Paroxetine
Pronunciation: puh-ROX-uh-teen.
- Generic name
- paroxetine
- Drug class
- Selective serotonin reuptake inhibitor (SSRI) antidepressant
- Form
- Tablet (immediate-release and controlled-release/CR), oral liquid (strengths vary by country and product, typically 10 mg, 12.5 mg CR, 20 mg, 25 mg CR, 30 mg, and 40 mg)
- Route
- Oral
- Legal status
- Prescription-only in all markets reviewed
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Aropax / Aropax CR (5) · Full directory
Boxed warning: Increased risk of suicidal thinking and behaviour in children, adolescents, and young adults
Paroxetine carries a boxed warning (the US FDA's strongest safety warning): antidepressants increased the risk of suicidal thoughts and behaviours in pediatric and young adult patients in short-term studies. The US label reports specific numeric differences: for every 1,000 patients treated, there were about 14 additional cases of suicidal thinking/behaviour compared with placebo in patients under 18, and about 5 additional cases in patients aged 18-24. In contrast, there was about 1 FEWER case in adults aged 25-64, and about 6 FEWER cases in adults aged 65 and older, compared with placebo. Paroxetine is not approved for use in pediatric patients at all -- a real difference from some other SSRIs (such as fluoxetine), which do have limited pediatric indications. All patients starting paroxetine, at any age, should be monitored closely for worsening symptoms and for the emergence of suicidal thoughts and behaviours, especially during the first few weeks of treatment or after a dose change. Families and caregivers should be told about this need for close observation and given clear instructions to contact the prescriber immediately if these signs appear. (1)
What paroxetine is and how it works
Paroxetine is a prescription antidepressant belonging to the SSRI (selective serotonin reuptake inhibitor) class. It works by increasing the amount of serotonin, a chemical messenger in the brain linked to mood and anxiety, available between nerve cells. (1) (2)
Paroxetine carries a genuine safety warning: in short-term studies, antidepressants as a class -- including paroxetine -- were linked to an increased risk of suicidal thinking and behaviour in children, adolescents, and young adults under 25. This risk was not seen in older adults, and was actually lower with antidepressant treatment in adults 65 and older. Paroxetine is not approved for use in children or adolescents at all. It also carries a more specific, well-documented pregnancy caution than most other antidepressants in its class: taking it during the first trimester of pregnancy is linked to a higher chance of certain heart defects in the baby. And because paroxetine leaves the body relatively quickly, stopping it suddenly -- or even missing a dose -- can cause withdrawal-like symptoms, so any change in dose should always be made gradually and with your prescriber's guidance.
Mechanism of action: how paroxetine works
Paroxetine is a selective serotonin reuptake inhibitor (SSRI). It blocks the reuptake transporter for serotonin at the presynaptic neuron, increasing the amount of serotonin available in the synapse. Unlike fluoxetine, paroxetine has a relatively short half-life and no long-acting active metabolite, which is why discontinuation symptoms can appear relatively quickly after a missed dose or abrupt cessation, and why washout/switching between antidepressants is managed differently than with fluoxetine. (1) (2)
What paroxetine is used for
Major depressive disorder (depression)
Used to treat major depressive episodes in adults. (1) (2) (5)
Obsessive-compulsive disorder (OCD)
Panic disorder
Used to treat panic disorder, with or without agoraphobia (fear of situations that might trigger panic), in adults. (1) (2) (5)
Social anxiety disorder (social phobia)
Used to treat social anxiety disorder in adults. (1) (2) (5)
Generalised anxiety disorder (GAD)
Used to treat generalised anxiety disorder in adults. (1) (2) (5)
Post-traumatic stress disorder (PTSD)
Before taking paroxetine
Do not take / not appropriate for
- Do not take paroxetine if you are taking, or have taken within the last 14 days, a monoamine oxidase inhibitor (MAOI) -- combining these can cause a serious, potentially fatal reaction. Linezolid may be used only under close monitoring per the UK source reviewed. (all countries) (1) (2)
- Do not take paroxetine together with pimozide or thioridazine, due to a risk of dangerous heart-rhythm changes (QT prolongation). (all countries) (1) (2)
- Do not take paroxetine if you have a known serious allergic reaction to paroxetine or its ingredients. (all countries) (1) (2)
Tell your clinician about
- Any history of suicidal thoughts, self-harm, or a family history of bipolar disorder or mania.
