Phenobarbital


w216



General information:


Withdrawn ID: w216
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): N03AA02
Molecular Formula: C12H12N2O3
Molweight: 232.235



Withdrawal information:


Withdrawn due to drug safety reasons:Yes
First approved: 1912
First death: 1929
First withdrawn: 1985
Last withdrawn: 1985
Reference: https://www.ncbi.nlm.nih.gov/pubmed/25651859



Side-effects:

Total reported cases (submitted by medical professionals) with Phenobarbital as primary suspect: 267


Reported final outcomes:
Hospitalization (initial or prolonged): 114
Death: 53
Life-Threatening condition: 25
Intervention required to prevent permanent impairment/damage: 15
Disability: 8
Congenital anomaly: 6


Reported side-effects:

Side-effect Case number
Drug reaction with eosinophilia and systemic symptoms32
DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS31
COMPLETED SUICIDE23
TOXICITY TO VARIOUS AGENTS19
PYREXIA16
DRUG INTERACTION15
CONVULSION15
STEVENS-JOHNSON SYNDROME12
CONFUSIONAL STATE11
CARDIO-RESPIRATORY ARREST11
CONDITION AGGRAVATED10
Seizure9
OVERDOSE9
HUMAN HERPESVIRUS 6 INFECTION9
DRUG INEFFECTIVE9
TOXIC EPIDERMAL NECROLYSIS8
SOMNOLENCE8
DEATH8
Apparent life threatening event8
OFF LABEL USE7
LYMPHADENOPATHY7
COMA7
ALANINE AMINOTRANSFERASE INCREASED7
AGGRESSION7
RESPIRATORY FAILURE6
Product substitution issue6
MEDICATION ERROR6
LOSS OF CONSCIOUSNESS6
Infantile apnoea6
FIBROMATOSIS6
EPILEPSY6
DUPUYTREN'S CONTRACTURE6
CYTOMEGALOVIRUS INFECTION6
ASPARTATE AMINOTRANSFERASE INCREASED6
TACHYCARDIA5
MATERNAL DRUGS AFFECTING FOETUS5
IRRITABILITY5
INTENTIONAL OVERDOSE5
HYPOTENSION5
GASTROINTESTINAL HAEMORRHAGE5
COGNITIVE DISORDER5
ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC5
ABNORMAL BEHAVIOUR5
RESTLESSNESS4
RESPIRATORY ARREST4
MALAISE4
LETHARGY4
HYPOTHERMIA4
HYPERAMMONAEMIC ENCEPHALOPATHY4
GRAND MAL CONVULSION4
Gastrooesophageal reflux disease4
DRUG HYPERSENSITIVITY4
DEPRESSED LEVEL OF CONSCIOUSNESS4
ANXIETY4
ANTICONVULSANT DRUG LEVEL INCREASED4
THROMBOCYTOPENIA3
STATUS EPILEPTICUS3
SLEEP DISORDER3
SKIN GRAFT3
RASH3
PSYCHOMOTOR HYPERACTIVITY3
PRODUCT QUALITY ISSUE3
PRODUCT PACKAGING QUANTITY ISSUE3
PNEUMONIA ASPIRATION3
NYSTAGMUS3
MULTI-ORGAN FAILURE3
MENTAL STATUS CHANGES3
LYMPHOCYTOSIS3
LIVER FUNCTION TEST ABNORMAL3
LACTIC ACIDOSIS3
HYPERAMMONAEMIA3
HEPATITIS3
HEPATIC NECROSIS3
HEADACHE3
GASTROINTESTINAL DISORDER3
FALL3
ERYTHEMA MULTIFORME3
ERYTHEMA3
EOSINOPHILIA3
Electrocardiogram QT prolonged3
DYSARTHRIA3
DRUG LEVEL INCREASED3
DRUG EXPOSURE DURING PREGNANCY3
DRUG EFFECT DECREASED3
DIZZINESS3
Disorientation3
DISEASE RECURRENCE3
DISEASE PROGRESSION3
Cyanosis3
CLEFT PALATE3
Choking3
CEREBRAL ATROPHY3
Altered state of consciousness3
AKATHISIA3
Acute kidney injury3
WITHDRAWAL SYNDROME2
WHITE BLOOD CELL COUNT INCREASED2
VOMITING2
VITAMIN D DEFICIENCY2
TREATMENT NONCOMPLIANCE2
Transcription medication error2
TOXIC SKIN ERUPTION2
TOXIC ENCEPHALOPATHY2
THERAPEUTIC AGENT TOXICITY2
Suspected transmission of an infectious agent via product2
