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)
Myopathy15.05.05.001--Not Available
Myositis15.05.01.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neck pain15.03.04.009--
Negativism19.05.01.012--Not Available
Neoplasm16.16.02.001--Not Available
Neoplasm malignant16.16.01.001--Not Available
Nephritis20.05.02.001--Not Available
Nephrolithiasis20.04.01.0020.000187%
Nephropathy20.05.03.001--Not Available
Nervous system disorder17.02.10.0010.000280%Not Available
Nervousness19.06.02.003--Not Available
Neuralgia17.02.07.005--
Neuritis17.09.03.001--Not Available
Neurogenic bladder20.03.03.001; 17.10.01.0020.000467%Not Available
Neuroleptic malignant syndrome17.05.02.003; 15.05.04.015; 12.03.01.003; 08.05.01.0050.000073%Not Available
Neuropathy peripheral17.09.03.003--Not Available
Neurosis19.06.01.001--Not Available
Neutropenia01.02.03.004--Not Available
Night blindness14.12.03.001; 06.02.02.003--
Nightmare19.02.03.003--Not Available
Nocturia20.02.03.001--Not Available
Nodal arrhythmia02.03.02.005--Not Available
Normochromic normocytic anaemia01.03.02.005--Not Available
Nystagmus17.02.02.006; 06.05.02.0060.000280%
Obesity14.03.02.009--
Obsessive-compulsive personality disorder19.05.04.001--Not Available
Oculogyric crisis17.01.03.002; 06.05.02.002--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
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