- Whether you are pregnant, plan to become pregnant, or are breastfeeding -- paroxetine has a more specific documented pregnancy caution than some other antidepressants in its class.
- Any history of bleeding problems, or if you take anticoagulants, aspirin, or NSAIDs.
- Any liver or kidney problems.
- All other medicines, especially MAOIs, other antidepressants or serotonergic medicines, tamoxifen, or St John's Wort.
- Any history of low blood sodium (hyponatraemia), especially if you are elderly or take diuretics.
- Any history of glaucoma or raised eye pressure.
How to take paroxetine
- Usually taken once daily, in the morning, with or without food.
- It can take several weeks of treatment before the full effect on mood or symptoms is felt -- do not expect an immediate result.
- Do not stop taking paroxetine suddenly, even if you feel better -- stopping abruptly can cause withdrawal-like symptoms (dizziness, sensory disturbances, sleep problems, agitation) because paroxetine leaves the body relatively quickly compared with some other antidepressants.
- Any change in dose, or a decision to stop paroxetine, should always be made together with your prescriber, who will usually direct a gradual dose reduction over weeks to months.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)
Missed dose
If you miss a dose, take it as soon as you remember on the same day, unless it is close to the time of your next dose -- in that case, skip the missed dose rather than doubling up, and contact your prescriber or pharmacist if you are unsure. Because paroxetine leaves the body relatively quickly, missing doses (or stopping suddenly) is more likely than with some other antidepressants to cause noticeable withdrawal-like symptoms.
Overdose
Seek urgent medical attention if you think you or someone else has taken too much paroxetine, or if you notice symptoms such as seizures, severe drowsiness, an irregular or fast heartbeat, agitation, confusion, or signs of serotonin syndrome (see Serious Warnings). Take the medicine packaging with you if possible. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Nausea and other gastrointestinal upset.
What to notice: Nausea and other gastrointestinal upset.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Sleep disturbances, including drowsiness or insomnia.
What to notice: Sleep disturbances, including drowsiness or insomnia.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Dizziness, tremor, and sweating.
What to notice: Dizziness, tremor, and sweating.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Sexual dysfunction, which can sometimes persist after stopping treatment.
What to notice: Sexual dysfunction, which can sometimes persist after stopping treatment.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Weakness (asthenia) and dry mouth.
What to notice: Weakness (asthenia) and dry mouth.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Constipation or diarrhoea.
What to notice: Constipation or diarrhoea.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Serious warnings
Worsening depression or emergence of suicidal thoughts (especially in children, adolescents, and young adults under 25) — boxed_warning
Symptoms: New or worsening depression, anxiety, agitation, panic attacks, irritability, hostility, aggression, impulsivity, restlessness, unusual changes in behaviour, or thoughts of suicide or self-harm -- particularly in the first few weeks of treatment or after a dose change.
Action: Contact your prescriber immediately, or seek emergency help if there is any immediate danger. Families and caregivers should watch closely for these signs, especially early in treatment, and report them to the prescriber right away. Remember paroxetine is not approved for use in children or adolescents. (1)
Cardiac malformation risk with first-trimester pregnancy exposure — high caution
Symptoms: Not applicable to the pregnant patient directly -- this reflects a risk to the developing baby rather than a symptom the patient experiences.
