Nefazodone


w145



General information:


Withdrawn ID: w145
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): N06AX06
Molecular Formula: C25H32ClN5O2
Molweight: 470.007



Withdrawal information:


Withdrawn due to drug safety reasons:Yes
First approved: 1994
First death: 2002
First withdrawn: 2003
Last withdrawn: 2007
Reference: https://www.ncbi.nlm.nih.gov/pubmed/9822781



Side-effects:

Total reported cases (submitted by medical professionals) with Nefazodone as primary suspect: 626


Reported final outcomes:
Hospitalization (initial or prolonged): 84
Death: 24
Disability: 8
Intervention required to prevent permanent impairment/damage: 7
Life-Threatening condition: 4


Reported side-effects:

Side-effect Case number
HEPATOCELLULAR DAMAGE128
ALANINE AMINOTRANSFERASE INCREASED71
ASPARTATE AMINOTRANSFERASE INCREASED53
NAUSEA49
HEPATIC STEATOSIS46
HEPATIC ENZYME INCREASED39
DIZZINESS35
LIVER FUNCTION TEST ABNORMAL33
FATIGUE33
HEPATITIS27
HEPATIC FAILURE27
INSOMNIA26
HEPATITIS C26
HEADACHE23
DIARRHOEA22
ANXIETY22
ABDOMINAL PAIN22
VOMITING21
BLOOD ALKALINE PHOSPHATASE INCREASED21
HEPATIC CIRRHOSIS20
CHROMATURIA19
GAMMA-GLUTAMYLTRANSFERASE INCREASED17
WEIGHT DECREASED16
DRUG INEFFECTIVE16
SUICIDAL IDEATION15
DEPRESSION15
ARTHRALGIA15
LIVER TRANSPLANT14
CHEST PAIN13
ABDOMINAL PAIN UPPER13
RASH12
LIVER DISORDER12
PAIN11
OEDEMA PERIPHERAL11
MEDICATION ERROR11
CONSTIPATION11
ANOREXIA11
VISUAL DISTURBANCE10
SOMNOLENCE10
JAUNDICE10
DRUG INTERACTION10
DRUG EXPOSURE DURING PREGNANCY10
DEATH10
PHARMACEUTICAL PRODUCT COMPLAINT9
PARAESTHESIA9
MYALGIA9
CHOLELITHIASIS9
BACK PAIN9
VISION BLURRED8
PREGNANCY8
PANIC ATTACK8
MALAISE8
GASTROOESOPHAGEAL REFLUX DISEASE8
GASTRITIS8
FEELING ABNORMAL8
ASTHENIA8
WEIGHT INCREASED7
HEPATIC FIBROSIS7
DYSPNOEA7
TREMOR6
PAIN IN EXTREMITY6
MENTAL STATUS CHANGES6
HYPERTENSION6
HEPATOMEGALY6
GALLBLADDER DISORDER6
DYSPEPSIA6
DRY MOUTH6
DRUG WITHDRAWAL SYNDROME6
CONFUSIONAL STATE6
VARICES OESOPHAGEAL5
SYNCOPE5
PRURITUS5
PALPITATIONS5
HEPATITIS B5
HEPATIC NECROSIS5
FLATULENCE5
BLOOD CHOLESTEROL INCREASED5
AGITATION5
TINNITUS4
SUICIDE ATTEMPT4
POLLAKIURIA4
PANCREATITIS4
NEUROPATHY PERIPHERAL4
MIGRAINE4
LOSS OF CONSCIOUSNESS4
HYPOAESTHESIA4
HYPERCHOLESTEROLAEMIA4
HEPATIC FUNCTION ABNORMAL4
FEELING COLD4
ERECTILE DYSFUNCTION4
DYSURIA4
DISTURBANCE IN ATTENTION4
DEHYDRATION4
BLOOD BILIRUBIN INCREASED4
ANAEMIA4
AMNESIA4
VERTIGO3
URINARY TRACT INFECTION3
