trabectedin


EMA47



General information:


Withdrawn ID: EMA47
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): L01CX01
Molecular Formula: C39H43N3O11S
Molweight: 761.837



Withdrawal information:


Withdrawn due to drug safety reasons:No



Side-effects:

Total reported cases (submitted by medical professionals) with trabectedin as primary suspect: 703


Reported final outcomes:
Hospitalization (initial or prolonged): 477
Death: 169
Life-Threatening condition: 78
Disability: 20


Reported side-effects:

Side-effect Case number
NEUTROPENIA102
ANAEMIA93
FEBRILE NEUTROPENIA87
THROMBOCYTOPENIA86
PANCYTOPENIA81
RHABDOMYOLYSIS79
ALANINE AMINOTRANSFERASE INCREASED79
ASPARTATE AMINOTRANSFERASE INCREASED74
NAUSEA66
PYREXIA64
NEUTROPHIL COUNT DECREASED56
Platelet count decreased54
Acute kidney injury52
White blood cell count decreased50
VOMITING49
LEUKOPENIA45
FATIGUE41
BLOOD CREATINE PHOSPHOKINASE INCREASED39
SEPSIS37
HEPATIC FUNCTION ABNORMAL35
ASTHENIA35
Pneumonia33
Off label use32
Death30
BLOOD ALKALINE PHOSPHATASE INCREASED30
DIARRHOEA28
TRANSAMINASES INCREASED27
HEPATOTOXICITY25
GAMMA-GLUTAMYLTRANSFERASE INCREASED25
Dyspnoea24
Blood bilirubin increased24
DECREASED APPETITE23
ABDOMINAL PAIN23
Renal failure22
BONE MARROW FAILURE22
Device related infection20
CARDIAC FAILURE20
Malaise19
EXTRAVASATION19
Myalgia16
HYPOALBUMINAEMIA16
Haemoglobin decreased16
HAEMATOTOXICITY16
CONSTIPATION15
URINARY TRACT INFECTION14
Septic shock14
Renal impairment14
Pneumonitis14
Hypokalaemia14
ATRIAL FIBRILLATION14
Underdose13
RESPIRATORY FAILURE13
INTERSTITIAL LUNG DISEASE13
Infusion site extravasation13
BLOOD CREATININE INCREASED13
Pleural effusion12
Hepatocellular injury12
Ejection fraction decreased12
Stomatitis11
PULMONARY EMBOLISM11
Oedema peripheral11
Multiple organ dysfunction syndrome11
Infection11
HEPATIC ENZYME INCREASED11
Blood albumin decreased11
Drug dose omission10
DEHYDRATION10
CARDIAC ARREST10
Ascites10
Product use issue9
NEUTROPENIC SEPSIS9
Mucosal inflammation9
Hepatic failure9
Capillary leak syndrome9
Liver disorder8
Intestinal obstruction8
HYPOTENSION8
Hyponatraemia8
Hypertransaminasaemia8
Cough8
Catheter site related reaction8
CARDIAC FAILURE CONGESTIVE8
Acute myeloid leukaemia8
Wrong technique in product usage process7
Pulmonary oedema7
Product use in unapproved indication7
Pain7
Myelosuppression7
Hypertension7
General physical health deterioration7
Febrile bone marrow aplasia7
Disease progression7
Device malfunction7
APLASIA7
Adverse event7
Toxicity to various agents6
RASH6
Myocardial infarction6
HYPERKALAEMIA6
Hepatitis6
Hepatic cytolysis6
Cholestasis6
Cellulitis6
Catheter site erythema6
Acute pulmonary oedema6
Subileus5
RENAL FAILURE ACUTE5
Palmar-plantar erythrodysaesthesia syndrome5
Oedema5
Muscular weakness5
Lung infection5
Liver injury5
Liver function test increased5
Liver function test abnormal5
Leiomyosarcoma5
GASTROINTESTINAL HAEMORRHAGE5
Erythema5
Drug-induced liver injury5
DRUG INTERACTION5
Disseminated intravascular coagulation5
Cardiomyopathy5
ACUTE RESPIRATORY DISTRESS SYNDROME5
Abdominal pain upper5
Weight increased4
Weight decreased4
Tumour lysis syndrome4
Troponin increased4
Renal tubular necrosis4
Product preparation error4
Pneumocystis jirovecii pneumonia4
NEUROPATHY PERIPHERAL4
Myocarditis4
Myelodysplastic syndrome4
Lymphocyte count decreased4
Lung disorder4
Ileus4
HYPOXIA4
Hyperuricaemia4
Electrocardiogram QT prolonged4
Device infusion issue4
Deep vein thrombosis4
Chest pain4
Catheter site pain4
