Sibutramine Side Effects

Some side effects of sibutramine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sibutramine: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking sibutramine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sibutramine and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeats;

• new or worsening shortness of breath;

• agitation, hallucinations, fever, tremor, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, dilated pupils;

• very stiff (rigid) muscles, high fever, sweating, confusion, feeling like you might pass out;

• easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, seizure);

• chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling; or

• sudden numbness or weakness (especially on one side of the body), problems with vision, speech, or balance.

Less serious side effects of sibutramine may include:

• dry mouth, upset stomach;

• changes in appetite;

• constipation, stomach pain;

• headache, back pain, joint pain;

• feeling nervous, dizzy, or depressed;

• flu symptoms, runny or stuffy nose, sore throat, cough;

• warmth, redness, or tingly feeling under your skin;

• trouble sleeping (insomnia); or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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%).

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.

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%).

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.

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%).

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.

Genitourinary

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

Cardiovascular

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.

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.

Other

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

Metabolic

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

Hematologic

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

Psychiatric

If depression occurs during treatment with sibutramine, further evaluation of the patient may be necessary.

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.

Hypersensitivity

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

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