pralatrexate


EMA34



General information:


Withdrawn ID: EMA34
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): L01BA05
Molecular Formula: C23H23N7O5
Molweight: 477.473



Withdrawal information:


Withdrawn due to drug safety reasons:No



Side-effects:

Total reported cases (submitted by medical professionals) with pralatrexate as primary suspect: 212


Reported final outcomes:
Hospitalization (initial or prolonged): 123
Death: 79
Life-Threatening condition: 22
Disability: 1
Intervention required to prevent permanent impairment/damage: 1


Reported side-effects:

Side-effect Case number
STOMATITIS83
Malignant neoplasm progression73
PLATELET COUNT DECREASED50
MUCOSAL INFLAMMATION37
NEUTROPHIL COUNT DECREASED35
DISEASE PROGRESSION30
Anaemia28
FEBRILE NEUTROPENIA22
DEATH20
Therapeutic response decreased20
PYREXIA19
BLOOD LACTATE DEHYDROGENASE INCREASED17
SEPSIS17
WHITE BLOOD CELL COUNT DECREASED15
NEUTROPENIA14
PNEUMONIA14
RASH13
PANCYTOPENIA12
DIARRHOEA11
NAUSEA11
THROMBOCYTOPENIA11
ASPARTATE AMINOTRANSFERASE INCREASED10
Off label use10
ALANINE AMINOTRANSFERASE INCREASED9
Lymphopenia9
RESPIRATORY FAILURE9
Malaise8
ORAL DISORDER8
TOXIC EPIDERMAL NECROLYSIS8
C-reactive protein increased7
FATIGUE7
PLEURAL EFFUSION7
DEHYDRATION6
DYSPNOEA6
HAEMOGLOBIN DECREASED6
Hepatic function abnormal6
Myelosuppression6
Pneumocystis jirovecii pneumonia6
RENAL FAILURE ACUTE6
SKIN DISORDER6
SKIN EXFOLIATION6
STEVENS-JOHNSON SYNDROME6
ABDOMINAL PAIN5
CELLULITIS5
ERYTHEMA5
HYPOTENSION5
Interstitial lung disease5
Lymphadenopathy5
TUMOUR LYSIS SYNDROME5
BLOOD BILIRUBIN INCREASED4
Cytomegalovirus infection4
DECREASED APPETITE4
HYPERKALAEMIA4
Liver disorder4
OEDEMA PERIPHERAL4
OROPHARYNGEAL PAIN4
PAIN IN EXTREMITY4
PERIPHERAL T-CELL LYMPHOMA UNSPECIFIED4
PRURITUS4
Skin infection4
SKIN ULCER4
VOMITING4
Acute myeloid leukaemia3
Altered state of consciousness3
ASCITES3
Asthenia3
BLISTER3
BLOOD ALKALINE PHOSPHATASE INCREASED3
BLOOD CREATININE INCREASED3
Bone marrow failure3
CHEST PAIN3
CONDITION AGGRAVATED3
COUGH3
Cytopenia3
Delirium3
DERMATITIS BULLOUS3
Drug ineffective3
Eczema3
EPISTAXIS3
Epstein-Barr virus associated lymphoproliferative disorder3
EXCORIATION3
Fall3
HAEMOPTYSIS3
HEAD INJURY3
HERPES ZOSTER3
HYPERGLYCAEMIA3
Hyponatraemia3
Infection3
Insomnia3
JAUNDICE3
Lung infection3
Lymphocyte count decreased3
LYMPHOMA3
Mycosis fungoides3
Neuropathy peripheral3
PULMONARY EMBOLISM3
SEPTIC SHOCK3
Skin reaction3
Small intestinal perforation3
STAPHYLOCOCCUS TEST POSITIVE3
WEIGHT DECREASED3
Abdominal distension2
Activated partial thromboplastin time prolonged2
ACUTE MYOCARDIAL INFARCTION2
ACUTE RESPIRATORY DISTRESS SYNDROME2
ARTHRALGIA2
Bilirubin conjugated increased2
Blood chloride decreased2
BLOOD POTASSIUM DECREASED2
Blood sodium decreased2
Blood uric acid increased2
Cheilitis2
Chills2
CONFUSIONAL STATE2
Constipation2
Contusion2
Cytomegalovirus chorioretinitis2
Cytomegalovirus viraemia2
DEVICE RELATED INFECTION2
DISSEMINATED INTRAVASCULAR COAGULATION2
DIZZINESS2
Drug eruption2
DRY SKIN2
DYSPHAGIA2
Eating disorder2
Epstein-Barr virus associated lymphoma2
Feeding disorder2
