romidepsin


EMA37



General information:


Withdrawn ID: EMA37
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): L01XX39
Molecular Formula: C24H36N4O6S2
Molweight: 540.696



Withdrawal information:


Withdrawn due to drug safety reasons:No



Side-effects:

Total reported cases (submitted by medical professionals) with romidepsin as primary suspect: 728


Reported final outcomes:
Hospitalization (initial or prolonged): 309
Death: 272
Life-Threatening condition: 55
Disability: 13
Intervention required to prevent permanent impairment/damage: 1


Reported side-effects:

Side-effect Case number
PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED112
DEATH88
NAUSEA85
THROMBOCYTOPENIA83
PYREXIA71
PLATELET COUNT DECREASED68
VOMITING55
ANAEMIA52
FATIGUE47
DECREASED APPETITE43
NEUTROPENIA41
ATRIAL FIBRILLATION39
Angioimmunoblastic T-cell lymphoma37
DIARRHOEA30
WHITE BLOOD CELL COUNT DECREASED26
PNEUMONIA26
NEUTROPHIL COUNT DECREASED24
ELECTROCARDIOGRAM QT PROLONGED24
ASTHENIA23
FEBRILE NEUTROPENIA22
TUMOUR LYSIS SYNDROME21
Malaise21
DISEASE PROGRESSION21
RASH19
Product storage error19
HYPOTENSION18
HEADACHE18
SEPSIS16
Pancytopenia16
MALIGNANT NEOPLASM PROGRESSION15
GENERAL PHYSICAL HEALTH DETERIORATION15
CHILLS15
RESPIRATORY FAILURE14
Liver disorder14
INFECTION13
DYSPNOEA13
CONSTIPATION13
Acute kidney injury13
T-CELL LYMPHOMA12
PAIN12
MYCOSIS FUNGOIDES12
Lymphocyte count decreased12
LEUKOPENIA12
FALL12
DEHYDRATION12
PLEURAL EFFUSION11
HYPONATRAEMIA11
DYSGEUSIA11
Bone marrow failure11
WEIGHT DECREASED10
SEPTIC SHOCK10
NEUROPATHY PERIPHERAL10
Hepatic failure10
DRUG INEFFECTIVE10
Taste disorder9
Stomatitis9
MUSCULAR WEAKNESS9
LYMPHOPENIA9
Lymphoma9
HAEMATOTOXICITY9
Epistaxis9
BLOOD LACTATE DEHYDROGENASE INCREASED9
ASPARTATE AMINOTRANSFERASE INCREASED9
HYPOKALAEMIA8
GASTROINTESTINAL HAEMORRHAGE8
Erythema8
EPSTEIN-BARR VIRUS INFECTION8
DISSEMINATED INTRAVASCULAR COAGULATION8
CYTOMEGALOVIRUS INFECTION8
Cutaneous T-cell lymphoma8
Cellulitis8
Anaplastic large-cell lymphoma8
TACHYCARDIA7
PULMONARY EMBOLISM7
PRURITUS7
Myelosuppression7
MUCOSAL INFLAMMATION7
INFUSION SITE EXTRAVASATION7
HOT FLUSH7
Hepatic function abnormal7
DYSPEPSIA7
DIZZINESS7
COUGH7
CARDIAC FAILURE CONGESTIVE7
Cardiac failure7
BLOOD CREATININE INCREASED7
ARTHRALGIA7
ALANINE AMINOTRANSFERASE INCREASED7
Urinary tract infection6
SKIN EXFOLIATION6
MYOCARDIAL INFARCTION6
MENTAL STATUS CHANGES6
INTERSTITIAL LUNG DISEASE6
HYPOCALCAEMIA6
HYPOALBUMINAEMIA6
HYPERGLYCAEMIA6
HAEMOGLOBIN DECREASED6
GASTROINTESTINAL DISORDER6
Febrile bone marrow aplasia6
EXTRAVASATION6
DEEP VEIN THROMBOSIS6
Cytomegalovirus viraemia6
Cytomegalovirus infection reactivation6
CARDIOTOXICITY6
C-reactive protein increased6
Amenorrhoea6
Acute myeloid leukaemia6
Toxicity to various agents5
PERIPHERAL SENSORY NEUROPATHY5
Palpitations5
Oxygen saturation decreased5
Oedema5
Myelodysplastic syndrome5
Melaena5
HYPOMAGNESAEMIA5
Electrocardiogram abnormal5
Cytopenia5
CONFUSIONAL STATE5
Clostridium difficile colitis5
ARRHYTHMIA5
Adverse event5
Wound infection4
VENTRICULAR TACHYCARDIA4
Syncope4
RENAL FAILURE ACUTE4
PAIN IN EXTREMITY4
Muscle spasms4
Multiple organ dysfunction syndrome4
Lymphadenopathy4
Leukocytosis4
INJECTION SITE EXTRAVASATION4
HYPOPHOSPHATAEMIA4
Hypertension4
HYPERKALAEMIA4
HYPERCALCAEMIA4
Graft versus host disease4
Gastrooesophageal reflux disease4
Gamma-glutamyltransferase increased4
Full blood count decreased4
Fracture4
Epstein-Barr virus infection reactivation4
Encephalopathy4
DRY SKIN4
DRUG INTOLERANCE4
COVID-194
Cardiomyopathy4
Cardio-respiratory arrest4
CARDIAC TAMPONADE4
BLOOD ALKALINE PHOSPHATASE INCREASED4
ALOPECIA4
Acute pulmonary oedema4
ABDOMINAL PAIN4
White blood cell count increased3
VISION BLURRED3
Urticaria3
TROPONIN I INCREASED3
