Doxylamine


w245



General information:


Withdrawn ID: w245
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): R06AA09
R06AA59
Molecular Formula: C17H22N2O
Molweight: 270.369



Withdrawal information:


Withdrawn due to drug safety reasons:Yes
First approved: 1956
First withdrawn: 1983
Last withdrawn: 1983
Reference: https://www.ncbi.nlm.nih.gov/pubmed/25502485



Side-effects:

Total reported cases (submitted by medical professionals) with Doxylamine as primary suspect: 184


Reported final outcomes:
Death: 45
Hospitalization (initial or prolonged): 25
Intervention required to prevent permanent impairment/damage: 19
Disability: 12
Congenital anomaly: 6
Life-Threatening condition: 4


Reported side-effects:

Side-effect Case number
ANOSMIA34
Drug abuse22
Toxicity to various agents20
AGEUSIA17
Overdose14
Completed suicide14
Somnolence12
Nausea11
NASAL DISCOMFORT6
LOSS OF CONSCIOUSNESS6
Drug screen false positive6
Drug dependence6
BURNING SENSATION6
Rebound effect5
Mydriasis5
Hypertension5
Headache5
Foetal exposure during pregnancy5
Dyspnoea5
Dizziness5
Diarrhoea5
Death5
Vomiting4
TACHYCARDIA4
Premature baby4
PAROSMIA4
Low birth weight baby4
HYPOSMIA4
Fall4
DYSGEUSIA4
Drug ineffective4
Depression4
Abortion spontaneous4
Urticaria3
Underdose3
Thrombocytopenia3
Suicide attempt3
Sinus tachycardia3
SINUS DISORDER3
Seizure3
Pyrexia3
Product use in unapproved indication3
Pain3
Mental status changes3
Intentional overdose3
HYPOTENSION3
HYPOGEUSIA3
Exposure during pregnancy3
Drug withdrawal syndrome neonatal3
Dehydration3
Contusion3
Confusional state3
CONDITION AGGRAVATED3
Wrong drug administered2
Vaginal haemorrhage2
Urinary retention2
Tremor neonatal2
Swelling2
Rhabdomyolysis2
Retching2
Rectal haemorrhage2
RASH2
Product quality issue2
Poisoning2
Pain in extremity2
Off label use2
Myalgia2
Miosis2
Migraine2
Metabolic alkalosis2
Maternal exposure during pregnancy2
Joint swelling2
Intentional product misuse2
IMPAIRED WORK ABILITY2
Hypoxia2
Hypothyroidism2
Hypokalaemia2
Hyperhidrosis2
Heart rate increased2
Head injury2
Haemoglobin decreased2
Frequent bowel movements2
Flushing2
Fatigue2
EYE IRRITATION2
Electrocardiogram QT prolonged2
Dysuria2
Dysarthria2
Drug hypersensitivity2
Drug dispensing error2
Congenital anomaly2
Concussion2
Choking2
Chills2
Cardio-respiratory arrest2
Cardiac arrest2
Caesarean section2
Brain oedema2
Blood glucose decreased2
Anxiety2
Abdominal pain upper2
Abdominal pain2
Wound haemorrhage1
Withdrawal syndrome1
WEIGHT INCREASED1
Vitreous disorder1
Visual field defect1
Vision blurred1
Ventricular tachycardia1
Ventricular fibrillation1
Ventricular extrasystoles1
Vaginal disorder1
Urine alcohol test positive1
Urinary tract infection pseudomonal1
Urinary tract infection1
Urinary incontinence1
Upper gastrointestinal haemorrhage1
Ulna fracture1
Trisomy 211
Tremor1
Traumatic lung injury1
Traumatic liver injury1
Transaminases increased1
Toxicologic test abnormal1
Toxic epidermal necrolysis1
Toxic encephalopathy1
Tooth hypoplasia1
Tooth fracture1
Tongue disorder1
Thyroxine free decreased1
THROAT IRRITATION1
Therapy change1
Tachypnoea1
SYNCOPE1
Sudden infant death syndrome1
Substance-induced psychotic disorder1
Subcutaneous emphysema1
Subcutaneous abscess1
Subarachnoid haemorrhage1
STEVENS-JOHNSON SYNDROME1
STATUS ASTHMATICUS1
Splenic rupture1
Spinal osteoarthritis1
Skull fracture1
Skin necrosis1
SINUS HEADACHE1
Sinus arrhythmia1
Septic shock1
Sepsis1
SENSATION OF PRESSURE1
Sedation1
Scrotal swelling1
Scar1
Road traffic accident1
Rib fracture1
Retroplacental haematoma1
Restless legs syndrome1
Respiratory syncytial virus infection1
Respiratory failure1
Respiratory distress1
Respiratory arrest1
