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Drug ReportsParoxetine
Paroxetine
Brisdelle, Paroxetine, Paxil (paroxetine) is a small molecule pharmaceutical. Paroxetine was first approved as Paxil on 1992-12-29. It is used to treat depressive disorder, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, and phobic disorders amongst others in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter. In addition, it is known to target P2X purinoceptor 4.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Brisdelle, Paroxetine, Paxil (discontinued: Paroxetine, Paxil, Pexeva)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Paroxetine hydrochloride
Tradename
Company
Number
Date
Products
PAXILApotexN-020031 RX1992-12-29
4 products, RLD, RS
PAXIL CRApotexN-020936 RX1999-02-16
3 products, RLD
Show 3 discontinued
Paroxetine mesylate
Tradename
Company
Number
Date
Products
BRISDELLESebela PharmaceuticalsN-204516 RX2013-06-28
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
paroxetineANDA2025-02-10
paroxetine hydrochlorideANDA2024-09-06
paroxetine hydrochloride anhydrousANDA2015-11-05
paxilNew Drug Application2024-09-10
paxil paxilNew Drug Application2020-06-26
paxilcrNew Drug Application2011-07-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
panic disorderEFO_0004262D016584F41.0
post-traumatic stress disordersEFO_0001358D013313F43.1
obsessive-compulsive disorderEFO_0004242D009771F42
depressive disorderEFO_1002014D003866F32.A
feeding and eating disorders—D001068F50
phobic disordersEFO_1001908D010698F40
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Paroxetine Mesylate, Brisdelle, Sebela Ireland Ltd
86586632029-04-06DS, DPU-904
89462512026-08-04DS, DPU-904
93932372026-08-04U-904
75982712025-05-04DP
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AB: Selective serotonin reuptake inhibitors
— N06AB05: Paroxetine
HCPCS
No data
Clinical
Clinical Trials
308 clinical trials
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Indications Phases 4
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Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
MalnutritionD044342EFO_0008572E40-E461————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameParoxetine
INNparoxetine
Description
Paroxetine is a benzodioxole that consists of piperidine bearing 1,3-benzodioxol-5-yloxy)methyl and 4-fluorophenyl substituents at positions 3 and 4 respectively; the (3S,4R)-diastereomer. Highly potent and selective 5-HT uptake inhibitor that binds with high affinity to the serotonin transporter (Ki = 0.05 nM). Ki values are 1.1, 350 and 1100 nM for inhibition of [3H]-5-HT, [3H]-l-NA and [3H]-DA uptake respectively. Displays minimal affinity for alpha1-, alpha2- or beta-adrenoceptors, 5-HT2A, 5-HT1A, D2 or H1 receptors at concentrations below 1000 nM, however displays weak affinity for muscarinic ACh receptors (Ki = 42 nM). Antidepressant and anxiolytic in vivo. It has a role as an antidepressant, an anxiolytic drug, a serotonin uptake inhibitor, a hepatotoxic agent and a P450 inhibitor. It is a member of piperidines, a member of benzodioxoles, an organofluorine compound and an aromatic ether. It is functionally related to a monofluorobenzene. It is a conjugate base of a paroxetinium(1+).
Classification
Small molecule
Drug classantidepressants (fluoxetine type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1
Identifiers
PDB—
CAS-ID61869-08-7
RxCUI—
ChEMBL IDCHEMBL490
ChEBI ID7936
PubChem CID43815
DrugBankDB00715
UNII ID41VRH5220H (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
P2RX4
P2RX4
MPO
MPO
Organism
Homo sapiens
Gene name
P2RX4
Gene synonyms
NCBI Gene ID
5025
Protein name
P2X purinoceptor 4
Protein synonyms
ATP receptor, ATP-gated cation channel protein, P2X receptor, subunit 4, Purinergic receptor, purinergic receptor P2X, ligand gated ion channel, 4, purinergic receptor P2X4, purinoceptor P2X4
Uniprot ID
Q99571
Mouse ortholog
P2rx4 (18438)
P2X purinoceptor 4 (Q9JJX6)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Paroxetine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 22,188 documents
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Safety
Black-box Warning
Black-box warning for: Paroxetine, Paroxetine hydrochloride, Paroxetine hydrochloride anhydrous, Paxil, Paxil paxil, Paxilcr
Adverse Events
Top Adverse Reactions
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63,890 adverse events reported
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