TRANSAMINASES INCREASED3
Therapy non-responder3
Therapeutic response decreased3
SUDDEN DEATH3
STEVENS-JOHNSON SYNDROME3
Staphylococcal sepsis3
Splenomegaly3
Soft tissue infection3
Skin ulcer3
Sinus tachycardia3
Seizure3
Retinal detachment3
Renal failure3
Red blood cell count decreased3
Pyoderma gangrenosum3
PULMONARY OEDEMA3
PNEUMONITIS3
Pneumonia klebsiella3
Pneumonia aspiration3
Platelet count abnormal3
Plasma cell myeloma3
Parosmia3
Oral candidiasis3
Non-Hodgkin's lymphoma3
Myalgia3
MULTI-ORGAN FAILURE3
Mitral valve incompetence3
LUNG INFILTRATION3
Lung disorder3
LABORATORY TEST ABNORMAL3
INJECTION SITE REACTION3
Influenza like illness3
Hypersensitivity3
HODGKIN'S DISEASE3
Herpes zoster3
Haemorrhage intracranial3
HAEMOLYTIC ANAEMIA3
Haemoglobin abnormal3
Graft versus host disease in skin3
Graft versus host disease in gastrointestinal tract3
Gastrointestinal sounds abnormal3
Femur fracture3
Escherichia sepsis3
Electrolyte imbalance3
Diffuse large B-cell lymphoma3
Cytomegalovirus chorioretinitis3
Cytokine release syndrome3
CYSTITIS HAEMORRHAGIC3
Chronic lymphocytic leukaemia3
Chronic graft versus host disease3
CHEST PAIN3
Cerebrovascular accident3
CEREBRAL HAEMORRHAGE3
CARDIAC DISORDER3
Bundle branch block left3
Bradycardia3
BLOOD BILIRUBIN INCREASED3
Bacteraemia3
Back pain3
ATRIAL FLUTTER3
Acute respiratory failure3
Acute respiratory distress syndrome3
Acute myocardial infarction3
Acute coronary syndrome3
Urinary retention2
Upper respiratory tract infection2
Upper gastrointestinal haemorrhage2
UNEVALUABLE EVENT2
Ulcer2
Tumour associated fever2
Transient ischaemic attack2
Therapeutic response unexpected2
Systemic inflammatory response syndrome2
Subcutaneous abscess2
STAPHYLOCOCCAL INFECTION2
SQUAMOUS CELL CARCINOMA OF SKIN2
Splenic infarction2
SMALL INTESTINAL OBSTRUCTION2
Skin irritation2
Skin burning sensation2
Sinus bradycardia2
Scleral haemorrhage2
Restlessness2
RESPIRATORY TRACT OEDEMA2
RESPIRATORY DISTRESS2
Rash maculo-papular2
Rash generalised2
Pulmonary nocardiosis2
Prostate cancer2
Product preparation issue2
Product preparation error2
Product label confusion2
PHOTOSENSITIVITY REACTION2
Peripheral T-cell lymphoma unspecified stage IV2
Peripheral T-cell lymphoma unspecified refractory2
Pericardial effusion2
Paraesthesia2
Pancreatitis2
Orthostatic hypotension2
ORGANISING PNEUMONIA2
Oesophagitis2
OEDEMA PERIPHERAL2
NON-HODGKIN'S LYMPHOMA RECURRENT2
NEOPLASM PROGRESSION2
Myocarditis2
MYCOSIS FUNGOIDES STAGE IV2
Mycosis fungoides recurrent2
Mouth ulceration2
Mouth haemorrhage2
Metastases to central nervous system2
Metabolic acidosis2
Malignant pleural effusion2
Lymphocytosis2
Lymphocytic leukaemia2
Lung infection2
Loss of consciousness2
Liver function test increased2
Liver function test abnormal2
LETHARGY2
Klebsiella infection2
Invasive ductal breast carcinoma2
International normalised ratio increased2
Intentional overdose2
Influenza2
Inflammation2
Hypoaesthesia2
HYPERURICAEMIA2
Hyperhidrosis2
Hepatocellular injury2
HEPATITIS B2
Hepatic mass2
Hepatic enzyme increased2
Hepatic cirrhosis2
Haemorrhage2
Haemophagocytic lymphohistiocytosis2
Haematochezia2
Glomerular filtration rate decreased2
Gingival bleeding2
Fungal infection2
FLATULENCE2
Feeling hot2
Feeling abnormal2
Facial paralysis2
Eye irritation2
Endocarditis2
ELECTROCARDIOGRAM T WAVE INVERSION2
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION2
Ejection fraction decreased2
Dyspnoea exertional2
DRY MOUTH2
Depression2
Delirium2
Deafness2
Conjunctivitis2
Conjunctival haemorrhage2
CONGESTIVE CARDIOMYOPATHY2
Condition aggravated2
Coma2
Cholecystitis2
Chest discomfort2
Cardiopulmonary failure2
Cardiac failure acute2
Cancer in remission2
Campylobacter infection2
Body temperature decreased2
Blood urine present2
BLOOD UREA INCREASED2
