Paroxetine

Your safety is our first priority. Learn more about key medication details, side effects, and other important info about treatment.

Important safety information

The information below includes important safety information about paroxetine, which is the generic version of the brand name drug Paxil. Read this information before you begin taking paroxetine. You must notify your healthcare provider if you start or stop taking paroxetine.

Paroxetine is a prescription medicine used to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder (social phobia), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), and vasomotor symptoms of menopause. Paroxetine is also used off-label to treat premature ejaculation.

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Paroxetine and other antidepressant medicines may increase suicidal thoughts or actions, especially in some people 24 years of age and younger within the first few months of treatment or when the dose is changed. If you are experiencing a mental health crisis, please call or text 988 to be connected with help, or go to your nearest hospital emergency department. Pay particular attention to such changes when paroxetine is started or when the dose is changed.

Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.

Do not take Paroxetine if you:

  • are allergic to paroxetine, or any of the ingredients in Fluoxetine

  • Take any medication for Parkinson’s Disease or depression called monoamine oxidase inhibitors (MAOI), or if you have stopped taking an MAOI in the last 14 days as they may cause a dangerous increase in blood pressure. MAOIs include, but are not limited to: isocarboxazid, phenelzine, rasagiline, selegiline, tranylcypromine

  • Take St John’s Wort or 5-Hydroxytryptophan (5-HTP)

  • taking thioridazine

  • taking tamoxifen

  • taking pimozide

  • are drinking large amounts of alcohol

  • are abusing recreation drugs or prescription medications

  • Are pregnant, plan to become pregnant, or are breastfeeding

Paroxetine can cause serious side effects. Rarely reported side effects include:

  • low sodium blood levels (symptoms may include headache, weakness and difficulty remembering or concentrating)

  • teeth grinding

  • angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye)

  • serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death)

  • seizures

  • increased risk of bleeding events when combined with use of aspirin, nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen), warfarin, and other anticoagulants

Before you take paroxetine, tell your healthcare provider if you:

  • have thoughts of suicide or harming yourself

  • have a history of psychiatric or medical problems, including bipolar disorder

  • have taken any medication in the past for your condition, whether effective or not

  • have suffered adverse or side effects from previous medication therapies

  • drink alcohol or use/abuse recreational or prescription drugs

  • are pregnant, plan to become pregnant, or are breastfeeding

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and recreational drugs.

Paroxetine may affect the way other medicines work, and other medicines may affect the way paroxetine works, causing side effects. Especially tell your healthcare provider if you take any of the following:

  • Aspirin or nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen, celecoxib, diclofenac)

  • Any other serotonergic medications including: trazodone, migraine medications (triptans), pain medications (tramadol), antibiotic linezolid, amphetamines

  • atomoxetine

  • antipsychotics (aripiprazole, risperidone)

  • Warfarin or other anticoagulants

  • cardiac medications (propafenone, metoprolol, propranolol)

  • tricyclic antidepressants (desipramine, imipramine)

During treatment with this medication, common side effects of this medication may go away as your body adjusts to the medication. The most common side effects of paroxetine: Headache, nausea, constipation, diarrhea, dry mouth, loss of appetite, weight loss, increased sweating, dizziness, feeling nervous, restless, fatigued, yawning, tremor, unusual dreams, sleepiness, ,or trouble sleeping (insomnia). Sexual side effects, such as erectile dysfunction, lowered interest in sex, and problems with orgasm or ejaculatory delay often do not diminish over time.

The controlled release form should be swallowed whole. Do not break, crush or chew it.

If you miss a dose of paroxetine, take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.

Do not stop taking paroxetine, even when you feel better. Abruptly stopping can cause withdrawal symptoms including: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances as electric shock sensations, tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, ringing in the ears, and seizures.

Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.

If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.

If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can follow these simple steps to dispose of most medicines in your trash at home:

  • Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;

  • Place the mixture in a container such as a sealed plastic bag;

  • Throw away the container in your trash at home; and

  • Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.