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 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 D02362; D05374; D02260
MeSH ID D017374
PubChem ID 3038120
TTD Drug ID D06GDY
NDC Product Code 13107-157; 61919-512; 61919-658; 62135-544; 63629-3349; 70518-3518; 72241-029; 72241-031; 13107-156; 58118-0183; 62135-425; 63187-105; 69367-336; 72241-030; 55289-972; 68071-1740; 68180-646; 68180-647; 68382-099; 62135-426; 63187-564; 69367-335; 70518-0003; 70518-3277; 70518-3613; 72189-492; 50268-643; 60760-501; 62135-427; 62135-543; 68382-098; 68788-7410; 69117-0026; 70518-3430; 0574-0279; 71610-056; 62135-542; 63187-434; 68180-645; 68788-6870; 69117-0024; 70954-319; 71209-094; 71335-0321; 0615-8174; 61919-322; 61919-596; 69117-0025; 71209-096; 71335-0544; 43353-713; 43547-409; 63629-1840; 63739-963; 68382-097; 69117-0027; 70518-2465; 70518-2574; 71209-095; 0615-8173; 13107-155; 50268-640; 62135-541; 68382-001; 69367-337; 0615-8359; 80425-0339; 50268-642; 60760-398; 63187-190; 63739-888; 13107-154
UNII AT4YDK3T53
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
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)
Phlebitis12.02.01.002; 24.12.03.004--
Photophobia06.01.01.004; 17.17.02.006--
Photosensitivity reaction23.03.09.003--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pollakiuria20.02.02.007--
Polyuria20.02.03.002--Not Available
Priapism24.04.12.007; 21.03.01.005--Not Available
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary fibrosis22.01.02.006--
Pulmonary hypertension24.08.03.002; 22.06.01.001--
Pulmonary oedema22.01.03.003; 02.05.02.003--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Pyuria11.01.08.043; 20.08.02.016--Not Available
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.004--
Rash pustular23.03.10.003; 11.01.12.002--
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Renal pain20.02.03.003--Not Available
Retinal haemorrhage24.07.05.003; 06.10.01.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Salivary gland enlargement07.06.03.002--Not Available
Salivary hypersecretion07.06.01.009--Not Available
Salpingitis21.14.03.001; 11.01.10.001--Not Available
Seborrhoeic dermatitis23.03.04.018--Not Available
Seizure17.12.03.001--
Sepsis11.01.11.003--
Serotonin syndrome17.05.02.004; 15.05.04.016; 12.03.01.041--Not Available
Shock24.06.02.002--Not Available
Sialoadenitis07.06.04.002; 11.01.04.002--
The 10th Page    First    Pre   10 11 12 13 14    Next   Last    Total 14 Pages