Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Scopolamine
Drug ID BADD_D01994
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 A04AD01; N05CM05; S01FA02
DrugBank ID DB00747
KEGG ID D00138
MeSH ID D012601
PubChem ID 5184
TTD Drug ID D0B7YT
NDC Product Code 0378-6470; 48954-540; 50090-5349; 50742-505; 0591-2258; 55742-126; 68404-1004
UNII DL48G20X8X
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
CAS Registry Number 51-34-3
SMILES CN1C2CC(CC1C3C2O3)OC(=O)C(CO)C4=CC=CC=C4
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)
Visual impairment06.02.10.0130.003138%Not Available
Vomiting07.01.07.0030.002387%
Withdrawal syndrome08.06.02.012; 19.07.06.0230.001193%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000972%Not Available
Conjunctival hyperaemia06.04.01.004--Not Available
Eye pruritus06.04.05.006--Not Available
Temperature intolerance08.01.09.022--Not Available
Eyelid irritation23.03.04.023; 06.04.04.007--Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.000442%
Mental disorder19.07.01.002--Not Available
Poisoning12.03.01.004--Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000442%
Inner ear disorder04.04.02.002--Not Available
Adverse drug reaction08.06.01.0090.002696%Not Available
Psychotic disorder19.03.01.0020.000442%
Application site burn23.03.11.013; 12.07.01.038; 08.02.01.038--Not Available
Application site erosion08.02.01.021; 23.07.03.011; 12.07.01.0210.000972%Not Available
Application site scab08.02.01.042; 23.03.03.050; 12.07.01.0420.000972%Not Available
Procedural nausea12.02.03.003; 07.01.07.005--Not Available
Pupil dilation procedure13.07.04.013--Not Available
Pupil fixed17.02.11.008; 06.05.03.0120.000972%Not Available
Anisocoria17.02.11.009; 06.05.03.0130.001105%Not Available
Drug effective for unapproved indication12.09.02.001; 08.06.01.0370.001503%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.003005%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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