Prescription medication · Selective Serotonin Reuptake Inhibitor (SSRI)
paroxetine
Also sold as Paxil. Paroxetine is used to treat several conditions in adults.
Data updated 2026-05-15
- 32,666
- FDA reportsModerately reported
- 51
- InteractionsMany interactions
- 95% less
- Generic vs brandHuge savings
- 3
- Recall records
What the data shows
paroxetine (Paxil) is a prescription Selective Serotonin Reuptake Inhibitor (SSRI), reported at a middle-of-the-pack volume (32,666 FDA reports), whose generic costs a fraction of the brand (about 95% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
paroxetine (Paxil) is a prescription Selective Serotonin Reuptake Inhibitor (SSRI). Paroxetine is used to treat several conditions in adults.
Paroxetine (Paxil) is a medicine that can help treat depression and anxiety disorders. It belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs).
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$9.38/unit
Generic Price
$0.50/unit
Generic Savings
95%
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Paroxetine is used to treat several conditions in adults.
Common side effects
Abnormal ejaculation, Weakness or fatigue, Constipation
Key warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in young adults.
The sections below are summarized in plain English from paroxetine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Paroxetine works by increasing the amount of serotonin in your brain. Serotonin is a natural substance that helps regulate mood. By increasing serotonin levels, paroxetine can help improve symptoms of depression and anxiety.
Side Effects (from patient reports)
Based on 32,666 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for paroxetine, by number of reports
- Drug Interaction
Drug Interaction
1,825 reports
- Fatigue
Fatigue
1,821 reports
- Nausea
Nausea
1,738 reports
- Toxicity To Various Agents
Toxicity To Various Agents
1,579 reports
- Anxiety
Anxiety
1,476 reports
- Diarrhoea
Diarrhoea
1,453 reports
- Headache
Headache
1,446 reports
- Dizziness
Dizziness
1,363 reports
- Fall
Fall
1,293 reports
- Drug Abuse
Drug Abuse
1,256 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for paroxetine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where paroxetine sits
paroxetine has more FDA adverse-event reports than 65% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is paroxetine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 32,666 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1995–2025.
Total Reports
32,666
Reports Mentioning Death
4,275
13.1% of reports — not proof of cause
Hospitalization Reports
12,918
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | DRUG INTERACTION | 1,825 |
| 3 | FATIGUE | 1,821 |
| 4 | NAUSEA | 1,738 |
| 5 | TOXICITY TO VARIOUS AGENTS | 1,579 |
| 6 | ANXIETY | 1,476 |
| 7 | DIARRHOEA | 1,453 |
| 8 | HEADACHE | 1,446 |
| 9 | DIZZINESS | 1,363 |
| 11 | FALL | 1,293 |
| 12 | DRUG ABUSE | 1,256 |
| 13 | CONFUSIONAL STATE | 1,229 |
| 14 | VOMITING | 1,189 |
| 15 | SOMNOLENCE | 1,158 |
| 16 | DYSPNOEA | 1,155 |
| 17 | DEPRESSION | 1,126 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Antidepressants may increase the risk of suicidal thoughts and behaviors in young adults. Your doctor will monitor you closely for worsening depression or suicidal thoughts. Paroxetine is not approved for use in children.
Known Drug Interactions
Intervention Paroxetine is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5 ), Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.
Mechanism: Linezolid acts like a specific brain chemical blocker that, when mixed with paroxetine, can cause a dangerous reaction in the nervous system. This can lead to serious side effects that affect your whole body.
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention Paroxetine is contraindicated in patients taking pimozide or thioridazine [see Contraindications ( 4 )] .
Mechanism: Paroxetine slows down how your body processes pimozide, causing the drug to build up to unsafe levels. High levels of pimozide can cause the heart to beat in a dangerous and irregular way.
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention Paroxetine is contraindicated in patients taking pimozide or thioridazine [see Contraindications ( 4 )] .
Mechanism: Paroxetine increases the amount of thioridazine in your blood by slowing down its breakdown. This can lead to a dangerous heart condition where the heart's electrical timing is thrown off.
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.
Mechanism: Taking these two drugs together can cause a dangerous buildup of brain chemicals that may lead to a severe reaction.
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.
Mechanism: These medications both affect the same brain chemicals, and using them together can cause your body to react poorly.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I stop taking paroxetine suddenly?
Can I drink alcohol while taking paroxetine?
How long does it take for paroxetine to start working?
What should I do if I experience side effects?
Can paroxetine interact with other medications?
Is paroxetine addictive?
Can I take paroxetine if I have kidney or liver problems?
Will paroxetine change my personality?
Can I drive while taking paroxetine?
What happens if I overdose on paroxetine?
What are the common side effects of paroxetine?
Does paroxetine interact with other medications?
What drug class is paroxetine?
Is there a generic version of paroxetine?
What pregnancy or breastfeeding source fields are listed for paroxetine?
Has paroxetine been recalled?
Active Recalls
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Apotex Corp.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Apotex Corp.
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Apotex Corp.
Related Medications in Selective Serotonin Reuptake Inhibitor (SSRI)
Other drugs grouped near paroxetine - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with paroxetine →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with paroxetine →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with paroxetine →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with paroxetine →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with paroxetine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for paroxetine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 32,666.
- tapentadol Δ 388 reports · Opioid / Norepinephrine Reuptake Inhibitor 33,054reports
- clarithromycin Δ 581 reports · Macrolide Antibiotic 33,247reports
- candesartan Δ 811 reports · Angiotensin II Receptor Blocker (ARB) 33,477reports
- telmisartan Δ 945 reports · Angiotensin II Receptor Blocker (ARB) 33,611reports
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 13.09%.
- zoledronic acid Δ 0.00 pts · 38,197 reports · Bisphosphonate (IV) 13.09%death share
- febuxostat Δ 0.03 pts · 16,005 reports · Xanthine Oxidase Inhibitor 13.11%death share
- cyclosporine Δ 0.03 pts · 106,440 reports · Calcineurin Inhibitor (Immunosuppressant) 13.12%death share
- docusate Δ 0.05 pts · 55,963 reports · Stool Softener 13.04%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on paroxetine
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What the FDA Data Shows for paroxetine
The FDA label for paroxetine (sold under brand names such as Paxil) classifies it as a prescription-only medication in the Selective Serotonin Reuptake Inhibitor (SSRI) class. Paroxetine is used to treat several conditions in adults. Official labeling lists 19 commonly reported side effects, including Abnormal ejaculation, Weakness or fatigue, Constipation.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 32,666 voluntary reports. The database also lists 51 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.50 versus $9.38 for the brand - a 95% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: June 19, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages