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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 the rates observed in practice.
Liver or kidney diseaseseizures or epilepsya bleeding or blood clotting disorderbipolar disordermanic depressionor a history of drug abuse or suicidal thoughts.
This drug has a black box warningThis is the most serious warning from the Food and Drug AdministrationFDAA black box warning alerts doctors and patients about drug effects that may be dangerousThis drug may increase suicidal thoughts or behavior in some childrenteenagersor young adultsThe risk of this is greatest within the first few months of treatment or when the dosage is changedCall your healthcare provider right away if you have new or sudden changes in your moodbehavioractionsthoughtsor feelingsespecially if they are severePay extra close attention when you start taking this drug or when your dosage is changed.
SNRIs and SSRIsincluding ZOLOFThave been associated with cases of clinically significant hyponatremia in elderly patientswho may be at greater risk for this adverse reactionSee WARNINGS AND PRECAUTIONS
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