Blood test abnormal2
Blood pressure systolic decreased2
Blood pressure diastolic decreased2
Blood pressure decreased2
Blood magnesium decreased2
Blood magnesium abnormal2
Blood glucose increased2
Atrioventricular block complete2
ATRIOVENTRICULAR BLOCK2
Ascites2
Anxiety2
Ageusia2
Adult T-cell lymphoma/leukaemia2
Acute graft versus host disease in skin2
Acute graft versus host disease2
Abscess2
Wolff-Parkinson-White syndrome1
Vocal cord thickening1
Visual impairment1
Viral load increased1
Viraemia1
VENTRICULAR ARRHYTHMIA1
Venoocclusive liver disease1
Vasogenic cerebral oedema1
Vascular device infection1
Varicella zoster virus infection1
VAGINAL HAEMORRHAGE1
Urosepsis1
Urine output decreased1
Urinary tract infection pseudomonal1
Upper limb fracture1
Underdose1
Tumour invasion1
Tumour flare1
Tubulointerstitial nephritis1
TROPONIN INCREASED1
Tremor1
TREATMENT NONCOMPLIANCE1
Transplantation complication1
Transplant failure1
Tongue oedema1
Tinea infection1
THROMBOSIS1
Throat tightness1
Therapy change1
Therapeutic product effect incomplete1
TENDON DISORDER1
T-cell prolymphocytic leukaemia1
T-cell lymphoma recurrent1
Systemic candida1
SWOLLEN TONGUE1
Swelling face1
Swelling1
Subileus1
Staphylococcal skin infection1
STAPHYLOCOCCAL ABSCESS1
Squamous cell carcinoma1
Skin toxicity1
Skin lesion1
Skin infection1
Skin fissures1
Skin discolouration1
Sinusitis1
Sinus headache1
Sinus arrest1
Rhinitis allergic1
Retinitis1
Respiratory arrest1
Renal tubular necrosis1
Renal disorder1
Refractory cytopenia with multilineage dysplasia1
Rectal polyp1
Rectal haemorrhage1
Rash pruritic1
Rash macular1
RASH ERYTHEMATOUS1
Radiation skin injury1
Radiation necrosis1
Quadriparesis1
Pupils unequal1
Pulmonary sepsis1
Pulmonary hypertension1
PULMONARY EOSINOPHILIA1
Pulmonary alveolar haemorrhage1
Pseudomonal sepsis1
PROTHROMBIN TIME PROLONGED1
Protein total decreased1
Product packaging quantity issue1
Product label issue1
PRODUCT CONTAMINATION MICROBIAL1
Procedural complication1
Premature menopause1
Pregnancy of partner1
Posterior reversible encephalopathy syndrome1
Post transplant lymphoproliferative disorder1
Portal vein thrombosis1
Polyneuropathy1
Pneumonia pneumococcal1
Pleuropericarditis1
Platelet disorder1
Plasmablastic lymphoma1
Photophobia1
Pharyngitis1
PETECHIAE1
Peritonitis bacterial1
Peripheral swelling1
Peripheral sensorimotor neuropathy1
Peripheral motor neuropathy1
Periorbital oedema1
Pericarditis1
PERIARTHRITIS1
Performance status decreased1
Pelvi-ureteric obstruction1
PAROTITIS1
PAROTID GLAND ENLARGEMENT1
Pancreatitis acute1
Palmar-plantar erythrodysaesthesia syndrome1
Overdose1
Ovarian cancer1
Otitis media acute1
Otitis externa1
Oropharyngeal pain1
Oropharyngeal candidiasis1
Oral mucosal blistering1
Oral herpes1
Oral dysaesthesia1
Off label use1
Oesophagitis haemorrhagic1
Oesophageal infection1
Oesophageal candidiasis1
Obstructive airways disorder1
Non-small cell lung cancer1
Non-cardiac chest pain1
NODULE1
NO THERAPEUTIC RESPONSE1
NIGHT SWEATS1
Neutrophilic dermatosis1
Neutrophil count abnormal1
Neutropenic sepsis1
NEUTROPENIC INFECTION1
Neuralgia1
Nervous system disorder1
Nephrotic syndrome1
Nephropathy toxic1
Neoplasm malignant1
Neck pain1
Nasopharyngitis1
Nasal congestion1
Myocardial necrosis marker increased1
Mycosis fungoides refractory1
MUSCULOSKELETAL DISORDER1
Muscle haemorrhage1
MULTIPLE MYELOMA1
Mucosal haemorrhage1
Motor dysfunction1
Monoparesis1
Microangiopathic haemolytic anaemia1
Metapneumovirus infection1
Mental disorder1
Meningoencephalitis herpetic1
Memory impairment1
Meibomianitis1
Mallory-Weiss syndrome1
LYMPHOPROLIFERATIVE DISORDER1
Lung adenocarcinoma1
Lung abscess1
Lower gastrointestinal haemorrhage1
Liver injury1
Lip swelling1
LICHENOID KERATOSIS1
Leukaemia1
Left ventricular dysfunction1
