Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Galantamine hydrobromide
Drug ID BADD_D00997
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 D02173
MeSH ID D005702
PubChem ID 121587
TTD Drug ID D0R9VR
NDC Product Code 0054-0137; 12578-890; 50458-388; 55111-081; 47335-836; 47335-835; 65372-1138; 63629-2364; 63629-2363; 10147-0891; 43353-984; 50458-389; 65862-487; 65129-1113; 50458-387; 10147-0892; 63629-2365; 10147-0893; 47335-837
Synonyms Galantamine | Lycoremine | Galantamin | Galanthamine | Nivaline | Nivalin | Razadyne | Reminyl | Galanthamine Hydrobromide
Chemical Information
Molecular Formula C17H22BrNO3
CAS Registry Number 1953-04-4
SMILES CN1CCC23C=CC(CC2OC4=C(C=CC(=C34)C1)OC)O.Br
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
AstheniaCholinesteraseP06276T99799Not Available
DiarrhoeaCholinesteraseP06276T99799Not Available
DizzinessCholinesteraseP06276T99799Not Available
VomitingCholinesteraseP06276T99799Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Paranoia19.05.01.005--Not Available
Pollakiuria20.02.02.007--
Purpura24.07.06.005; 01.01.04.003; 23.06.01.004--
Pyrexia08.05.02.003--
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal failure20.01.03.005--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Salivary hypersecretion07.06.01.009--Not Available
Seizure17.12.03.001--
Somnolence19.02.05.003; 17.02.04.006--
Suicidal ideation19.12.01.003--
Supraventricular tachycardia02.03.03.012--
Syncope24.06.02.012; 17.02.04.008; 02.01.02.008--
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.002--
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.006--
Urinary retention20.02.02.011--
Urinary tract infection20.08.02.001; 11.01.14.004--
Ventricular tachycardia02.03.04.010--
Vertigo04.04.01.003; 17.02.12.002--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Lower gastrointestinal haemorrhage24.07.02.030; 07.12.02.007--
Blood alkaline phosphatase increased13.04.02.004--
Decreased appetite14.03.01.005; 08.01.09.028--
The 3th Page    First    Pre   3    Total 3 Pages