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)
Hyponatraemia14.05.04.002--
Hyporeflexia17.02.01.003--
Hypotension24.06.03.002--
Hypothyroidism14.11.01.012; 05.02.03.001--
Ileus07.13.01.001--
Immunoglobulins increased13.06.05.005--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intestinal obstruction07.13.01.002--Not Available
Iron deficiency anaemia14.13.02.001; 01.03.01.002--Not Available
Jaundice09.01.01.004; 01.06.04.004; 23.03.03.030--Not Available
Keratitis06.04.02.002--
Ketosis14.01.01.001--Not Available
Laryngospasm22.04.02.002--
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Libido increased21.03.02.007; 19.08.03.002--
Liver function test abnormal13.03.01.013--Not Available
Loss of consciousness17.02.04.004--Not Available
Lymphadenopathy01.09.01.002--Not Available
Lymphocyte count abnormal13.01.06.022--Not Available
Lymphocytosis01.02.01.003--Not Available
Lymphoedema01.09.01.006; 24.09.01.001--
Malaise08.01.01.003--
Mania19.16.02.002--
Mass08.03.05.003--Not Available
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