Prescription medicine
Paroxetine Brand names: Paxil, Brisdelle
Paroxetine (Paxil) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 45 generic labelers, and pharmacies paid $0.0611 per paroxetine HCl 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the paroxetine FDA label on DailyMed (effective February 12, 2026, Mylan Pharmaceuticals Inc.); the NDA 20031 record on Drugs@FDA; every paroxetine label on DailyMed.
Highlights of the record
FDA label of February 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SUICIDAL THOUGHTS AND BEHAVIORS.
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ]. Paroxetine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Paroxetine tablets are not approved for use in pediatric patients.
Used for
From the label: indications and usageParoxetine tablets are indicated in adults for the treatment of:
Major depressive disorder (MDD)
Obsessive compulsive disorder (OCD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Generalized anxiety disorder (GAD)
Posttraumatic stress disorder (PTSD) Paroxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ):
Major Depressive Disorder (MDD)
Forms and strengths
- 7.5 mg
- 10 mg
- 12.5 mg
- 20 mg
- 25 mg
- 30 mg
- 37.5 mg
- 40 mg
- 10 mg/5ml
Film-coated tablet; film-coated extended-release tablet; capsule; suspension.
On the market
- Earliest approval on file
- December 29, 1992 Paxil, Apotex; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 29 first July 30, 2003; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 48 of which 45 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 6, 2029 Brisdelle capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0611 per tablet Paroxetine HCl 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 15 since 2013 0 Class I among all firms' recalls; latest August 13, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 41,809 through July 30, 2026
What is paroxetine used for?
From the label: indications and usageParoxetine tablets are indicated in adults for the treatment of:
Major depressive disorder (MDD)
Obsessive compulsive disorder (OCD)
Panic disorder (PD)
Social anxiety disorder (SAD)
Generalized anxiety disorder (GAD)
Posttraumatic stress disorder (PTSD) Paroxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of ( 1 ):
Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Generalized Anxiety Disorder (GAD)
Posttraumatic Stress Disorder (PTSD)
Conditions named in the indications of paroxetine's FDA labels, with every medicine labeled for each:
From other paroxetine labelsMenopause symptoms: Paroxetine Capsules are indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
FDA pharmacologic class: Serotonin Reuptake Inhibitor.
Source: FDA drug label (Paroxetine), Mylan Pharmaceuticals Inc., effective February 12, 2026 (SPL set 89dd7e24-85fc-4152-89ea-47ec2b48a1ed), via openFDA; the full label on DailyMed
What does the patient leaflet for paroxetine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about paroxetine tablets?Paroxetine tablets can cause serious side effects, including: • Increased risk of suicidal thoughts or actions. Paroxetine tablets and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Paroxetine tablets are not for use in children. o Depression or other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions? o Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. o Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: o attempts to commit suicide o acting aggressive or violent o new or worse depression o feeling agitated, restless, angry, or irritable o an increase in activity and talking more than what is normal for you o acting on dangerous impulses o thoughts about suicide or dying o new or worse anxiety or panic attacks o trouble sleeping o other unusual changes in behavior or mood
From the patient leaflet: How should I store paroxetine tablets?Store paroxetine tablets between 20° to 25°C (68° to 77°F). Keep paroxetine tablets and all medicines out of the reach of children.
Source: FDA drug label (Paroxetine), Mylan Pharmaceuticals Inc., effective February 12, 2026 (SPL set 89dd7e24-85fc-4152-89ea-47ec2b48a1ed), via openFDA; the full label on DailyMed
Is there a generic for paroxetine (Paxil)?