TORSADE DE POINTES3
SPLENOMEGALY3
SEROTONIN SYNDROME3
SEPSIS3
Secondary adrenocortical insufficiency3
RENAL FAILURE3
OVERDOSE3
NERVOUSNESS3
MUSCLE SPASMS3
INJURY3
Hypogammaglobulinaemia3
HYPERSENSITIVITY3
HEPATITIS TOXIC3
HEPATITIS ALCOHOLIC3
HEPATITIS ACUTE3
HEPATIC NEOPLASM MALIGNANT3
HEPATIC NEOPLASM3
HALLUCINATION, AUDITORY3
HALLUCINATION3
HAEMATURIA3
HAEMANGIOMA OF LIVER3
FEELING HOT3
DUODENITIS3
DRUG TOXICITY3
DIABETES MELLITUS NON-INSULIN-DEPENDENT3
CRYPTOGENIC CIRRHOSIS3
CONVULSION3
COAGULOPATHY3
CHOLESTASIS3
CHILLS3
CELLULITIS3
BLOOD GLUCOSE INCREASED3
ARTHRITIS3
ALOPECIA3
Adrenal suppression3
ABDOMINAL DISTENSION3
WITHDRAWAL SYNDROME2
WHITE BLOOD CELL COUNT INCREASED2
VISUAL IMPAIRMENT2
VIRAL INFECTION2
VENTRICULAR TACHYCARDIA2
URTICARIA2
URINARY INCONTINENCE2
UNEVALUABLE EVENT2
TOOTHACHE2
THROMBOCYTOPENIA2
SOCIAL AVOIDANT BEHAVIOUR2
SLEEP APNOEA SYNDROME2
SINUSITIS2
SEXUAL DYSFUNCTION2
SEDATION2
ROAD TRAFFIC ACCIDENT2
RHEUMATOID ARTHRITIS2
RESTLESSNESS2
RESTLESS LEGS SYNDROME2
RENAL FAILURE ACUTE2
RENAL CYST2
RASH PRURITIC2
PYREXIA2
PSYCHOTIC DISORDER2
PRURITUS GENERALISED2
PROTHROMBIN TIME PROLONGED2
Product availability issue2
PRIAPISM2
PREMATURE BABY2
PORTAL HYPERTENSIVE GASTROPATHY2
PNEUMONIA2
PLEURAL EFFUSION2
PEPTIC ULCER2
PANCREATITIS ACUTE2
OVARIAN CYST2
OSTEOARTHRITIS2
ORTHOSTATIC HYPOTENSION2
OESOPHAGITIS2
OESOPHAGEAL CANDIDIASIS2
NORMAL NEWBORN2
NEUROPATHY2
MYOCARDIAL INFARCTION2
MOOD SWINGS2
MICTURITION URGENCY2
MENSTRUATION IRREGULAR2
MEMORY IMPAIRMENT2
MAJOR DEPRESSION2
LIVER ABSCESS2
LIBIDO DECREASED2
LETHARGY2
IRRITABILITY2
INTENTIONAL SELF-INJURY2
HYPOTENSION2
HYPONATRAEMIA2
HYPOKALAEMIA2
HYPERTRIGLYCERIDAEMIA2
HYPERLIPIDAEMIA2
HYPERHIDROSIS2
HOT FLUSH2
HIATUS HERNIA2
HEPATOTOXICITY2
HEPATOSPLENOMEGALY2
HEPATIC ENZYME ABNORMAL2
HEPATIC ENCEPHALOPATHY2
HEART RATE IRREGULAR2
HAEMORRHOIDS2
GASTROENTERITIS2
GASTRITIS EROSIVE2
FEELING HOT AND COLD2
ERECTION INCREASED2
EPISTAXIS2
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED2
DYSPHAGIA2
DUODENAL ULCER2
Drug hypersensitivity2
DIABETES MELLITUS2
DECREASED APPETITE2
CYST2
COORDINATION ABNORMAL2
COMPLICATIONS OF TRANSPLANT SURGERY2
COMPLEX PARTIAL SEIZURES2
CHRONIC OBSTRUCTIVE AIRWAYS DISEASE2
CHOLANGITIS SCLEROSING2
CEREBROVASCULAR ACCIDENT2
BREAST MASS2
BRADYCARDIA2
BLOOD LACTATE DEHYDROGENASE INCREASED2
BLOOD CREATININE INCREASED2
BLOOD CALCIUM INCREASED2
AUTOIMMUNE HEPATITIS2
ATAXIA2
ASCITES2
