis3
COUGH3
BURNING SENSATION3
Vascular pain2
Urticaria2
Thrombophlebitis2
THROMBOCYTOPENIA2
SURGERY2
Skin necrosis2
Skin infection2
Septic shock2
RED BLOOD CELL COUNT DECREASED2
Rash erythematous2
Rash2
Pruritus2
Osteosarcoma2
OEDEMA2
Neutrophil count decreased2
NECROSIS2
Lymphocyte count decreased2
Leukopenia2
Insomnia2
INFUSION SITE NECROSIS2
INFECTION2
Incorrect drug administration duration2
Incorrect dose administered2
HYPOXIA2
Hypertension2
Hyperkalaemia2
HYPERGLYCAEMIA2
Hiccups2
Hepatic function abnormal2
HEPATIC ENZYME INCREASED2
HAEMATOCRIT DECREASED2
Gastrointestinal toxicity2
FATIGUE2
DRUG HYPERSENSITIVITY2
Delirium2
DEHYDRATION2
Decreased appetite2
Death2
Cardiotoxicity2
BLOOD UREA INCREASED2
BLOOD SODIUM DECREASED2
Blood fibrinogen decreased2
BLOOD CREATININE INCREASED2
Application site swelling2
Application site pain2
Application site erythema2
Anxiety2
ANAPHYLACTIC REACTION2
ANAEMIA2
Wrong technique in drug usage process1
Weight increased1
Weight decreased1
Vitreous detachment1
Vitamin K deficiency1
Visual impairment1
Visual field defect1
Vision blurred1
Varicella1
Urinary tract infection1
Urinary incontinence1
Unresponsive to stimuli1
Tumour lysis syndrome1
Trismus1
Transaminases increased1
Toxicity to various agents1
Tinnitus1
Thrombectomy1
Throat tightness1
Swelling face1
Stridor1
Streptococcal bacteraemia1
Stomatitis1
Staphylococcal sepsis1
Somnolence1
Skin irritation1
SKIN GRAFT1
Sinus bradycardia1
Sensory disturbance1
SENSATION OF PRESSURE1
Second primary malignancy1
RETINOIC ACID SYNDROME1
Respiratory distress1
Respiratory arrest1
RENAL FAILURE ACUTE1
Recurrent cancer1
Rash vesicular1
Rash pustular1
Rales1
Pulseless electrical activity1
Pulmonary embolism1
Progressive multifocal leukoencephalopathy1
Product use issue1
Product use in unapproved indication1
Product reconstitution quality issue1
Product preparation issue1
Product leakage1
Product label issue1
Product colour issue1
Proctalgia1
Prinzmetal angina1
Presyncope1
Pneumonia aspiration1
Platelet count decreased1
Peripheral swelling1
Peripheral embolism1
Periodontitis1
Panniculitis1
PANCREATIC ENZYMES INCREASED1
Palpitations1
Pain in jaw1
PAIN1
OSTEOARTHRITIS1
Oral candidiasis1
Oliguria1
NO ADVERSE EVENT1
Neutrophil count increased1
Neutropenic sepsis1
Neoplasm progression1
Necrotising fasciitis1
Nail disorder1
Myocardial infarction1
Myelodysplastic syndrome1
MUSCULOSKELETAL CHEST PAIN1
Muscular weakness1
Muscle tightness1
Muscle spasms1
Mental impairment1
Lymphoma1
LYMPHOEDEMA1
Lung disorder1
Lung adenocarcinoma1
Loss of consciousness1
Local swelling1
Left ventricular failure1
Laryngeal oedema1
Intestinal perforation1
Interstitial lung disease1
Intercepted product selection error1
Intercepted product preparation error1
INJECTION SITE ULCER1
INJECTION SITE SWELLING1
Injection site rash1
Injection site phlebitis1
Injection site oedema1
INJECTION SITE EXTRAVASATION1
INJECTION SITE ERYTHEMA1
INFUSION SITE ULCER1
INFUSION SITE SWELLING1
INFUSION SITE IRRITATION1
Infectious pleural effusion1
INDURATION1
Ileus1
Hypoprothrombinaemia1
Hypertriglyceridaemia1
Hypertransaminasaemia1
Hyperhidrosis1
Hypercholesterolaemia1
Hypercalcaemia1
Hot flush1
HODGKIN'S DISEASE1
Hidradenitis1
Hepatitis cholestatic1
Heart sounds abnormal1
Haemorrhoids1
Haemorrhage subcutaneous1
HAEMOGLOBIN DECREASED1
Haematuria1
Granulomatous pneumonitis1
GENERALISED ERYTHEMA1
Gas gangrene1
Gamma-glutamyltransferase increased1
Gait inability1
Full blood count abnormal1
Folliculitis1
Eye pain1
Eye haemorrhage1
EXTRAVASATION1
Enterococcal bacteraemia1
Encephalopathy1
Ecchymosis1
DYSPHAGIA1
DRUG TOXICITY1
Drug prescribing error1
Drug interaction1
Drug ineffective for unapproved indication1
Drug dose omission1
Dizziness1
Device related infection1
Dermatitis bullous1
Deep vein thrombosis1
Cystitis haemorrhagic1
Confusional state1
Coma1
Cold sweat1
Chest pain1
Cerebral infarction1
CATHETER SITE ERYTHEMA1
CATHETER SITE CELLULITIS1
CAPILLARY LEAK SYNDROME1
Cancer pain1
BURSITIS1
Burkitt's lymphoma1
Bronchospasm1
Bronchitis1
Breast cellulitis1
Breast cancer1
Bradycardia1
Bone marrow disorder1
Blood potassium decreased1
BLOOD GLUCOSE INCREASED1
Blood chloride decreased1
Blood beta-D-glucan increased1
Blood alkaline phosphatase increased1
BLISTER1
Bladder spasm1
Basophil count increased1
Bacterial sepsis1
Bacteraemia1
Back pain1
Atypical teratoid/rhabdoid tumour of CNS1
ARTHRALGIA1
Angioedema1
Altered state of consciousness1
Acute myelomonocytic leukaemia1
Acute kidney injury1
Acne1
Acarodermatitis1





Toxicity information:

Toxicity class: 4
Toxicity type: N/A
LD50: 1750 mg/kg



External links:

ChEBML: CHEMBL1738
DrugBank: DB00380