Laryngitis1
Large intestine infection1
Klebsiella sepsis1
Klebsiella bacteraemia1
JUGULAR VEIN THROMBOSIS1
JOINT SWELLING1
Intracranial haematoma1
INTRACARDIAC THROMBUS1
Intra-abdominal haemorrhage1
Intestinal perforation1
INTESTINAL OBSTRUCTION1
Interleukin-2 receptor increased1
INSOMNIA1
Injection site pruritus1
Injection site hypersensitivity1
Injection site erythema1
Infusion site vesicles1
Infusion site ulcer1
Infusion site pruritus1
Infusion site oedema1
Infusion site cellulitis1
Infusion related reaction1
Infective aortitis1
Incorrect drug administration duration1
IMMUNOSUPPRESSION1
Hypozincaemia1
Hypoxic-ischaemic encephalopathy1
Hypoxia1
HYPOPHAGIA1
HYPOGLYCAEMIA1
Hypogeusia1
Hypoacusis1
Hypertriglyceridaemia1
Hypernatraemia1
HYPERMAGNESAEMIA1
Histiocytosis haematophagic1
Hip fracture1
Hiccups1
Herpes zoster reactivation1
Herpes virus infection1
Hepatotoxicity1
HEMICEPHALALGIA1
Heart rate increased1
Heart rate decreased1
HAEMODYNAMIC INSTABILITY1
Haematuria1
Haematology test abnormal1
Haemangioma1
H1N1 influenza1
GRANULOCYTOPENIA1
GRANULOCYTE COUNT DECREASED1
Graft versus host disease in liver1
Glomerulonephritis proliferative1
Glomerulonephritis acute1
Gastrointestinal toxicity1
Gastrointestinal pain1
Gastritis1
Gastric haemorrhage1
GAIT DISTURBANCE1
Fibrin D dimer increased1
Feeling cold1
Faecaloma1
Face oedema1
Eyelid ptosis1
Eye swelling1
Eye movement disorder1
Eye haemorrhage1
Escherichia bacteraemia1
ERYTHEMA MULTIFORME1
Epstein-Barr virus test positive1
Epstein-Barr virus associated lymphoproliferative disorder1
Epstein Barr virus positive mucocutaneous ulcer1
Eosinophilia1
Enteropathy-associated T-cell lymphoma1
Enterococcal infection1
Enterococcal bacteraemia1
Enteritis1
Endocarditis bacterial1
Encephalitis autoimmune1
Encephalitis1
Embolism1
ELECTROCARDIOGRAM T WAVE ABNORMAL1
Electrocardiogram QT interval abnormal1
Electrocardiogram change1
Ear pain1
Ear haemorrhage1
Dysphagia1
Dry eye1
Drug resistance1
Drug eruption1
Drug dose omission1
Disseminated cytomegaloviral infection1
Diabetic hyperosmolar coma1
Device related infection1
Device related bacteraemia1
DEVICE OCCLUSION1
Dermatomyositis1
Dermatitis exfoliative1
Dermatitis allergic1
Dermatitis acneiform1
Depressed mood1
Cytokine storm1
Coronary artery stenosis1
Convulsion1
Contusion1
Colitis ischaemic1
Colitis1
Cognitive disorder1
Clostridium difficile sepsis1
Clostridium difficile infection1
Clostridium colitis1
Chronic myelomonocytic leukaemia1
Cholestasis1
Cholelithiasis1
Cholecystitis acute1
Chalazion1
CEREBRAL TOXOPLASMOSIS1
Cerebral infarction1
Cerebral disorder1
CENTRAL NERVOUS SYSTEM LYMPHOMA1
Cell death1
Cardiogenic shock1
Cardiac dysfunction1
Cardiac death1
Cardiac arrest1
Bronchospasm1
Bronchopulmonary aspergillosis1
Bronchopneumonia1
Bronchitis1
Bronchial carcinoma1
Breast cancer metastatic1
Breast cancer1
Brain natriuretic peptide increased1
Bradyarrhythmia1
Bone pain1
Body temperature increased1
Blood uric acid increased1
Blood sodium decreased1
Blood potassium increased1
Blood potassium decreased1
Blood pH increased1
Blood disorder1
Blood creatinine decreased1
BLOOD CHOLESTEROL INCREASED1
Blood calcium decreased1
BLOOD AMYLASE INCREASED1
Blindness1
Bladder cancer1
Bedridden1
Bacterial infection1
Atrioventricular block second degree1
Atelectasis1
Aspiration1
Asphyxia1
ARTHROPATHY1
ARRHYTHMIA SUPRAVENTRICULAR1
Aortic thrombosis1
Anaplastic large cell lymphoma T- and null-cell types recurrent1
Anaphylactoid reaction1
Anaemia macrocytic1
Amylase increased1
Altered state of consciousness1
Alcohol withdrawal syndrome1
ADULT T-CELL LYMPHOMA/LEUKAEMIA REFRACTORY1
Accidental exposure to product1
ABSCESS LIMB1
Abdominal wall wound1
Abdominal pain upper1
Abdominal mass1
Abdominal discomfort1
Abasia1