SJOGREN'S SYNDROME2
SHOCK HAEMORRHAGIC2
SEPTIC SHOCK2
RICKETS2
RENAL IMPAIRMENT2
RENAL FAILURE2
RASH ERYTHEMATOUS2
RALES2
PUPILLARY REFLEX IMPAIRED2
PULMONARY OEDEMA2
PSYCHOTIC DISORDER2
PRODUCT TAMPERING2
Product dispensing error2
Product contamination2
Potentiating drug interaction2
Porphyria acute2
PNEUMONITIS2
PLATELET COUNT INCREASED2
PATENT DUCTUS ARTERIOSUS2
Partial seizures2
OROPHARYNGEAL PAIN2
Oedema peripheral2
ODYNOPHAGIA2
OBSTRUCTIVE AIRWAYS DISORDER2
NODULE2
NO THERAPEUTIC RESPONSE2
MYOCLONIC EPILEPSY2
Myocarditis2
Myocardial ischaemia2
Metabolic acidosis2
LIVER DISORDER2
LEUKOPENIA2
Leukocytosis2
KIDNEY TRANSPLANT REJECTION2
Injection site reaction2
INFECTION2
Incorrect dose administered2
Inappropriate antidiuretic hormone secretion2
Hypoxia2
HYPOTONIA2
HYPOGLYCAEMIA2
HYPOCALCAEMIA2
HEPATOSPLENOMEGALY2
HEPATIC ENZYME INCREASED2
Hepatic encephalopathy2
Hepatic adenoma2
HEMIPARESIS2
HAEMOGLOBIN DECREASED2
Generalised tonic-clonic seizure2
GENERALISED ERYTHEMA2
GENERAL PHYSICAL HEALTH DETERIORATION2
GAIT DISTURBANCE2
FEBRILE CONVULSION2
EXTRAPYRAMIDAL DISORDER2
Exposure during pregnancy2
Encephalitis2
Electroencephalogram abnormal2
DYSTONIA2
Dyspnoea2
DRUG TOXICITY2
DRUG LEVEL ABOVE THERAPEUTIC2
Drug eruption2
DRUG DOSE OMISSION2
Drug abuse2
DIFFICULTY IN WALKING2
DECREASED APPETITE2
CONJUNCTIVAL HYPERAEMIA2
COMMUNICATION DISORDER2
CLEFT LIP2
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR2
CHOLELITHIASIS2
CHOLANGITIS2
CEREBRAL CALCIFICATION2
Cardiac failure acute2
CARDIAC ARREST2
BLOOD SODIUM DECREASED2
BLOOD LACTATE DEHYDROGENASE INCREASED2
BLOOD CALCIUM DECREASED2
BLOOD ALKALINE PHOSPHATASE INCREASED2
BLISTER2
BALANCE DISORDER2
BACK PAIN2
ATAXIA2
ANTICONVULSANT DRUG LEVEL ABOVE THERAPEUTIC2
ANAPHYLACTIC REACTION2
ANAEMIA2
ALOPECIA2
AGITATION2
Affective disorder2
ADVERSE DRUG REACTION2
ABDOMINAL PAIN2
Wrong product administered1
WHITE BLOOD CELLS URINE POSITIVE1
White blood cell count decreased1
Wheezing1
VULVOVAGINAL BURNING SENSATION1
Vitamin K deficiency1
Visual field defect1
VISION BLURRED1
VISCERAL CONGESTION1
VIRAL RASH1
VESICOURETERIC REFLUX1
Vanishing bile duct syndrome1
UTERINE CANCER1
Uterine aplasia1
URINE CALCIUM INCREASED1
URINARY TRACT INFECTION1
URINARY INCONTINENCE1
Unevaluable event1
Underdose1
Trousseau's sign1
TREMOR1
TRAUMATIC FRACTURE1
TOXICOLOGIC TEST ABNORMAL1
TORTICOLLIS1
Tooth loss1
TONSILLITIS1
Tinnitus1
Thyroid cancer1
Thrombocytopenia neonatal1
Throat tightness1
Throat irritation1
Therapy non-responder1
TACHYPNOEA1
SYSTEMIC LUPUS ERYTHEMATOSUS1
Syringe issue1
SWELLING1
Suicide attempt1
SUDDEN DEATH1
SUBCUTANEOUS EMPHYSEMA1
Subcorneal pustular dermatosis1
Stupor1
STRIDOR1
Stress cardiomyopathy1
STRESS1
STOMATITIS1
Stillbirth1
Staphylococcus test positive1
STAPHYLOCOCCAL INFECTION1
SPLENIC INJURY1
SPLENIC HAEMORRHAGE1
Sopor1
SMOOTH MUSCLE ANTIBODY POSITIVE1
Skin warm1
SKIN NODULE1
SKIN LESION1
SKIN DISORDER1
Skin discolouration1
Sirenomelia1
Single umbilical artery1
Shock1
SEPSIS1
SELF-MEDICATION1
