Brand Names: alli, Xenical

Generic Name: orlistat (Pronunciation: OR li stat)

What is orlistat (alli, Xenical)?

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

Orlistat 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).

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

What are the possible side effects of orlistat (alli, Xenical)?

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 ofpancreatitis.

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

Other side effects that may occur while taking orlistat include:

problems with your teeth or gums;
cold or flu symptoms;
headache, back pain; or
skin rash or itching.

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 is the most important information I should know about orlistat (alli, Xenical)?

Do not take this medication 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 orlistat, tell your doctor if you have an underactive thyroid, a history of kidney stones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, 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.

Orlistat 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.

Orlistat 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 orlistat during or within 1 hour after a meal that contains some fat (no more than 30% of the calories for that meal). Orlistat is usually taken 3 times daily. If you skip a meal or you eat a meal that does not contain any fat, skip your orlistat dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. Avoid a diet that is high in fat. High-fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

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 orlistat. 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 orlistat.

What should I discuss with my healthcare provider before taking orlistat (alli, Xenical)?

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

chronic malabsorption syndrome (an inability to absorb food and nutrients properly); or
gallbladder problems.

Before taking orlistat, tell your doctor if you are allergic to any drugs, or if you have:

an underactive thyroid;
a history of kidney stones;
a history of pancreatitis;
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 orlistat, 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 orlistat can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medication 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.

How should I take orlistat (alli, Xenical)?

Take this medication 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.

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

Take this medicine with a full glass of water.

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

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

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

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

Keep track of how many pills have been used from each new bottle of this medicine. Orlistat 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 (alli, Xenical)?

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 orlistat for that meal also.

What happens if I overdose (alli, Xenical)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an orlistat overdose are not known.

What should I avoid while taking orlistat (alli, Xenical)?

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

What other drugs will affect orlistat (alli, Xenical)?

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

cyclosporine (Gengraf, Neoral, Sandimmune);
digoxin (digitalis, Lanoxin, Lanoxicaps); or
a blood thinner such as warfarin (Coumadin).

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

There may be other drugs not listed that can affect orlistat. 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.

Where can I get more information?

Your pharmacist has information about orlistat written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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