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Xenical

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Xenical

Xenical

Xenical Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Xenical (orlistat) is a drug that is used to help with weight loss by preventing the digestion and absorption of fat in food by inhibiting the enzyme lipase in the intestine. The most common side effects of Xenical are oily spotting on underwear, flatulence, urgent bowel movements, fatty or oily stools, increased number of bowel movements, abdominal pain, and incontinence of stool.

Xenical is taken as oral capsules. Xenical may reduce the absorption and blood levels of cyclosporine when both drugs are administered together. Xenical may also cause vitamin K levels to decline, and patients taking warfarin (Coumadin) must have their blood clotting monitored closely. The safety of Xenical in pregnancy and nursing mothers has not been determined.

Our Xenical Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Xenical in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking orlistat and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and a fast heart rate. These could be signs of pancreatitis.

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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xenical (Orlistat 120 mg) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Xenical Overview - Patient Information: Side Effects

SIDE EFFECTS: Changes in your bowel function often occur because of the unabsorbed fat. Fatty/oily stool, oily spotting, intestinal gas with discharge, a feeling of needing to have a bowel movement right away, increased number of bowel movements, or poor bowel control may occur. These side effects may get worse if you eat more fat than you should. If these effects persist or worsen, notify your doctor promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking this medication and tell your doctor immediately if any of these rare but serious side effects occur: symptoms of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin), symptoms of kidney stones (such as back pain, pain when urinating, pink/bloody urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Xenical (Orlistat 120 mg)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Xenical FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.

Commonly Observed (based on first year and second year data)

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.)

Table 4 : Commonly Observed Adverse Events

  Year 1 Year 2
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 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
* Treatment designates XENICAL three times a day plus diet or placebo plus diet
† Oily discharge may be clear or have a coloration such as orange or brown.

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 XENICAL 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.

Other Adverse Clinical Events

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.

Table 5 : Other Treatment-Emergent Adverse Events From Seven Placebo-Controlled Clinical Trials

  Year 1 Year 2
XENICAL* % Patients (N=1913) Placebo* % Patients (N=1466) XENICAL* % Patients (N=613) Placebo* % Patients (N=524)
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
* Treatment designates XENICAL 120 mg three times a day plus diet or placebo plus diet
- None reported at a frequency ≥ 2% and greater than placebo

In the 4-year XENDOS study, the general pattern of adverse events was similar to that reported for the 1- and 2year studies with the total incidence of gastrointestinal-related adverse events occurring in year 1 decreasing each year over the 4-year period.

In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed.

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.

Postmarketing Surveillance

The following adverse reactions have been identified during postapproval use of XENICAL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to XENICAL exposure.

  • Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reported. There have been reports of hepatic failure observed with the use of XENICAL in postmarketing surveillance, with some of these cases resulting in liver transplant or death [see WARNINGS AND PRECAUTIONS].
  • Cases of reduced concentrations of cyclosporine have been reported when cyclosporine was co-administered with XENICAL [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
  • 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 have been reported.
  • Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with XENICAL and anticoagulants [see DRUG INTERACTIONS].
  • Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine [see DRUG INTERACTIONS].
  • Acute oxalate nephropathy after treatment with XENICAL has been reported in patients with or at risk for renal disease [see WARNINGS AND PRECAUTIONS].
  • 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.
  • Lower gastrointestinal bleeding has been reported in patients treated with XENICAL. Most reports are nonserious; severe or persistent cases should be investigated further.

Read the entire FDA prescribing information for Xenical (Orlistat 120 mg) »

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Xenical - User Reviews

Xenical User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Xenical sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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