Generic Name: orlistat (OR-li-stat)
Brand Name: Xenical

Xenical is used for:

Managing obesity in adults and adolescents 12 years old and older. It is also used to reduce the risk of weight regain after previous weight loss. It is used along with a reduced-calorie diet.

Xenical is a gastrointestinal lipase inhibitor. It works by blocking the digestion of fats from the diet.

Do NOT use Xenical if:

  • you are allergic to any ingredient in Xenical
  • you are pregnant
  • you have bile flow problems (eg, cholestasis) or problems absorbing food (malabsorption)

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Xenical:

Some medical conditions may interact with Xenical. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have an eating disorder (eg, anorexia, bulimia)
  • if you have a history of gallbladder, kidney, liver, pancreas, or thyroid problems; diabetes; kidney stones; seizures; or organ transplant
  • if you are taking another medicine for weight loss
  • if you are taking insulin or another medicine for diabetes

Some MEDICINES MAY INTERACT with Xenical. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased
  • Cyclosporine, medicines used to treat seizures, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Xenical

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xenical may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xenical:

Use Xenical as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Xenical. Talk to your pharmacist if you have questions about this information.
  • Take Xenical by mouth with or up to 1 hour after each main meal that contains fat (up to 3 per day).
  • If a meal is missed or contains no fat, do not take a dose of Xenical.
  • You should take a multivitamin supplement containing vitamins A, D, E, and K to ensure good nutrition. The supplement should be taken at least 2 hours before or after you take Xenical, such as at bedtime.
  • If you also take a thyroid hormone (eg, levothyroxine), do not take it within 4 hours before or after taking Xenical. Check with your doctor if you have questions.
  • If you also take cyclosporine, do not take it within 3 hours before or after taking Xenical. Check with your doctor if you have questions.
  • If you miss a dose of Xenical, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xenical.

Important safety information:

  • Do NOT take more than the recommended dose without checking with your doctor. Taking more than the recommended dose will not make you lose more weight and may increase side effects.
  • Tell your doctor or dentist that you take Xenical before you receive any medical or dental care, emergency care, or surgery.
  • Follow the diet program given to you by your health care provider. Your daily intake of fat should be divided evenly over 3 meals.
  • Eating a meal high in fat while taking Xenical increases the risk of side effects involving the stomach and bowels.
  • Medicines used to treat seizures may not work as well while taking Xenical. Call your doctor right away if your seizures happen more often or get worse while taking Xenical.
  • Diabetes patients - Xenical may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Rarely, some patients taking Xenical have developed severe liver problems. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, pale stools, unusual weakness, loss of appetite, or severe or persistent nausea.
  • Xenical should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not take Xenical if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Xenical is found in breast milk. If you are or will be breast-feeding while you take Xenical, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of 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:

Bowel movement urgency; gas with discharge; inability to control bowel movements; increased number of bowel movements; oily discharge; oily or fatty stools; oily spotting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); black, tarry, or bloody stools; bloody urine; decreased, frequent, or painful urination; new or unusual back or groin pain; severe or persistent stomach pain (with or without nausea and vomiting); swelling of the legs and feet; symptoms of liver damage (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, severe or persistent nausea).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Xenical:

Store Xenical at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xenical out of the reach of children and away from pets.

General information:

  • If you have any questions about Xenical, please talk with your doctor, pharmacist, or other health care provider.
  • Xenical is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Xenical or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xenical. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xenical. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Xenical.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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