Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Doxylamine
Drug ID BADD_D02418
Description Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in parkinsonism.
Indications and Usage Used alone as a short-term sleep aid, in combination with other drugs as a night-time cold and allergy relief drug. Also used in combination with Vitamin B6 (pyridoxine) to prevent morning sickness in pregnant women.
Marketing Status approved; vet_approved
ATC Code R06AA09
DrugBank ID DB00366
KEGG ID D07878
MeSH ID D004319
PubChem ID 3162
TTD Drug ID D0Y2LR
NDC Product Code Not Available
UNII 95QB77JKPL
Synonyms Doxylamine
Chemical Information
Molecular Formula C17H22N2O
CAS Registry Number 469-21-6
SMILES CC(C1=CC=CC=C1)(C2=CC=CC=N2)OCCN(C)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acute hepatic failure09.01.03.0010.006036%-
Agitation17.02.05.012; 19.06.02.0010.012073%
Coma17.02.09.0010.006036%-
Completed suicide08.04.01.010; 19.12.01.0010.006036%-
Confusional state17.02.03.005; 19.13.01.0010.006036%
Death08.04.01.0010.015091%
Drug abuse19.07.06.0100.009055%-
Drug dependence19.07.06.0110.012073%-
Drug ineffective08.06.01.0060.039841%-
Dysarthria17.02.08.001; 19.19.03.0010.006036%
Encephalopathy17.13.02.0010.006036%
Flushing08.01.03.025; 23.06.05.003; 24.03.01.0020.006036%
Generalised tonic-clonic seizure17.12.01.0020.006036%-
Hallucination19.10.04.0030.006036%
Hallucination, visual19.10.04.0070.006036%-
Hepatocellular injury09.01.07.0080.006036%-
Leukocytosis01.02.01.0020.006036%
Musculoskeletal pain15.03.04.0070.009055%
Mydriasis06.05.03.004; 17.02.11.0030.009055%-
Nystagmus06.05.02.006; 17.02.02.0060.006036%
Oliguria20.01.03.0040.006036%-
Pyrexia08.05.02.0030.006036%
Rhabdomyolysis15.05.05.0020.024146%
Sedation17.02.04.0050.006036%-
Seizure17.12.03.0010.018109%
Somnolence17.02.04.006; 19.02.05.0030.009055%
Suicide attempt19.12.01.0040.015091%
Tachypnoea22.02.01.0140.006036%-
Torsade de pointes02.03.04.0050.006036%-
Ventricular extrasystoles02.03.04.0070.006036%-
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