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Precautions and Warnings With Paroxetine Mesylate

Specific Paroxetine Mesylate Warnings and Precautions

Some warnings and precautions to be aware of prior to taking this drug include the following:
  • Just like other antidepressants, paroxetine mesylate may increase the risk of suicidal thinking or behavior in children, adolescents, and young adults. Anyone taking an antidepressant should be closely monitored for worsening depression, suicidal thoughts, and any unusual behavior, especially in the beginning of treatment and whenever the dose is increased (see Pexeva and Suicide for more information).
  • Before prescribing paroxetine mesylate for depression, your healthcare provider should make sure that you do not have bipolar disorder instead. Bipolar disorder involves alternating cycles of depression and mania (an overly excited or elevated mood). There is a concern that antidepressants like paroxetine mesylate may lead to mania in people with bipolar disorder.
  • Antidepressants like paroxetine mesylate can cause a dangerous reaction known as serotonin syndrome. Taking paroxetine mesylate with other medications that affect serotonin can increase your risk for this reaction; however, it may also occur with paroxetine mesylate alone. Contact your healthcare provider immediately if you notice any possible symptoms of serotonin syndrome, including:
    • Confusion
    • Seeing or hearing things that are not really there (hallucinations)
    • Fast heartbeat (tachycardia)
    • Fever
    • Sweating
    • Nausea and vomiting
    • Diarrhea
    • Muscle spasms
    • Difficulty walking.
  • In rare cases, paroxetine mesylate may increase the risk for seizures, especially in people with a seizure disorder. Talk to your healthcare provider before taking paroxetine mesylate if you have a seizure disorder or have ever had a seizure.
  • This medication may cause a condition known as akathisia, which is an internal feeling of restlessness, especially at the start of treatment. People with this condition find it difficult to sit or stand still. Talk to your healthcare provider if you experience these symptoms while taking paroxetine mesylate.
  • Paroxetine mesylate may cause low blood sodium (hyponatremia). Older adults, people taking diuretics ("water pills"), and people who are dehydrated appear to have a greater risk for hyponatremia with paroxetine mesylate use. If you develop symptoms of hyponatremia, contact your healthcare provider. Early symptoms may include:
    • Headache
    • Confusion
    • Problems concentrating
    • Memory problems
    • Weakness
    • Unsteadiness or falling down.
  • In general, this medicine should not be stopped abruptly, as doing so may lead to withdrawal symptoms. If you need to stop taking paroxetine mesylate, your healthcare provider will slowly take you off this medication. If you do develop any symptoms of withdrawal, such as headache, irritability, anxiety, confusion, or insomnia, your healthcare provider may take you off paroxetine mesylate even slower.
  • Paroxetine mesylate 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, call your healthcare provider right away.
  • If you have severe liver problems or kidney problems, you may need a lower paroxetine mesylate dosage. Make sure your healthcare provider knows if you have liver or kidney problems before starting treatment.
  • Paroxetine mesylate may make glaucoma (a condition of the eye) worse. Talk to your healthcare provider before taking it if you have glaucoma.
  • This medication may affect your ability to perform complex tasks requiring mental and motor skills. Taking paroxetine mesylate with alcohol or other medications that cause drowsiness can increase this effect. To be safe, do not perform activities requiring mental or motor concentration (such as driving a car or operating machinery) until you know how this medication affects you.
  • Paroxetine mesylate 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 (see Pexeva and Pregnancy for more information).
  • Paroxetine mesylate passes through breast milk. Therefore, if you are breastfeeding or plan to start, be sure to talk with your healthcare provider about this issue first (see Pexeva and Breastfeeding).
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