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 Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.[L13571]
Marketing Status approved
ATC Code N06DA04
DrugBank ID DB00674
KEGG ID D04292
MeSH ID D005702
PubChem ID 9651
TTD Drug ID D0R9VR
NDC Product Code 57237-051; 65841-757; 68382-178; 65862-458; 70436-006; 65862-459; 57237-050; 65841-755; 65129-1332; 57237-049; 65862-746; 65841-756; 65862-460; 65862-744; 65862-745; 68084-729; 68382-179; 70436-004; 70436-005; 0904-7104; 68382-177
UNII 0D3Q044KCA
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
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)
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cataract06.06.01.001--
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Cerebrovascular disorder24.03.05.002; 17.08.02.002--Not Available
Chest pain08.01.08.002; 02.02.02.011; 22.12.02.0030.000802%Not Available
Choking22.12.03.003--Not Available
Circulatory collapse24.06.02.0010.002406%Not Available
Coagulopathy01.01.02.001--Not Available
Completed suicide19.12.01.001; 08.04.01.010--Not Available
Condition aggravated08.01.03.0040.007219%Not Available
Confusional state19.13.01.001; 17.02.03.0050.005214%
Constipation07.02.02.001--
Cough22.02.03.001--
Cystitis20.03.02.002; 11.01.14.001--
Dehydration14.05.05.0010.002005%
Delirium19.13.02.0010.001765%
Delusion19.10.01.001--
Dementia17.03.01.001; 19.20.02.0010.001203%Not Available
Dementia Alzheimer's type19.20.03.001; 17.03.06.0010.000802%Not Available
Depressed mood19.15.02.0010.002005%Not Available
Depression19.15.01.0010.000802%
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Diverticulitis11.01.07.003; 07.10.02.001--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug interaction08.06.03.0010.000802%Not Available
Dry mouth07.06.01.002--
Dysarthria19.19.03.001; 17.02.08.001--
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ADReCS-Target
Drug Name ADR Term Target
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