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 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
MeSH ID D017374
PubChem ID 43815
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 41VRH5220H
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
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)
Acute kidney injury20.01.03.016--
Use of accessory respiratory muscles22.12.02.0150.000043%Not Available
Foetal growth restriction18.03.01.0020.000043%
Toxicity to various agents12.03.01.046--Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.023--Not Available
Candida infection11.03.03.021--
Language disorder19.19.01.006; 17.02.08.0150.000064%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.000043%
Liver function test increased13.03.04.031--Not Available
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Gambling disorder19.07.06.015--Not Available
Adenoidal hypertrophy22.04.05.0150.000043%Not Available
Alcohol interaction08.06.03.003--Not Available
Astigmatism06.02.04.0090.000043%Not Available
Drug withdrawal headache17.14.01.006; 08.06.02.011--Not Available
Impulsive behaviour19.18.01.001--Not Available
Intraventricular haemorrhage neonatal24.07.04.029; 18.04.16.002; 17.08.01.0530.000043%Not Available
Large for dates baby18.04.02.0040.000043%Not Available
Mitral valve prolapse02.07.01.0080.000064%Not Available
Mitral valve stenosis02.07.01.0090.000064%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.000300%Not Available
Neuroblastoma17.20.03.002; 16.30.03.002; 05.01.04.0010.000043%Not Available
Persecutory delusion19.10.01.0070.000086%Not Available
Placenta praevia18.05.02.0040.000043%Not Available
Pulmonary artery stenosis24.04.09.011; 22.06.03.0060.000064%Not Available
Pulmonary valve stenosis02.07.04.0050.000600%Not Available
Social anxiety disorder19.06.03.0100.000043%Not Available
Speech disorder developmental19.19.01.003; 17.02.08.0110.000150%Not Available
Transient tachypnoea of the newborn22.11.01.010; 18.04.09.0100.000086%Not Available
Umbilical cord around neck18.04.14.0040.000043%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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