WARNING: Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paxil is not approved for use in pediatric patients.
In case of overdoes, seek medical attention.
Commonly reported adverse events associated with Paxil overdosage include coma, nausea, tremor, confusion, vomiting, and dizziness.
Other notable signs and symptoms observed with overdoses involving Paxil (alone or with other substances) include convulsions, hypertension, aggressive reactions, syncope, hypotension, stupor, serotonin syndrome, manic reactions, acute renal failure, and urinary retention.
Acute overdosage is often manifested by emesis, lethargy, ataxia, tachycardia and seizures. Plasma, serum or blood concentrations of Paxil may be measured to monitor therapeutic administration, confirm a diagnosis of poisoning in hospitalized patients or to aid in the medicolegal investigation of fatalities.
Paxil is available in 10 mg, 20 mg, 30 mg, and 40 mg tablets.
Paxil is also available in an Oral Suspension 10 mg/5 mL.
Active ingredient: paroxetine hydrochloride
Inactive ingredients in tablets: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake.
Inactive ingredients in suspension for oral administration: polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, flavorings, FD&C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.
Paxil (paroxetine) is an oral medication used primarily to treat major depressive disorder and generalized anxiety disorder. It has also been used to treat obsessive-compulsive disorder, panic disorder, social anxiety disorder, pre-menstrual dysphoric disorder, and post-traumatic stress disorder. It is part of a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the levels of serotonin in the brain, a neurotransmitter chemical that plays an important role in maintaining mood signals in the brain.
It is believed that a possible cause of depression is a low amount of the neurotransmitter serotonin. In the brain, the space between where two neurons meet to communicate is called a synapse, and the synapse is where serotonin is used to communicate between neurons. In depression, people may not have enough serotonin in their brain. Normally after a chemical message is sent between neurons, the serotonin is reabsorbed by the sending neuron (presynaptic neuron). A selective serotonin reuptake inhibitor will bind to the presynaptic neuron and prevent it from absorbing the serotonin, and leaving the neurotransmitter active in the synapse, and improving mood.
Paxil and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
- Paxil and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
- Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
- Watch for these changes and call your healthcare provider right away if you notice:
- New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
- Pay particular attention to such changes when Paxil is started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, 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 or talking more than what is normal for you
- other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Paxil may be associated with these serious side effects:
2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:
- agitation, hallucinations, coma, or other changes in mental status
- coordination problems or muscle twitching (overactive reflexes)
- racing heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle rigidity
3. Severe allergic reactions:
- trouble breathing
- swelling of the face, tongue, eyes, or mouth
- rash, itchy welts (hives), or blisters, alone or with fever or joint pain
4. Abnormal bleeding: Paxil and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
5. Seizures or convulsions
6. Manic episodes:
- greatly increased energy
- severe trouble sleeping
- racing thoughts
- reckless behavior
- unusually grand ideas
- excessive happiness or irritability
- talking more or faster than usual
7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
- headache
- weakness or feeling unsteady
- confusion, problems concentrating or thinking, or memory problems
Do not stop Paxil without first talking to your healthcare provider. Stopping Paxil too quickly may cause serious symptoms including:
- anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
- headache, sweating, nausea, dizziness
- electric shock-like sensations, shaking, confusion
Do not take Paxil if you:
- are allergic to paroxetine or any of the ingredients in Paxil.
- take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
- Do not take an MAOI within 2 weeks of stopping Paxil unless directed to do so by your physician.
- Do not start Paxil if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
- People who take Paxil close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
- high fever
- uncontrolled muscle spasms
- stiff muscles
- rapid changes in heart rate or blood pressure
- confusion
- loss of consciousness (pass out)
- take Mellaril (thioridazine). Do not take Mellaril together with Paxil because this can cause serious heart rhythm problems or sudden death.
- take the antipsychotic medicine pimozide (Orap) because this can cause serious heart problems.
Paxil can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Paxil affects you. Do not drink alcohol while using Paxil.
- Take Paxil exactly as prescribed. Your healthcare provider may need to change the dose of Paxil until it is the right dose for you.
- Paxil may be taken with or without food.
- If you are taking Paxil Oral Suspension, shake the suspension well before use.
- If you miss a dose of Paxil, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Paxil at the same time.
- If you take too much Paxil, call your healthcare provider or poison control center right away, or get emergency treatment.
- Do not stop taking Paxil suddenly without talking to your doctor (unless you have symptoms of a severe allergic reaction). If you need to stop taking Paxil, your healthcare provider can tell you how to safely stop taking it.
Before starting Paxil, tell your healthcare provider if you:
- are pregnant or breastfeeding
- have liver problems
- have kidney problems
- have heart problems
- have or had seizures or convulsions
- have bipolar disorder or mania
- have low sodium levels in your blood
- have a history of a stroke
- have high blood pressure
- have or had bleeding problems
- have glaucoma (high pressure in the eye)
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Paxil passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking Paxil.
Take Paxil exactly as prescribed. Your healthcare provider may need to change the dose of Paxil until it is the right dose for you.
Paxil may be taken with or without food. If you miss a dose of Paxil, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Paxil at the same time.
If you are taking Paxil Oral Suspension, shake the suspension well before use.
Do not stop taking Paxil suddenly without talking to your doctor (unless you have symptoms of a severe allergic reaction). If you need to stop taking Paxil, your healthcare provider can tell you how to safely stop taking it.
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL is not approved for use in pediatric patients.
- Store Paxil Tablets at room temperature between 59º and 86ºF (15º and 30ºC).
