Sibutramine Side Effects
Applies to sibutramine: oral capsule.
General side effects, unrelated to a specific organ system, have included headaches (30.3%), back pain (8.2%), flu syndrome (8.2%), accidental injury (5.9%), asthenia (5.9%), abdominal pain (4.5%), chest pain (1.8%), and neck pain (1.6%).[Ref]
Nervous system side effects have included dry mouth (17.2%), insomnia (10.7%), dizziness (7.0%), nervousness (5.2%), anxiety (4.5%), depression (4.3%), paresthesia (2.0%), somnolence (1.7%), CNS stimulation (1.5%), emotional lability (1.3%), amnesia, abnormal dreams, abnormal gait, amnesia, anger, cerebrovascular accident, impaired concentration, confusion, aggravated depression, Gilles de la Tourette's syndrome, hypesthesia, decreased libido, increased libido, mood changes, nightmares, short term memory loss, speech disorder, transient ischemic attack, tremor, twitch, and vertigo. Less than 0.1% of patients have experienced seizures during therapy.[Ref]
Gastrointestinal side effects have included anorexia (13.0%), constipation (11.5%), increased appetite (8.7%), nausea (5.9%), dyspepsia (5.0%), gastritis (1.7%), vomiting (1.5%), and rectal disorder (1.2%).[Ref]
Cardiovascular side effects have included tachycardia (2.6%), vasodilation (2.4%), migraine (2.4%), hypertension/increased blood pressure (2.1%), and palpitation (2.0%), arrhythmias, myocardial infarction, and cardiac arrest. A few cases of QT interval prolongation have also been reported.[Ref]
The manufacturer has reported that in placebo-controlled obesity studies, sibutramine 5 to 20 mg once a day has been associated with mean increases in systolic and diastolic blood pressure of approximately 1 to 3 mm Hg relative to placebo, and mean increases in pulse rate of approximately 4 to 5 beats per minute.[Ref]
Other side effects have included taste perversion (2.2%), ear disorder (1.7%), and ear pain (1.1%).[Ref]
Hematologic side effects including significant improvements in serum triglyceride and HDL-C levels have been reported.[Ref]
Psychiatric side effects including cases of depression, psychosis, mania, suicidal ideation and suicide have been reported. If any of these events should occur during treatment with sibutramine, discontinuation should be considered. One case of exacerbation of panic attacks has also been reported.[Ref]
If depression occurs during treatment with sibutramine, further evaluation of the patient may be necessary.[Ref]
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1. Product Information. Meridia (sibutramine). Knoll Pharmaceutical Company. 2001.
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4. Harrison-Woolrych M, Clark DW, Hill GR, Rees MI, Skinner JR. QT interval prolongation associated with sibutramine treatment. Br J Clin Pharmacol. 2006;61:464-9.
5. Ernest D, Gershenzon A, Corallo CE, Nagappan R. Sibutramine-Associated QT Interval Prolongation and Cardiac Arrest (October). Ann Pharmacother. 2008.
6. Dujovne CA, Zavoral JH, Rowe E, Mendel CM. Effects of sibutramine on body weight and serum lipids: a double-blind, randomized, placebo-controlled study in 322 overweight and obese patients with dyslipidemia. Am Heart J. 2001;142:489-97.
7. Binkley K, Knowles SR. Sibutramine and Panic Attacks. Am J Psychiatry. 2002;159:1793-1794.
8. Rosenbohm A, Bux CJ, Connemann BJ. Psychosis with sibutramine. J Clin Psychopharmacol. 2007;27:315-7.
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Some side effects may not be reported. You may report them to the FDA.