Note: This document contains side effect information about orlistat. Some dosage forms listed on this page may not apply to the brand name Xenical.

Summary

Common side effects of Xenical include: bowel urgency, frequent bowel movements, oily evacuation, oily rectal leakage, steatorrhea, and flatulence with discharge. Other side effects include: fecal incontinence. Continue reading for a comprehensive list of adverse effects.

Applies to orlistat: oral capsules.

Side effects include:

Oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation, fecal incontinence.

In clinical studies, adverse effects reported in individuals receiving orlistat (the active ingredient contained in Xenical) 60 mg 3 times daily were similar to those reported in patients receiving 120 mg 3 times daily, and were primarily GI related.

For Healthcare Professionals

Applies to orlistat: oral capsule.

General

The most commonly reported adverse events have included oily spotting, flatus with discharge, fecal urgency fatty/oily stool, oily evacuation, increased defecation and fecal incontinence.^[Ref]

Gastrointestinal

Gastrointestinal events usually occur within the first 3 months. Approximately 50% of all GI events lasted for less than 1 week with a majority lasting no more than 4 weeks. Although, in some individuals, gastrointestinal events have lasted 6 months or more. In clinical trials, gastrointestinal adverse effects were the most common reason for treatment discontinuation.^[Ref]

Very common (10% or more): Oily spotting (up to 26.6%), flatus with discharge (up to 23.9%), fecal urgency (up to 22.1%), fatty/oily stool (up to 20%), oily evacuation (up to 11.9%), increased defecation (up to 10.8%), abdominal pain/discomfort (up to 25.5%)

Common (1% to 10%): Fecal incontinence, nausea, infectious diarrhea, rectal pain/discomfort, tooth disorder, gingival disorder, vomiting

Frequency not reported: Abdominal distention

Postmarketing reports: Pancreatitis, lower gastrointestinal bleeding^[Ref]

Hepatic

Postmarketing reports: Increases in hepatic transaminases, alkaline phosphatase elevations, hepatitis, hepatic failure, liver transplant^[Ref]

Reports of hepatic failure have been received during postmarketing surveillance, with some of these cases resulting in liver transplant or death. Rare cases of increased transaminases, alkaline phosphatase, and hepatitis have been received.^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions including pruritus, rash, urticaria, angioedema, bronchospasm, and anaphylaxis; at least one case of cutaneous leukocytoclastic vasculitis^[Ref]

Metabolic

Frequency not reported: Hypoglycemia, at least one case of diabetic ketoacidosis; polyuria, polydipsia^[Ref]

Dermatologic

Cases of leukocytoclastic vasculitis have been reported during the postmarketing period. Clinical signs include palpable purpura, maculopapular lesions, or bullous eruption.^[Ref]

Postmarketing reports: Bullous eruption, leukocytoclastic vasculitis^[Ref]

Renal

Postmarketing reports: Acute oxalate nephropathy^[Ref]

Nervous system

Convulsions have been reported in patients concomitantly receiving this drug with antiepileptic drugs.^[Ref]

Very common (10% or more): Headache (up to 30.6%)

Common (1% to 10%): Dizziness

Postmarketing reports: Convulsions^[Ref]

Psychiatric

Common (1% to 10%): Sleep disorder, anxiety, depression^[Ref]

Respiratory

Very common (10% or more): Influenza (up to 39.7%), upper respiratory infection (up to 38.1%)

Common (1% to 10%): Lower respiratory infection, ear, nose & throat symptoms^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (up to 13.9%)

Common (1% to 10%): Arthritis, myalgia, joint disorder, tendonitis^[Ref]

Genitourinary

Common (1% to 10%): Menstrual irregularity, vaginitis, urinary tract infection^[Ref]

Cardiovascular

Common (1% to 10%): Pedal edema^[Ref]

Hematologic

Postmarketing reports: Decreased prothrombin, increased INR and unbalanced anticoagulant treatment^[Ref]

Decreased prothrombin and increased INR resulting in unbalanced anticoagulant treatment has been reported in patients treated concomitantly with anticoagulants.^[Ref]

Other

Common (1% to 10%): Fatigue, otitis^[Ref]

Endocrine

For patients receiving levothyroxine, hypothyroidism has been reported requiring an adjustment to levothyroxine therapy.^[Ref]

Postmarketing reports: Hypothyroidism^[Ref]