Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Buspirone hydrochloride
Drug ID BADD_D00317
Description Buspirone is a novel anxiolytic agent with a unique structure and a pharmacological profile. Belonging to the azaspirodecanedione drug class,[A180991] buspirone is a serotonin 5-HT1A receptor agonist that is not chemically or pharmacologically related to benzodiazepines, barbiturates, and other sedative/anxiolytic drugs.[L4478] Unlike many drugs used to treat anxiety, buspirone does not exhibit anticonvulsant, sedative, hypnotic, and muscle-relaxant properties. Due to these characteristics, buspirone been termed 'anxioselective'.[A180985] First synthesized in 1968 then patented in 1975,[L7375] it is commonly marketed under the brand name Buspar®. Buspirone was first approved in 1986 by the FDA [A181751] and has been used to treat anxiety disorders, such as generalized anxiety disorder (GAD), and relieve symptoms of anxiety. It has also been used as a second-line therapy for unipolar depression when the use of selective serotonin reuptake inhibitors (SSRIs) is deemed clinically inadequate or inappropriate.[L7375] The potential use of buspirone in combination with [melatonin] in depression and cognitive impairment via promoting neurogenesis has also been investigated.[A181751]
Indications and Usage Indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.[L4478]
Marketing Status approved; investigational
ATC Code N05BE01
DrugBank ID DB00490
KEGG ID D00702
MeSH ID D002065
PubChem ID 36431
TTD Drug ID D0U2OO
NDC Product Code 49452-1310; 0093-0053; 16729-202; 16729-289; 42543-744; 55111-475; 55154-4312; 60760-548; 63187-402; 0378-1140; 65841-784; 68382-183; 68382-623; 70518-0682; 70518-1530; 70518-3065; 70518-3279; 70518-3727; 70934-967; 71335-2150; 72888-062; 12780-2940; 14593-948; 23155-097; 29300-244; 42806-085; 50090-5405; 50090-5614; 50090-5762; 53002-1424; 55154-5494; 64380-741; 68382-180; 69117-0043; 70518-2031; 70518-2987; 71335-1144; 71610-291; 71610-640; 0615-7718; 72789-139; 72888-066; 75834-267; 16729-203; 23155-025; 42543-742; 42806-086; 50090-4859; 51079-985; 51407-202; 55700-937; 59651-389; 59651-393; 63629-2409; 0378-1150; 64380-743; 68071-2995; 69117-0040; 70518-1050; 70518-3607; 71335-1605; 71335-1924; 71610-206; 0615-7714; 72189-200; 55154-5397; 59651-392; 61919-166; 63187-645; 0378-1145; 0378-1175; 64380-787; 65841-782; 69238-1116; 70518-3686; 70934-859; 71335-1752; 71335-2193; 71610-267; 71610-596; 72888-065; 42543-741; 42806-662; 50090-5797; 51079-986; 51407-203; 51407-378; 51655-015; 53002-1425; 55154-3364; 55154-4305; 63629-2408; 63629-2412; 63629-2413; 69238-1115; 69238-1117; 70518-0380; 70518-2591; 70518-2724; 70518-2803; 70518-3561; 75834-269; 29300-247; 42806-665; 50268-135; 51079-960; 51079-994; 55111-473; 61919-579; 63187-904; 65841-783; 67296-1520; 68071-2572; 68382-181; 68788-6984; 68788-7462; 69117-0042; 69238-1119; 69584-094; 70518-1747; 70518-2830; 70518-3428; 70934-850; 71205-493; 71205-799; 71335-1930; 71610-257; 71610-608; 0615-7689; 72789-140; 72888-063; 80425-0334; 0904-7121; 0904-7122; 51927-0169; 16729-200; 16729-201; 42806-083; 43063-785; 50090-4862; 50090-6188; 59651-390; 63629-2411; 64380-744; 65841-842; 68071-2987; 68382-182; 68788-8086; 69584-092; 69584-093; 70518-2660; 70518-3165; 71335-1608; 71335-2060; 71610-203; 71610-266; 71610-281; 71610-604; 72789-142; 72789-181; 72888-064; 75834-266; 0093-0054; 0093-5200; 42543-787; 42806-663; 42806-664; 55111-472; 63629-2410; 64380-742; 67296-0925; 70518-2300; 70518-2977; 71335-1105; 71335-2073; 0615-8434; 72789-141; 80425-0303; 0904-6899; 0093-1003; 23155-024; 29300-246; 42543-743; 42806-082; 42806-084; 50090-4182; 50090-5347; 51407-413; 51407-414; 51407-416; 55700-837; 55700-869; 63187-221; 63629-2415; 65841-781; 69117-0041; 70518-3091; 71205-280; 71335-0007; 71335-1938; 71335-9673; 71610-183; 71610-208; 71610-487; 75834-268; 53747-040; 23155-023; 51407-201; 51407-417; 51655-796; 53808-1102; 55111-474; 58118-0742; 63629-2414; 0378-1165; 68788-7952; 68788-7968; 69238-1118; 69584-091; 70518-3382; 71335-0222; 71335-1673; 71335-1749; 71335-2081; 71610-165; 71610-307; 71610-404; 72189-175; 75834-270; 29300-245; 43353-060; 50090-5886; 51407-415; 51655-511; 53002-1017; 59651-391
UNII 207LT9J9OC
Synonyms Buspirone | N-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-1-cyclopentanediacetamide | Buspirone Hydrochloride | Hydrochloride, Buspirone | Gen-Buspirone | Gen Buspirone | Lin-Buspirone | Lin Buspirone | MJ-9022-1 | MJ 9022 1 | MJ90221 | Neurosine | Busp | Nu-Buspirone | Nu Buspirone | PMS-Buspirone | PMS Buspirone | Ratio-Buspirone | Ratio Buspirone | Anxut | Apo-Buspirone | Apo Buspirone | Buspar | Bespar | Novo-Buspirone | Novo Buspirone
Chemical Information
Molecular Formula C21H32ClN5O2
CAS Registry Number 33386-08-2
SMILES C1CCC2(C1)CC(=O)N(C(=O)C2)CCCCN3CCN(CC3)C4=NC=CC=N4.Cl
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)
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Salivary hypersecretion07.06.01.009--Not Available
Seizure17.12.03.001--
Serotonin syndrome15.05.04.016; 12.03.01.041; 17.05.02.004--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stupor19.02.05.004; 17.02.04.007--Not Available
Suicidal ideation19.12.01.003--
Syncope24.06.02.012; 17.02.04.008; 02.11.04.015--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thyroid function test abnormal13.10.06.001--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Urinary hesitation20.02.02.009--Not Available
Urinary retention20.02.02.011--
Vision blurred17.17.01.010; 06.02.06.007--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Contusion24.07.06.001; 23.03.11.002; 12.01.06.001; 15.03.05.007--
Ocular discomfort06.08.03.008--Not Available
Respiratory tract congestion22.02.07.003--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Affect lability19.04.01.001--Not Available
Temperature intolerance08.01.09.022--Not Available
Therapeutic reaction time decreased08.06.01.015--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction19.08.04.001; 21.03.01.007--
Inner ear disorder04.04.02.002--Not Available
Psychotic disorder19.03.01.002--
Exposure to noise12.03.05.001--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
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