Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Paroxetine impurity a
Drug ID BADD_D01682
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 3038120
TTD Drug ID D06GDY
NDC Product Code 0615-8174; 50268-643; 54766-907; 61919-322; 66267-721; 68071-1594; 68180-647; 70518-1202; 72241-030; 50268-640; 61919-658; 63187-564; 63629-1840; 68788-7410; 69117-0026; 69367-336; 13107-156; 13107-157; 51655-356; 60760-398; 68788-6870; 70518-0739; 70518-1721; 61919-596; 69117-0025; 70518-0003; 71209-094; 13107-155; 50090-0848; 50090-2143; 53002-1174; 63187-434; 63629-3349; 63739-963; 68382-097; 69117-0024; 69367-337; 70518-2574; 71335-0544; 55289-972; 61919-512; 68382-098; 71209-096; 71335-0321; 58118-0183; 60760-501; 68071-1740; 68180-646; 72241-031; 13107-154; 50268-642; 63187-105; 69117-0027; 69367-335; 70518-3277; 71209-095; 43353-713; 43547-409; 63187-190; 63739-888; 68071-1746; 68071-4997; 68180-645; 68382-001; 70954-319; 71610-056; 0574-0279; 0615-8173; 0615-8359; 68382-099; 70518-2465; 72241-029
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 C19H21NO3
CAS Registry Number 112058-81-8
SMILES C1CNCC(C1C2=CC=CC=C2)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 AvailableNot Available
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)
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Withdrawal syndrome19.07.02.005; 08.06.02.012--Not Available
Yawning22.02.05.017--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Musculoskeletal stiffness15.03.01.005--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.001--Not Available
Affect lability19.04.01.001--Not Available
Transaminases increased13.03.01.015--Not Available
Faecaloma07.01.03.004--Not Available
Faecalith07.01.03.007--Not Available
Bipolar disorder19.16.01.003--Not Available
Female sexual dysfunction21.03.02.004; 19.08.05.001--Not Available
Major depression19.15.01.003--Not Available
Nuchal rigidity15.05.04.005; 17.05.02.006--Not Available
Vasodilation procedure25.03.01.001--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002--Not Available
Genital disorder female21.10.05.003--Not Available
Genital disorder male21.10.05.005--Not Available
Mental disorder19.07.01.002--Not Available
Porphyrin metabolism disorder14.14.01.006; 09.01.10.004; 03.08.01.006--Not Available
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Reproductive tract disorder21.10.05.006--Not Available
Ill-defined disorder08.01.03.049--Not Available
Psychotic disorder19.03.01.002--
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