Safety Information for Paroxetine Controlled Release

Some Precautions and Warnings With Paroxetine Controlled Release

Some paroxetine controlled release precautions and warnings include:
  • Antidepressants (including paroxetine controlled release) may increase the risk of suicidal thinking or behavior in children, teenagers, and adults (see Antidepressants and Suicide for more information). Therefore, if you notice any changes in symptoms or new symptoms while taking paroxetine controlled release, be sure to talk with your healthcare provider immediately. Some of these symptoms include anxiety, hostility, agitation, panic, restlessness, hallucinations, extreme hyperactivity, and suicidal thinking or behavior (see Paxil CR and Suicide for more information).
  • Before prescribing paroxetine controlled release for depression, your healthcare provider should make sure that you do not have bipolar disorder (instead of depression). Sometimes, the symptoms of bipolar disorder and depression are very similar, and paroxetine controlled release can cause problems in people with bipolar disorder.
  • Paroxetine controlled release can interact with certain other medications (see Drug Interactions With Paroxetine Controlled Release).
  • Taking paroxetine controlled release with thioridazine (Mellaril®) can increase your risk of a dangerous irregular heart rhythm called QT prolongation. Therefore, it is not recommended that you take these two medications together (see Drug Interactions With Paroxetine Controlled Release for more information).
  • Antidepressants can cause a group of dangerous symptoms known as serotonin syndrome. Taking paroxetine controlled release with other medications that affect serotonin can increase your risk of serotonin syndrome. These other medications can include other antidepressants, triptans (migraine medications), and several other medications (see Drug Interactions With Paroxetine Controlled Release for more information). Contact your healthcare provider immediately if you have any possible symptoms of serotonin syndrome, including:


    • Confusion
    • Seeing or hearing things that are not really there (hallucinations)
    • A fast heartbeat (tachycardia)
    • Feeling faint
    • A fever
    • Sweating
    • Muscle spasms
    • Difficulty walking
    • Diarrhea.


  • If you have a seizure disorder, there is a possibility that taking paroxetine controlled release may cause seizures. Talk with your healthcare professional before taking paroxetine controlled release if you have seizures.
  • Paroxetine controlled release can cause akathisia, an internal feeling of jitteriness or restlessness. Akathisia can be very disturbing, so make sure to tell your healthcare provider if you are experiencing this paroxetine controlled release side effect.
  • If you are stopping paroxetine controlled release, you should be monitored by a healthcare professional for paroxetine controlled release withdrawal symptoms. If you do develop any symptoms of withdrawal -- such as irritability, anxiety, confusion, headaches, lethargy, or insomnia -- your healthcare provider may slow down the rate at which the paroxetine controlled release is stopped (see Paxil CR Withdrawal).
  • Paroxetine controlled release may cause bleeding in the stomach or intestines. This risk is increased in those taking aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen. Symptoms of gastrointestinal bleeding may include:


    • Bright red blood coating the stool
    • Dark blood mixed with the stool
    • Black or tarry stool
    • Bright red blood in vomit
    • Vomit that has the appearance of coffee grounds.
If you experience any of these symptoms during treatment with paroxetine controlled release, call your healthcare provider.
  • If you are elderly or are taking a diuretic, paroxetine controlled release could cause low salt levels in the blood (hyponatremia). These levels generally return to "normal" when paroxetine controlled release is stopped.
  • If you have liver or kidney problems, you may need a lower paroxetine controlled release dose, since the liver helps to remove paroxetine controlled release from the blood.
  • Paroxetine controlled release can make glaucoma (a condition of the eye) worse. Talk with your healthcare provider before taking paroxetine controlled release if you have glaucoma.
  • Paroxetine controlled release may affect your ability to perform complex tasks requiring mental and motor skills. Therefore, it is recommended that you become accustomed to its effect on you before becoming involved in activities requiring mental or motor concentration (such as driving a car or operating machinery). Taking paroxetine controlled release with alcohol or other medications that cause drowsiness can increase this effect.
  • Paroxetine controlled release is considered a pregnancy Category D medication. This means that the drug may cause harm to an unborn baby if it is used during pregnancy. In particular, there is evidence that paroxetine controlled release taken during early pregnancy can increase the risk of heart problems in babies. In general, paroxetine controlled release is not recommended for use during pregnancy. Talk with your healthcare provider about the risks and benefits of using paroxetine controlled release during pregnancy (see Paxil CR and Pregnancy for more information).
  • Paroxetine controlled release passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this (see Paxil CR and Breastfeeding).
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