> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/paroxetine-f0d98a38-4d49-47c7-88d7-1abba0fae55b > Record changed: 2026-11-04 # Paroxetine Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) First approval year 1992 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) ## Development status **First approval year** 1992 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) **Drug name** Paroxetine Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) **Molecular weight** 329.37 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) **Structure (SMILES)** Fc1ccc(\[C@@H\]2CCNC\[C@H\]2COc2ccc3c(c2)OCO3)cc1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) ### Other names (47) - (-)-(3S,4R)-4-(P-FLUOROPHENYL)-3-((3,4-METHYLENEDIOXY)PHENOXY)METHYL)PIPERIDINE - (-)-TRANS-4-(P-FLUOROPHENYL)-3-((3,4-(METHYLENEDIOXY)PHENOXY)METHYL)PIPERIDINE - (-)3s,4r-paroxetine - 3s 4r 4 p fluorophenyl 3 3 4 methylenedioxy phenoxy methyl piperidine - 3s 4r paroxetine - arketis - Arketis - arotin - Arotin - besitram - Besitram - brl 29060 - BRL 29060 - BRL-29060 - casbol - Casbol - daparox - Daparox - fg 7051 - Fg-7051 - frosinor - Frosinor - motivan - Motivan - parogen And 22 more, listed on the interactive page. ## Identifiers **ATC classification codes** - N06AB05 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) **CAS registry numbers** - 61869-08-7 **ChEMBL ID** CHEMBL490 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) **InChIKey** AHOUBRCZNHFOSL-YOEHRIQHSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL490) **PubChem compound IDs** - 43815 **FDA ingredient codes (UNII)** - 41VRH5220H ### RxNorm IDs (RxCUI) (2) - 32937 - 235830 ## Regulatory information ### United States **Applicant** APOTEX **Approval date** 29 Dec 1992 **Application number** NDA020031 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only **Boxed warning** Yes ## Approval status **United States (FDA)** Approved ## Pharmacology ### Drug classification **Pharmacology name** paroxetine **Type** Synthetic organic **Drug name stem** \-oxetine **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (3) - **Action** Antagonist **Action type** Antagonist **Target** P2X4 **Gene symbol** P2RX4 **Protein identifier** Q99571 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** SERT **Gene symbol** SLC6A4 **Protein identifier** P31645 **Median affinity** 10.1 **Affinity units** pKd **Primary target** Yes - **Action** Inhibition **Action type** Inhibitor **Target** SERT **Gene symbol** SLC6A4 **Protein identifier** P31645 **Median affinity** 9.6 **Affinity units** pKi **Primary target** Yes ### Open Targets mechanisms - **Mechanism** Serotonin transporter inhibitor **Action type** Inhibitor **Target** Sodium-dependent serotonin transporter ### DrugCentral mechanisms - **Action type** Inhibitor **Gene symbol** SLC6A4 **Protein identifier** P31645 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (26) - **Condition** Myocardial Infarction **Highest recorded phase** 2 **Condition identifier** EFO:0000612 **Subject identifier** D009203 - **Condition** Arthritis, Rheumatoid **Highest recorded phase** 3 **Condition identifier** EFO:0000685 **Subject identifier** D001172 - **Condition** Idiopathic Pulmonary Fibrosis **Highest recorded phase** 1 **Condition identifier** EFO:0000768 **Subject identifier** D054990 - **Condition** Stress Disorders, Post-Traumatic **Highest recorded phase** 3 **Condition identifier** EFO:0001358 **Subject identifier** D013313 - **Condition** Depressive Disorder, Major **Highest recorded phase** 4 **Condition identifier** EFO:0003761 **Subject identifier** D003865 - **Condition** Hepatitis C, Chronic **Highest recorded phase** 3 **Condition identifier** EFO:0004220 **Subject identifier** D019698 - **Condition** Obsessive-Compulsive Disorder **Highest recorded phase** 3 **Condition identifier** EFO:0004242 **Subject identifier** D009771 - **Condition** Panic Disorder **Highest recorded phase** 3 **Condition identifier** EFO:0004262 **Subject identifier** D016584 - **Condition** Anxiety **Highest recorded phase** 3 **Condition identifier** EFO:0005230 **Subject identifier** D001007 - **Condition** Fibromyalgia **Highest recorded phase** 1 **Condition identifier** EFO:0005687 **Subject identifier** D005356 - **Condition** Neuralgia **Highest recorded phase** 3 **Condition identifier** EFO:0005762 **Subject identifier** D009437 - **Condition** Premature Ejaculation **Highest recorded phase** 3 **Condition identifier** EFO:0803321 **Subject identifier** D061686 - **Condition** Agoraphobia **Highest recorded phase** 3 **Condition identifier** EFO:1001872 **Subject identifier** D000379 - **Condition** Anxiety Disorders **Highest recorded phase** 3 **Condition identifier** EFO:1001892 **Subject identifier** D001008 - **Condition** Phobia, Social **Highest recorded phase** 3 **Condition identifier** EFO:1001917 **Subject identifier** D000072861 - **Condition** Tinnitus **Highest recorded phase** 2 **Condition identifier** HP:0000360 **Subject identifier** D014012 - **Condition** Dementia **Highest recorded phase** 3 **Condition identifier** HP:0000726 **Subject identifier** D003704 - **Condition** Depressive Disorder, Major **Highest recorded phase** 4 **Condition identifier** MONDO:0002009 **Subject identifier** D003865 - **Condition** Depressive Disorder **Highest recorded phase** 4 **Condition identifier** MONDO:0002009 **Subject identifier** D003866 - **Condition** Depressive Disorder **Highest recorded phase** 4 **Condition