Filtered ChEMBL targets:

Target UniProtKB ID Activity in nm Target Name Target gene
O15379 0.15 Histone deacetylase 3 HDAC3_HUMAN
O60885 36 Bromodomain-containing protein 4 BRD4_HUMAN
O75376 0.15 Nuclear receptor corepressor 1 NCOR1_HUMAN
P56524 20.5 Histone deacetylase 4 HDAC4_HUMAN
Q13547 0.0015 Histone deacetylase 1 HDAC1_HUMAN
Q8WUI4 1250 Histone deacetylase 7 HDAC7_HUMAN
Q92769 0.038 Histone deacetylase 2 HDAC2_HUMAN
Q969S8 0.9 Polyamine deacetylase HDAC10 HDA10_HUMAN
Q96DB2 0.3 Histone deacetylase 11 HDA11_HUMAN
Q9BY41 0.15 Histone deacetylase 8 HDAC8_HUMAN
Q9UBN7 9.5 Histone deacetylase 6 HDAC6_HUMAN
Q9UKV0 1100 Histone deacetylase 9 HDAC9_HUMAN
Q9UQL6 550 Histone deacetylase 5 HDAC5_HUMAN
Q9Y618 3 Nuclear receptor corepressor 2 NCOR2_HUMAN



Toxicity information:

Toxicity type: N/A



External links:

ChEBML: CHEMBL343448
DrugBank: N/A