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)
Abdominal pain07.01.05.002--
Accommodation disorder06.02.04.001---
Acute psychosis19.03.01.001---
Agitation17.02.05.012; 19.06.02.0010.000884%
Altered state of consciousness17.02.04.001; 19.07.01.0030.000442%-
Amblyopia06.02.01.001---
Amnesia17.03.02.001; 19.20.01.001--
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.0010.000442%-
Angle closure glaucoma06.03.01.001---
Anticholinergic syndrome17.05.01.0010.000663%-
Anxiety19.06.02.0020.000442%
Aphasia17.02.03.001; 19.21.01.0010.000442%
Application site erythema08.02.01.001; 12.07.01.001; 23.03.06.0050.003226%-
Application site irritation08.02.01.003; 12.07.01.0030.005259%-
Application site pain08.02.01.004; 12.07.01.0040.001945%-
Application site pruritus08.02.01.005; 12.07.01.005; 23.03.12.0040.001724%-
Application site rash08.02.01.016; 12.07.01.016; 23.03.13.0080.007204%-
Application site reaction08.02.01.006; 12.07.01.0060.003226%-
Application site ulcer08.02.01.007; 12.07.01.007; 23.07.03.0100.001503%-
Asthenia08.01.01.0010.001414%-
Body temperature increased13.15.01.001---
Bradycardia02.03.02.002---
Condition aggravated08.01.03.0040.001945%-
Confusional state17.02.03.005; 19.13.01.0010.003094%
Conjunctivitis06.04.01.002; 11.01.06.012--
Constipation07.02.02.001--
Cycloplegia06.05.03.002; 17.17.02.003---
Dehydration14.05.05.0010.000663%
Delirium19.13.02.0010.000884%
Dental caries07.09.01.001--
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ADReCS-Target
Drug Name ADR Term Target
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