ALANINE AMINOTRANSFERASE ABNORMAL2
ACUTE HEPATIC FAILURE2
ABNORMAL BEHAVIOUR2
ABDOMINAL PAIN LOWER2
ABDOMINAL DISCOMFORT2
WOUND INFECTION1
Withdrawal hypertension1
WHITE BLOOD CELL COUNT DECREASED1
WAIST CIRCUMFERENCE INCREASED1
VISUAL ACUITY REDUCED1
VERY LOW DENSITY LIPOPROTEIN INCREASED1
VAGINITIS ATROPHIC1
VAGINAL BURNING SENSATION1
UTERINE LEIOMYOMA1
URTICARIA CHRONIC1
UROBILIN URINE PRESENT1
URINE ABNORMALITY1
URINARY RETENTION1
URINARY HESITATION1
URETHRAL DISORDER1
UPPER GASTROINTESTINAL HAEMORRHAGE1
ULCER1
TRANSIENT ISCHAEMIC ATTACK1
TRANSAMINASES INCREASED1
TOTAL CHOLESTEROL/HDL RATIO INCREASED1
TORTICOLLIS1
TOOTH LOSS1
Tongue haemorrhage1
TONGUE DISORDER1
TINEA INFECTION1
THROMBOSIS1
Therapy non-responder1
THERAPEUTIC PRODUCT INEFFECTIVE1
THEFT1
TARDIVE DYSKINESIA1
TACHYCARDIA1
SYSTEMIC LUPUS ERYTHEMATOSUS1
SYNCOPE VASOVAGAL1
SWELLING FACE1
STUPOR1
STRESS1
STOMACH DISCOMFORT1
STATUS EPILEPTICUS1
SPONDYLOARTHROPATHY1
SPINAL OSTEOARTHRITIS1
Spinal fracture1
SPEECH DISORDER1
SOMATISATION DISORDER1
SLUGGISHNESS1
SLEEP WALKING1
SLEEP TALKING1
SLEEP DISORDER1
SKIN LESION1
SKIN EXFOLIATION1
Sjogren's syndrome1
SINOBRONCHITIS1
SIMPLE PARTIAL SEIZURES1
Serum serotonin decreased1
SENSORY LOSS1
SENSATION OF PRESSURE IN EAR1
SCOTOMA1
SCLERODERMA1
RHEUMATOID FACTOR POSITIVE1
RESPIRATORY RATE DECREASED1
RESPIRATORY FAILURE1
RENAL IMPAIRMENT1
RENAL DISORDER1
REFUSAL OF EXAMINATION1
RECTAL HAEMORRHAGE1
QUADRIPLEGIA1
PYELOCALIECTASIS1
PULMONARY EMBOLISM1
PSYCHOMOTOR HYPERACTIVITY1
PSYCHIATRIC SYMPTOM1
PRURITUS ANI1
PROTHROMBIN LEVEL DECREASED1
PROTEIN TOTAL INCREASED1
PROTEIN C DEFICIENCY1
PROSTATITIS1
Product supply issue1
Product dose omission issue1
PREMATURE LABOUR1
PREMATURE EJACULATION1
Post-traumatic stress disorder1
PORTAL TRIADITIS1
PORTAL HYPERTENSION1
POLYP1
Polyglandular autoimmune syndrome type II1
PLEURITIC PAIN1
PHOTOPSIA1
PHOTOPHOBIA1
PHARYNGOLARYNGEAL PAIN1
Pharyngitis1
PETECHIAE1
PERONEAL NERVE PALSY1
PERICARDIAL EFFUSION1
PAROSMIA1
PARAESTHESIA OF GENITAL MALE1
PANIC DISORDER1
PANCYTOPENIA1
PANCREATITIS CHRONIC1
PANCREATIC MASS1
PANCREATIC CARCINOMA1
OROPHARYNGEAL SWELLING1
ORAL MUCOSAL BLISTERING1
ORAL INTAKE REDUCED1
Oral candidiasis1
OESOPHAGEAL PAIN1
OESOPHAGEAL CARCINOMA1
OEDEMA1
OCULAR ICTERUS1
NIGHTMARE1
NIGHT SWEATS1
NEPHROLITHIASIS1
NECK PAIN1
NECK INJURY1
Near death experience1
NASOPHARYNGITIS1
NASAL CONGESTION1
Myopathy1
MYOCLONUS1
MYDRIASIS1
MYCOSIS FUNGOIDES1