- Store Paxil Oral Suspension at or below 77ºF (25ºC).
- Keep Paxil away from light.
- Keep bottle of Paxil closed tightly.
Tell your healthcare provider if you are pregnant, may be pregnant, or plan to become pregnant. There is a possibility that Paxil may harm your unborn baby, including an increased risk of birth defects, particularly heart defects. Other risks may include a serious condition in which there is not enough oxygen in the baby’s blood. Your baby may also have certain other symptoms shortly after birth. Premature births have also been reported in some women who used Paxil during pregnancy.
Paxil can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Paxil affects you. Do not drink alcohol while using Paxil.
Before starting Paxil, tell your healthcare provider if you:are pregnant, may be pregnant, or plan to become pregnant. There is a possibility that Paxil may harm your unborn baby, including an increased risk of birth defects, particularly heart defects. Other risks may include a serious condition in which there is not enough oxygen in the baby’s blood. Your baby may also have certain other symptoms shortly after birth. Premature births have also been reported in some women who used Paxil during pregnanc
- are breastfeeding. Paxil passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking Paxil.
- are taking certain drugs such as triptans used to treat migraine headache, other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics, drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort, certain drugs used to treat irregular heart beats. certain drugs used to treat schizophrenia. certain drugs used to treat HIV infection. certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen, certain drugs used to treat epilepsy. atomoxetine, cimetidine. fentanyl, metoprolol, pimozide, procyclidine, tamoxifen
- have liver problems
- have kidney problems
- have heart problems
- have or had seizures or convulsions
- have bipolar disorder or mania
- have low sodium levels in your blood
- have a history of a stroke
- have high blood pressure
- have or had bleeding problems
- have glaucoma (high pressure in the eye)
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Paxil and some medicines may interact with each other, may not work as well, or may cause serious side effects.
If you take Paxil, you should not take any other medicines that contain paroxetine hydrochloride, including Paxil CR and Prexeva(paroxetine mesylate).
Paxil is a prescription medicine used to treat depression. Paxil is also used to treat:
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Social Anxiety Disorder
- Generalized Anxiety Disorder (GAD)
- Posttraumatic Stress Disorder (PTSD)
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Active Ingredients:
Paroxetine hydrochloride
For More Information on the conditions Paxil treats go to:
1-800-Therapist Depression Encyclopedia
It is important to keep a list of all medications you are currently taking. This should include all prescription, over the counter, and supplemental medications. This list should be kept with you at all times. Whenever you are beginning a new medication, be sure to consult your doctor and provide him or her with your list of medications.
For further information on Paxil speak with a pharmacist.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Paxil there are no specific foods that you must exclude from your diet when receiving Paxil.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Eldepryl, Zelapar) and tranylcypromine (Parnate)
- Mellaril (thioridazine)
- Orap (pimozide)
- triptans used to treat migraine headache
- other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics
- drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort
- certain drugs used to treat irregular heart beats
- certain drugs used to treat schizophrenia
- certain drugs used to treat HIV infection
- certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen
- certain drugs used to treat epilepsy
- atomoxetine
- cimetidine
- fentanyl
- metoprolol
- pimozide
- procyclidine
- tamoxifen
This is not a complete list of Paxil drug interactions. Ask your doctor or pharmacist for more information.
Common possible side effects in people who take Paxil include:
- Nausea
- Sleepiness
- Weakness
- Dizziness
- Feeling anxious or trouble sleeping
- Sexual problems
- Sweating
- Shaking
- Not feeling hungry
- Dry mouth
- Constipation
- Infection
- Yawning
Paxil and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions. Paxil and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life-threatening and may include:
- Agitation, hallucinations, coma, or other changes in mental status
- Coordination problems or muscle twitching (overactive reflexes)
- Racing heartbeat, high or low blood pressure
- Sweating or fever
- Nausea, vomiting, or diarrhea
- Muscle rigidity
3. Severe allergic reactions:
- Trouble breathing
- Swelling of the face, tongue, eyes, or mouth
- Rash, itchy welts (hives), or blisters, alone or with fever or joint pain
4. Abnormal bleeding: Paxil and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
5. Seizures or convulsions
6. Manic episodes:
- Greatly increased energy
- Severe trouble sleeping
- Racing thoughts
- Reckless behavior
- Unusually grand ideas
- Excessive happiness or irritability
- Talking more or faster than usual
7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
- Headache
- Weakness or feeling unsteady
- Confusion, problems concentrating or thinking, or memory problems
Do not stop Paxil without first talking to your healthcare provider. Stopping Paxil too quickly may cause serious symptoms including:
- Anxiety, irritability, high or low mood, feeling restless, or changes in sleep habits
- Headache, sweating, nausea, dizziness
- Electric shock-like sensations, shaking, confusion
Take Paxil exactly as prescribed. Follow the directions on your prescription label carefully. Your healthcare provider will determine the best dose for you based on the medical condition being treated, as well as your age, other medical conditions you have, and other medications you are taking.
The recommended starting dose is usually 20 mg daily, although for people with panic disorder, the starting dose is usually 10 mg. The dose may be increased gradually.
The maximum recommended dose is 50 or 60 mg daily, depending on the condition being treated. Elderly patients and patients with severe liver or kidney disease should not receive more than 40 mg daily.
Paxil is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Paxil is also used to treat:
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Social Anxiety Disorder
- Generalized Anxiety Disorder (GAD)
- Posttraumatic Stress Disorder (PTSD)