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November 25, 2009
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sibutramine (cont.)

PREGNANCY: No adequate studies with sibutramine have been done in pregnant women. The use of sibutramine during pregnancy, therefore, is not recommended. Women who could become pregnant should use adequate contraception while taking sibutramine.

NURSING MOTHERS: It is unknown whether sibutramine or its active products accumulate in breast milk. Sibutramine, therefore, is not recommended for nursing mothers.

SIDE EFFECTS: In general, sibutramine is well-tolerated. The most common side effects have been constipation, inability to sleep, headache, and dry mouth. Other side effects include abdominal pain, acne, rash, chest pain, anxiety, joint pain, back pain, excitation, depression, sweating, dizziness, drowsiness, changes in taste, irregular or painful menstrual periods, flu-like syndrome, increased cough, muscle pain, nausea, vomiting, neck pain, nervousness, palpitations, tingling of the extremities, sore throat, and sinus congestion.

Abnormal liver tests have been reported in 1 in 60 persons who receive sibutramine.

Depression, psychosis, mania, suicidal thoughts and suicide have been reported rarely during treatment with sibutramine; however, it has not been established that sibutramine caused these events.  If any of these events occur during treatment, sibutramine probably should be discontinued.

Reference: FDA Prescribing Information


Last Editorial Review: 1/25/1999 7:47:00 PM




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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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