Paroxetine Oral Tablet

Name: Paroxetine Oral Tablet

Important warnings

FDA warning: Suicide warning
  • This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
  • Antidepressant medications, such as paroxetine, may increase suicidal thoughts and behaviors, especially within the first few months of treatment or when your dose is changed. This risk is higher in children, teenagers, and young adults. You, family members, caregivers, and your doctor should pay attention to any unusual changes in your mood, behaviors, thoughts, or feelings.
  • Serotonin syndrome warning: This drug can cause a potentially life-threatening condition called serotonin syndrome. It can be caused by this drug alone or with the use of other medications that have similar effects. Symptoms of serotonin syndrome can include agitation, hallucinations, confusion, difficulty thinking, coma, coordination problems, muscle twitching (overactive reflexes), rigid muscles, racing heartbeat, high or low blood pressure, sweating, fever, nausea, vomiting, and diarrhea.
  • Worsened depression warning: Paroxetine may worsen your depression. If you experience any unusual changes in behavior, especially during the first few months of treatment or when your dose changes, call your doctor. These can include anxiety, agitation, restlessness, panic attacks, sleeplessness, irritability, hostility, aggressiveness, acting on dangerous impulses, attempts to commit suicide, and extreme mood swings.
  • Stopping treatment warning: If you’re stopping treatment with this drug, it shouldn’t be stopped abruptly. Withdrawal symptoms can occur when this drug is stopped too quickly. Symptoms of withdrawal include anxiety, irritability, high or low mood, restlessness, changes in sleep habits, headache, sweating, nausea, dizziness, electric shock-like sensations, shaking, and confusion. You should be monitored for these symptoms when stopping treatment with paroxetine.

What is paroxetine?

Paroxetine is a prescription drug that’s available as the following brand-name drugs: Paxil, Paxil CR, and Pexeva. All brands do not treat all conditions. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version. It’s also available as an oral capsule (brand name: Brisdelle) and an oral solution.

Why it's used

Paroxetine can be used to treat depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, posttraumatic stress disorder, premenstrual dysphoric disorder, and hot flushes associated with menopause.

Paroxetine may be used as part of a combination therapy. This means you may need to take it with other medications.

How it works

This drug belongs to a class of drugs called selective serotonin reuptake inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

This drug increases the amount of serotonin that your body makes and releases in your brain. Serotonin helps with symptoms of depression, compulsions, stress, anxiety, and hot flashes.

Paroxetine may interact with other medications

Paroxetine oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Drugs you should not take with paroxetine

Do not take these drugs with paroxetine. Taking these drugs with paroxetine can cause dangerous effects in your body. Examples of these drugs include:

  • thioridazine. Taking this drug with paroxetine can cause serious heart rhythm problems or sudden death.
  • pimozide: Taking this drug with paroxetine can cause serious heart problems.
  • monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, and tranylcypromine. Taking these drugs with paroxetine increases your risk of serotonin syndrome so much that they should not be taken with paroxetine. You should wait at least 14 days between use of paroxetine and these drugs.
  • tryptophan (found in dietary supplements). Taking tryptophan with paroxetine increases your risk of serotonin syndrome. It should not be taken with paroxetine.
  • linezolid, and intravenous methylene blue. Taking these drugs with paroxetine increases your risk of serotonin syndrome so much that they should not be used together.

Interactions that can increase your risk of side effects

Taking paroxetine with certain drugs raises your risk of side effects. Examples of these drugs include:

  • nonsteroidal anti-inflammatory drugs (NSAIDs), such as, ibuprofen and naproxen as well as aspirin and warfarin. Taking these drugs with paroxetine can increase your risk of bleeding or bruising.
  • triptans such as sumatriptan
  • lithium
  • serotonergic drugs, such as fentanyl, tramadol, and St. John’s wort. Taking these drugs with paroxetine can increase your risk of serotonin syndrome.
  • amphetamines, such as lisdexamfetamine and methamphetamine. Taking these drugs with paroxetine can increase your risk of serotonin syndrome.
  • theophylline. Taking this drug with paroxetine can increase your risk of restlessness, trouble sleeping, and irritability.
  • risperidone. Taking this drug with paroxetine can increase your risk of sleeping difficulty, anxiety, restlessness, and constipation.
  • cimetidine
  • antiarrhythmics, such as flecainide, and propafenone
  • phenothiazines, such as chlorpromazine, and fluphenazine
  • tricyclic antidepressants (TCAs), such as amitriptyline, imipramine and desipramine
  • quinidine. Taking this drug with paroxetine can increase your risk of tiredness, decreased appetite, sweating, dry mouth, and decreased sexual desire.