Bone marrow toxicity4
Bacteraemia4
ACUTE MYOCARDIAL INFARCTION4
Venous thrombosis3
Vascular device infection3
Uterine leiomyosarcoma3
Syncope3
Supraventricular tachycardia3
Somnolence3
Soft tissue sarcoma3
Shock3
Product quality issue3
Oesophagitis3
Medical device site fibrosis3
Liposarcoma3
Insomnia3
Infusion site necrosis3
Incorrect dose administered3
Inappropriate schedule of product administration3
Hypophosphataemia3
Hypocalcaemia3
Hyperbilirubinaemia3
Hospitalisation3
Headache3
Escherichia infection3
Enteritis3
Device related thrombosis3
Device occlusion3
Cytopenia3
Complication associated with device3
Cholecystitis acute3
Catheter site inflammation3
Cardiac disorder3
CARBOHYDRATE ANTIGEN 125 INCREASED3
Blood sodium decreased3
Azotaemia3
Arrhythmia3
Administration site extravasation3
Abdominal discomfort3
Vertigo2
URINARY RETENTION2
Tumour haemorrhage2
Thrombosis in device2
Thrombosis2
Synovial sarcoma metastatic2
Swelling2
Suicide attempt2
Small intestinal obstruction2
Skin necrosis2
Seizure2
Respiratory disorder2
Renal disorder2
Red blood cell count decreased2
Rectal haemorrhage2
Pruritus2
Product substitution issue2
Product dose omission2
Pneumothorax2
Pneumonia legionella2
Pneumonia aspiration2
Pharyngitis2
Pericardial effusion2
Paraesthesia2
Pancreatitis2
OVARIAN CANCER METASTATIC2
Oliguria2
Neuromuscular toxicity2
Nervous system disorder2
Neoplasm progression2
Mood altered2
Mixed liver injury2
Medication error2
Lymphopenia2
Lipase increased2
Left ventricular dysfunction2
Jugular vein thrombosis2
Injection site erythema2
Infusion site reaction2
Infusion related reaction2
INFLUENZA LIKE ILLNESS2
Influenza2
Incorrect drug administration rate2
Incorrect drug administration duration2
Implant site ulcer2
Implant site extravasation2
Ileus paralytic2
Hypomagnesaemia2
Hypersensitivity2
Hyperpyrexia2
HYPERGLYCAEMIA2
Herpes zoster2
Hepatobiliary disease2
Hepatitis acute2
Hepatic enzyme abnormal2
Hepatic cirrhosis2
Heart rate increased2
Haemorrhage2
Haemoptysis2
Haematuria2
Generalised oedema2
Gastrointestinal toxicity2
Face oedema2
Escherichia sepsis2
Epistaxis2
Embolism2
Dyspepsia2
Dry skin2
Drug delivery system malfunction2
Device leakage2
Device issue2
Delirium2
Congestive cardiomyopathy2
Confusional state2
Colitis ischaemic2
Clostridium difficile infection2
CHEST DISCOMFORT2
Cerebrovascular accident2
Cardiovascular disorder2
Cardiotoxicity2
Cardiogenic shock2
Cardiac failure acute2
Blood potassium increased2
Blood creatinine abnormal2
BLOOD BILIRUBIN ABNORMAL2
BLOOD ALKALINE PHOSPHATASE ABNORMAL2
Back pain2
Atrial flutter2
ANXIETY2
Angiosarcoma metastatic2
Altered state of consciousness2
ALANINE AMINOTRANSFERASE ABNORMAL2
Acute respiratory failure2
Acute leukaemia2
Acute coronary syndrome2
Wrong technique in device usage process1
Wound infection staphylococcal1
White blood cell count increased1
White blood cell count1
Visual impairment1
Visual acuity reduced1
Ventricular tachycardia1
Ventricular hypokinesia1
Venous thrombosis limb1
Vasculitis1
Urosepsis1
Urogenital disorder1
Urine output decreased1
Urinary tract obstruction1
Urinary tract disorder1
Urinary sediment abnormal1
Upper respiratory tract infection1
Upper gastrointestinal haemorrhage1
Unresponsive to stimuli1
Tumour compression1
Tremor1
Treatment failure1
Traumatic liver injury1
Transient ischaemic attack1
Toxic skin eruption1
Torsade de pointes1
Tissue injury1
Thrombophlebitis migrans1
Thrombophlebitis1
Throat tightness1
Thermal burn1
Therapy interrupted1
Therapy change1
