Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Paroxetine hydrochloride hemihydrate
Drug ID BADD_D01681
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 D02260
MeSH ID D017374
PubChem ID 9843029
TTD Drug ID D06GDY
NDC Product Code 0378-7002; 42858-705; 70518-1253; 62350-0044; 53296-0057; 71205-198; 71610-243; 55700-379; 0378-7003; 71205-527; 70518-2598; 68788-7677; 43353-544; 0615-7985; 72969-054; 43547-347; 0378-7001; 50090-4838; 70518-2376; 70518-0550; 0378-7004; 70518-2182; 43547-348; 71610-204; 71335-0675; 70518-2387; 63187-927; 43547-349; 42858-703; 43353-554; 73377-051; 50090-4207; 64220-113; 55700-503; 43547-350; 42858-707; 71335-1506; 55289-037; 53002-2174; 70934-107; 71335-0603; 55289-053
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 C19H23ClFNO4
CAS Registry Number 110429-35-1
SMILES C1CNCC(C1C2=CC=C(C=C2)F)COC3=CC4=C(C=C3)OCO4.O.Cl
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)
Urinary casts13.13.02.014--Not Available
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary retention20.02.02.011--
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria23.04.02.001; 10.01.06.001--
Uterine spasm21.07.03.002--Not Available
Vaginal discharge21.08.02.002--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vaginal infection11.01.10.002; 21.14.02.002--
Varicose vein24.10.04.001--Not Available
Vascular headache17.14.01.005; 24.03.05.007--Not Available
Vascular purpura24.07.06.011; 23.06.01.008; 01.01.04.007--Not Available
Ventricular extrasystoles02.03.04.007--Not Available
Ventricular fibrillation02.03.04.008--
Ventricular tachycardia02.03.04.010--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Visual impairment06.02.06.008--Not Available
Vomiting07.01.07.003--
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
Inappropriate antidiuretic hormone secretion05.03.03.001; 14.05.07.001--Not Available
Affect lability19.04.01.001--Not Available
Transaminases increased13.03.01.015--Not Available
Faecaloma07.01.03.004--Not Available
Paraesthesia oral17.02.06.008; 07.05.03.003--Not Available
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