FOLLICULITIS2
GENERAL PHYSICAL HEALTH DETERIORATION2
Haematemesis2
HEPATIC FAILURE2
HISTIOCYTOSIS HAEMATOPHAGIC2
HYPERSENSITIVITY2
Hypoaesthesia2
Hypoalbuminaemia2
International normalised ratio increased2
INTESTINAL ISCHAEMIA2
JOINT SWELLING2
Leukopenia2
Lip swelling2
METABOLIC ACIDOSIS2
Mucosal disorder2
Myalgia2
NEOPLASM PROGRESSION2
Pain2
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME2
Peripheral T-cell lymphoma unspecified recurrent2
Peritonitis2
PNEUMONITIS2
Prostate cancer2
RECALL PHENOMENON2
RENAL FAILURE2
Renal impairment2
RENAL TUBULAR NECROSIS2
Respiratory distress2
Sinus tachycardia2
SKIN BURNING SENSATION2
Skin erosion2
SKIN NECROSIS2
Transaminases increased2
Tumour associated fever2
Tumour invasion2
ULCER2
UNRESPONSIVE TO STIMULI2
Urinary tract infection2
Urticaria2
White blood cell count increased2
Abdominal wall haematoma1
Acute kidney injury1
AGITATION1
Alopecia1
Amylase increased1
Anal erosion1
Anaplastic large cell lymphoma T- and null-cell types recurrent1
Aphasia1
ARTERIAL RUPTURE1
Arteriosclerosis1
Back pain1
BACTERAEMIA1
Bacterial infection1
BACTERIAL TEST POSITIVE1
Bedridden1
Blastic plasmacytoid dendritic cell neoplasia1
Blood albumin decreased1
Blood creatine phosphokinase increased1
BLOOD CULTURE POSITIVE1
Blood lactate dehydrogenase decreased1
Blood osmolarity decreased1
Blood pressure decreased1
Blood pressure increased1
Blood sodium increased1
Blood urea increased1
Blood uric acid decreased1
BRADYCARDIA1
CANDIDIASIS1
Carbon dioxide decreased1
Cardiac arrest1
Cardio-respiratory arrest1
Cerebral haemorrhage1
Cholangitis1
Cholecystitis1
CLOSTRIDIAL INFECTION1
Clostridium difficile colitis1
COAGULOPATHY1
Colitis1
Composite lymphoma1
CONJUNCTIVITIS1
Continuous haemodiafiltration1
CORONAVIRUS TEST POSITIVE1
CORYNEBACTERIUM TEST POSITIVE1
COVID-191
CSF PROTEIN INCREASED1
CULTURE POSITIVE1
Culture urine positive1
Cystitis haemorrhagic1
Cytomegalovirus infection reactivation1
Decreased activity1
DEEP VEIN THROMBOSIS1
DEPRESSED LEVEL OF CONSCIOUSNESS1
Dermatitis1
Dialysis1
Diffuse large B-cell lymphoma1
Discomfort1
Disease recurrence1
Drug intolerance1
Drug tolerance1
DYSPEPSIA1
Dyspnoea exertional1
EAR PAIN1
Embolic stroke1
Embolism1
Encephalopathy1
Enteritis1
ENTEROBACTER SEPSIS1
Enterocolitis1
Eosinophilia1
Epstein-Barr virus test positive1
Erythema multiforme1
Escherichia infection1
Escherichia sepsis1
FACE OEDEMA1
Fluid overload1
FUNGAEMIA1
Fungal skin infection1
Gamma-glutamyltransferase increased1
Gastric perforation1
Gastric ulcer1
Gastric ulcer haemorrhage1
Gastrointestinal haemorrhage1
Gastrointestinal infection1
Gastrointestinal ulcer1
Genital herpes1
Gingivitis1
Gout1
HAEMATOCRIT DECREASED1
HAEMATURIA1
Haemophagocytic lymphohistiocytosis1
HAEMORRHAGE1
Haemorrhoidal haemorrhage1
Hallucination, visual1
Headache1
Helicobacter infection1
Hepatic atrophy1
Hepatic cirrhosis1
HEPATIC ENZYME INCREASED1
Hepatitis C1
Hepatotoxicity1
HERPES VIRUS INFECTION1
Hiccups1
Hospitalisation1
HYPERHIDROSIS1
HYPERPHOSPHATAEMIA1
Hyperphosphatasaemia1
Hypersensitivity vasculitis1
Hypertension1
HYPERURICAEMIA1
HYPOCALCAEMIA1
Hypoglycaemia1