Interactions that can make drugs less effective

Taking paroxetine with certain drugs may cause one or both of the drugs to not work as well. This is because the interaction between the drugs may cause a decrease in your body of paroxetine or the other drug. Examples of these drugs include:

  • tamoxifen, a breast cancer drug
  • digoxin
  • protease inhibitors, such as fosamprenavir and ritonavir
  • phenobarbital
  • phenytoin

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Paroxetine warnings

Paroxetine oral tablet comes with several warnings.

Allergy warning

This drug can cause a severe allergic reaction. Symptoms can include:

  • trouble breathing
  • swelling of your face, tongue, eyes, or mouth
  • rash, itchy welts (hives), or blisters, alone or with fever or joint pain

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Alcohol interaction

You should avoid drinks that contain alcohol when taking this drug.

Warnings for people with certain health conditions

For people with glaucoma: Paroxetine may dilate your pupils, which may trigger a glaucoma attack. Notify your doctor if you have glaucoma before taking this drug.

For people with bipolar disorder: Caution should be used when taking this drug if you have bipolar disorder. Taking paroxetine alone may trigger a mixed or manic episode.

For people with seizures: Caution should be used when taking this drug if you have a history of seizures. If seizures occur while you take this drug, you should stop taking it and contact your doctor.

For people with kidney disease: If you have kidney disease, your kidneys may not be able to get rid of this drug as well as they should. This may cause levels of the drug to build up in your body and cause more side effects.

For people with liver disease: If you have liver disease, your body may not be able to process this drug as well as it should. This may increase the levels of this drug to build up in your body and cause more side effects.

Warnings for other groups

For pregnant women: The paroxetine brand-named drug Brisdelle is a category X drug. Category X drugs should never be used during pregnancy.

Women of childbearing age should use reliable birth control while taking this drug.

Paroxetine (except for the brand-named drug Brisdelle) is a category D pregnancy drug. That means two things:

  1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
  2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

Talk to your doctor if you’re pregnant or planning to become pregnant. Ask your doctor to tell you about the specific harm that may be done to the fetus. This drug should be only used if the potential risk to the fetus is acceptable given the drug’s potential benefit. Call your doctor right away if you become pregnant while taking this drug.

For women who are breastfeeding: This drug passes into breast milk and may cause side effects in a child who is breastfed. Caution should be used when taking this drug while breastfeeding. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

If you’re over the age of 65 years, you may be at higher risk of developing side effects while taking this drug, including low sodium levels in your blood (known as hyponatremia).

For children: It hasn’t been confirmed that this drug is safe and effective for use in people younger than 18 years.

Take as directed

Paroxetine oral tablet can be used for long-term or short-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: If you don’t take it at all, your condition won’t get any better. If you suddenly stop taking it, you may see symptoms, such as anxiety, irritability, high or low mood, restlessness, changes in sleep habits, headache, sweating, nausea, dizziness, electric shock-like sensations, shaking, and confusion.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

  • sleepiness
  • dizziness
  • nausea
  • vomiting
  • fast heart rate
  • tremor
  • confusion
  • coma

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working:

  • Major depressive disorder: You should have decreased feelings of depression and your mood should improve.
  • Obsessive-compulsive disorder: You should have decreased feelings of obsessions and compulsions.
  • Panic disorder: You should have decreased feelings of anxiety and panic.
  • Social anxiety disorder: You should have decreased feelings of anxiety.
  • Generalized anxiety disorder: You should have decreased feelings of anxiety.
  • Posttraumatic stress disorder: You should have decreased feelings of anxiety, memories, or dreams of traumatic events (flashbacks) and nightmares.
  • Premenstrual dysphoric disorder: You should have decreased tiredness, irritability, mood swings, sleeplessness, and anxiety.
  • Hot flushes: You should have decreased hot flushes.
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