Scrotal haematocoele1
SCREAMING1
SCHIZOPHRENIA1
SALIVARY HYPERSECRETION1
RHONCHI1
REYE'S SYNDROME1
Respiratory distress1
Respiratory depression1
Renal disorder1
Renal aplasia1
Refusal of treatment by patient1
RED BLOOD CELLS URINE POSITIVE1
RECTAL HAEMORRHAGE1
REACTION TO AZO-DYES1
Rash maculo-papular1
Rash macular1
Rash generalised1
PYURIA1
PYELONEPHRITIS1
Purpura neonatal1
PULMONARY EMBOLISM1
PULMONARY CONGESTION1
Pseudolymphoma1
PSEUDOHYPOPARATHYROIDISM1
Prothrombin time prolonged1
Prothrombin level decreased1
Prognathism1
Product use issue1
Product packaging confusion1
Product monitoring error1
Product label issue1
PRODUCT LABEL CONFUSION1
Premature baby1
POST TRANSPLANT DISTAL LIMB SYNDROME1
POST ABORTION INFECTION1
Poisoning1
PNEUMOTHORAX1
Pneumonia klebsiella1
PNEUMOMEDIASTINUM1
PLEURAL EFFUSION1
PLAGIOCEPHALY1
PHYSICAL PRODUCT LABEL ISSUE1
PHARMACEUTICAL PRODUCT COMPLAINT1
PERSISTENT CLOACA1
PERSECUTORY DELUSION1
PERITONITIS SCLEROSING1
PERITONEAL EFFUSION1
PERICARDIAL EFFUSION1
Parinaud syndrome1
PARANOIA1
PANCYTOPENIA1
Pain in extremity1
Pain1
Packaging design issue1
OVERWEIGHT1
OVARIAN GRANULOSA-THECA CELL TUMOUR1
OSTEOPOROSIS1
OSTEOPENIA1
OSMOLAR GAP ABNORMAL1
Orthostatic hypotension1
Oropharyngeal swelling1
Nicotinic acid deficiency1
NEUTROPHIL PERCENTAGE INCREASED1
NERVOUS SYSTEM DISORDER1
Neonatal respiratory depression1
Neonatal oversedation1
NAIL DISCOLOURATION1
MYOCLONUS1
Myocardial infarction1
MYOCARDIAL FIBROSIS1
MYDRIASIS1
Myalgia1
Munchausen's syndrome1
MULTIPLE DRUG OVERDOSE INTENTIONAL1
MULTIPLE DRUG OVERDOSE ACCIDENTAL1
MULTIPLE DRUG OVERDOSE1
Mouth haemorrhage1
MENTAL IMPAIRMENT1
Mental disorder1
Memory impairment1
MEGACOLON1
Maternal exposure during pregnancy1
MALNUTRITION1
Lymphoma1
Lymphocytic infiltration1
LUNG HYPERINFLATION1
Lung disorder1
LOWER RESPIRATORY TRACT INFECTION1
Low set ears1
Local swelling1
Liver function test1
LIP EROSION1
Leukaemoid reaction1
Left ventricular dysfunction1
LARYNGEAL OEDEMA1
Kounis syndrome1
JUDGEMENT IMPAIRED1
Jaundice1
INTERSTITIAL LUNG DISEASE1
International normalised ratio increased1
Intercepted product administration error1
Intentional drug misuse1
INSOMNIA1
INJURY1
Injection site haemorrhage1
Injection site discolouration1
INHIBITORY DRUG INTERACTION1
Infusion site pain1
Infective exacerbation of chronic obstructive airways disease1
Infantile spasms1
INCONTINENCE1
Ill-defined disorder1
Hypovolaemic shock1
Hypovolaemia1
HYPOTHYROIDISM1
HYPOREFLEXIA1
Hypokalaemia1
HYPOCHROMIC ANAEMIA1
HYPOALBUMINAEMIA1
HYPERTONIA1
Hyperthermia1
Hypertensive crisis1
Hypertension1
HYPERPHOSPHATASAEMIA1
Hyperglycaemia1
HYDROXYPROLINE INCREASED1
HUMAN HERPESVIRUS 8 INFECTION1
HUMAN HERPES VIRUS 6 SEROLOGY POSITIVE1
HISTIOCYTOSIS HAEMATOPHAGIC1
HIP DYSPLASIA1
Herbal interaction1
Hepatotoxicity1
HEPATITIS A1
Hepatic neoplasm1
HEPATIC FUNCTION ABNORMAL1
Hepatic fibrosis1
Hepatic failure1
HELICOBACTER PYLORI IDENTIFICATION TEST POSITIVE1
Haemorrhage1
Haemoptysis1
Haemodynamic instability1
Haemodialysis1
