Zoloft Warnings Of Adverse
Affects And Interactions

ZOLOFT (Pfizer) Generic: not available
Fluoxetine (floo ox uh teen), paroxetine (pa rox uh teen), sertraline (ser tral leen), and fluvoxamine (floo vox uh meen) all belong to the family of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Fluoxetine, paroxetine, and sertraline are approved to treat severe depression and obsessive compulsive disorder. Fluoxetine is also approved for the eating disorder bulimia, and paroxetine and sertraline for the treatment of panic disorder. Fluvoxamine is only approved for obsessive compulsive disorder at this time. This table compares the most common adverse effects of the antidepressant drugs.
Fluoxetine, paroxetine, and sertraline are used to treat severe depression that is not caused by other drugs, by alcohol, or by emotional losses (such as a death in the family). These are effective medications in many patients including some whose depression has not improved on other drugs. Fluoxetine appears to be most appropriate for patients who are at special risk from the fatigue, low blood pressure, dry mouth, and constipation caused by other antidepressants. It is safer in overdoses than some other antidepressants, but there is no evidence that the death rate from suicides with antidepressants has decreased with the widespread use of fluoxetine and the other SSRI antidepressants.
Fluoxetine and the other SSRIs may reduce the risk of suicide in depressed patients. However, there have been a few reports that fluoxetine may actually induce suicidal thoughts in selected patients, although this has not been confirmed. Public Citizens Health Research Group petitioned the Food and Drug Administration in 1991 to require a box warning in the professional product labeling for fluoxetine warning doctors that a small minority of persons taking the drug have experienced intense, violent, suicidal thoughts, agitation, and impulsivity after starting treatment with the drug. You should not take this drug for mild depression or anxiety, or as a sleeping pill.
A review of 64 randomized controlled trials comparing SSRIs to the older tricyclic antidepressants such as imipramine (Tofranil) found similar benefit from the new and older drugs. When the results of many clinical trials were pooled, called a meta-analysis, no clear benefit was found for the new drugs over the older antidepressants. The adverse effects of the new and old antidepressants have little in common except for withdrawal symptoms. For example, SSRIs are less likely than the tricyclic drugs to cause sedation, anticholinergic effects, and heart rhythm disturbances. On the other hand, SSRIs adverse effects commonly affect the gastrointestinal tract, especially causing nausea and diarrhea, and may also cause insomnia, agitation, extrapyramidal symptoms (drug-induced parkinsonism), and withdrawal effects.
One group of adverse effects is traded for another between the SSRIs and tricyclic antidepressants and there does not appear to be any difference in the proportion of people who can tolerate these two groups of antidepressants. When the number of people who stopped taking an antidepressant in 58 clinical trials were studied there was no clinically important difference between the SSRIs and the tricyclic and related antidepressants.
When you take these medicines you may experience some adverse effects. The most frequently reported include nausea, anxiety, headache, and insomnia. These adverse effects tend to be worst at the start of treatment, and improve over a few weeks. Akathisia, or symptoms of restlessness, constant pacing, and purposeless movements of the feet and legs, may also occur. Dry mouth, sweating, diarrhea, tremor, loss of appetite, and dizziness are also common adverse effects.
The length of time it takes an antidepressant to work can overlap with the time of spontaneous recovery, especially if the depression is situational - caused by a death or other external circumstances. Antidepressant drugs should be reserved for depression that is major and does not respond to psychotherapy alone. WARNING
A small number of people taking fluoxetine have experienced intense, violent, suicidal thoughts, agitation, and impulsivity. Whether their symptoms were induced by fluoxetine or were related to their underlying psychological problems is unclear. As with any other antidepressant, fluoxetine should only be used under close medical supervision. Patients are advised to consider telling relatives and friends about their use of this drug and the risk of suicidal obsession and self-injurious behavior.
Do not take fluoxetine, paroxetine, sertraline, or fluvoxamine with monoamine oxidase (MAO) inhibitors (see Interactions with Other Drugs) because the combinations may produce a syndrome of rising temperature, tremor, and seizures.
Before You Use This Drug
Tell your doctor if you have or have had:
* allergies to drugs
* suicidal thoughts or actions
* kidney or liver problems
* diabetes
* epilepsy or seizures
* brain disease or damage
Tell your doctor about any other drugs you take, including aspirin, herbs,
vitamins, and other nonprescription products.
When You Use This Drug
* Until you know how you react to these drugs, do not drive or
perform other activities requiring alertness. These drug may cause
* Do not drink alcohol or take other drugs that can cause drowsiness.
* You may feel dizzy when rising from a lying or sitting position.
When getting out of bed, hang your legs over the side of the bed for a few
minutes, then get up slowly. When getting up from a chair, stay by the
chair until you are sure that you are not dizzy.
* Stop taking these drugs and check with your doctor as soon as
possible if you develop skin rash or hives.