Action: Tell your prescriber immediately if you are pregnant, think you may be pregnant, or are planning a pregnancy. First-trimester paroxetine exposure is associated with a less-than-2-fold increased risk of cardiovascular malformations in the baby (absolute risk rising from about 1% to about 2%), a risk more specifically documented for paroxetine than for most other SSRIs. Never stop paroxetine on your own if you become pregnant -- discuss the balance of risks and benefits with your prescriber first. (1) (2)
Discontinuation (withdrawal-like) symptoms — high caution
Symptoms: Dizziness, sensory disturbances (including 'electric shock' sensations), sleep disturbance, agitation, nausea, sweating, or irritability, occurring after stopping or reducing the dose, or sometimes even after a missed dose.
Action: Never stop paroxetine suddenly. Contact your prescriber, who will usually recommend a gradual dose reduction over weeks to months. (1) (2)
Signs of serotonin syndrome or neuroleptic malignant syndrome-like reaction — emergency
Symptoms: Agitation, hallucinations, fast heartbeat, high body temperature, muscle rigidity or twitching, loss of coordination, sweating, shivering, nausea, vomiting, or diarrhoea -- especially if combined with another serotonergic medicine or an MAOI.
Action: Seek emergency medical help immediately. This is a rare but potentially life-threatening reaction; your prescriber will manage any concurrent serotonergic medicines with this risk in mind. (1) (2)
Unusual bleeding or bruising — high caution
Symptoms: Nosebleeds, easy bruising, blood in vomit or stool, or unusually heavy menstrual bleeding -- risk is higher when combined with NSAIDs, aspirin, or anticoagulants.
Action: Contact your prescriber for assessment, particularly if you also take a blood-thinning or anti-inflammatory medicine. (2)
Interactions
- Monoamine oxidase inhibitors (MAOIs): must not be combined with paroxetine, due to risk of a serious, potentially fatal reaction (serotonin syndrome). A washout period of at least 14 days is required after stopping an MAOI before starting paroxetine. (1) (2)
- Pimozide and thioridazine: contraindicated due to risk of dangerous heart-rhythm changes (QT prolongation). (1) (2)
- Tamoxifen: avoid combining where possible -- paroxetine's inhibition of the CYP2D6 enzyme reduces formation of tamoxifen's active metabolite (endoxifen), which may reduce tamoxifen's effectiveness, particularly relevant in breast cancer treatment. (2)
- Other serotonergic medicines (triptans, tramadol, lithium, St John's Wort): increase the risk of serotonin syndrome when combined with paroxetine. (1)
- Anticoagulants, aspirin, and NSAIDs: combined use with paroxetine is associated with a higher risk of bleeding, particularly gastrointestinal bleeding. (2)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Paroxetine carries a more specific, well-documented pregnancy caution than most other SSRIs. Exposure in the first trimester is associated with a less-than-2-fold increased risk of cardiovascular malformations in the baby (absolute risk of a cardiac defect rising from roughly 1% to roughly 2%), most consistently described as ventricular septal and atrial septal defects, with meta-analyses cited in the US label describing a 2 to 2.5-fold increase specifically for right ventricular outflow tract defects. Increased postpartum haemorrhage risk has also been noted. Use only when clearly indicated, and never stop or start paroxetine in pregnancy without discussing the balance of risks and benefits with your prescriber. (1) (2) (3) (4) (5) (6)
Breastfeeding
Paroxetine passes into breast milk in small amounts. Continuing to breastfeed, switching to a different antidepressant, or using the lowest effective dose are all decisions to make together with your prescriber. (1) (2) (3) (4) (5) (6)
Children
Paroxetine is NOT approved for use in children or adolescents in any of the markets reviewed. The New Zealand data sheet specifically states clinical trials do not support its use for major depressive disorder in children, and controlled trials found an increased risk of suicidal behaviour and hostility in this age group, per the UK source reviewed. (1) (2) (3) (4) (5) (6)
Elderly
A lower maximum dose is generally used (commonly up to 40 mg/day per the UK source reviewed). The US label describes a reduced (not increased) suicidality risk with antidepressant treatment in adults 65 and older, compared with placebo. Elderly patients also have a higher risk of low blood sodium (hyponatraemia) with SSRIs. (1) (2) (3) (4) (5) (6)
Hepatic_impairment
Use the lower end of the dosage range, per the UK source reviewed. (1) (2) (3) (4) (5) (6)
Renal_impairment
Use the lower end of the dosage range, per the UK source reviewed. (1) (2) (3) (4) (5) (6)
Source_ids
US-DAILYMED-PAROXETINE-2026,UK-EMC-SEROXAT-2026,NZ-MEDSAFE-AROPAX-2026 (1) (2) (3) (4) (5) (6)
Monitoring
Before starting
- Assessment for personal or family history of bipolar disorder, mania, or suicidal thoughts
- Pregnancy status and discussion of the cardiac-malformation risk if applicable
- Review of all other medicines for MAOI, tamoxifen, or serotonergic interactions
During treatment
- Close monitoring for worsening mood or emergence of suicidal thoughts, especially in the first few weeks of treatment or after a dose change, and especially in patients under 25.
