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 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 D02260
MeSH ID D017374
PubChem ID 9843029
TTD Drug ID D06GDY
NDC Product Code 42858-705; 70518-1253; 71610-243; 42858-707; 63629-9498; 70518-0550; 73377-051; 70518-2376; 43547-348; 55700-503; 63187-927; 70518-2387; 43353-544; 55289-053; 63629-9499; 63629-9500; 0378-7003; 0378-7004; 70518-1406; 53296-0057; 42858-703; 43547-349; 50090-5987; 71205-527; 71610-204; 0615-7985; 62350-0044; 43353-554; 43547-350; 0378-7001; 0378-7002; 70518-2182; 70518-2598; 64220-113; 55289-037; 71205-198; 43547-347
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 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
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)
Eye pain06.08.03.002--
Eyelid ptosis17.17.02.004; 06.05.01.002--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Feeling abnormal08.01.09.014--Not Available
Fibrocystic breast disease21.05.04.018; 16.14.01.003--Not Available
Flatulence07.01.04.002--
Fungal skin infection23.11.03.006; 11.03.05.002--Not Available
Furuncle23.11.02.009; 11.02.05.008--Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.002--
Galactorrhoea21.05.02.002; 05.03.04.002--Not Available
Gastric ulcer07.04.03.002--
Gastritis07.08.02.001--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Generalised tonic-clonic seizure17.12.01.002--Not Available
Gingival bleeding24.07.02.010; 07.09.07.001--Not Available
Gingivitis07.09.10.002; 11.01.04.013--
Glaucoma06.03.01.002--
Glossitis07.14.01.001--Not Available
Goitre14.11.01.008; 05.02.01.001--Not Available
Gout15.01.06.001; 14.09.01.001--Not Available
Guillain-Barre syndrome17.09.01.001; 11.07.01.001; 10.04.10.005--
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematoma24.07.01.001--
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemolytic anaemia01.06.03.002--Not Available
Haemoptysis22.02.03.004; 02.11.04.009; 24.07.01.006--Not Available
Hallucination19.10.04.003--
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001--Not Available
Hepatic necrosis09.01.07.002--
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