What is paroxetine?
Paroxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors
(SSRIs). Paroxetine affects chemicals in the brain that may become unbalanced.
Paroxetine is used to treat depression, obsessive-compulsive disorder, anxiety disorders,
post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).
Paroxetine may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking paroxetine?
Do not use paroxetine if you are using pimozide (Orap), thioridazine (Mellaril), or an MAO
inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline
(Azilect), or selegiline (Eldepryl, Emsam).
Serious and sometimes fatal reactions can occur when these medicines are taken with
paroxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take
paroxetine. After you stop taking paroxetine, you must wait at least 14 days before you start taking an
MAOI.
Before taking paroxetine, tell your doctor if you are allergic to any drugs, or if you have:
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liver or kidney disease;
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a bleeding or blood clotting disorder;
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seizures or epilepsy; or
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bipolar disorder (manic depression), or a history of drug
abuse or suicidal thoughts.
If you have any of these conditions, you may need a dose adjustment or
special tests to safely use this medication.
You may have thoughts about suicide while taking an antidepressant, especially if you are
younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts
during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms.
Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
FDA pregnancy category D. Paroxetine may cause heart defects or serious,
life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy.
However, you may have a relapse of depression if you stop taking your antidepressant during
pregnancy. If you are planning a pregnancy, or if you become pregnant while taking paroxetine, do not
stop taking the medication without first talking to your doctor.
Paroxetine can pass into breast milk and may harm a nursing baby. Do not use this
medication without telling your doctor if you are breast-feeding a baby.
How should I take paroxetine?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger
amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally
change your dose to make sure you get the best results from the medication.
Try to take the medicine at the same time each day. Follow the directions on your prescription
label.
Do not crush, chew, or break a controlled-release tablet. Swallow the pill whole. It is
specially made to release medicine slowly in the body. Breaking the pill would cause too much of the
drug to be released at one time.
Shake the liquid form of paroxetine well just before you measure a dose. To be sure you
get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a
regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
It may take up to 4 weeks of using this medicine before your symptoms improve. For best
results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve
after 4 weeks of treatment.
You may have withdrawal symptoms (such as agitation, dizziness, numbness or tingling, ringing
in your ears, confusion, or behavior changes) after you stop taking paroxetine. Do not stop taking this
medication suddenly without first talking to your doctor.
Store paroxetine at room temperature away from moisture and heat.
What happens if I miss a dose of paroxetine?
Take the missed dose as soon as you remember. However, if it is almost time for the next
regularly scheduled dose, skip the missed dose and take the next one as directed.
Do not
take extra medicine to make up the missed dose.
Where can I get more information about paroxetine?
Your pharmacist has information about paroxetine written for health professionals that you may read.
What are the possible side effects of paroxetine?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Contact your doctor promptly if you have any of the following side effects, especially if they
are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping,
irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity),
thoughts of suicide or hurting yourself.
Call your doctor at once if you have any of these serious side effects:
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easy bruising or bleeding (such as a nosebleed);
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very stiff (rigid) muscles, high fever, sweating, fast or
uneven heartbeats, tremors, overactive reflexes;
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nausea, vomiting, diarrhea, loss of appetite, feeling
unsteady, loss of coordination; or
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headache, trouble concentrating, memory problems,
weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.
Less serious side effects may include:
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feeling nervous;
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drowsiness, dizziness;
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sleep problems (insomnia);
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mild nausea, constipation;
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weight changes;
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decreased sex drive, impotence, or difficulty having an
orgasm; or
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dry mouth, yawning, or ringing in your ears.
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about paroxetine?
You may have thoughts about suicide when you first start taking an antidepressant, especially if
you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the
first 12 weeks of treatment.
Call your doctor at once if you have any new or worsening symptoms such as: mood or
behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated,
hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts
about suicide or hurting yourself.
Paroxetine may cause heart defects or serious, life-threatening lung problems in newborn
babies whose mothers take the medication during pregnancy. However, you may have a relapse of
depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or
if you become pregnant while taking paroxetine, do not stop taking the medication without first talking
to your doctor.
Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), or a
monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline
(Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).
What should I avoid while taking paroxetine?
Avoid drinking alcohol, which can increase some of the side effects of paroxetine.
Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and
medicine for seizures, or anxiety can add to sleepiness caused by paroxetine. Tell your doctor if you
regularly use any of these medicines, or any other antidepressant.
Paroxetine can cause side effects that may impair your thinking or reactions. Be careful if
you drive or do anything that requires you to be awake and alert.
What other drugs will affect paroxetine?
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This
includes aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin),
naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone
(Relafen), etodolac (Lodine), and others. Taking any of these drugs with paroxetine may cause you to
bruise or bleed easily.
Many drugs can interact with paroxetine. Below is just a partial list. Tell your doctor if you are
using:
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a blood thinner such as warfarin (Coumadin);
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cimetidine (Tagamet);
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fosamprenavir (Lexiva);
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linezolid (Zyvox);
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ritonavir (Norvir);
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St. John's wort;
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tamoxifen (Nolvadex, Soltamox);
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theophylline (Elixophyllin, Theo-24, Uniphyl);
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tramadol (Ultram);
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tryptophan (also called L-tryptophan);
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heart medication such as digoxin (digitalis, Lanoxin),
disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), morizicine (Ethmozine),
propafenone, (Rythmol), procainamide (Procan, Procanbid, Pronestyl), quinidine (QuinaGlute,
Quinidex, Quin-Release), or risperidone (Risperdal);
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any other antidepressant such as amitriptyline (Elavil),
citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac,
Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), or sertraline
(Zoloft);
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medicine to treat psychiatric disorders, such as
chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), lithium
(Lithobid, Eskalith), or perphenazine (Trilafon); or
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almotriptan (Axert), frovatriptan (Frova), sumatriptan
(Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig).
This list is not complete and there may be other drugs that can interact with
paroxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This
includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using
a new medication without telling your doctor.
What happens if I have an overdose of paroxetine?