The FDA approved the first generic paroxetine on July 30, 2003. 29 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists paroxetine from 45 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Paxil CR tablets; a patent listed only for Brisdelle capsules runs to April 6, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1992 earliest approval on file
- 2003 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for paroxetine (Paxil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0611 per Paroxetine HCl 20 mg tablet, down 16% from $0.0729 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Paroxetine HCl 20 mg tablet (generic)
- Paxil 20 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Paroxetine cr 12.5 mg tablet | Generic | $0.520 per tablet | $15.60 | +5% |
| Paroxetine cr 25 mg tablet | Generic | $0.386 per tablet | $11.57 | -21% |
| Paroxetine cr 37.5 mg tablet | Generic | $0.397 per tablet | $11.92 | -28% |
| Paroxetine ER 12.5 mg tablet | Generic | $0.520 per tablet | $15.60 | +5% |
| Paroxetine ER 25 mg tablet | Generic | $0.386 per tablet | $11.57 | -21% |
| Paroxetine ER 37.5 mg tablet | Generic | $0.397 per tablet | $11.92 | -28% |
| Paroxetine HCl 10 mg tablet | Generic | $0.0619 per tablet | $1.86 | -8% |
| Paroxetine HCl 10 mg/5 mL suspension | Generic | $1.40 per mL | n/a | +5% |
| Paroxetine HCl 20 mg tablet | Generic | $0.0611 per tablet | $1.83 | -16% |
| Paroxetine HCl 30 mg tablet | Generic | $0.0954 per tablet | $2.86 | -5% |
| Paroxetine HCl 40 mg tablet | Generic | $0.0965 per tablet | $2.90 | -10% |
| Paroxetine mesylate 7.5 mg capsule | Generic | $2.62 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $78.67 | +11% |
| Paxil 20 mg tablet | Brand | $10.74 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $322.12 | +9% |
| Paxil 30 mg tablet | Brand | $10.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $324.22 | +7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has paroxetine been recalled?
The FDA's Enforcement Report lists 16 recalls naming paroxetine since 2013: 0 Class I (the most serious), 15 Class II, 1 Class III; 5 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of paroxetine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 13, 2026 | Class II | Apotex Corp. | Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria |
| November 10, 2023 | Class II | Golden State Medical Supply Inc. | Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose … |
| November 1, 2023 | Class II | Apotex Corp. | Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine |
| November 20, 2017 | Class II | Zydus Pharmaceuticals USA Inc | Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets |
| October 24, 2017 | Class II | Amerisource Health Services | Presence of Foreign Tablets/Capsules. |
| August 18, 2017 | Class II | Zydus Pharmaceuticals USA Inc | Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets |
| June 22, 2017 | Class III | Lupin Pharmaceuticals Inc. | Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study. |
| March 24, 2014 | Class II | Apotex Inc. | Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the paroxetine label say about other medicines?
The paroxetine label names 42 other medicines in its interaction, contraindication or warning sections. The labels of 50 other medicines name paroxetine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amitriptyline | drug interactions | Use caution with concomitant use of BRISDELLE with other drugs that are metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines, risperidone, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide). |
| Aspirin | drug interactions | Examples aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact Paroxetine tablets are highly bound to plasma protein. The concomitant use of paroxetine tablets with another drug that is highly bound to plasma protein may increase free concentrations of paroxetine tablets or other … |
| Atomoxetine | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Buspirone | drug interactions | … Precautions (5.2) ]. Examples other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort. |
| Cimetidine | drug interactions | Cimetidine Increased plasma concentration of paroxetine Use caution if BRISDELLE is used concomitantly with other drugs that inhibit CYP2D6 (e.g., quinidine). |
| Clopidogrel | drug interactions | Examples aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact Paroxetine tablets are highly bound to plasma protein. The concomitant use of paroxetine tablets with another drug that is highly bound to plasma protein may increase free concentrations of paroxetine tablets or other … |
| Desipramine | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Dextromethorphan | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Digoxin | drug interactions | Digoxin Decreased plasma concentrations of digoxin The digoxin dosage of may need to be increased. Monitor digoxin concentrations and clinical effect. |
| Fentanyl | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines and St. … |
| Flecainide | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Fluoxetine | drug interactions | Use caution with concomitant use of BRISDELLE with other drugs that are metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines, risperidone, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide). |
| Fosamprenavir | drug interactions | Clinical Impact; Co-administration of fosamprenavir/ritonavir with paroxetine tablets significantly decreased plasma levels of paroxetine. |
