Important Safety Information
Prescription Paxil CR and Paxil are not for everyone. Don't take with
MAOIs, thioridazine, or pimozide. Paxil CR and Paxil are generally
well tolerated. As with many medications, there can be side effects.
Some of the side effects may include infection, injury, nausea,
diarrhea, dry mouth, constipation, decreased appetite, sleepiness,
dizziness, sexual side effects, nervousness, tremor, yawning,
sweating, abnormal vision, weakness, or insomnia. Talk to your doctor
if you are taking prescription medication known as triptans, which are
used for migraine or cluster headaches. When used in combination with
Paxil CR or other anti-depressant treatments, these drugs may lead to
potentially life-threatening complications.
Paxil CR and Paxil are approved only for adults 18 years and over. In
some children and teens, antidepressants increase suicidal thoughts or
actions. Young adults, especially those with depression, may be at
increased risk for suicidal actions. Whether or not you are taking
antidepressants, you or your family should call the doctor right away
if you have worsening depression, thoughts of suicide, or sudden or
severe changes in mood or behavior (for example feeling anxious,
agitated, panicky, irritable, hostile, aggressive, impulsive, severely
restless, hyperactive, overly excited, or not being able to sleep),
especially at the beginning of treatment or after a change in dose.
Don't stop taking Paxil CR and Paxil before talking to your doctor
since side effects may result from stopping the medicine, particularly
when abrupt. Symptoms some patients have reported on stopping Paxil CR
and Paxil include: dizziness, sensory disturbances (including electric
shock sensations and tinnitus), abnormal dreams, agitation, anxiety,
nausea, sweating, mood fluctuations, headache, fatigue, nervousness
and sleep disturbances.
Tell your doctor if you are pregnant or plan to become pregnant, as
there is a potential risk to the fetus with paroxetine. Some studies
of paroxetine in pregnant women have suggested an increased risk of
heart malformations. In addition, babies born to mothers who have
taken antidepressants, including SSRIs such as Paxil CR and Paxil, in
the latter half of pregnancy have reported complications, including
difficulties with breathing, turning blue, seizures, changing body
temperature, feeding problems, vomiting, low blood sugar, floppiness,
stiffness, tremor, shakiness, irritability or constant crying. Tube
feeding, help with breathing, and longer hospitalization may be
needed. There have also been reports of premature births in pregnant
women exposed to SSRIs, including Paxil CR and Paxil.
Like many antidepressants, Paxil CR and Paxil can be present in breast
milk so tell your doctor if you are nursing.
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Special warnings about Paxil
In clinical studies, antidepressants increased the risk of suicidal
thinking and behavior in children and adolescents with depression and
other psychiatric disorders. Anyone considering the use of Paxil or
any other antidepressant in a child or adolescent must balance this
risk with the clinical need. Paxil has not been studied in children or
adolescents and is not approved for treating anyone less than 18 years
old.
Additionally, the progression of major depression is associated with a
worsening of symptoms and/or the emergence of suicidal thinking or
behavior in both adults and children, whether or not they are taking
antidepressants. Individuals being treated with Paxil and their
caregivers should watch for any change in symptoms or any new symptoms
that appear suddenly-especially agitation, anxiety, hostility, panic,
restlessness, extreme hyperactivity, and suicidal thinking or behavior-
and report them to the doctor immediately. Be especially observant at
the beginning of treatment or whenever there is a change in dose.
Paxil should be used cautiously by people with a history of manic
disorders and those with high pressure in the eyes (glaucoma).
If you have a history of seizures, make sure your doctor knows about
it. Paxil should be used with caution in this situation. If you
develop seizures once therapy has begun, the drug should be
discontinued.
If you have a disease or condition that affects your metabolism or
blood circulation, make sure your doctor is aware of it. Paxil should
be used cautiously in this situation.
Paxil may impair your judgment, thinking, or motor skills. Do not
drive, operate dangerous machinery, or participate in any hazardous
activity that requires full mental alertness until you are sure Paxil
is not affecting you in this way.
Antidepressants such as Paxil could potentially cause stomach
bleeding, especially when combined with nonsteroidal anti-inflammatory
drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen
(Aleve), and ketoprofen (Orudis KT). Consult your doctor before
combining Paxil with NSAIDs or blood-thinning drugs.
Paxil contains paroxetine, which is associated with serotonin
syndrome. Symptoms include agitation, confusion, sweating,
hallucinations, abnormal reflexes, muscle spasms, shivering, rapid
heartbeat, and tremors. Contact your doctor immediately if you
experience any of these symptoms.
It's best to avoid an abrupt discontinuation of Paxil therapy. It can
lead to symptoms such as dizziness, abnormal dreams, and tingling
sensations. To prevent such problems, your doctor will reduce your
dose gradually.
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