Xenical Adverse Reactions

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 are 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 counselled 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 monitor and regulate their fat intake.
These adverse gastrointestinal reactions are generally mild and transient. They occurred early in treatment (within 3 months) and most patients experienced only 1 episode.
Treatment-emergent GI adverse events that occurred commonly among patients treated with Xenical were: Abdominal pain/discomfort, flatulence, liquid stools, soft stools, rectal pain/discomfort, tooth disorder and gingival disorder.
Other events observed rarely were: Upper and lower respiratory infections; influenza; headache; menstrual irregularity; anxiety; fatigue; urinary tract infection.
In type 2 diabetic patients, adverse event reporting was comparable to that reported in overweight and obese patients. The only unique treatment adverse events that occurred at a frequency of >2% and with an incidence ≥1% above placebo were hypoglycemia (which may occur as a result of improved glycaemic control) and abdominal distention.
Post-Marketing Experience: Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, rash, urticaria, angioedema and anaphylaxis.