| Heparin | drug interactions | Examples aspirin, clopidogrel, heparin, warfarin Drugs Highly Bound to Plasma Protein Clinical Impact Paroxetine tablets are highly bound to plasma protein. The concomitant use of paroxetine tablets with another drug that is highly bound to plasma protein may increase free concentrations of paroxetine tablets or other … |
Every other medicine the paroxetine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Imipramine | drug interactions | Use caution with concomitant use of BRISDELLE with other drugs that are metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines … |
| Isocarboxazid | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Linezolid | contraindications | CONTRAINDICATIONS Paroxetine tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an … |
| Lithium | drug interactions | … other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort. |
| Meperidine | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone … |
| Methadone | warnings and precautions | … tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines and St. … |
| Methylene blue | contraindications | … of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7) ]. |
| Metoprolol | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Nebivolol | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Nortriptyline | drug interactions | Use caution with concomitant use of BRISDELLE with other drugs that are metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines … |
| Perphenazine | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Phenelzine | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Phenobarbital | drug interactions | Concomitant Drug Name: Phenobarbital; Effect of Concomitant Drug on Paroxetine: Decreased paroxetine exposure |
| Phenytoin | drug interactions | Concomitant Drug Name: Phenytoin; Effect of Concomitant Drug on Paroxetine: Decreased paroxetine exposure |
| Pimozide | contraindications | Taking pimozide because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interactions (7) ]. |
| Propafenone | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Quinidine | drug interactions | Cimetidine Increased plasma concentration of paroxetine Use caution if BRISDELLE is used concomitantly with other drugs that inhibit CYP2D6 (e.g., quinidine). |
| Risperidone | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Ritonavir | drug interactions | Clinical Impact; Co-administration of fosamprenavir/ritonavir with paroxetine tablets significantly decreased plasma levels of paroxetine. |
| Selegiline | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Tamoxifen | drug interactions | Clinical Impact; Concomitant use of tamoxifen with paroxetine tablets may lead to reduced plasma concentrations of the active metabolite (endoxifen) and reduced efficacy of tamoxifen |
| Theophylline | drug interactions | Theophylline Increased plasma concentrations of theophylline The theophylline dosage of may need to be decreased. Monitor theophylline concentrations and tolerability. |
| Thioridazine | contraindications | Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions (5.3), Drug Interactions (7) ]. |
| Tolterodine | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Tramadol | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone … |
| Tranylcypromine | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Venlafaxine | drug interactions | Examples; propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. |
| Warfarin | drug interactions | … tablets and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see ]. |
Other labels that name paroxetine
Source: FDA drug label (Paroxetine), Mylan Pharmaceuticals Inc., effective February 12, 2026 (SPL set 89dd7e24-85fc-4152-89ea-47ec2b48a1ed), via openFDA; the full label on DailyMed
What do FAERS reports show for paroxetine?
The FDA Adverse Event Reporting System holds 41,809 reports that list paroxetine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,358 are coded as a death and 16,709 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as paroxetine?
30 other medicines are given the same way (oral) and in the same FDA class as paroxetine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluoxetine | Depression, Anxiety | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression, Anxiety | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Trazodone | Depression | 38 labelers | $0.0307 per tablet 50 mg tablet | No current entry |
| Escitalopram | Depression, Anxiety | 44 labelers | $0.0632 per tablet 20 mg tablet | No current entry |
| Citalopram | Depression | 35 labelers | $0.026 per tablet 10 mg tablet | No current entry |
| Fluoxetine and olanzapine | Depression | 3 labelers | $3.44 per unit 3-25 mg | No current entry |
| Nefazodone | Depression | 2 labelers | $1.17 per tablet 100 mg tablet | No current entry |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
Every medicine labeled for the same conditions as paroxetine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does paroxetine compare with medicines for the same use?
14 side-by-side pages set paroxetine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to paroxetine
- 30 medicines for the same use
- Other serotonin reuptake inhibitors
- the pharmacologic class, with prices and generics
- Paroxetine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other