Xenical Side Effects
Generic Name: orlistat
Please note - some side effects for Xenical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Xenical - for the Consumer
Xenical
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xenical:
Seek medical attention right away if any of these SEVERE side effects occur when using Xenical:Bowel movement urgency; gas with discharge; inability to control bowel movements; increased number of bowel movements; oily discharge; oily or fatty stools; oily spotting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent stomach pain.
Xenical Side Effects - for the Professional
Xenical
Commonly Observed (based on first year and second year data - Xenical 120 mg three times a day versus placebo):
Gastrointestinal (GI) symptoms were the most commonly observed treatment-emergent adverse events associated with the use of Xenical in the seven double-blind, placebo-controlled clinical trials and are primarily a manifestation of the mechanism of action. (Commonly observed is defined as an incidence of ≥ 5% and an incidence in the Xenical 120 mg group that is at least twice that of placebo.)
| Year 1 | Year 2 | |||
|---|---|---|---|---|
| Adverse Event | Xenical* % Patients (N=1913) |
Placebo* % Patients (N=1466) |
Xenical* % Patients (N=613) |
Placebo* % Patients (N=524) |
|
||||
| Oily Spotting | 26.6 | 1.3 | 4.4 | 0.2 |
| Flatus with Discharge | 23.9 | 1.4 | 2.1 | 0.2 |
| Fecal Urgency | 22.1 | 6.7 | 2.8 | 1.7 |
| Fatty/Oily Stool | 20.0 | 2.9 | 5.5 | 0.6 |
| Oily Evacuation | 11.9 | 0.8 | 2.3 | 0.2 |
| Increased Defecation | 10.8 | 4.1 | 2.6 | 0.8 |
| Fecal Incontinence | 7.7 | 0.9 | 1.8 | 0.2 |
These and other commonly observed adverse reactions were generally mild and transient, and they decreased during the second year of treatment. In general, the first occurrence of these events was within 3 months of starting therapy. Overall, approximately 50% of all episodes of GI adverse events associated with orlistat treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.
Discontinuation of Treatment
In controlled clinical trials, 8.8% of patients treated with Xenical discontinued treatment due to adverse events, compared with 5.0% of placebo-treated patients. For Xenical, the most common adverse events resulting in discontinuation of treatment were gastrointestinal.
Incidence in Controlled Clinical Trials
The following table lists other treatment-emergent adverse events from seven multicenter, double-blind, placebo-controlled clinical trials that occurred at a frequency of ≥ 2% among patients treated with Xenical 120 mg three times a day and with an incidence that was greater than placebo during year 1 and year 2, regardless of relationship to study medication.
| Year 1 | Year 2 | |||
|---|---|---|---|---|
| Body System/Adverse Event | Xenical* % Patients (N=1913) |
Placebo* % Patients (N=1466) |
Xenical* % Patients (N=613) |
Placebo* % Patients (N=524) |
| – None reported at a frequency≥ 2% and greater than placebo | ||||
|
||||
| Gastrointestinal System | ||||
| Abdominal Pain/Discomfort | 25.5 | 21.4 | – | – |
| Nausea | 8.1 | 7.3 | 3.6 | 2.7 |
| Infectious Diarrhea | 5.3 | 4.4 | – | – |
| Rectal Pain/Discomfort | 5.2 | 4.0 | 3.3 | 1.9 |
| Tooth Disorder | 4.3 | 3.1 | 2.9 | 2.3 |
| Gingival Disorder | 4.1 | 2.9 | 2.0 | 1.5 |
| Vomiting | 3.8 | 3.5 | – | – |
| Respiratory System | ||||
| Influenza | 39.7 | 36.2 | – | – |
| Upper Respiratory Infection | 38.1 | 32.8 | 26.1 | 25.8 |
| Lower Respiratory Infection | 7.8 | 6.6 | – | – |
| Ear, Nose & Throat Symptoms | 2.0 | 1.6 | – | – |
| Musculoskeletal System | ||||
| Back Pain | 13.9 | 12.1 | – | – |
| Pain Lower Extremities | – | – | 10.8 | 10.3 |
| Arthritis | 5.4 | 4.8 | – | – |
| Myalgia | 4.2 | 3.3 | – | – |
| Joint Disorder | 2.3 | 2.2 | – | – |
| Tendonitis | – | – | 2.0 | 1.9 |
| Central Nervous System | ||||
| Headache | 30.6 | 27.6 | – | – |
| Dizziness | 5.2 | 5.0 | – | – |
| Body as a Whole | ||||
| Fatigue | 7.2 | 6.4 | 3.1 | 1.7 |
| Sleep Disorder | 3.9 | 3.3 | – | – |
| Skin & Appendages | ||||
| Rash | 4.3 | 4.0 | – | – |
| Dry Skin | 2.1 | 1.4 | – | – |
| Reproductive, Female | ||||
| Menstrual Irregularity | 9.8 | 7.5 | – | – |
| Vaginitis | 3.8 | 3.6 | 2.6 | 1.9 |
| Urinary System | ||||
| Urinary Tract Infection | 7.5 | 7.3 | 5.9 | 4.8 |
| Psychiatric Disorder | ||||
| Psychiatric Anxiety | 4.7 | 2.9 | 2.8 | 2.1 |
| Depression | – | – | 3.4 | 2.5 |
| Hearing & Vestibular Disorders | ||||
| Otitis | 4.3 | 3.4 | 2.9 | 2.5 |
| Cardiovascular Disorders | ||||
| Pedal Edema | – | – | 2.8 | 1.9 |
In the 4-year XENDOS study, the general pattern of adverse events 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 each year over the 4-year period.
Other Clinical Studies or Postmarketing Surveillance
Rare cases of hypersensitivity have been reported with the use of Xenical. Signs and symptoms have included 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. 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. Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine. Pancreatitis has been reported with the use of Xenical in postmarketing surveillance. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established.
In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed.
Preliminary data from a Xenical and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when Xenical was coadministered with cyclosporine.
Pediatric Patients
In clinical trials with Xenical in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults.
TopSide Effects by Body System
General
In general, the adverse effects of orlistat 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 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 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 and anticoagulants.
Metabolic
An 18-year-old female with type 1 diabetes for the past 3 years experienced diabetic ketoacidosis coincident with orlistat 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 very rare reports of increase in transaminases and in alkaline phosphatase, and exceptional cases of hepatitis. No causal relationship or physiopathological mechanism between hepatitis and orlistat therapy has been established. At least one case of severe hepatic injury has also been reported.
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 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.
TopMore resources:
Xenical - Includes detailed dosage instructions.
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