Therapeutic response decreased1
Tachypnoea1
Tachycardia1
SYNCOPE VASOVAGAL1
Swelling face1
Supraventricular extrasystoles1
Superior vena cava syndrome1
Sudden death1
Stress cardiomyopathy1
Streptococcus test positive1
Streptococcal bacteraemia1
Staphylococcal sepsis1
Staphylococcal osteomyelitis1
Sputum increased1
Spinal compression fracture1
Small intestinal haemorrhage1
Sleep disorder1
Skin ulcer1
Skin lesion1
Skin exfoliation1
Skin disorder1
Sinus tachycardia1
Sinus node dysfunction1
Sinus disorder1
Sinus bradycardia1
Sinus arrest1
SHOCK HAEMORRHAGIC1
Second primary malignancy1
Scoliosis1
SCIATICA1
Scar1
Sarcoma1
Retinopathy1
Retinal detachment1
Retching1
Respiratory tract infection viral1
Respiratory tract infection1
Respiratory distress1
Renal injury1
Rash maculo-papular1
Rash generalised1
Radiation oesophagitis1
Pyelonephritis1
Putamen haemorrhage1
Pulmonary mass1
Pulmonary hypertension1
Pulmonary haemorrhage1
Pulmonary congestion1
Psoriasis1
Pseudomonal sepsis1
Pseudoaldosteronism1
PROTHROMBIN TIME PROLONGED1
Protein total decreased1
Prostate infection1
Product quality control issue1
Product packaging issue1
Product label issue1
Procalcitonin increased1
Presyncope1
Post procedural haemorrhage1
Polyneuropathy1
Pneumocystis jirovecii infection1
Pleural thickening1
PHLEBITIS1
Phaeochromocytoma1
Persistent depressive disorder1
Peroneal nerve palsy1
Peripheral sensory neuropathy1
PERIPHERAL ISCHAEMIA1
Pancreatitis acute1
PALPITATIONS1
Overdose1
Ovarian cancer recurrent1
OVARIAN CANCER1
Otitis media1
ORAL PAIN1
Oral candidiasis1
Oesophageal infection1
Occupational exposure to product1
Non-cardiac chest pain1
Nodal arrhythmia1
Neutrophilic dermatosis1
Neurotoxicity1
Nephropathy toxic1
Needle issue1
Necrotising fasciitis1
Necrosis1
Nasal herpes1
Myocardial necrosis marker increased1
Musculoskeletal pain1
Musculoskeletal disorder1
Muscle spasms1
Muscle fatigue1
Multi-organ failure1
Mucous membrane disorder1
Metastases to lung1
Metastases to liver1
Metabolic disorder1
Metabolic acidosis1
Medical device site thrombosis1
Mass1
Malignant neoplasm progression1
Macrocytosis1
Lymphatic disorder1
Lymphangiosis carcinomatosa1
Lymphangioleiomyomatosis1
Lung opacity1
Lower respiratory tract infection1
Lower gastrointestinal haemorrhage1
Loss of consciousness1
Liver abscess1
Liquid product physical issue1
Leukocytosis1
Leiomyosarcoma metastatic1
Large intestine perforation1
Large intestinal haemorrhage1
Laboratory test abnormal1
Kidney infection1
Jaundice1
Ischaemic stroke1
Intestinal pseudo-obstruction1
Intestinal perforation1
Intestinal haemorrhage1
Intercepted medication error1
Intentional product use issue1
Injection site thrombosis1
Injection site swelling1
Injection site paraesthesia1
Injection site pain1
Injection site necrosis1
Injection site mass1
Injection site extravasation1
Infusion site pain1
Infusion site irritation1
Infusion site infection1
Infusion site haemorrhage1
Infusion site erythema1
Infertility1
Infected neoplasm1
Infected lymphocele1
Incorrect product storage1
Implant site thrombosis1
Implant site necrosis1
Implant site inflammation1
Implant site infection1
Implant site erythema1
Impaired gastric emptying1
Hypothyroidism1
Hypoproteinaemia1
Hyperventilation1
Hyperthyroidism1
Hypertensive crisis1
Hyperphosphatasaemia1
Hypernatraemia1
Hyperhidrosis1
Hypercreatinaemia1
Hypercalcaemia1
HYDROTHORAX1
Hydronephrosis1
Hot flush1
Hirsutism1
Hip fracture1
Herpes ophthalmic1
Hepatorenal failure1
HEPATITIS TOXIC1
Hepatitis cholestatic1
