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Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.
Commonly Observed (based on first year and second year data)
Gastrointestinal (GI) symptoms were the most commonly observed treatment-emergent adverse events associated with the use of XENICAL in the seven double-blind, placebo-controlled clinical trials and are primarily a manifestation of the mechanism of action. (Commonly observed is defined as an incidence of ≥ 5% and an incidence in the XENICAL 120 mg group that is at least twice that of placebo.)
Table 4 : Commonly Observed Adverse Events
|Year 1||Year 2|
|XENICAL* % Patients
|Placebo* % Patients
|XENICAL* % Patients
|Placebo* % Patients
|Flatus with Discharge||23.9||1.4||2.1||0.2|
|* Treatment designates XENICAL
three times a day plus diet or placebo plus diet
† Oily discharge may be clear or have a coloration such as orange or brown.
In general, the first occurrence of these events was within 3 months of starting therapy. Overall, approximately 50% of all episodes of GI adverse events associated with XENICAL treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.
Discontinuation of Treatment
In controlled clinical trials, 8.8% of patients treated with XENICAL discontinued treatment due to adverse events, compared with 5.0% of placebo-treated patients. For XENICAL, the most common adverse events resulting in discontinuation of treatment were gastrointestinal.
Other Adverse Clinical Events
The following table lists other treatment-emergent adverse events from seven multicenter, double-blind, placebo-controlled clinical trials that occurred at a frequency of ≥ 2% among patients treated with XENICAL 120 mg three times a day and with an incidence that was greater than placebo during year 1 and year 2, regardless of relationship to study medication.
Table 5 : Other Treatment-Emergent Adverse Events From
Seven Placebo-Controlled Clinical Trials
|Year 1||Year 2|
|XENICAL* % Patients (N=1913)||Placebo* % Patients (N=1466)||XENICAL* % Patients (N=613)||Placebo* % Patients (N=524)|
|Upper Respiratory Infection||38.1||32.8||26.1||25.8|
|Lower Respiratory Infection||7.8||6.6||–||–|
|Ear, Nose & Throat Symptoms||2.0||1.6||–||–|
|Pain Lower Extremities||–||–||10.8||10.3|
|Central Nervous System|
|Body as a Whole|
|Skin & Appendages|
|Urinary System Urinary Tract Infection||7.5||7.3||5.9||4.8|
|Hearing & Vestibular Disorders Otitis||4.3||3.4||2.9||2.5|
|Cardiovascular Disorders Pedal Edema||–||–||2.8||1.9|
|* Treatment designates XENICAL 120
mg three times a day plus diet or placebo plus diet
– None reported at a frequency ≥ 2% and greater than placebo
In the 4-year XENDOS study, the general pattern of adverse events was similar to that reported for the 1- and 2year studies with the total incidence of gastrointestinal-related adverse events occurring in year 1 decreasing each year over the 4-year period.
In clinical trials with XENICAL in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults.
The following adverse reactions have been identified during postapproval use of XENICAL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to XENICAL exposure.
- Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reported. There have been reports of hepatic failure observed with the use of XENICAL in postmarketing surveillance, with some of these cases resulting in liver transplant or death [see WARNINGS AND PRECAUTIONS].
- Cases of reduced concentrations of cyclosporine have been reported when cyclosporine was co-administered with XENICAL [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
- Rare cases of hypersensitivity have been reported with the use of XENICAL. Signs and symptoms have included pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis. Very rare cases of bullous eruption have been reported.
- Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with XENICAL and anticoagulants [see DRUG INTERACTIONS].
- Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine [see DRUG INTERACTIONS].
- Acute oxalate nephropathy after treatment with XENICAL has been reported in patients with or at risk for renal disease [see WARNINGS AND PRECAUTIONS].
- Pancreatitis has been reported with the use of XENICAL in postmarketing surveillance. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established.
- Lower gastrointestinal bleeding has been reported in patients treated with XENICAL. Most reports are nonserious; severe or persistent cases should be investigated further.
Read the Xenical (orlistat 120 mg) Side Effects Center for a complete guide to possible side effects »
Data from a XENICAL and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when XENICAL was coadministered with cyclosporine. XENICAL and cyclosporine should not be simultaneously coadministered. Cyclosporine should be administered 3 hours after the administration of XENICAL [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS].
Fat-soluble Vitamin Supplements and Analogues
Data from a pharmacokinetic interaction study showed that the absorption of beta-carotene supplement is reduced when concomitantly administered with XENICAL. XENICAL inhibited absorption of a vitamin E acetate supplement. The effect of XENICAL on the absorption of supplemental vitamin D, vitamin A, and nutritionally-derived vitamin K is not known at this time [see Pharmacokinetics].
Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine postmarketing [see ADVERSE REACTIONS]. Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function. Administer levothyroxine and XENICAL at least 4 hours apart [see DOSAGE AND ADMINISTRATION].
Vitamin K absorption may be decreased with XENICAL. Patients on chronic stable doses of warfarin who are prescribed XENICAL should be monitored closely for changes in coagulation parameters [see Pharmacokinetics].
Drug Abuse And Dependence
As with any weight-loss agent, the potential exists for abuse of XENICAL in inappropriate patient populations (eg, patients with anorexia nervosa or bulimia). See INDICATIONS AND USAGE for recommended prescribing guidelines.
Last reviewed on RxList: 2/7/2012
This monograph has been modified to include the generic and brand name in many instances.
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