Hypokalaemia1
Hypophagia1
HYPOPHOSPHATAEMIA1
Hypovolaemia1
Hypoxia1
Ileus paralytic1
Immobile1
Immune reconstitution inflammatory syndrome1
Immune thrombocytopenia1
IMPAIRED HEALING1
Incontinence1
Infected dermal cyst1
Infected skin ulcer1
INFLUENZA1
INFLUENZA B VIRUS TEST POSITIVE1
Intestinal haemorrhage1
Intestinal obstruction1
JC virus infection1
LARYNGEAL INFLAMMATION1
Laryngeal oedema1
Laryngeal pain1
Leukocytosis1
Liver function test increased1
Liver injury1
LOCALISED INTRAABDOMINAL FLUID COLLECTION1
Loss of consciousness1
Loss of personal independence in daily activities1
LUNG CONSOLIDATION1
Lung infiltration1
Lymphocyte count abnormal1
Lymphocyte morphology abnormal1
Lymphocyte percentage decreased1
Malnutrition1
MEDICATION ERROR1
Melaena1
MENTAL DISORDER1
Metastases to central nervous system1
METASTASES TO LIVER1
METASTASES TO NERVOUS SYSTEM1
Metastasis1
Mucous membrane disorder1
Multiple organ dysfunction syndrome1
Muscular weakness1
Musculoskeletal pain1
Mycobacterium avium complex infection1
Mycobacterium test positive1
Myocardial infarction1
Myocardial ischaemia1
Nasal mucosal blistering1
NASAL MUCOSAL DISORDER1
Nasopharyngitis1
Neck mass1
NEOPLASM MALIGNANT1
NEPHROLITHIASIS1
Nephropathy1
NERVE INJURY1
No adverse event1
Nodule1
OESOPHAGITIS1
OLIGURIA1
Oral candidiasis1
Oral herpes1
Oral mucosal eruption1
Oral pain1
Pancreatic carcinoma1
Paralysis1
Paraneoplastic pemphigus1
PENILE ULCERATION1
Performance status decreased1
Periodontitis1
Peripheral sensory neuropathy1
Peripheral swelling1
Petechiae1
PHARYNGEAL INFLAMMATION1
Pharyngitis1
Platelet count increased1
PLEOCYTOSIS1
Pleural fibrosis1
Pneumonia bacterial1
PRESYNCOPE1
Proctitis1
Product dose omission issue1
Product use issue1
Progressive multifocal leukoencephalopathy1
Prostatic specific antigen increased1
PROTEUS INFECTION1
Prothrombin time prolonged1
Pruritus generalised1
PSEUDOMONAS TEST POSITIVE1
Pulmonary oedema1
Pyelonephritis1
Rash erythematous1
Rash pruritic1
Rash vesicular1
Rectal haemorrhage1
RED BLOOD CELL COUNT DECREASED1
Respiratory depression1
Rhabdomyolysis1
Rhinitis1
SCAB1
Secretion discharge1
Sinusitis fungal1
Skin discolouration1
Skin hyperpigmentation1
Skin lesion1
Skin maceration1
Skin toxicity1
Small intestinal obstruction1
Somnolence1
SPLEEN DISORDER1
SPLENOMEGALY1
STAPHYLOCOCCAL INFECTION1
STAPHYLOCOCCAL SEPSIS1
Streptococcal bacteraemia1
Stridor1
T-CELL LYMPHOMA1
Tachypnoea1
Therapy interrupted1
Tonsillitis1
TOXICITY TO VARIOUS AGENTS1
Traumatic intracranial haemorrhage1
Treatment delayed1
Tuberculosis1
Tumour pain1
Urinary retention1
Urine output decreased1
VENTRICULAR EXTRASYSTOLES1
VIRAL INFECTION1
Vision blurred1
Vitamin K deficiency1
Weight increased1
Wound infection1
WOUND INFECTION BACTERIAL1
WOUND SECRETION1





Filtered ChEMBL targets:

Target UniProtKB ID Activity in nm Target Name Target gene
P15328 168 Folate receptor alpha FOLR1_HUMAN
P41440 0.69 Reduced folate transporter S19A1_HUMAN
Q96NT5 57 Proton-coupled folate transporter PCFT_HUMAN



Toxicity information:

Toxicity type: N/A



External links:

ChEBML: CHEMBL1201746
DrugBank: DB06813