Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Scopolamine hydrobromide
Drug ID BADD_D01995
Description Scopolamine is a tropane alkaloid isolated from members of the _Solanaceae_ family of plants, similar to [atropine] and [hyoscyamine], all of which structurally mimic the natural neurotransmitter [acetylcholine].[A228423, A228763] Scopolamine was first synthesized in 1959, but to date, synthesis remains less efficient than extracting scopolamine from plants.[A228763] As an acetylcholine analogue, scopolamine can antagonize muscarinic acetylcholine receptors (mAChRs) in the central nervous system and throughout the body, inducing several therapeutic and adverse effects related to alteration of parasympathetic nervous system and cholinergic signalling.[A228758, L31578] Due to its dose-dependent adverse effects, scopolamine was the first drug to be offered commercially as a transdermal delivery system, Scopoderm TTS®, in 1981.[A228423, A228758] As a result of its anticholinergic effects, scopolamine is being investigated for diverse therapeutic applications; currently, it is approved for the prevention of nausea and vomiting associated with motion sickness and surgical procedures.[A228773, L31578] Scopolamine was first approved by the FDA on December 31, 1979, and is currently available as both oral tablets and a transdermal delivery system.[L31578]
Indications and Usage Scopolamine is indicated in adult patients for the prevention of nausea and vomiting associated with motion sickness and for the prevention of postoperative nausea and vomiting (PONV) associated with anesthesia or opiate analgesia.[L31578]
Marketing Status approved; investigational
ATC Code S01FA02; A04AD01; N05CM05
DrugBank ID DB00747
KEGG ID D02071
MeSH ID D012601
PubChem ID 517999
TTD Drug ID D0B7YT
NDC Product Code 55742-011
UNII 451IFR0GXB
Synonyms Scopolamine | Hyoscine | Transderm Scop | Scopoderm TTS | Transderm-V | Transderm V | Travacalm HO | Vorigeno | Boro-Scopol | Boro Scopol | Isopto Hyoscine | Kwells | Scoburen | Scopace | Scopolamine Cooper | Scopolamine Hydrobromide
Chemical Information
Molecular Formula C17H21NO4.BrH
CAS Registry Number 114-49-8
SMILES CN1C2CC(CC1C3C2O3)OC(=O)C(CO)C4=CC=CC=C4.Br
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)
Agitation17.02.05.012; 19.06.02.001--
Angle closure glaucoma06.03.01.001--Not Available
Arrhythmia02.03.02.001--Not Available
Bradycardia02.03.02.002--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Depressed level of consciousness17.02.04.002--
Dermatitis23.03.04.002--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Eczema23.03.04.006--
Erythema23.03.06.001--Not Available
Feeling abnormal08.01.09.014--Not Available
Hallucination19.10.04.003--
Hallucination, visual19.10.04.007--Not Available
Hypotension24.06.03.002--
Injection site irritation08.02.03.027; 12.07.03.027--Not Available
Irritability19.04.02.013; 08.01.03.011--
Mydriasis17.02.11.003; 06.05.03.004--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Pain08.01.08.004--
Pericardial effusion02.06.01.002--
Rash23.03.13.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Tachycardia02.03.02.007--Not Available
Tremor17.01.06.002--
Vision blurred17.17.01.010; 06.02.06.007--
Vascular occlusion24.04.02.015--Not Available
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