After numerous clinical trials, it is apparent that, compared with other older antidepressants, Prozac has an exceptionally low incidence of side effects. Nevertheless, there are some side effects. In clinical trials of about three thousand patients, the following reactions were seen:
• Nausea. Some 21% of the patients in clinical trials complained about nausea, making it the most frequent side effect associated with Prozac. However, only 2% of the patients actually vomited. Complaints of nausea were most frequent during the first few days to two weeks, after which the number of complaints dropped precipitously. After a few weeks, almost all of the nausea subsided. Nausea is Prozac’s most notable side effect, so it is worth pointing out that in clinical studies comparing Prozac with tricyclic antidepressants and a placebo,. 15% of those taking the TCAs also complained of nausea, and so did 10% of those receiving a placebo.
• Headaches. About 20% of the Prozac patients experienced this side effect, but it caused only 2% to stop taking the drug. Again, approximately equal numbers of those taking the TCA imipramine or placebo also complained about headache.
• Nervousness and anxiety. Between 10% and 15% of the Prozac patients registered these complaints. For the most part, these side effects were relatively mild, causing only 5% of the patients actually to discontinue treatment
Insomnia. About 14% of the patients had difficulty sleeping, and 2% discontinued the drug as a result.
• Drowsiness. About 12% of the patients were bothered by drowsiness.
• Anorexia. This affected 9% of the patients. Some investigators (but not most) have concluded that this could explain why most Prozac patients fail to gain weight, in contrast to patients who take most of the tricyclic and MAOl antidepressants. This is one incredibly important aspect of Prozac that makes it particularly desirable among patients who are obese or tend to gain weight easily, especially with other antidepressant drugs.
• Diarrhea. About 12% of the patients experienced diarrhea.
• Dry mouth. Only 9.5% of Prozac patients experienced dry mouth—a stunning improvement over the 64.3% of patients taking tricyclic antidepressants who complained about this irritating (for some) symptom. Sucking hard candy helps.
• Sweating and tremor. These symptoms affected about 8% of the patients taking Prozac.
• Rash. Rashes showed up in about 3% of the patients, a figure not so different from the 4% who break out in rashes after taking tricyclic antidepressants (and the 2% of patients taking a placebo who develop a rash). Typically, the rash appeared during the first few weeks and usually disappeared within a week, whether or not the patient stopped taking Prozac. Occasionally, hives, pains in the joints, or other systemic problems occurred simultaneously with the rash. For this reason, most physician recommend that, if a rash appears, the patient should immediately stop taking the medication.
Laboratory data have shown no evidence of damage to the liver, kidneys, bone marrow, or heart associated with Prozac.
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