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)
Lethargy17.02.04.003; 19.04.04.004; 08.01.01.0080.000972%
Malaise08.01.01.0030.002696%
Memory impairment19.20.01.003; 17.03.02.003--
Muscular weakness17.05.03.005; 15.05.06.001--
Mydriasis06.05.03.004; 17.02.11.0030.006850%Not Available
Nausea07.01.07.0010.009060%
Nervous system disorder17.02.10.001--Not Available
Ocular hyperaemia06.04.05.0040.000972%Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Paraesthesia23.03.03.094; 17.02.06.0050.000442%
Paranoia19.05.01.005--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Photophobia17.17.02.006; 06.01.01.004--
Pruritus23.03.12.001--
Rash23.03.13.0010.003005%Not Available
Restlessness19.11.02.002; 17.02.05.0210.000972%
Seizure17.12.03.0010.000663%
Skin disorder23.03.03.007--Not Available
Skin irritation23.03.04.009--Not Available
Somnolence19.02.05.003; 17.02.04.0060.001193%
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.001414%Not Available
Strangury20.02.02.017--Not Available
Tachycardia02.03.02.0070.001105%Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Tremor17.01.06.002--
Urethral disorder20.07.01.002--Not Available
Urinary retention20.02.02.0110.000442%
Urinary tract disorder20.08.01.001--Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.0070.004331%
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ADReCS-Target
Drug Name ADR Term Target
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