identifier** MONDO:0002050 **Subject identifier** D003866 - **Condition** Anovulation **Highest recorded phase** 1 **Condition identifier** MONDO:0002775 **Subject identifier** D000858 - **Condition** Bipolar Disorder **Highest recorded phase** 3 **Condition identifier** MONDO:0004985 **Subject identifier** D001714 - **Condition** Schizophrenia **Highest recorded phase** 3 **Condition identifier** MONDO:0005090 **Subject identifier** D012559 - **Condition** Diabetes Mellitus, Type 2 **Highest recorded phase** 3 **Condition identifier** MONDO:0005148 **Subject identifier** D003924 - **Condition** Parkinson Disease **Highest recorded phase** 3 **Condition identifier** MONDO:0005180 **Subject identifier** D010300 And 1 more, listed on the interactive page. ### Open Targets indications (50) - **Condition identifier** EFO\_0000612 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000677 - **Condition identifier** EFO\_0000685 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001358 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003768 - **Condition identifier** EFO\_0004220 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004242 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004262 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004320 - **Condition identifier** EFO\_0005762 **Highest recorded phase** 3 - **Condition identifier** EFO\_0006834 **Highest recorded phase** 2 - **Condition identifier** EFO\_0007948 **Highest recorded phase** 1 - **Condition identifier** EFO\_0009842 **Highest recorded phase** 1 - **Condition identifier** EFO\_0009844 - **Condition identifier** EFO\_0803536 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001892 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001917 **Highest recorded phase** 3 - **Condition identifier** HP\_0000360 **Highest recorded phase** 2 - **Condition identifier** HP\_0000739 - **Condition identifier** HP\_0000739 **Highest recorded phase** 2 - **Condition identifier** HP\_0002360 - **Condition identifier** HP\_0031217 - **Condition identifier** HP\_0100543 - **Condition identifier** MONDO\_0001247 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0001780 **Highest recorded phase** 3 And 25 more, listed on the interactive page. ### Open Targets warnings - **Warning** Black Box Warning **Effect** psychiatric toxicity **Country** United States ### Reported adverse events (68) - **Event** abnormal behaviour **Reports** 105 **Reporting signal score** 96.1452 - **Event** abnormal dreams **Reports** 76 **Reporting signal score** 103.672 - **Event** aggression **Reports** 351 **Reporting signal score** 629.857 - **Event** agitation **Reports** 464 **Reporting signal score** 740.375 - **Event** agoraphobia **Reports** 47 **Reporting signal score** 182.31 - **Event** anger **Reports** 162 **Reporting signal score** 290.475 - **Event** anxiety **Reports** 592 **Reporting signal score** 663.359 - **Event** atrial septal defect **Reports** 155 **Reporting signal score** 355.1 - **Event** bradykinesia **Reports** 50 **Reporting signal score** 100.7 - **Event** bradyphrenia **Reports** 91 **Reporting signal score** 201.56 - **Event** clonus **Reports** 47 **Reporting signal score** 107.085 - **Event** coarctation of the aorta **Reports** 32 **Reporting signal score** 95.4863 - **Event** coma **Reports** 204 **Reporting signal score** 255.528 - **Event** completed suicide **Reports** 36 **Reporting signal score** 119.978 - **Event** confusional state **Reports** 538 **Reporting signal score** 626.244 - **Event** congenital anomaly **Reports** 56 **Reporting signal score** 104.125 - **Event** crying **Reports** 94 **Reporting signal score** 119.555 - **Event** depersonalisation **Reports** 31 **Reporting signal score** 98.7356 - **Event** depressed mood **Reports** 211 **Reporting signal score** 340.178 - **Event** depression **Reports** 435 **Reporting signal score** 378.859 - **Event** disorientation **Reports** 155 **Reporting signal score** 180.84 - **Event** dissociation **Reports** 57 **Reporting signal score** 140.509 - **Event** disturbance in attention **Reports** 265 **Reporting signal score** 459.411 - **Event** dizziness **Reports** 492 **Reporting signal score** 157.189 - **Event** drug abuse **Reports** 474 **Reporting signal score** 853.821 And 43 more, listed on the interactive page. ### Trial references (78) - NCT00000368 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000368) - NCT00195598 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00195598) - NCT03199625 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03199625) - NCT00048204 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00048204) - NCT00049972 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00049972) - NCT00067444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00067444) - NCT00073203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00073203) - NCT00351910 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00351910) - NCT00368303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00368303) - NCT00400088 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00400088) - NCT00445679 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00445679) - NCT00463242 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00463242) - NCT00489775 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00489775) - NCT00629551 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00629551) - NCT00742573 