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.

Some side effects of Xenical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to orlistat: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking orlistat (the active ingredient contained in Xenical) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using orlistat and call your doctor at once if you have a serious side effect such as:

• severe pain in your lower back, blood in your urine;

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst;

• swelling, weight gain, feeling short of breath;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

• nausea, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

The following side effects occur commonly with the use of orlistat. They are the natural effects of orlistat's fat-blocking action and are actually signs that the medication is working properly. These side effects are usually temporary and may lessen as you continue treatment with orlistat:

• oily spotting in your undergarments;

• oily or fatty stools;

• orange or brown colored oil in your stool;

• gas with discharge, an oily discharge;

• loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;

• an increased number of bowel movements;

• stomach pain, nausea, vomiting, diarrhea, rectal pain; or

• weakness, dark urine, clay-colored stools, itching, loss of appetite, or jaundice (yellowing of the skin or eyes).

Other side effects that may occur while taking orlistat include:

• problems with your teeth or gums;

• cold symptoms such as stuffy nose, sneezing, cough;

• fever, chills, sore throat, flu symptoms;

• headache, back pain; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to orlistat: oral capsule

General

In general, the adverse effects of orlistat (the active ingredient contained in Xenical) are mild and transient. Because the drug is not systemically absorbed, most adverse effects are limited to the gastrointestinal tract and are primarily extensions of the pharmacologic activity of the drug.

Gastrointestinal

During clinical trials, approximately half of all incidents of GI adverse events associated with orlistat (the active ingredient contained in Xenical) treatment lasted less than one week, and a majority lasted for no more than four weeks. However, these side effects may occur in some persons over a period of 6 months or longer.

A 42-year-old female experienced constipation, polyuria, polydipsia, and increased lower-leg edema after 2 weeks of treatment with orlistat 120 mg 3 times daily. After the drug was discontinued for 4 days, the symptoms resolved. On reinstitution of the orlistat therapy, the symptoms reappeared within 2 days. Thereafter, the drug was permanently discontinued.

Gastrointestinal (GI) side effects including oily spotting, flatus with discharge, fecal urgency, fatty or oily stool, oily evacuation, increased defecation, and fecal incontinence have been reported in greater than or equal to 5% of patients. Cholelithiasis has been reported in 2.9% of patients versus 1.8% in placebo. Other GI side effects possibly related to orlistat treatment have included abdominal pain and discomfort, nausea, infectious diarrhea, rectal pain and discomfort, tooth disorder, gingival disorder, and vomiting. At least one case of constipation has been reported. Pancreatitis has also been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have rarely included pruritus, rash, urticaria, angioedema, bronchospasm, and anaphylaxis. At least one case of cutaneous leukocytoclastic vasculitis has also been reported.

A 34-year-old male with a history of obesity experienced cutaneous leukocytoclastic vasculitis coincident with orlistat therapy. He decided to take orlistat (120 mg before meals) as medical therapy for obesity. Seventy-two hours after the onset of this treatment, he experienced myalgias and arthralgias. He also observed the presence of maculopapular lesions in rapidly increasing numbers in his lower extremities. A skin biopsy revealed leukocytoclastic vasculitis affecting capillaries and venules. Orlistat was discontinued and bed rest and nonsteroidal anti-inflammatory drugs were prescribed. Following initiation of this procedure, a rapid improvement of the cutaneous lesions was attained.

Respiratory

Respiratory side effects have included influenza, upper respiratory infection, lower respiratory infection, and ear, nose and throat symptoms.

Musculoskeletal

Musculoskeletal side effects have included back pain, pain in the lower extremities, arthritis, myalgia, joint disorder, and tendonitis.

Nervous system

Nervous system side effects have included headache and dizziness.

Dermatologic

Dermatologic side effects have included rash and dry skin. Rare cases of bullous eruptions have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included menstrual irregularities and vaginitis. Urinary tract infection has also been reported.

Psychiatric

Psychiatric side effects have included psychiatric anxiety and depression.

Cardiovascular

A 40-year-old previously healthy female experienced hypertension coincident with orlistat (the active ingredient contained in Xenical) therapy. She took sporadic doses for some months and then increased the dosage to 120 mg three times a day. She experienced dizziness, peripheral edema, and pulsating headache and discontinued treatment. On medical examination, her blood pressure was 190/100 mm Hg on three different measurements. She was advised to discontinue orlistat, and a few days later her blood pressure had decreased to 160/90 mm Hg and the edema had regressed.

Cardiovascular side effects have included pedal edema. At least one case of hypertension has also been reported.

Hematologic

Hematologic side effects have included decreased prothrombin, increased INR, and unbalanced anticoagulant treatment with changes of hemostatic parameters in patients treated concomitantly with orlistat (the active ingredient contained in Xenical) and anticoagulants.

Metabolic

An 18-year-old female with type 1 diabetes for the past 3 years experienced diabetic ketoacidosis coincident with orlistat (the active ingredient contained in Xenical) therapy. She presented to the hospital after she began taking, on her own, orlistat 120 mg three times per day in addition to a low-calorie diet. Laboratory data showed severe ketosis and positive urinary ketones. Orlistat was discontinued, and she was started on intravenous hydration and insulin. She showed significant improvement over a period of 5 days.

A 42-year-old female experienced constipation, polyuria, polydipsia, and increased lower-leg edema after 2 weeks of treatment with orlistat 120 mg 3 times daily. After the drug was discontinued for 4 days, the symptoms resolved. On reinstitution of the orlistat therapy, the symptoms reappeared within 2 days. Thereafter, the drug was permanently discontinued.

Metabolic side effects have included hypoglycemia in clinical trials of obese diabetic patients. At least one case of diabetic ketoacidosis has also been reported, in addition to a case of polyuria and polydipsia.

Hepatic

Hepatic side effects have included rare reports of an increase in transaminases and in alkaline phosphatase, and exceptional cases of hepatitis. No causal relationship or physiopathological mechanism between hepatitis and orlistat (the active ingredient contained in Xenical) therapy has been established. At least one case of severe hepatic injury has also been reported. Hepatic side effects submitted post-marketing to the FDA's Adverse Event Reporting System have included jaundice, weakness, and abdominal pain. The FDA has not established an association between liver injury and orlistat at this time.

A 15-year-old female without a remarkable medical history experienced severe hepatic injury coincident with orlistat therapy. She had taken orlistat 120 mg three times daily for 7 days for obesity. One week later, she was admitted to an emergency hospital with abdominal pain, malaise, nausea, and diarrhea. Her serum aspartate aminotransferase and alanine aminotransferase levels were surprisingly high at 8269 intl units/L and 9976 intl units/L, respectively. She was given vitamin K intravenously for 5 days, and liver function tests results normalized within 1 month.

Renal

A 57-year-old female with underlying chronic kidney disease experienced acute kidney injury secondary to acute oxalate nephropathy coincident with orlistat (the active ingredient contained in Xenical) therapy. Acute kidney injury was associated temporally with an increased dosage of orlistat therapy and the development of increased fat malabsorption. Kidney biopsy indicated deposition of calcium oxalate crystals within tubular lumens, consistent with acute oxalate crystals within tubules. A steady improvement in renal function was subsequently observed. Results of a repeated 24-hour urine oxalate collection performed 3 weeks later when kidney function had improved were within normal parameters.

Renal side effects including at least one case of acute oxalate nephropathy have been reported.

Other

Other side effects have included fatigue, otitis, and sleep disorders.

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