Xenical Adverse Reactions

Clinical Trials: Adverse reactions to Xenical are largely gastrointestinal in nature and related to the pharmacologic effect of the drug on preventing the absorption of ingested fat. Commonly observed events were oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. The incidence of these increases the higher the fat content of the diet. Patients should be counseled as to the possibility of gastrointestinal effects occurring and how best to handle them eg, reinforcing the diet, particularly the percentage of fat it contains. Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal events and this may help patients to monitor and regulate their fat intake.
These adverse gastrointestinal reactions are generally mild and transient. They occurred early in the treatment (within 3 months) and most patients experienced only one episode.
Treatment-emergent GI-adverse events that occurred commonly among patients treated with Xenical were the following: Abdominal pain/discomfort, flatulence, liquid stools, soft stools, rectal pain/discomfort, tooth disorder, gingival disorder.
Other events observed were the following: Upper respiratory infection, lower respiratory infection, influenza, headache, menstrual irregularity, anxiety, fatigue, urinary tract infection.
Unique treatment adverse events observed in obese type 2 diabetic patients were hypoglycemia (very common) and abdominal distension (common). Weight loss induced by Xenical is accompanied by improved metabolic control in type 2 diabetics which might allow or require reduction in the dose of hypoglycemic medication (see Precautions).
In a 4-year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1- and 2-year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the 4-year period.
Post-Marketing: Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis. Very rare cases of bullous eruption, increase in transaminases and in alkaline phosphatase, and exceptional cases of hepatitis that may be serious have been reported during the post-marketing. No causal relationship or physiopathological mechanism between hepatitis and orlistat therapy has been established. Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants during post-marketing.
Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs (see Interactions).