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)
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Breast enlargement21.05.04.001--Not Available
Breast feeding26.05.01.001--Not Available
Breast neoplasm21.05.01.004; 16.10.02.001--Not Available
Breast pain21.05.05.003--
Breech presentation18.03.04.0010.000187%Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Bronchopulmonary dysplasia22.11.01.001; 18.04.10.0010.000049%Not Available
Bruxism19.11.03.001; 07.01.06.008--Not Available
Bulimia nervosa19.09.01.006; 14.03.03.001--Not Available
Bundle branch block02.03.01.009--Not Available
Bundle branch block right02.03.01.0110.000561%Not Available
Bursitis15.04.01.001--Not Available
C-reactive protein increased13.09.01.007--Not Available
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.009--Not Available
Calculus urinary20.04.02.001--Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002--Not Available
Cardiac murmur13.14.01.0010.009536%Not Available
Cardiac output decreased13.14.02.001--Not Available
Cardiomegaly02.04.02.0010.000293%Not Available
Cardiomyopathy02.04.01.0010.000374%Not Available
Cardiospasm07.02.04.007--Not Available
Cardiovascular disorder24.03.02.009; 02.01.01.001--Not Available
Cataract06.06.01.001--
Cellulitis23.09.01.001; 11.02.01.0010.000280%Not Available
Cerebellar infarction17.08.01.013; 24.04.06.0070.000187%Not Available
Cerebral atrophy17.11.01.0010.000187%Not Available
Cerebral infarction24.04.06.002; 17.08.01.004--Not Available
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