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
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
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)
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; Available
Atrial fibrillation02.03.03.002--
Atrial septal defect03.07.02.002; Available
Atrioventricular block02.03.01.0020.000280%Not Available
Atrioventricular block second degree02.03.01.0050.000187%
Attention deficit/hyperactivity disorder19.21.04.0010.002057%Not Available
Autism19.22.02.001; Available
Back pain15.03.04.005--
Basophilia01.02.01.009--Not Available
Bipolar I disorder19.16.01.002--Not Available
Bladder pain20.02.02.001--Not Available
Bleeding time prolonged13.01.02.002--Not Available
Blepharitis23.03.04.012; Available
Blindness17.17.01.003; Available
Blister23.03.01.001; Available
Blood creatine phosphokinase increased13.04.01.001--
Blood glucose increased13.02.02.002--Not Available
Blood lactate dehydrogenase increased13.04.02.002--
Blood pressure increased13.14.03.005--Not Available
Blood urea increased13.13.01.006--Not Available
Body temperature decreased13.15.01.010--Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.0040.000561%Not Available
Bradycardia02.03.02.002--Not Available
Bradykinesia17.01.02.0040.000187%Not Available
Breast atrophy21.05.04.005--
The 3th Page    First    Pre   3 4 5 6 7    Next   Last    Total 30 Pages