- Monitoring for signs of serotonin syndrome if other serotonergic medicines are used concurrently.
- Awareness of discontinuation symptoms if a dose is reduced, missed, or stopped.
Storage
Store at room temperature, away from moisture and direct light, out of reach of children.
Study the drug class: SSRI antidepressants
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information and the UK emc SmPC reviewed for this dossier; verify against the current full label before prescribing.
United States
Indication: MDD, OCD, panic disorder, social anxiety disorder, GAD, PTSD
Dose summary: Dosing individualised by indication; boxed warning applies to all age groups; not approved for pediatric use. See the UK/Australia dose_context entries above for representative indication-specific starting/maximum doses, which are broadly consistent with the US label's dosing philosophy.
Renal context: Use the lower end of the dosage range in renal impairment, per the UK source reviewed. (1)
United Kingdom / European Union (Ireland) / Australia / New Zealand
Indication: MDD, OCD, panic disorder, social anxiety disorder, GAD, PTSD
Dose summary: Depression: 20 mg/day initial, max 50 mg/day. OCD: 20 mg/day initial, 40 mg/day recommended, max 60 mg/day. Panic disorder: 10 mg/day initial, 40 mg/day recommended, max 60 mg/day. Social anxiety/GAD/PTSD: 20 mg/day initial, max 50 mg/day. Elderly: max 40 mg/day.
Renal context: Use the lower end of the dosage range in renal or hepatic impairment. (2) (5)
Hepatic guidance
Use the lower end of the dosage range in hepatic impairment, per the UK source reviewed.
Overdose note
Manage with supportive care and close monitoring for seizures, cardiac arrhythmia, and serotonin syndrome; no specific antidote. (1) (2)
Frequently asked questions
Is paroxetine available in the US, UK, Europe, Canada, Australia, and New Zealand?
Yes. This review confirmed paroxetine is authorised and marketed in all six markets reviewed: the United States and Canada (Paxil/Paxil CR and generics), the United Kingdom and Ireland/European Union (Seroxat and, in Ireland, five further generic brand names), and Australia/New Zealand (Aropax/Aropax CR). (1) (2) (3) (4) (5) (6)
Why does paroxetine have a boxed warning about suicidal thoughts?
Because in short-term clinical trials, antidepressants as a class -- including paroxetine -- were linked to a higher rate of suicidal thinking and behaviour in children, adolescents, and young adults under 25, compared with placebo. The US label reports specific numbers: about 14 additional cases per 1,000 patients under 18, and about 5 additional cases per 1,000 patients aged 18-24, compared with placebo -- while adults 25-64 and 65+ actually showed slightly fewer cases than placebo. Paroxetine is not approved for use in children or adolescents at all. (1)
Is it true paroxetine carries a bigger pregnancy risk than other antidepressants like it?