* If you develop dryness of the mouth, take sips of water. If dry
mouth persists for more than two weeks, check with your doctor.
* Check with your doctor before you take any other drugs,
prescription or nonprescription. These drugs frequently interact with other
* The effects of these drugs may last for several weeks after you
stop taking them. Do not drink alcohol and heed all other warnings for this
time period.
How to Use This Drug
* Measure liquid with a calibrated teaspoon.
* Capsules may be opened and mixed with food or drink. Food does not
affect the extent of absorption, although rate may be slightly decreased.
* If you are taking other drugs, take them one to two hours before
taking one of these drugs.
* If you miss a dose, skip the missed dose, and continue with your
next scheduled dose. Do not take double doses.
* Store both forms at room temperature with cap on tightly.
* Do not store in the bathroom. Do not expose to heat, moisture, or
strong light.
Interactions with Other Drugs
The following drugs are listed in the Evaluations of Drug Interactions 1999 as causing highly clinically significant or clinically significant interactions when used together with this drug. We have also included potentially serious interactions listed in the drugs FDA-approved professional product labeling or package insert. New scientific techniques have allowed researchers to predict some drug interactions before they have been documented in people. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. The number of new drugs approved for marketing increases the chance of drug interactions, and new drug interactions are being identified with old drugs. Be vigilant. Make sure to tell your doctor and pharmacist the drugs you are taking and tell your doctor if you are taking any of these interacting drugs:
At least two weeks should elapse between stopping a monoamine oxidase (MAO) inhibitor and starting one of these drugs. You should wait at least five weeks after stopping one of these drugs and starting one of these MAO inhibitors: deprenyl, ELDEPRYL, furazolidone, FUROXONE, isocarboxazid, MARPLAN, MATULANE, NARDIL, PARNATE, phenelzine, procarbazine, selegiline, tranylcypromine.
Other interacting drugs are: alprazolam, astemizole, DESYREL, DILANTIN, HISMANAL, lithium, LITHOBID, LITHONATE, marijuana, phenytoin, trazodone, XANAX and the herbal supplement ST. JOHN'S WORT.
Central nervous system (CNS) depressant drugs including: alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills and tranquilizers. These drugs can increase the blood levels of other antidepressants, potentially increasing adverse effects from those medications.
Adverse Effects
Call your doctor immediately if you experience:
* signs of overdose: agitation and restlessness, convulsions,
seizures, unusual excitement, severe nausea and vomiting, severe
drowsiness, dry mouth, irritability, large pupils, fast heartbeat
* signs of allergic reaction or serum sickness-like syndrome: skin
rash or hives associated with burning or tingling in fingers, hands, or
arms, chills or fever, swollen glands, joint or muscle pain, swelling of
feet or lower legs, or trouble breathing
* signs of hypoglycemia: anxiety, chills, cold sweats, confusion,
cool, pale skin, difficulty in concentration, drowsiness, excessive hunger,
fast heartbeat, headache, nervousness, shakiness, unsteady walk, unusual
tiredness or weakness
* suicidal thoughts or behavior
* chills or fever
* joint or muscle pain
* skin rash, hives, or itching
* difficulty breathing
* cold sweats
* confusion
* excessive hunger
* unusual excitement
* swollen glands
* swelling of feet or lower legs
* difficulty speaking
* dry mouth
* decreased sexual drive
* stomach or abdominal cramps
* gas
* tiredness or weakness
* trouble sleeping
* mania
Call your doctor if these symptoms continue:
* anxiety and nervousness
* nausea, vomiting, or diarrhea
* increased or decreased appetite or weight loss
* constipation
* frequent urination
* change in taste
* drowsiness
* dizziness
* headache
* increased sweating
* disturbing dreams
* changes in vision
* chest pain
* irregular or fast heartbeat
* stuffy nose
* cough
* impaired concentration
* trembling or quivering
* feeling of warmth or heat
* flushing or redness of skin, especially on face and neck
Periodic Tests
Ask your doctor which of these tests should be done periodically while you are taking this drug:
*supervision of depression with suicidal tendencies
A withdrawal reaction has been reported with all SSRI antidepressants. The symptoms generally start within one to three days after stopping the drug, and generally resolve within one to two weeks after the drug has been discontinued. Withdrawal symptoms may occur even when the dosage of the drug is gradually decreased. The main symptoms of this reaction are: dizziness, vertigo, uncoordination, nausea and vomiting, and flu-like symptoms that include fatigue, lethargy, muscle pain and chills.
This reaction appears to be most common with paroxetine, and to a lesser extent with sertraline and fluoxetine. Withdrawal has also been reported with fluvoxamine. Because this is the newest SSRI how often the withdrawal reaction occurs is unknown.
Luvox caused harm to developing fetuses in animal studies, or such studies were not done. Use during pregnancy only for clear medical reasons. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.

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