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 disorders | D001523 |
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 mesylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BRISDELLE | Sebela Pharmaceuticals | N-204516 RX | 2013-06-28 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| brisdelle | New Drug Application | 2025-04-28 |
| paroxetine | ANDA | 2025-11-17 |
| paroxetine hydrochloride | NDA authorized generic | 2025-09-22 |
| paroxetine hydrochloride anhydrous | ANDA | 2015-11-05 |
| paxil | New Drug Application | 2025-09-22 |
| paxil paxil | New Drug Application | 2020-06-26 |
| paxilcr | New Drug Application | 2011-07-15 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
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HCPCS
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Clinical
Clinical Trials
314 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 1 | 13 | 24 | 33 | 30 | 100 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 13 | 15 | 22 | 25 | 21 | 94 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 5 | 15 | 24 | 21 | 16 | 78 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 6 | 8 | 10 | 5 | 6 | 35 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 3 | 4 | 5 | 11 | 7 | 28 |
| Healthy volunteers/patients | — | — | — | 16 | — | — | 1 | 3 | 20 |
| Panic disorder | D016584 | EFO_0004262 | F41.0 | 1 | 1 | 3 | 7 | 6 | 18 |
| Traumatic stress disorders | D040921 | — | — | 2 | 4 | 3 | 6 | 4 | 17 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | — | 1 | 5 | 7 | 14 |
| Compulsive personality disorder | D003193 | — | F60.5 | — | — | 1 | 5 | 6 | 12 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cognitive dysfunction | D060825 | — | G31.84 | — | — | 1 | — | 3 | 4 |
| Premature ejaculation | D061686 | — | F52.4 | — | — | 2 | — | 2 | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | 1 | — | 1 | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | 1 | — | 1 | 3 |
| Hepatitis c | D006526 | — | B19.2 | — | 1 | 1 | — | 1 | 3 |
| Hepatitis | D006505 | — | K75.9 | — | 1 | 1 | — | 1 | 3 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | — | 1 | — | 1 | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | 1 | — | — | 2 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | 1 | 1 | — | — | 2 |
| Postmenopause | D017698 | — | — | 1 | — | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dysthymic disorder | D019263 | EFO_0008623 | F34.1 | — | 2 | — | — | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 1 | 2 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | 1 | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | 1 | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | — | 1 |
| Fatigue | D005221 | — | R53.83 | — | 1 | — | — | — | 1 |
| Sleep deprivation | D012892 | — | F51.12 | 1 | 1 | — | — | — | 1 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | — | 1 | — | — | — | 1 |
| Hearing loss | D034381 | EFO_0004238 | H91.9 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 3 | — | — | — | 1 | 4 |
| Respiratory insufficiency | D012131 | — | J96.9 | 3 | — | — | — | — | 3 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | — | — | — | 1 | 2 |
| Hypercapnia | D006935 | — | — | 2 | — | — | — | — | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | 1 | — | — | — | — | 1 |
| Anovulation | D000858 | — | — | 1 | — | — | — | — | 1 |
| Phase i metabolic detoxication | D050216 | — | — | 1 | — | — | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 1 | — | — | — | — | 1 |
| Pulmonary fibrosis | D011658 | — | J84.10 | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 4 | 4 |
| Taste disorders | D013651 | — | — | — | — | — | — | 3 | 3 |
| Psychological distress | D000079225 | — | — | — | — | — | — | 3 | 3 |
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | — | — | — | 2 | 2 |
| Hypoglycemia | D007003 | — | E16.2 | — | — | — | — | 2 | 2 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 2 | 2 |
| Parasomnias | D020447 | — | G47.5 | — | — | — | — | 2 | 2 |
| Chronic disease | D002908 | — | — | — | — | — | — | 1 | 1 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | — | 1 | 1 |
| Alcohol-related disorders | D019973 | — | F10 | — | — | — | — | 1 | 1 |
Show 23 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Paroxetine |
| INN | paroxetine |
| 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 class | antidepressants (fluoxetine type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Fc1ccc([C@@H]2CCNC[C@H]2COc2ccc3c(c2)OCO3)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 61869-08-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL490 |
| ChEBI ID | 7936 |
| PubChem CID | 43815 |
| DrugBank | DB00715 |
| UNII ID | 41VRH5220H (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
P2RX4
P2RX4
MPO
MPO
Organism
Homo sapiens
Gene name
P2RX4
Gene synonyms
NCBI Gene ID
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
Mouse ortholog
P2rx4 (18438)
P2X purinoceptor 4 (Q9JJX6)
Variants
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Financial
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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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 23,762 documents
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Safety
Black-box Warning
Black-box warning for: Brisdelle, Paroxetine, Paroxetine hydrochloride, Paroxetine hydrochloride anhydrous, Paxil, Paxil paxil, Paxilcr
Adverse Events
Top Adverse Reactions
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65,490 adverse events reported
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