Hepatic lesion1
Hepatic infection1
Haemorrhoids1
Haemorrhage intracranial1
Haemoglobinaemia1
Haematemesis1
Gingivitis1
Gingival pain1
General physical condition abnormal1
Gastrooesophageal reflux disease1
Gastrointestinal perforation1
Gastrointestinal pain1
Gastrointestinal obstruction1
Gastrointestinal necrosis1
Gastrointestinal disorder1
Gastroenteritis1
Gastritis1
Gastric haemorrhage1
Gamma-glutamyltransferase1
Furuncle1
Fungaemia1
Full blood count decreased1
Fracture1
Food intolerance1
Folliculitis1
Flushing1
Fluid retention1
Flatulence1
Fistula of small intestine1
Femoral neck fracture1
Feeling hot1
Fall1
Failure to thrive1
Facial paresis1
Fabry's disease1
Eye disorder1
Extra-osseous Ewing's sarcoma1
Expired product administered1
Erythema multiforme1
Enterobacter bacteraemia1
Endocrine disorder1
Encephalopathy1
Embolism arterial1
Embolic stroke1
ELECTROMECHANICAL DISSOCIATION1
ELECTROCARDIOGRAM CHANGE1
Ejection fraction1
Dyspnoea exertional1
Dysphonia1
Dysphagia1
Dysgeusia1
Dysarthria1
Duodenal ulcer haemorrhage1
Duodenal ulcer1
DRUG TOXICITY1
Drug intolerance1
Drug ineffective1
Drug hypersensitivity1
Drug effect decreased1
Drug administration error1
Drug administered to patient of inappropriate age1
DRUG ADMINISTERED AT INAPPROPRIATE SITE1
Dizziness1
Dilated cardiomyopathy1
Dialysis1
Diabetes mellitus1
Device use issue1
Device dislocation1
Device breakage1
Dermatitis bullous1
Dermatitis1
Depression1
Depressed mood1
Cytokine release syndrome1
Cranial nerve paralysis1
Contraindication to medical treatment1
Condition aggravated1
Colour blindness1
Colon cancer1
Colon adenoma1
COLITIS1
COGNITIVE DISORDER1
Coagulopathy1
Clostridium difficile colitis1
Clostridial sepsis1
Circulatory collapse1
Chronic kidney disease1
Cholecystitis1
Cholangitis1
Chills1
Childhood1
Cerebral infarction1
Catheter site swelling1
Catheter site pruritus1
Catheter site discharge1
Catheter site cellulitis1
Carotid artery perforation1
Cardiovascular insufficiency1
Cardiopulmonary failure1
Cardiac pacemaker insertion1
Capillary permeability increased1
Cancer fatigue1
Calculus ureteric1
Cachexia1
Burning sensation1
Bronchostenosis1
Bradycardia1
Body temperature increased1
Blood uric acid increased1
Blood thyroid stimulating hormone increased1
Blood thyroid stimulating hormone decreased1
Blood product transfusion dependent1
Blood pressure systolic increased1
Blood pressure increased1
Blood lactate dehydrogenase increased1
Blood glucose increased1
Blood electrolytes decreased1
Blood disorder1
Blood creatine phosphokinase MB increased1
Blood creatine phosphokinase1
Blood creatine abnormal1
Blood calcium decreased1
Blood alkaline phosphatase1
Blood albumin increased1
Blood acid phosphatase increased1
Blister1
Bile duct stenosis1
Bicytopenia1
Auditory disorder1
Aspartate aminotransferase abnormal1
Aspartate aminotransferase1
Arthralgia1
Arteritis1
ARTERIAL THROMBOSIS LIMB1
Application site induration1
Aplastic anaemia1
Angiosarcoma1
Angiopathy1
Angina pectoris1
Anal incontinence1
Anaemia of malignant disease1
Amylase increased1
Alveolar rhabdomyosarcoma1
Alopecia1
Alanine aminotransferase1
Akinaesthesia1
Agitation1
Adverse drug reaction1
Adolescence1
Administration site inflammation1
Acute hepatic failure1
Acinetobacter infection1
Accidental overdose1
Accidental exposure to product1
Accident at home1
Abdominal pain lower1
Abdominal mass1
Abdominal infection1





Toxicity information:

Toxicity type: N/A



External links:

ChEBML: CHEMBL450449
DrugBank: DB05109