Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Paroxetine hydrochloride
Drug ID BADD_D01680
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 Paroxetine is indicated for the management of depression, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder.[L3358] One form of paroxetine, commercially known as Brisdelle, is used to manage mild to moderate vasomotor symptoms of menopause.[L7703] Off-label, paroxetine may be used for the treatment of premature ejaculation or irritable bowel syndrome (IBS).[A1093,A181754,A181904]
Marketing Status approved; investigational
ATC Code N06AB05
DrugBank ID DB00715
KEGG ID D05374
MeSH ID D017374
PubChem ID 62878
TTD Drug ID D06GDY
NDC Product Code 65862-155; 16714-184; 49999-632; 65841-098; 65862-157; 67544-492; 68084-045; 68084-046; 71335-9650; 60505-0402; 60505-1317; 68084-044; 68788-0797; 0904-5676; 60505-1318; 60505-4520; 69584-673; 60429-735; 60505-4519; 69584-671; 16714-183; 60505-4377; 60505-4379; 68071-4283; 68788-9074; 69584-672; 71335-1205; 65862-154; 43353-845; 43353-994; 60429-736; 65841-099; 65841-601; 65862-156; 61187-005; 16714-182; 60429-737; 60505-0083; 60505-1316; 60505-4517; 60505-4518; 70518-0993; 70518-2871; 55154-7999; 60429-734; 60505-0084; 60505-0097; 62175-470; 62175-471; 67544-317; 62175-472; 63629-8527; 0904-5677; 16714-181; 60505-0101; 60505-4378; 65841-097; 68084-047; 69584-674; 70518-1460; 70518-2118
UNII X2ELS050D8
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 C19H21ClFNO3
CAS Registry Number 78246-49-8
SMILES C1CNCC(C1C2=CC=C(C=C2)F)COC3=CC4=C(C=C3)OCO4.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Anticonvulsant drug level increased13.17.01.009--Not Available
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Vasodilation procedure25.03.01.001--Not Available
Restless legs syndrome15.05.03.012; 17.02.07.008--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Red blood cell abnormality01.07.02.006--Not Available
Psychotic disorder19.03.01.002--
Ulcerative keratitis10.02.01.021; 06.04.02.004--
Bone marrow failure01.03.03.005--
Oropharyngeal discomfort22.12.03.015; 07.05.05.008--Not Available
Acute kidney injury20.01.03.016--
Candida infection11.03.03.021--
Anal incontinence17.05.01.021; 07.01.06.029--
Liver function test increased13.03.04.031--Not Available
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Anisocoria17.02.11.009; 06.05.03.013--Not Available
Female reproductive tract disorder21.10.05.020--Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hypersensitivity pneumonitis10.01.03.056; 22.01.01.027--Not Available
Intermenstrual bleeding21.01.01.015--Not Available
Male reproductive tract disorder21.10.05.024--Not Available
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