Sibutramine Side Effects

It is possible that some side effects of sibutramine may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sibutramine: oral capsule

As well as its needed effects, sibutramine may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sibutramine, check with your doctor immediately:

Less common
  • Achiness
  • chills
  • fast or irregular heartbeat
  • increased blood pressure
  • mental depression
  • painful menstruation
  • swelling of the body, feet, or ankles
Rare
  • Bruising or red spots or patches on the skin
  • convulsions (seizures)
  • excessive bleeding following injury
  • headache (severe)
  • rapidly changing moods
  • skin rash
  • weight gain (unusual)

Some sibutramine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Anxiety
  • constipation
  • dizziness
  • dryness of the mouth
  • headache
  • irritability or unusual impatience
  • nervousness
  • stuffy or runny nose
  • trouble with sleeping
Less common
  • Abdominal or stomach pain
  • back pain
  • burning, itching, prickling, or tingling of the skin
  • change in sense of taste
  • diarrhea
  • drowsiness
  • increase in appetite
  • increased sweating
  • increased thirst
  • indigestion
  • nausea
  • unusual warmth or flushing of the skin

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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