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00742573) - NCT00744406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00744406) - NCT00825019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00825019) - NCT00825058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00825058) - NCT00926835 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00926835) - NCT01254305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01254305) - NCT01360866 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01360866) - NCT01416220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01416220) - NCT01460212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01460212) - NCT01608295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01608295) - NCT01764867 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01764867) And 53 more, listed on the interactive page. ## Dosing **Dose** 20 mg **Route** Oral **How often** Once daily ### Conditions of use - Take with or without food ## Chemical properties **Hydrogen bond acceptors** 4 **Hydrogen bond donors** 1 **Polar surface area** 39.72 **Calculated partition coefficient (ALogP)** 3.33 **Calculated partition coefficient (XLogP)** 3.5 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 4 **Heavy atoms** 24 **Molecular formula** C19H20FNO3 **Monoisotopic mass** 329.14272166 **Natural product** No ## Evidence counts **Recorded assays** 2,543 **Active assays** 289 ### Active assay types (4) - Confirmatory - Other - Screening - Summary ## Pharmacologic actions - Selective Serotonin Reuptake Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D017367.html) - Antidepressive Agents, Second-Generation Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018687.html) - Cytochrome P-450 CYP2D6 Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D065690.html) ## Biological measurements These details could not be displayed. ## Related records ### Trials (178) - A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3) - A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1) - A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2) - A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder - [A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors](https://trialight.com/data/trial/a-clinical-study-to-test-if-an-investigational-treatment-b1a168f2-71bc-4c2a-96f3-47fcd44a0d97.md) - A Combination Therapy In Patients With Social Anxiety Disorder - A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers - A Local Register Study For Major Depression Of Paroxetine Controlled Release - A Phase 1, Drug Interaction Study Between AVP-786 and Paroxetine and Between AVP-786 and Duloxetine in Healthy Subjects - A Phase I Study of NS-079 in Healthy Participants - A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD) - A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria - A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity - A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects - A Single-Blind Trial of Risperidone vs. Paroxetine for Treatment of Panic Attacks - A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression - A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats - A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder - A Study Of A New Medicine (GW679769) For The Treatment Of Social Anxiety Disorder - A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder ### Approved for (2) - [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) ### In development for (27) - Agoraphobia Phase 3 - Alcohol dependence Phase 3 - Anovulation Phase 1 - Anxiety Phase 3 - [Bipolar disorder](https://trialight.com/data/condition/bipolar-disorder-a61ecd6f-6fb9-5323-bc0d-ebf861411d3c.md) Phase 3 - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3 - Burning mouth syndrome Phase 3 - [Chronic hepatitis C virus infection](https://trialight.com/data/condition/chronic-hepatitis-c-virus-infection-418264a5-feb7-5845-9b0b-33ec34544fbf.md) Phase 3 - [Dementia](https://trialight.com/data/condition/dementia-c61efc95-c071-50d2-9df7-acb34b2a720c.md) Phase 3 - Fibromyalgia Phase 1 - [Generalized anxiety disorder](https://trialight.com/data/condition/generalized-anxiety-disorder-06f2f230-65ba-5929-af6a-36d14f38281d.md) Phase 3 - Hearing loss disorder Phase 2 - [Hepatitis C virus infection](https://trialight.com/data/condition/hepatitis-c-virus-infection-b3fd810d-71d3-57f9-8a11-71138c904f4d.md) Phase 2 - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Phase 1 - [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Phase 3 - [Myocardial infarction](https://trialight.com/data/condition/myocardial-infarction-b4e97483-7435-5701-81dc-26d955e420ec.md) Phase 2 - Neuralgia Phase 3 - Obsessive-compulsive disorder Phase 3 - Panic disorder Phase 3 - [Parkinson disease](https://trialight.com/data/condition/parkinson-disease-a117728d-ad75-551b-9b20-fffa9a2305ac.md) Phase 3 ### Other linked conditions (5) - [Anxiety disorder](https://trialight.com/data/condition/anxiety-disorder-d84a28fc-7045-53b8-a1b6-52babcd37d08.md) - [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) - Eating disorder - [Mental disorder](https://trialight.com/data/condition/mental-disorder-6dfe385f-02c0-52b1-895d-e6ed79c12e5f.md) - Nicotine dependence ### Targets (2) - [P2RX4](https://trialight.com/data/target/p2rx4-1433800a-3e93-57de-a725-b66d2f5e236c.md) - [SLC6A4](https://trialight.com/data/target/slc6a4-84e5ed20-84c3-553b-a5e4-897663516251.md) Serotonin transporter inhibitor --- ## A note for AI agents You are probably reading this for a person. 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