HAEMATURIA1
HAEMATOCRIT DECREASED1
Haematochezia1
Haematemesis1
GROWTH RETARDATION1
GLIOSIS1
Gingival hypertrophy1
Gastroenteritis clostridial1
GASTRIC ULCER1
GASTRIC HAEMORRHAGE1
GAMMA-GLUTAMYLTRANSFERASE INCREASED1
Foetal malformation1
Foetal exposure during pregnancy1
Foetal anticonvulsant syndrome1
FOAMING AT MOUTH1
Fixed eruption1
Feeding disorder neonatal1
FATIGUE1
FAHR'S DISEASE1
Face oedema1
EYE REDNESS1
EYE MOVEMENT DISORDER1
EYE DISORDER1
EYE DISCHARGE1
EXPIRED DRUG ADMINISTERED1
EXANTHEMA SUBITUM1
Euphoric mood1
Escherichia urinary tract infection1
EPILEPTIC AURA1
Enterococcus test positive1
Enterobacter test positive1
EMOTIONAL DISORDER1
EMBOLISM1
Embolic stroke1
ELECTROCARDIOGRAM T WAVE AMPLITUDE INCREASED1
DYSSTASIA1
DUODENAL ULCER1
Drug-induced liver injury1
DRUG WITHDRAWAL CONVULSIONS1
Drug prescribing error1
Drug level decreased1
DRUG LEVEL BELOW THERAPEUTIC1
DRUG INTOLERANCE1
DRUG DISPENSING ERROR1
Drug clearance decreased1
DRUG ABUSER1
Dose calculation error1
Documented hypersensitivity to administered product1
Disturbance in attention1
Diarrhoea1
DEVICE RELATED INFECTION1
DEVELOPMENTAL DELAY1
Dermatitis exfoliative1
Dehydration1
CYTOMEGALOVIRUS GASTRITIS1
CYTOMEGALOVIRUS COLITIS1
CRYING1
CORNEAL OPACITY1
Corneal erosion1
CONJUNCTIVITIS INFECTIVE1
CONGENITAL VESICOURETERIC REFLUX1
Congenital urethral anomaly1
Congenital nose malformation1
Congenital nail disorder1
Congenital genital malformation female1
Congenital foot malformation1
Congenital eyelid malformation1
COMPLEX PARTIAL SEIZURES1
COAGULOPATHY1
Coagulation factor X level decreased1
Coagulation factor VII level decreased1
CIRCADIAN RHYTHM SLEEP DISORDER1
Chvostek's sign1
Chromaturia1
Cholestasis1
CHILLS1
Chest pain1
Chest discomfort1
CEREBRAL HAEMANGIOMA1
CEREBRAL DISORDER1
CEREBELLAR ATROPHY1
Cardiac murmur1
Cardiac failure congestive1
Cardiac failure1
Cardiac dysfunction1
Caesarean section1
Bronchopneumopathy1
BRONCHOPNEUMONIA1
BRAIN STEM SYNDROME1
Brain oedema1
Bradycardia1
Brachydactyly1
BRACHIAL PLEXOPATHY1
BLOODY DISCHARGE1
BLOOD UREA INCREASED1
BLOOD UREA DECREASED1
Blood pressure increased1
BLOOD PHOSPHORUS INCREASED1
BLOOD OSMOLARITY INCREASED1
BLOOD CREATININE INCREASED1
BLOOD CHLORIDE DECREASED1
Blood bilirubin increased1
BLOOD BICARBONATE DECREASED1
Bladder agenesis1
BACILLARY ANGIOMATOSIS1
AURA1
ATRIAL FIBRILLATION1
ARTERIOSCLEROSIS1
Arterial injury1
AREFLEXIA1
Antiviral drug level below therapeutic1
ANTINUCLEAR ANTIBODY POSITIVE1
ANTICONVULSANT DRUG LEVEL DECREASED1
ANTICONVULSANT DRUG LEVEL ABNORMAL1
Anosognosia1
Anion gap increased1
ANGIOEDEMA1
Anal atresia1
Anaemia neonatal1
Amyloidosis1
Ammonia increased1
ALOPECIA AREATA1
ALCOHOL USE1
ALCOHOL POISONING1
ACUTE RESPIRATORY DISTRESS SYNDROME1
ACUTE HEPATIC FAILURE1
Acute generalised exanthematous pustulosis1
ACINETOBACTER TEST POSITIVE1
ABORTION INDUCED1
ABASIA1





Toxicity information:

Toxicity class: 3
Toxicity type: multiple; dermatological
LD50: 300 mg/kg



External links:

ChEBML: CHEMBL40
DrugBank: DB01174