This is a real, specifically documented finding, not a general antidepressant-class statement. Exposure to paroxetine in the first trimester of pregnancy is associated with a less-than-2-fold increased risk of cardiovascular malformations in the baby -- the US label frames this as an absolute risk rising from about 1% to about 2%, most often ventricular or atrial septal defects, with a 2 to 2.5-fold increase specifically described for right ventricular outflow tract defects in cited meta-analyses. This is why paroxetine is used in pregnancy only when clearly needed, and why you should never stop or start it in pregnancy without discussing it with your prescriber first. (1) (2)
Why can't I just stop taking paroxetine when I feel better?
Because paroxetine leaves the body relatively quickly compared with some other antidepressants, and stopping it suddenly -- or even missing a dose -- can cause withdrawal-like discontinuation symptoms such as dizziness, sensory disturbances, sleep problems, and agitation. Every regulator source reviewed for this dossier recommends a gradual, prescriber-guided dose reduction rather than abrupt discontinuation. (1) (2)
What is the mechanism of action of paroxetine?
Paroxetine is a selective serotonin reuptake inhibitor (SSRI). It blocks the reuptake transporter for serotonin at the presynaptic neuron, increasing the amount of serotonin available in the synapse. Unlike fluoxetine, paroxetine has a relatively short half-life and no long-acting active metabolite, which is why discontinuation symptoms can appear relatively quickly after a missed dose or abrupt cessation, and why washout/switching between antidepressants is managed differently than with fluoxetine. (1) (2)
References
- PAROXETINE tablet, film coated -- full prescribing informationDailyMed (U.S. National Library of Medicine) -- FDA-approved drug labeling · United States · accessed 2026-07-30 · source 1
- Seroxat 20mg Tablets -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- GlaxoSmithKline UK · United Kingdom · accessed 2026-07-30 · source 2
- Seroxat 10mg Tablets (medicines.ie/HPRA) and HPRA safety notice listing 6 Irish paroxetine brand namesHealth Products Regulatory Authority (HPRA), Ireland -- national marketing authorisation and safety-notice brand listing · European Union (Ireland, as a directly confirmed EU member state) · accessed 2026-07-30 · source 3
- PAROXETINE Tablets (paroxetine hydrochloride) -- Product Monograph, and Paxil / Paxil CR (GSK Canada)Health Canada -- Product Monograph · Canada · accessed 2026-07-30 · source 4
- AROPAX paroxetine 20mg (as hydrochloride) tablet -- ARTG entry 57927, and related Aropax/Aropax CR formulationsTherapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) · Australia · accessed 2026-07-30 · source 5
- AROPAX (paroxetine) -- New Zealand Data SheetMedsafe (New Zealand regulator) -- New Zealand Data Sheet · New Zealand · accessed 2026-07-30 · source 6
Brand names by country
Single-ingredient paroxetine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- PAXIL20 mg, 25 mg, 37.5 mg, 10 mg, 30 mg, 12.5 mg, 40 mg · apotex corp
- BRISDELLE7.5 mg · legacy pharma usa, inc.
United Kingdom
- Seroxat (2)MHRA licensed emc smpc confirmed · 10 mg, 20 mg, 30 mg · GlaxoSmithKline UK
Canada
- PAXIL
- PAXIL CR
Australia
- Aropax / Aropax CR (5)TGA ARTG registered 1997-01-15 confirmed · 20 mg, 30 mg, oral liquid, 12.5 mg CR, 25 mg CR · Aspen Pharmacare Australia Pty Ltd (ARTG 57927 and related entries)
New Zealand
- Aropax (6)Medsafe registered confirmed · 20 mg, 30 mg · GlaxoSmithKline (per Medsafe data sheet)
View brands in additional countries.
European Union
Seroxat, and 5 further Irish generic brand names (Meloxat, Paroser, Parox, Paroxetine, Paxt) (3)