Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Galantamine
Drug ID BADD_D00996
Description Galantamine is a tertiary alkaloid and reversible, competitive inhibitor of the acetylcholinesterase (AChE) enzyme, which is a widely studied therapeutic target used in the treatment of Alzheimer's disease.[A1018] First characterized in the early 1950s, galantamine is a tertiary alkaloid that was extracted from botanical sources, such as _Galanthus nivalis_.[A201968] Galantamine was first studied in paralytic and neuropathic conditions, such as myopathies and postpolio paralytic conditions, and for reversal of neuromuscular blockade.[A182993,A201968] Following the discovery of its AChE-inhibiting properties, the cognitive effects of galantamine were studied in a wide variety of psychiatric disorders such as mild cognitive impairment, cognitive impairment in schizophrenia and bipolar disorder, and autism; however, re-development of the drug for Alzheimer’s disease did not commence until the early 1990s due to difficulties in extraction and synthesis.[A201968] Galantamine blocks the breakdown of acetylcholine in the synaptic cleft, thereby increasing acetylcholine neurotransmission. It also acts as an allosteric modulator of the nicotinic receptor, giving its dual mechanism of action clinical significance.[A182993] The drug was approved by the FDA in 2001 for the treatment of mild to moderate dementia of the Alzheimer's type. As Alzheimer's disease is a progressive neurodegenerative disorder, galantamine is not known to alter the course of the underlying dementing process. Galantamine works to block the enzyme responsible for the breakdown of acetylcholine in the synaptic cleft, thereby enhancing cholinergic neuron function and signalling. Under this hypothesized mechanism of action, the therapeutic effects of galantamine may decrease as the disease progression advances and fewer cholinergic neurons remain functionally intact.[L13571] It is therefore not considered to be a disease-modifying drug.[A203558] Galantamine is marketed under the brand name Razadyne, and is available as oral immediate- and extended-release tablets and solution.[L13571]
Indications and Usage For the treatment of mild to moderate dementia of the Alzheimer's type. Has also been investigated in patients with mild cognitive impairment who did not meet the diagnostic criteria for Alzheimer's disease.
Marketing Status Prescription; Discontinued
ATC Code N06DA04
DrugBank ID DB00674
KEGG ID D04292
MeSH ID D005702
PubChem ID 9651
TTD Drug ID D0R9VR
NDC Product Code 0591-3498; 57237-050; 0904-7104; 65862-744; 65862-458; 57237-051; 0591-3496; 68084-729; 65841-755; 70436-005; 65129-1332; 65862-745; 68382-177; 68382-179; 70436-006; 65862-746; 65841-757; 65862-460; 70436-004; 65862-459; 0591-3497; 65841-756; 68382-178; 57237-049
Synonyms Galantamine | Lycoremine | Galantamin | Galanthamine | Nivaline | Nivalin | Razadyne | Reminyl | Galanthamine Hydrobromide
Chemical Information
Molecular Formula C17H21NO3
CAS Registry Number 357-70-0
SMILES CN1CCC23C=CC(CC2OC4=C(C=CC(=C34)C1)OC)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
AstheniaCholinesteraseP06276T9979911475943; 9880090; 16437532; 10090427
DiarrhoeaCholinesteraseP06276T9979911475943; 9880090; 16437532; 10090427
DizzinessCholinesteraseP06276T9979911475943; 9880090; 16437532; 10090427
VomitingCholinesteraseP06276T9979911475943; 9880090; 16437532; 10090427
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Somnolence17.02.04.006; 19.02.05.003--
Suicidal ideation19.12.01.003--
Suicide attempt19.12.01.004--
Supraventricular extrasystoles02.03.03.011--Not Available
Supraventricular tachycardia02.03.03.012--
Syncope24.06.02.012; 02.01.02.008; 17.02.04.0080.011029%
Tachycardia02.03.02.0070.003676%Not Available
Tension19.06.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.0020.007353%
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.006--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection11.01.14.004; 20.08.02.001--
Vascular purpura24.07.06.011; 23.06.01.008; 01.01.04.007--Not Available
Ventricular tachycardia02.03.04.010--
Vertigo17.02.12.002; 04.04.01.0030.003676%
Vision blurred06.02.06.007; 17.17.01.010--
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.0030.007353%
Weight decreased13.15.01.0050.003676%
Withdrawal syndrome08.06.02.012; 19.07.02.0050.005515%Not Available
Acute generalised exanthematous pustulosis23.03.10.002; 12.03.01.0050.014706%Not Available
Excoriation23.03.11.003; 12.01.06.007--Not Available
Lower gastrointestinal haemorrhage24.07.02.030; 07.12.02.007--
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