Renal tubular necrosis1
Renal injury1
Rehabilitation therapy1
Regurgitation1
Rash maculo-papular1
Pulmonary oedema1
Pulmonary contusion1
Pulmonary congestion1
Pseudomonas infection1
Pruritus generalised1
Productive cough1
Product use issue1
Product taste abnormal1
Product packaging issue1
Prescribed overdose1
Premature separation of placenta1
Post-traumatic amnestic disorder1
Post procedural infection1
Poor quality sleep1
Pneumothorax1
Pneumonia1
Pleural effusion1
Photophobia1
Pharyngitis1
PHARMACEUTICAL PRODUCT COMPLAINT1
Perinatal depression1
Penoscrotal fusion1
Pectus excavatum1
PARAESTHESIA1
Oropharyngeal pain1
OLFACTORY NERVE DISORDER1
Oedematous kidney1
OEDEMA MUCOSAL1
Ocular hyperaemia1
No therapeutic response1
NO ADVERSE EVENT1
Nightmare1
Neonatal hypoxia1
NASOPHARYNGITIS1
NASAL CONGESTION1
Nail infection1
Musculoskeletal stiffness1
Multiple organ dysfunction syndrome1
Multiple injuries1
Mucosal exfoliation1
METABOLIC DISORDER1
Maternal exposure timing unspecified1
Maternal drugs affecting foetus1
Malnutrition1
Malaise1
Lower limb fracture1
Local swelling1
Liver function test increased1
Lethargy1
Lactic acidosis1
Lacrimation increased1
Laceration1
Labelled drug-drug interaction medication error1
Keratitis1
Jaundice neonatal1
Jaundice1
Ischaemic hepatitis1
Incorrect dose administered1
Incisional drainage1
Inappropriate schedule of drug administration1
Inappropriate antidiuretic hormone secretion1
Impaired gastric emptying1
Hypothalamo-pituitary disorder1
Hypopnoea1
Hypoplastic left heart syndrome1
Hyponatraemia1
Hypoaesthesia oral1
HYPOAESTHESIA1
Hypertensive heart disease1
Hypersensitivity1
Hypernatraemia1
HYPERAESTHESIA1
HOT FLUSH1
Hepato-lenticular degeneration1
Hepatitis cholestatic1
Hepatic encephalopathy1
Haemorrhagic anaemia1
Haemorrhage1
Haematoma1
Haematochezia1
Generalised tonic-clonic seizure1
General physical health deterioration1
Gastroenteritis viral1
Gastritis1
Foreign body in respiratory tract1
Foetal hypokinesia1
Foetal growth restriction1
Foetal death1
Foetal arrhythmia1
Femur fracture1
Feeding disorder1
Febrile convulsion1
Eyelid oedema1
Eyelid disorder1
Eye pruritus1
Eye pain1
Eye injury1
Eye discharge1
Extraskeletal ossification1
Excoriation1
Encephalopathy1
Ecchymosis1
Dysstasia1
Dyskinesia1
Dry mouth1
Dry eye1
Drug withdrawal syndrome1
Drug screen positive1
Drug level increased1
Drug interaction1
Drug effect decreased1
Drug administration error1
Disturbance in social behaviour1
Disturbance in attention1
Depressed level of consciousness1
Delirium1
Deformity1
Decreased appetite1
Decorticate posture1
Decerebrate posture1
Craniocerebral injury1
Cough1
Constipation1
Conjunctivitis1
Congenital spinal cord anomaly1
Congenital joint malformation1
Congenital hand malformation1
Congenital central nervous system anomaly1
Congenital aortic anomaly1
Computerised tomogram abnormal1
Coma1
Choking sensation1
CHEMICAL INJURY1
Cervix dystocia1
Cardiac septal defect1
Cachexia1
Bronchitis1
Blood thyroid stimulating hormone decreased1
Blood pressure increased1
Blood ethanol increased1
Blood alkaline phosphatase increased1
Balance disorder1
Azotaemia1
Atrial fibrillation1
Aspartate aminotransferase increased1
Arthritis1
Arthralgia1
Arterial injury1
Application site reaction1
APPLICATION SITE PAIN1
APPLICATION SITE BURNING1
Anger1
Anaphylactic reaction1
Analgesic drug level increased1
Anaemia1
Ammonia increased1
Acute kidney injury1
Acute hepatic failure1
Accidental overdose1
ACCIDENTAL DRUG INTAKE BY CHILD1
Accidental death1
Abdominal distension1
Abdominal discomfort1





Toxicity information:

Toxicity class: 4
Toxicity type: reproductive
LD50: 316 mg/kg



External links:

ChEBML: CHEMBL1004
DrugBank: DB00366