MUSCULOSKELETAL STIFFNESS1
MUSCULOSKELETAL DISCOMFORT1
MUSCLE TWITCHING1
MUSCLE RIGIDITY1
MOOD ALTERED1
MIDDLE INSOMNIA1
METASTASES TO LIVER1
MENTAL IMPAIRMENT1
MENTAL DISORDER1
MEAN CELL VOLUME INCREASED1
MEAN CELL VOLUME DECREASED1
MARROW HYPERPLASIA1
MALIGNANT MELANOMA OF SITES OTHER THAN SKIN1
LYMPHADENOPATHY1
Low birth weight baby1
LOSS OF LIBIDO1
LOCAL SWELLING1
LIVER TRANSPLANT REJECTION1
LIVER TENDERNESS1
LABORATORY TEST ABNORMAL1
KERATOCONJUNCTIVITIS SICCA1
JOINT SWELLING1
JAUNDICE CHOLESTATIC1
IRRITABLE BOWEL SYNDROME1
IRON DEFICIENCY1
INTERVERTEBRAL DISC PROTRUSION1
INTERVERTEBRAL DISC DEGENERATION1
INTERNATIONAL NORMALISED RATIO INCREASED1
INTERNATIONAL NORMALISED RATIO DECREASED1
INTERCEPTED DRUG DISPENSING ERROR1
INTENTIONAL OVERDOSE1
INITIAL INSOMNIA1
INFLUENZA LIKE ILLNESS1
INFLUENZA1
INFERTILITY1
INCONTINENCE1
IMPAIRED WORK ABILITY1
IMPAIRED HEALING1
IMPAIRED DRIVING ABILITY1
IMMATURE RESPIRATORY SYSTEM1
Illness1
HYPOVOLAEMIA1
HYPOTHYROIDISM1
HYPOACUSIS1
HYPERTRICHOSIS1
HYPERSOMNIA1
HYPERGAMMAGLOBULINAEMIA1
HYPERCALCAEMIA1
HYPERADRENALISM1
Hospitalisation1
HORDEOLUM1
HIRSUTISM1
HIGH DENSITY LIPOPROTEIN DECREASED1
HEPATORENAL SYNDROME1
Hepatocellular injury1
HEPATOBLASTOMA1
HEPATITIS INFECTIOUS MONONUCLEOSIS1
HEPATITIS CHRONIC ACTIVE1
HEPATITIS CHOLESTATIC1
HEPATITIS C VIRUS1
HEPATITIS C ANTIBODY POSITIVE1
HEPATITIS B SURFACE ANTIGEN POSITIVE1
HEPATITIS A ANTIBODY1
HEPATITIS A1
HEPATIC PAIN1
HEPATIC MASS1
HEPATIC HAEMORRHAGE1
HEPATIC CYST1
HEMIPARESIS1
HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE1
HELICOBACTER GASTRITIS1
HAIR TEXTURE ABNORMAL1
HAEMORRHOIDAL HAEMORRHAGE1
HAEMOLYSIS1
HAEMOGLOBIN DECREASED1
HAEMATOMA1
HAEMATOCHEZIA1
HAEMATEMESIS1
HAEMANGIOMA1
GRANULOMA1
GRAND MAL CONVULSION1
GOUT1
GINGIVAL BLEEDING1
GENITAL PRURITUS FEMALE1
GASTROINTESTINAL PAIN1
GASTROINTESTINAL HAEMORRHAGE1
GASTROINTESTINAL DISORDER1
Gastroenteritis viral1
GASTRIC OUTLET OBSTRUCTION1
GASTRIC DISORDER1
GAMMA-GLUTAMYLTRANSFERASE ABNORMAL1
GALACTORRHOEA1
Food craving1
Foetal exposure during pregnancy1
FLUSHING1
FLUID RETENTION1
FLIGHT OF IDEAS1
Fistula1
FIBROSIS1
FIBROMYALGIA1
FEELING OF BODY TEMPERATURE CHANGE1
FEELING JITTERY1
FAT TISSUE INCREASED1
FALL1
FAECES PALE1
FAECES DISCOLOURED1
FAECAL INCONTINENCE1
FACIAL PALSY1
FACIAL PAIN1
EYE SWELLING1
EYE PAIN1
EYE DISORDER1
EXAGGERATED STARTLE RESPONSE1
Escherichia infection1
EPSTEIN-BARR VIRUS ANTIBODY POSITIVE1
EPIDIDYMITIS1
