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.
How to Take It
Take paroxetine once a day, in the morning. You can take it with or without food. The starting dose is usually 20 mg daily, but it depends on your condition. Your doctor may increase your dose by 10 mg per day every week, depending on how you feel.
This is a plain-language summary of paroxetine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Paroxetine may cause harm to your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Taking paroxetine later in pregnancy may cause problems for the newborn.
This is a plain-language summary of paroxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of paroxetine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store paroxetine at room temperature, between 68°F and 77°F.
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
- Reaction with another medicine
Reaction with another medicine
1,825 reports
- Tiredness
Tiredness
1,821 reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,738 reports
- Harmful effect from different substances
Harmful effect from different substances
1,579 reports
- Worry or nervousness
Worry or nervousness
1,476 reports
- Loose stools
Loose stools
1,453 reports
- Pain in your head
Pain in your head
1,446 reports
- Feeling lightheaded
Feeling lightheaded
1,363 reports
- Accidentally falling down
Accidentally falling down
1,293 reports
- Misusing the medicine
Misusing the medicine
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) 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.
What to do: This combination is not allowed and must be avoided. If you need to take linezolid, your doctor will have you stop taking paroxetine first.
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.
What to do: Do not take these two medications together. Your doctor will choose a different medicine to avoid the risk of life-threatening heart rhythm problems.
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.
What to do: This combination is contraindicated and should never be used. Your healthcare provider will need to adjust your treatment plan to use safer alternatives.
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.
What to do: Avoid this combination entirely as it can be very dangerous.
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.
What to do: Do not use these drugs together and ask your doctor for a different treatment plan.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is paroxetine safe during pregnancy?
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 →
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
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: June 19, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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