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Sibutramine Side Effects

Applies to sibutramine: oral capsule.

General

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

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

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]

Respiratory

Respiratory system side effects have included rhinitis (10.2%), pharyngitis (10.0%), sinusitis (5.0%), increased cough (3.8%), and laryngitis (1.3%). Causal relationships have not been proven.[Ref]

Musculoskeletal

Musculoskeletal aches and pains associated with the use of this drug have included arthralgia (5.9%), myalgia (1.9%), tenosynovitis (1.2%), and joint disorder (1.1%).[Ref]

Dermatologic

Dermatologic side effects have included rash (3.8%), sweating (2.5%), herpes simplex (1.3%), and acne (1.0%). A case of severe bullous drug eruption due to sibutramine has also been reported.[Ref]

Genitourinary

Genitourinary side effects have included dysmenorrhea (3.5%), urinary tract infection (2.3%), vaginal monilia (1.2%), metrorrhagia (1.0%), and urinary retention.[Ref]

Cardiovascular

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

Other side effects have included taste perversion (2.2%), ear disorder (1.7%), and ear pain (1.1%).[Ref]

Metabolic

Metabolic side effects have included thirst (1.7%) and generalized edema (1.2%).[Ref]

Hematologic

Hematologic side effects including significant improvements in serum triglyceride and HDL-C levels have been reported.[Ref]

Psychiatric

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]

Hypersensitivity

Hypersensitivity side effects have included reactions ranging from mild skin eruptions and urticaria to angioedema and anaphylaxis.[Ref]

References

1. Product Information. Meridia (sibutramine). Knoll Pharmaceutical Company. 2001.

2. Clark DW, Harrison-Woolrych M. Sibutramine may be associated with memory impairment. BMJ. 2004;329:1316.

3. Goh BK, Ng PP, Giam YC. Severe bullous drug eruption due to sibutramine (Reductil(R)). Br J Dermatol. 2003;149:215-6.

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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