EOSINOPHIL COUNT INCREASED1
ENTEROCOLITIS1
ENCEPHALOPATHY1
EMOTIONAL DISTRESS1
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED1
EJACULATION DISORDER1
ECZEMA1
EATING DISORDER1
EAR PAIN1
DYSPHORIA1
DYSPHASIA1
DYSKINESIA1
DYSGEUSIA1
Drug-induced liver injury1
DRUG SCREEN POSITIVE1
DRUG SCREEN FALSE POSITIVE1
Drug level decreased1
DRUG DEPENDENCE1
DNA ANTIBODY POSITIVE1
DIVERTICULUM1
DIVERTICULITIS1
DISSOCIATION1
DISORIENTATION1
DIABETES MELLITUS INADEQUATE CONTROL1
Developmental hip dysplasia1
DERMATITIS1
DEREALISATION1
DEPRESSION SUICIDAL1
DEMENTIA1
DELUSION1
DEEP VEIN THROMBOSIS1
DEAFNESS1
CYTOMEGALOVIRUS TEST POSITIVE1
CRYING1
COUGH1
COSTOCHONDRITIS1
CORONARY ARTERY DISEASE1
Coronary artery bypass1
CONTUSION1
CONNECTIVE TISSUE DISORDER1
CONJUNCTIVITIS1
CONGENITAL ATRIAL SEPTAL DEFECT1
CONDITION AGGRAVATED1
COMPLETED SUICIDE1
COMA HEPATIC1
COMA1
COGNITIVE DISORDER1
CIRRHOSIS ALCOHOLIC1
CHRONIC HEPATITIS1
CHOLECYSTITIS CHRONIC1
CHOLECYSTITIS ACUTE1
CHOLECYSTITIS1
CHEST DISCOMFORT1
Cervical vertebral fracture1
CATARACT1
CAROTID ARTERY STENOSIS1
CARDIOMEGALY1
CARDIO-RESPIRATORY ARREST1
CARDIAC FAILURE CONGESTIVE1
CARDIAC FAILURE1
CARBON MONOXIDE POISONING1
Candida infection1
BRUXISM1
BREAST DISCHARGE1
BRAIN DAMAGE1
BLOOD URINE1
BLOOD UREA INCREASED1
BLOOD TRIGLYCERIDES INCREASED1
BLOOD PRESSURE DECREASED1
BLOOD ALBUMIN DECREASED1
BLEPHAROSPASM1
BLEPHARITIS1
BLEEDING TIME PROLONGED1
BLADDER HYPERTROPHY1
Bipolar disorder1
BIOPSY LIVER ABNORMAL1
BILOMA1
BILIARY TRACT DISORDER1
BILIARY CIRRHOSIS PRIMARY1
BENIGN PROSTATIC HYPERPLASIA1
BENIGN PENILE NEOPLASM1
BALANCE DISORDER1
Autoimmune thyroiditis1
ASTHMA1
ARTERIOSCLEROSIS CORONARY ARTERY1
AREFLEXIA1
APPETITE DISORDER1
ANTIBODY TEST POSITIVE1
ANTI-HBC IGG ANTIBODY POSITIVE1
ANORGASMIA1
ANGINA PECTORIS1
ANGER1
ANAEMIA MACROCYTIC1
AMPUTATION1
AMINO ACID METABOLISM DISORDER1
ALPHA 1 FOETOPROTEIN INCREASED1
ALCOHOL USE1
AGGRESSION1
AFFECTIVE DISORDER1
ADRENAL INSUFFICIENCY1
ACUTE MYELOID LEUKAEMIA1
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED1
ACTINIC KERATOSIS1
ACNE1
ABNORMAL DREAMS1
ABDOMINAL TENDERNESS1





Filtered ChEMBL targets:

Target UniProtKB ID Activity in nm Target Name Target gene
O95342 4200 Bile salt export pump ABCBB_HUMAN
P22303 1037 Acetylcholinesterase ACES_HUMAN



Toxicity information:

Toxicity class: 4
Toxicity type: hepatic
LD50: 397 mg/kg



External links:

ChEBML: CHEMBL623
DrugBank: DB01149