Xenical (Orlistat)







What is Xenical?

Xenical blocks some of the fat that you eat, keeping it from being absorbed by your body.

Xenical is used together with a reduced-calorie diet and weight maintenance to treat obesity in people with certain risk factors (such as diabetes, high blood pressure, and high cholesterol or triglycerides).

Xenical may also be used for purposes other than those listed in this medication guide.

Important information about Xenical

Do not take Xenical if you are allergic to orlistat, or if you have gallbladder problems, or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).

Before taking Xenical, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver disease, or if you take other weight-loss medications (prescription or over-the-counter).

Do not give over-the-counter orlistat (Alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor. Xenical should be used only by the person it was prescribed or recommended for and should never be shared with another person, especially someone who has a history of eating disorder. Store this medication in a place where others cannot get to it.

Xenical is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

While taking Xenical avoid a diet that is high in fat. High-fat meals taken in combination with Xenical can increase your risk of unpleasant side effects on your stomach or intestines.

Before taking Xenical

Do not take Xenical if you are allergic to orlistat, or if you have:

  • chronic malabsorption syndrome (an inability to absorb food and nutrients properly); or

  • gallbladder problems.

If you have any of these other conditions, you may need adjust your dose of Xenical or have special tests:

  • an underactive thyroid;

  • a history of gallstones;

  • a history of pancreatitis;

  • liver disease;

  • type 1 or type 2 diabetes;

  • an eating disorder (anorexia or bulimia); or

  • if you take any other weight-loss medications (prescription or over-the-counter).

If you have any of these conditions, you may not be able to use Xenical, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking Xenical can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use Xenical without telling your doctor if you are breast-feeding a baby.

Do not give over-the-counter orlistat (Alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor. Xenical should be used only by the person it was prescribed or recommended for and should never be shared with another person, especially someone who has a history of eating disorder. Keep the medication in a secure place where others cannot get to it.

How should I take Xenical?

Take Xenical exactly as directed on the label, or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Xenical comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Xenical is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Take Xenical during or within 1 hour after a meal that contains some fat (no more than 30% of the calories for that meal). Xenical is usually taken 3 times daily.

If you skip a meal or you eat a meal that does not contain any fat, skip your Xenical dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. For example, if you eat 1200 calories per day, no more than 360 of those calories should be in the form of fat.

Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.

Your doctor may recommend you take vitamin and mineral supplements while you are taking Xenical. This medication can make it harder for your body to absorb fat-soluble vitamins, such as vitamins A, D, E, and K. Follow your doctor's instructions about the type of multi-vitamin or mineral supplement to use.

Take the supplement at least 2 hours before or after you take Xenical.

Store Xenical at room temperature away from moisture and heat. Keep the bottle tightly closed.

Keep track of how many capsules have been used from each new bottle. Xenical is a drug that may be misused as a weight-loss aid, and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

If you miss a meal, or if you have a meal without fat, you can skip your dose of Xenical for that meal also.




What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Xenical?

Avoid a diet that is high in fat. High-fat meals taken in combination with Xenical can increase your risk of unpleasant side effects on your stomach or intestines.

Xenical 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 Xenical 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 Xenical. They are the natural effects of Xenical'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 Xenical:

  • 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 Xenical 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.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Xenical?

Before taking Xenical, tell your doctor if you are using any of the following drugs:

  • insulin or diabetes medications you take by mouth;

  • cyclosporine (Gengraf, Neoral, Sandimmune);

  • digoxin (digitalis, Lanoxin, Lanoxicaps);

  • levothyroxine (Synthroid, Levoxyl, Levothroid); or

  • a blood thinner such as warfarin (Coumadin).

If you are using any of these drugs, you may not be able to use Xenical, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Xenical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.








Xenical (Orlistat)
Xenical (Orlistat)