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Patients with concurrent disease or on multiple concomitant medications may require dosage adjustmentssee WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY
Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.
During marketing of SARAFEMSNRIsand SSRIsthere have been spontaneous reports of adverse reactions occurring upon discontinuation of these drugsparticularly when abruptincluding the followingdysphoric moodirritabilityagitationdizzinesssensory disturbancesfor exampleparesthesias such as electric shock sensationsanxietyconfusionheadachelethargyemotional labilityinsomniaand hypomaniaWhile these reactions are generally self-limitingthere have been reports of serious discontinuation symptoms.
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