Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Paroxetine
Drug ID BADD_D01679
Description Paroxetine is a selective serotonin reuptake inhibitor (SSRI) drug commonly known as Paxil. It has a variety of uses, including the treatment of anxiety disorders, major depression, posttraumatic stress disorder, and symptoms of menopause, among others.[T653] It was approved by the FDA in the early 1990s and marketed by SmithKline Beecham.[L7712,L7715] A unique feature of this drug is that it is highly potent and selective in its inhibition of serotonin reuptake and has little effect on other neurotransmitters.[A31914] Because of its potent inhibition of serotonin reuptake, paroxetine is more likely to cause withdrawal effects upon cessation. Paroxetine is well tolerated in most patients with a similar adverse effect profile to other members of its drug class.[A31914] The controlled release formulation was designed to decrease the likelihood of nausea that is sometimes associated with paroxetine.[L7700,L7742]
Indications and Usage Labeled indications include: major depressive disorder (MDD), panic disorder with or without agoraphobia, obsessive-compulsive disorder (OCD), social anxiety disorder (social phobia), generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). Unlabeled indications include: eating disorders, impulse control disorders, vasomotor symptoms of menopause, obsessive-compulsive disorder (OCD) in children, and mild dementia-associated agitation in nonpsychotic individuals. Brisdelle, which consists of paroxetine mesylate is indicated for the treatment of moderate to severe vasomotor symptoms (like hot flashes) associated with menopause.
Marketing Status Prescription; Discontinued
ATC Code N06AB05
DrugBank ID DB00715
KEGG ID D02362
MeSH ID D017374
PubChem ID 43815
TTD Drug ID D06GDY
NDC Product Code 53002-1174; 71209-095; 70518-0739; 71209-096; 50268-640; 68180-646; 70954-319; 69117-0027; 58118-0183; 69117-0026; 54766-907; 68382-001; 69367-337; 61919-512; 71335-0544; 61919-658; 70518-1721; 0574-0279; 68071-1594; 63187-564; 68180-647; 70518-1202; 13107-156; 13107-157; 68382-099; 68071-1746; 68180-645; 69367-335; 63629-1840; 0615-8173; 55289-972; 50268-643; 68788-6870; 43547-409; 68788-7410; 69367-336; 68071-4997; 50090-0848; 70518-0003; 71335-0321; 63187-190; 72241-030; 72241-031; 63739-963; 68382-097; 70518-2465; 0615-8174; 60760-501; 63629-3349; 60760-398; 68071-1740; 13107-155; 63187-105; 66267-721; 69117-0025; 63187-434; 71610-056; 13107-154; 61919-322; 71209-094; 43353-713; 70518-2574; 72241-029; 51655-356; 61919-596; 50090-2143; 63739-888; 69117-0024; 68382-098; 70518-3277; 50268-642; 0615-8359
Synonyms Paroxetine | Aropax | BRL-29060 | BRL 29060 | BRL29060 | FG-7051 | FG 7051 | FG7051 | Paroxetine Acetate | Seroxat | Paroxetine Hydrochloride Anhydrous | Paroxetine Maleate | Paroxetine, cis-(+)-Isomer | Paroxetine, cis-(-)-Isomer | Paroxetine, trans-(+)-Isomer | Paxil | Paroxetine Hydrochloride Hemihydrate | Paroxetine Hydrochloride, Hemihydrate | Paroxetine Hydrochloride
Chemical Information
Molecular Formula C19H20FNO3
CAS Registry Number 61869-08-7
SMILES C1CNCC(C1C2=CC=C(C=C2)F)COC3=CC4=C(C=C3)OCO4
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Metabolic disorderActivity-regulated cytoskeleton-associated proteinQ9WV31Not Available14580947; 15838995; 15087240
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Macrocephaly15.11.02.007; 03.11.02.0070.000049%Not Available
Right ventricular hypertrophy02.04.02.0340.000561%Not Available
Congenital scoliosis15.11.04.004; 03.11.04.0040.000561%Not Available
Congenital multiplex arthrogryposis15.11.06.007; 03.11.06.0070.000280%Not Available
Congenital pulmonary valve atresia03.07.05.009; 02.07.04.0030.000187%Not Available
Cleft uvula07.05.01.014; 03.04.03.0020.000280%Not Available
External auditory canal atresia04.01.01.005; 03.13.01.0050.000073%Not Available
Holoprosencephaly17.19.01.010; 03.10.03.0070.000073%Not Available
Aortic occlusion24.04.01.0050.000467%Not Available
Urethral meatus stenosis20.07.03.0010.000049%Not Available
Rib deformity15.10.06.0010.000073%Not Available
Congenital aortic anomaly24.03.03.021; 03.07.08.0030.000467%Not Available
Congenital cardiovascular anomaly24.03.03.011; 03.07.10.001; 02.08.02.0040.000935%Not Available
Congenital coronary artery malformation24.03.03.023; 03.07.09.0030.000374%Not Available
Congenital pulmonary valve disorder03.07.05.010; 02.07.04.0040.000280%Not Available
Foot deformity15.10.03.0050.000654%Not Available
Neck deformity15.10.04.0090.000187%Not Available
Skull fracture15.08.04.002; 12.04.05.0030.000049%Not Available
Tricuspid valve disease02.07.05.0040.000280%
Congenital optic nerve anomaly17.19.02.006; 06.13.01.005; 03.01.10.0010.000049%Not Available
Aortic valve disease02.07.03.0020.000654%
Deformity08.01.03.0220.000187%Not Available
Nose deformity15.10.05.0060.000280%Not Available
Gastrointestinal disorder congenital07.11.01.026; 03.04.07.0080.000748%Not Available
Congenital neurological disorder17.02.10.021; 03.10.01.0060.000049%Not Available
Congenital nose malformation22.10.02.003; 03.16.04.0010.000187%Not Available
Bicuspid pulmonary valve03.07.05.004; 02.07.04.0020.000187%Not Available
Atrioventricular septal defect03.07.02.005; 02.04.02.0290.000467%Not Available
Congenital heart valve disorder03.07.05.001; 02.07.02.0020.001309%Not Available
Amniotic band syndrome18.05.01.006; 15.11.07.017; 03.11.07.0170.000187%Not Available
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