Drugs A - Z

Paroxetine Hydrochloride Oral suspension

It is used to treat depression

Generic Name: paroxetine  |  Brand Name: Pexeva

Brand Names: Pexeva, Paxil, Paroxetine Hydrochloride ER, Paxil CR

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: [Web], [Web] and [Web].

[Posted 07/19/2006] FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.

One study illustrated the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. In this study, women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were women who continued to take their antidepressant medicine while pregnant.

The second study suggests there may be additional, though rare, risks of taking SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth. Babies born with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. In this study, PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk of one drug compared to another. The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing.

Additionally, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiologic study that suggests that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant medication without first consulting their physician. The FDA is seeking additional information about the possible risk of PPHN in newborn babies of mothers who took SSRI antidepressants in pregnancy. FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN. For more information visit the FDA website at: [Web] and [Web].

[Posted 07/19/2006] FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea.

Healthcare professionals prescribing a triptan, SSRI or SNRI should keep in mind that triptans are often used intermittently and either the triptan, SSRI or SNRI may be prescribed by a different physician; weigh the potential risk of serotonin syndrome with the expected benefit of using the above combination; discuss the possibility of serotonin syndrome with patients if a triptan and an SSRI or SNRI will be used together; and follow patients closely during treatment if a triptan and an SSRI or SNRI are used together.

Patients taking a triptan along with an SSRI or SNRI should talk to their doctor before stopping their medication and should immediately seek medical attention if they experience any of the above symptoms. FDA requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when these medications are taken together. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

PAROXETINE (pa ROX e teen) is used to treat depression. It may also be used to treat anxiety disorders, obsessive compulsive disorder, panic attacks, post traumatic stress, and premenstrual dysphoric disorder (PMDD).

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • bleeding disorders
  • glaucoma
  • heart disease
  • kidney disease
  • liver disease
  • low levels of sodium in the blood
  • mania or bipolar disorder
  • seizures
  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
  • take MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • take medicines that treat or prevent blood clots
  • an unusual or allergic reaction to paroxetine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • linezolid
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • methylene blue (injected into a vein)
  • pimozide
  • thioridazine

This medicine may also interact with the following medications:

  • alcohol
  • aspirin and aspirin-like medicines
  • atomoxetine
  • certain medicines for depression, anxiety, or psychotic disturbances
  • certain medicines for irregular heart beat like propafenone, flecainide, encainide, and quinidine
  • certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
  • cimetidine
  • digoxin
  • diuretics
  • fentanyl
  • fosamprenavir/ritonavir
  • furazolidone
  • isoniazid
  • lithium
  • medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
  • medicines for sleep
  • metoprolol
  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
  • phenobarbital
  • phenytoin
  • procarbazine
  • procyclidine
  • rasagiline
  • supplements like St. John's wort, kava kava, valerian
  • tamoxifen
  • theophylline
  • tramadol
  • tryptophan


Last Updated: August 01, 2013
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