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paroxetine

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Brand names: Paxil

Selective Serotonin Reuptake Inhibitor (SSRI) Rx

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).

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.

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.

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.

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.

Storage

Store paroxetine at room temperature, between 68°F and 77°F.

Side Effects (from patient reports)

Based on 16,044 FDA adverse event reports.

Medicine not working
2,032
Reaction with another medicine
1,825
Tiredness
1,821
Feeling sick to your stomach
1,738
Harmful effect from different substances
1,579
Worry or nervousness
1,476
Loose stools
1,453
Pain in your head
1,446
Feeling lightheaded
1,363
Using the medicine for something it's not approved for
1,311

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

Death-Related Reports

4,275

Hospitalization Reports

12,918

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 19,170 (65%)
Male 10,466 (35%)

Age Distribution

0–17 730
18–44 6,097
45–64 8,712
65–74 4,425
75+ 4,429

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 2,032
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
10 OFF LABEL USE 1,311
11 FALL 1,293
12 DRUG ABUSE 1,256
13 CONFUSIONAL STATE 1,229
14 VOMITING 1,189
15 SOMNOLENCE 1,158

Reactions in Death Reports

COMPLETED SUICIDE 944
DEATH 911
TOXICITY TO VARIOUS AGENTS 839
DRUG ABUSE 345
CARDIO-RESPIRATORY ARREST 225
CARDIAC ARREST 201
OVERDOSE 176
DRUG INTERACTION 162
DYSPNOEA 126
OFF LABEL USE 124

Reactions in Hospitalization Reports

DRUG INTERACTION 1,045
FALL 820
CONFUSIONAL STATE 751
TOXICITY TO VARIOUS AGENTS 700
SOMNOLENCE 647
SEROTONIN SYNDROME 620
DYSPNOEA 593
VOMITING 590
DRUG ABUSE 572
FATIGUE 571

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.

moderate phenelzine

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.

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Common Questions

Can I stop taking paroxetine suddenly?
No, you should not stop taking paroxetine suddenly. Talk to your doctor about slowly reducing your dose to avoid withdrawal symptoms.
Can I drink alcohol while taking paroxetine?
It is best to avoid alcohol while taking paroxetine, as it can worsen side effects like drowsiness.
How long does it take for paroxetine to start working?
It may take several weeks for you to feel the full effects of paroxetine. Be patient and continue taking it as prescribed.
What should I do if I experience side effects?
Talk to your doctor about any side effects you experience. They may be able to adjust your dose or suggest ways to manage them.
Can paroxetine interact with other medications?
Yes, paroxetine can interact with other medications. Tell your doctor about all the medications you are taking, including over-the-counter drugs and supplements.
Is paroxetine addictive?
Paroxetine is not considered addictive, but you may experience withdrawal symptoms if you stop taking it suddenly.
Can I take paroxetine if I have kidney or liver problems?
If you have severe kidney or liver problems, your doctor may need to adjust your dose of paroxetine.
Will paroxetine change my personality?
Paroxetine is not expected to change your personality, but it can help improve your mood and reduce anxiety.
Can I drive while taking paroxetine?
Paroxetine can cause drowsiness, so be careful when driving or operating machinery until you know how it affects you.
What happens if I overdose on paroxetine?
If you think you have taken too much paroxetine, seek medical attention immediately.
What are the common side effects of paroxetine?
The most commonly reported side effects of paroxetine include Abnormal ejaculation, Weakness or fatigue, Constipation, Decreased appetite, Diarrhea. Based on 16,044 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does paroxetine interact with other medications?
Yes, paroxetine has 51 known drug interactions. Notable interactions include linezolid, pimozide, thioridazine. Always inform your doctor about all medications you are taking.
What drug class is paroxetine?
paroxetine belongs to the Selective Serotonin Reuptake Inhibitor (SSRI) drug class. It requires a prescription (Rx). Paroxetine is used to treat several conditions in adults.
Is there a generic version of paroxetine?
Yes, generic paroxetine is available from 15 manufacturers. The generic costs $0.50 per unit compared to $9.38 for the brand version, saving approximately 95%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is paroxetine safe during pregnancy?
Paroxetine may cause harm to your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has paroxetine been recalled?
There are 3 recalls associated with paroxetine products. Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine. Check the recalls section below for full details and affected products.

Active Recalls

Class II November 1, 2023

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Apotex Corp.

Class II November 1, 2023

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Apotex Corp.

Class II November 1, 2023

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Apotex Corp.

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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 16,044 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

All federal data sources used on this page