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Precautions
Pregnancy and Lactation: - Safe use of fluoxetine during pregnancy and lactation has not been established. Therefore, it should not be administered to women of childbearing potential or nursing mother
s unless, in the opinion of the treating physician, the expected benefits to the patient markedly outweigh the possible hazards to the child or fetus. In 1 breast milk sample, the concentration of flu
oxetine plus norfluoxetine was 70.4 ng/mL. The concentration in the mother's plasma was 295 ng/mL. No adverse effects on the infant were reported.
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Side Effects of This Medicine
More common side effects may include:
- Abnormal dreams, abnormal ejaculation, abnormal vision, anxiety, diminished sex drive, dizziness, dry mouth, flu-like symptoms, flushing, gas, headache, im
potence, insomnia, itching, loss of appetite, nausea, nervousness, rash, sinusitis, sleepiness, sore throat, sweating, tremors, upset stomach, vomiting, weakness, yawning
Less common side eff
ects may include:
- Abnormal taste, agitation, bleeding problems, chills, confusion, ear pain, emotional instability, fever, frequent urination, high blood pressure, increased appetite, loss of m
emory, palpitations, ringing in the ears, sleep disorders, weight gain
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Overdose
- unsteadiness
- confusion
- unresponsiveness
- nervousness
- tremor
- dizziness
- rapid, irregular, or pounding heartbeat
- seeing things or hearing voices tha
t do not exist (hallucinating)
- fever
- fainting
- coma
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Possible food and drug interactions
Venlafaxine (e.g., Effexor)¡XUsing these medicines with fluoxetine or within 5 weeks of stopping fluoxetine may increase the chance of developing a rare, but very serious, unwanted effect known as the
serotonin syndrome. This syndrome may cause confusion, diarrhea, fever, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking
, or twitching. If you develop these symptoms contact your doctor as soon as possible. Taking tramadol with fluoxetine increases the chance of having convulsions (seizures). Also, taking tryptophan wi
th fluoxetine may result in increased agitation or restlessness and intestinal or stomach problems
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Adverse Effects
Adverse Events Leading to Discontinuation of Treatment: - Fifteen percent of approximately 4000 patients who received fluoxetine in North American clinical trials discontinued treatment due to an adve
rse event. The more common events causing discontinuation included: Psychiatric, primarily nervousness, anxiety, and insomnia; digestive, primarily nausea; nervous system, primarily dizziness, astheni
a and headaches; skin, primarily rash and pruritus. In obsessive compulsive disorder studies, 12.1% of fluoxetine treated patients discontinued treatment early because of adverse events. Anxiety, and
rash, at incidences of less than 2%, were the most frequently reported events.
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Significant Interactions:
General Anesthetics: - Since little is known about the interaction between fluoxetine and general anesthetics, fluoxetine should be discontinued for as long as clinically possible prior to elective su
rgery.
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