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Xenical Side Effects

Generic Name: orlistat

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

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to orlistat: oral capsule

Along with its needed effects, orlistat (the active ingredient contained in Xenical) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking orlistat:

More Common

  • Bladder pain
  • body aches
  • chills
  • cough
  • diarrhea
  • difficulty with breathing
  • ear congestion
  • fever
  • general feeling of discomfort or illness
  • headache
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • muscle aches and pains
  • nasal congestion
  • nausea
  • runny nose
  • shivering
  • sneezing
  • sore throat
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

Less Common

  • Tightness in the chest
  • tooth or gum problems
  • troubled breathing
  • wheezing

Rare

  • Bloody or cloudy urine
  • change in hearing
  • contagious diarrhea
  • dark urine
  • difficult or painful urination
  • earache
  • fast heartbeat
  • frequent urge to urinate
  • general tiredness and weakness
  • hives
  • hoarseness
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • noisy breathing
  • pain in the ears
  • rash
  • redness of the skin
  • shortness of breath
  • skin blisters
  • swelling of the eyelids, face, lips, hands, or feet
  • troubled swallowing
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Incidence Not Known

Some side effects of orlistat may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Abdominal or stomach pain or discomfort
  • back pain
  • difficulty with moving
  • gas with leaky bowel movements
  • inability to hold bowel movement
  • increases in bowel movements
  • loss of bowel control
  • oily bowel movements
  • oily spotting of underclothes

Less Common

  • Itching of the vagina or genital area
  • menstrual changes
  • pain during sexual intercourse
  • rectal pain or discomfort
  • thick, white vaginal discharge with no odor or with a mild odor

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

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]

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]

Hepatic

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]

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

Postmarketing reports: Hypothyroidism[Ref]

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

References

1. "Product Information. alli (orlistat)." GlaxoSmithKline Healthcare, Pittsburgh, PA.

2. "Product Information. Xenical (orlistat)." Roche Laboratories, Nutley, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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