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.
Depression or other mental illnesses are the most important causes of suicidal thoughts and actions.

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 does is changed.
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.
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: 
•   attempts to commit suicide 
•   acting on dangerous impulses
•   acting aggressive or
•   violent                                                                                           
•   thoughts about suicide or dying
•   new or worse depression 
•   new or worse anxiety or panic attacks
•   feeling agitated, restless, angry, or irritable 
•   trouble sleeping
•   an increase in activity and talking more than what is normal for you      
•  other unusual changes in behavior or mood

Paroxetine tablets are a prescription medicine used in adults to treat:
A certain type of depression called Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder (PD)
Social Anxiety Disorder (SAD)
Generalized Anxiety Disorder (GAD)
Posttraumatic Stress Disorder (PTSD)

take a monoamine oxidase inhibitor (MAOI)
have stopped taking an MAOI in the last 14 days
are being treated with the antibiotic linezolid or the intravenous methylene blue
are taking pimozide
are taking thioridazine
are allergic to paroxetine or any of the ingredients in paroxetine tablets. See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets.
Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.  

Do not start taking an MAOI for at least 14 days after you stop treatment with paroxetine tablets.

have heart problems
have or had bleeding problems
have, or have a family history of, bipolar disorder, mania or hypomania
have or had seizures or convulsions
have glaucoma (high pressure in the eye)
have low sodium levels in your blood
have bone problems
have kidney or liver problems
are pregnant or plan to become pregnant. Paroxetine tablets may harm your unborn baby. Talk to your healthcare provider about the risks to your unborn baby if you take paroxetine tablets during pregnancy. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with paroxetine tablets.  
are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with paroxetine tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Paroxetine tablets and some other medicines may affect each other causing possible serious side effects. Paroxetine tablets may affect the way other medicines work and other medicines may affect the way paroxetine tablets work.

Especially tell your healthcare provider if you take:
medicines used to treat migraine headaches called triptans
tricyclic antidepressants
lithium
tramadol, fentanyl, meperidine, methadone, or other opioids
tryptophan
buspirone
amphetamines
St. John’s Wort
medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin
diuretics
tamoxifen
medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take paroxetine tablets with your other medicines. 

Do not start or stop any other medicines during treatment with paroxetine tablets without talking to your healthcare provider first. Stopping paroxetine tablets suddenly may cause you to have serious side effects. See, “What are the possible side effects of paroxetine tablets?”

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Take paroxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine tablets until it is the right dose for you.
Take paroxetine tablets 1 time each day in the morning.
Paroxetine tablets may be taken with or without food.
If you take too much paroxetine, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Paroxetine tablets can cause serious side effects, including:  
See, “What is the most important information I should know about paroxetine tablets?”
Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine tablets with certain other medicines. See, “Who should not take paroxetine tablets?” Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
•   agitation
•   sweating
•   seeing or hearing things that are not real (hallucinations) 
•   flushing
•   confusion   
•   high body temperature (hyperthermia)
•   coma  
•   shaking (tremors), stiff muscles, or muscle twitching
•   fast heart beat         
•   loss of coordination
•   changes in blood pressure 
•   seizures
•   dizziness   
•   nausea, vomiting, diarrhea
Eye problems (angle-closure glaucoma). Paroxetine tablets may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.  Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.
Medicine interactions. Taking paroxetine tablets with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation.
Seizures (convulsions).
Manic episodes. Manic episodes may happen in people with bipolar disorder who take paroxetine tablets. Symptoms may include:
•   greatly increased energy  
•   severe problems sleeping
•   racing thoughts   
•   reckless behavior
•   unusually grand ideas 
•   excessive happiness or irritability
•   talking more or faster than usual

Discontinuation syndrome. Suddenly stopping paroxetine tablets may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
•   nausea
•   electric shock feeling (paresthesia) 
•   tiredness
•   sweating
•   tremor
•   problems sleeping
•   changes in your mood 
•   anxiety 
•   hypomania
•   irritability and agitation
•   confusion  
•   ringing in your ears (tinnitus)
•   dizziness
•   headache                
•   seizures
Low sodium levels in your blood (hyponatremia). Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with paroxetine tablets. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include:
headache
difficulty concentrating
memory changes
confusion
weakness and unsteadiness on your feet which can lead to falls
In more severe or more sudden cases, signs and symptoms include:
seeing or hearing things that are not real (hallucinations)
fainting
seizures
coma
stopping breathing (respiratory arrest)
Abnormal bleeding. Taking paroxetine tablets with aspirin, NSAIDs, or blood thinners may increase this risk. Tell your healthcare provider about any unusual bleeding or bruising.
Bone fractures.
Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including paroxetine tablets, may cause sexual problems.

Symptoms in males may include:

 Delayed ejaculation or inability to have an ejaculation
 Decreased sex drive
 Problems getting or keeping an erection

Symptoms in females may include:

  Decreased sex drive
  Delayed orgasm or inability to have an orgasm

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with paroxetine tablets. There may be treatments your healthcare provider can suggest.
The most common side effects of paroxetine tablets include:
•   male and female sexual function problems 
•   weakness (asthenia)
•   constipation      
•   decreased appetite
•   diarrhea  
•   dizziness
•   dry mouth
•   infection
•   problems sleeping   
•   nausea
•   nervousness  
•   sleepiness
•   sweating      
•   shaking (tremor)
•   yawning
These are not all the possible side effects of paroxetine tablets. 

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Store paroxetine tablets between 20° to 25°C (68° to 77°F).
Keep paroxetine tablets and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take paroxetine tablets for a condition for which it was not prescribed. Do not give paroxetine tablets to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about paroxetine tablets that is written for healthcare professionals.  

Active ingredient: paroxetine hydrochloride