alli

alli (orlistat 60 mg) is an FDA-approved, over-the-counter weight loss pill for overweight adults aged 18 and older. alli works by preventing your body from absorbing some of the fat you eat, which reduces your overall calorie intake and supports gradual weight loss when combined with a reduced-calorie, low-fat diet and exercise.

alli contains orlistat, the same active ingredient as the prescription weight loss medication Xenical (120 mg), but at half the dose.

alli works by blocking enzymes called lipases in your stomach and small intestine. These enzymes normally break down dietary fat so it can be absorbed into your body. When alli inhibits them, approximately 30% of the fat you eat passes through your digestive system unabsorbed and is eliminated in your stool. Because this fat is never absorbed, your body takes in fewer calories, which helps support weight loss over time.

alli does not affect appetite or brain chemistry. Its action is entirely local, within the digestive tract.

alli is FDA-approved for weight loss in overweight adults aged 18 and older when used alongside a reduced-calorie, low-fat diet and regular physical activity. It is intended for adults who are overweight, not those who are already at a healthy weight.

Diet and exercise are the starting points for any weight loss program. Try these first before adding alli.

• Store at room temperature between 20 and 25°C (68 to 77°F)
• Keep away from excessive light, moisture, and heat above 30°C (86°F)
• Keep out of reach of children
• In the event of an overdose, call a Poison Control Center or seek emergency medical help immediately

Organ transplant alert

Do not use alli if you have had an organ transplant. Orlistat can interfere with the medicines used to prevent your body from rejecting a transplanted organ.

Allergy alert

Do not use alli if you have a known allergy to any ingredient in the product.

Do not use alli if you are:

• Taking cyclosporine
• Diagnosed with a condition that affects how your body absorbs food
• Not overweight

Ask a doctor before use if you have ever had:

• Gallbladder problems
• Kidney disease or kidney stones
• Pancreatitis

Liver injury

Rare cases of liver injury have been reported in people taking orlistat. Stop taking alli and ask a doctor straight away if you notice itching, yellowing of the eyes or skin, dark urine, or a sudden loss of appetite.

Kidney injury

The FDA has updated the alli Drug Facts Label to warn of the risk of acute kidney injury, a rare side effect of orlistat. Stop taking alli and ask a doctor straight away if you develop any of the following symptoms of kidney injury or kidney stones: back or groin pain, painful urination, blood in your urine, swelling of the feet or legs, or less frequent urination.

Pregnancy and breastfeeding

Do not use alli if you are pregnant or breastfeeding.

Do not use alli if you:

• Have had an organ transplant
• Are currently taking cyclosporine
• Have a condition that affects food absorption
• Are not overweight
• Are pregnant or breastfeeding
• Are allergic to orlistat or any other ingredient in alli

Talk to a doctor before using alli if you have a history of gallbladder problems, kidney disease, kidney stones, or pancreatitis.

Common alli side effects

The most common side effects of alli affect the digestive system. They happen because alli prevents some of the fat you eat from being absorbed, and that unabsorbed fat passes out of your body. Following a low-fat diet reduces the likelihood of these effects.

• Gas with oily spotting
• Loose stools
• More frequent bowel movements that may be difficult to control

Serious side effects

Stop use and ask a doctor if:

• You notice itching, yellowing of the eyes or skin, dark urine, or loss of appetite, as these may be signs of liver injury
• You develop back or groin pain, painful urination, blood in your urine, swelling of the feet or legs, or less frequent urination. These may be signs of acute kidney injury or kidney stones, a risk the FDA has specifically added to the alli label as of June 2026.
• You experience severe or ongoing stomach pain, which may indicate a serious medical condition
• You take seizure medication and notice your seizures becoming more frequent or severe.

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 the FDA at 1-800-FDA-1088

Ask a doctor or pharmacist before using alli if you take any prescription medications. Some doses may need to be adjusted, or some medicines may not work as well when taken alongside orlistat.

• Anticoagulants (blood thinners): alli can lower your body's absorption of vitamin K, which may reduce the effectiveness of blood thinners such as warfarin. Your doctor should monitor your clotting levels while you use alli.
• Amiodarone (heart medicine): alli may reduce how much amiodarone your body absorbs. Tell your doctor you are taking alli if you use this medication.
• Diabetes medicine: losing weight with alli may improve your blood sugar control, which could mean your diabetes medication needs to be adjusted. Let your healthcare provider know you are taking alli.
• Thyroid disease medicine: some people have experienced changes in thyroid hormone levels while taking orlistat. Ask your doctor or pharmacist whether you need to take your thyroid medication at a different time of day.
• Seizure medicine: stop taking alli and speak with a doctor if your seizures become more frequent or more severe.
• Antiretrovirals (HIV medicine): some people taking orlistat alongside HIV medication have experienced a loss of viral control. Your doctor should monitor your HIV RNA levels if you use both.
• Other weight loss products: do not take alli alongside other weight loss products without first speaking to a healthcare provider.

Other drugs may interact with alli, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here

Weight loss with alli is gradual. The alli label states that for every 5 pounds you lose through diet alone, alli can help you lose an additional 2 to 3 pounds. In clinical studies, most people using alli lost between 5 and 10 pounds over 6 months. Most of the weight loss occurs within the first 6 months of use.

For the best results, follow a well-balanced, reduced-calorie, low-fat diet throughout your treatment. The alli label recommends starting this diet before your first dose.

alli is intended for overweight adults aged 18 and older. To help you decide whether alli may be suitable, check your height against the minimum weight thresholds in the table below. You may consider using alli as part of a weight loss program if your current weight is at or above the figure shown for your height.

• Take 1 capsule with each meal that contains fat
• Do not exceed 3 capsules per day
• Use alli alongside a reduced-calorie, low-fat diet and exercise program until you reach your goal weight
• Take a multivitamin once a day at bedtime throughout your treatment
• If you stop taking alli, continue with your diet and exercise program
• If you begin to regain weight after stopping alli, you may need to resume taking it alongside your diet and exercise program

How do I take alli?

Read all the information in the enclosed brochure before you start taking alli.

• Take 1 capsule with each fat-containing meal
• Do not take more than 3 capsules in a single day
• Follow a reduced-calorie, low-fat diet and exercise program throughout treatment
• Take a multivitamin once a day at bedtime
• Check with your doctor before beginning any new exercise program
• If you stop taking alli, keep following your diet and exercise program
• If your weight starts to increase after stopping alli, speak with your healthcare provider about whether to restart

How long should you take alli?

Continue taking alli alongside a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss with alli happens within the first 6 months. If you are consistently following a low-fat diet and not losing weight, talk to your healthcare provider about other options.

Important information when using alli

• Take a multivitamin once a day at bedtime. alli can reduce your body's absorption of certain vitamins, so daily supplementation is important throughout treatment.
• Follow a well-balanced, reduced-calorie, low-fat diet. Starting this diet before your first dose can help your body adjust and reduce the likelihood of side effects.
• Check with your doctor before starting any new exercise program.

Active ingredient: orlistat 60 mg

Inactive ingredients: edible ink, FD&C blue no. 2, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide.