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Weight lossTwo labels compared

Xenical vs Alli

Xenical and Alli contain the same active ingredient, orlistat, at different strengths. One is a prescription medicine, the other is sold over the counter. The two are approved through different routes, and their labels are written for different readers: one for a prescriber, one for the person buying the box.

Xenical

Ingredient
Orlistat
Approved for
Obesity managementcovers weight loss
Supply
Prescription
Boxed warning
None
Pharmacy cost
$4.62 per tablet, capsule or pen, brandwhat pharmacies pay to buy it, not the price at the counter
H2-Pharma LLC. Label version 10, effective 9 January 2026.

Alli

Ingredient
Orlistat
Approved for
Weight loss aidcovers weight loss
Supply
Over the counter
Boxed warning
None
Pharmacy cost
not listedwhat pharmacies pay to buy it, not the price at the counter
Haleon US Holdings LLC. Label version 15, effective 18 March 2026.
01From the FDA label

Side by side, straight from the labels

Generated from the two source labels, not typed out by hand, so it cannot drift from what the regulator approved. Rows where both labels say exactly the same thing are marked.

Active ingredientsame in bothXenicalOrlistatLipase inhibitorAlliOrlistatLipase inhibitor
Approved forXenicalObesity managementAlliWeight loss aid
SupplyXenicalPrescriptionAlliOver the counter
What pharmacies payAcquisition cost, not retailXenical$4.62 per tablet, capsule or pen, brandAllinot listed
Boxed warningsame in bothXenicalNoneAlliNone
What the FDA approved it forXenical
  • XENICAL is also indicated to reduce the risk for weight regain after prior weight loss.
  • XENICAL is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m 2 or ≥27 kg/m 2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).
  • Table 1 illustrates body mass index (BMI) according to a variety of weights and heights.
  • The BMI is calculated by dividing weight in kilograms by height in meters squared.
  • For example, a person who weighs 180 lbs and is 5 ' 5 " would have a BMI of 30.
  • Table 1 Body Mass Index (BMI), kg/m 2 Conversion Factors: Weight in lbs ÷ 2.2 = weight in kilograms (kg)
Alli
  • Weight loss aid
  • for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
Forms and strengthsXenical
  • XENICAL 120 mg turquoise capsules imprinted with XENICAL 120 in black ink.
  • Capsules: 120 mg.
Alli
  • Orlistat 60 mg
How the label says it is takenXenical
  • One 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal).
  • Advise patients to take a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat.
  • Distribute the daily intake of fat, carbohydrate, and protein over three main meals.
  • Advise patients to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition.
  • Take the vitamin supplement at least 2 hours before or after the administration of XENICAL, such as at bedtime.
  • For patients receiving both XENICAL and cyclosporine therapy, administer cyclosporine 3 hours after XENICAL.
Alli
  • read the enclosed brochure for other important information
  • diet and exercise are the starting points for any weight loss program. Try these first before adding orlistat. Check with your doctor before starting any exercise program.
  • to see if orlistat capsules are right for you, find your height on the chart to the right. You may consider starting a weight loss program with orlistat if your weight is the same or more than the weight shown for your height.
  • for overweight adults 18 years and older: take 1 capsule with each meal containing fat
  • do not take more than 3 capsules daily
  • use with a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss occurs in the first 6 months.
  • if you stop taking orlistat, continue with your diet and exercise program
  • if you start to regain weight after you stop taking orlistat, you may need to start taking orlistat again along with your diet and exercise program
  • take a multivitamin once a day, at bedtime, when using orlistat
Most common adverse reactionsXenical
  • most common adverse events resulting in discontinuation of treatment were gastrointestinal.
Alli
  • you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat.
  • you develop severe pain in the back or groin, painful urination, blood in your urine, swelling of the legs or feet, or are urinating less often than normal. There have been rare reports of kidney injury in people taking orlistat.
  • severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition.
  • you are taking medicine for seizures and your seizures happen more often or get worse
Warnings and precautionsXenical
  • XENICAL has drug interactions and can decrease vitamin absorption.
  • Take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition.
  • Rare cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported.
  • Patients may develop oxalate nephrolithiasis and oxalate nephropathy following treatment with XENICAL. Monitor renal function in patients at risk for renal insufficiency. Discontinue XENICAL if oxalate nephropathy develops.
  • Substantial weight loss can increase the risk of cholelithiasis.
  • Exclude organic causes of obesity (eg, hypothyroidism) before prescribing XENICAL.
  • Gastrointestinal events may increase when XENICAL is taken with a diet high in fat (>30% total daily calories from fat).
Alli
  • gallbladder problems
  • kidney disease or kidney stones
  • pancreatitis
  • take a multivitamin once a day, at bedtime . Orlistat can reduce the absorption of some vitamins.
  • follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking orlistat.
  • orlistat works by preventing the absorption of some of the fat you eat. The fat passes out of your body, so you may have bowel changes. You may get: gas with oily spotting
  • loose stools
  • more frequent stools that may be hard to control
  • eating a low-fat diet lowers the chance of having these bowel changes
  • for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.
ContraindicationsXenical
  • XENICAL is contraindicated in: Pregnancy Patients with chronic malabsorption syndrome Patients with cholestasis Patients with known hypersensitivity to XENICAL or to any component of this product Pregnancy
  • Chronic malabsorption syndrome
  • Known hypersensitivity to XENICAL or to any component of this product
Alli
  • if you are taking cyclosporine
  • if you have been diagnosed with problems absorbing food
  • if you are not overweight
Drug interactionsXenical
  • Cyclosporine: Reduction in cyclosporine plasma levels was observed when XENICAL was coadministered with cyclosporine.
  • Fat-soluble Vitamin Supplements and Analogues: All patients should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene.
  • Levothyroxine: Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function.
  • Warfarin: Patients on chronic stable doses of warfarin who are prescribed XENICAL should be monitored closely for changes in coagulation parameters.
  • Amiodarone: A reduction in exposure to amiodarone was observed when XENICAL was co-administered.
  • Antiepileptic Drugs: Convulsions have been reported in patients taking XENICAL with antiepileptic drugs. Patients should be monitored for possible changes in frequency or severity of convulsions.
Alli-
Label versionXenical9 January 2026Alli18 March 2026
02Written by us

Same ingredient, different strength and different route

Xenical is a prescription capsule. Alli is sold without a prescription and contains a lower amount of orlistat per capsule. The exact strengths are in the table above, taken from each label.

This is not the same arrangement as two brand names for one prescription medicine. Here the difference is regulatory as well: an over-the-counter product carries a Drug Facts label written for the buyer, while a prescription product carries prescribing information written for a clinician. The two documents are not directly comparable line by line, and this page does not force them to be.

03Written by us

The approved uses are worded differently

The Xenical label indicates it for obesity management including weight loss and weight maintenance when used together with a reduced-calorie diet, and separately to reduce the risk of weight regain after prior weight loss. It states body mass index thresholds: a starting index of 30 or above, or 27 or above in the presence of other risk factors such as hypertension, diabetes or dyslipidaemia.

The Alli label describes it as a weight loss aid, for weight loss in overweight adults aged 18 years and older, used along with a reduced-calorie and low-fat diet. There are no body mass index thresholds in that document, and there is an age floor that the Xenical label does not state in the same way.

04Written by us

Neither carries a boxed warning, and the cautions differ

Neither label carries a boxed warning. The Xenical label is contraindicated in pregnancy, in chronic malabsorption syndrome, in cholestasis, and in known hypersensitivity to the product or its components.

The Alli label tells the buyer not to use it while taking cyclosporine, if they have been diagnosed with problems absorbing food, or if they are not overweight. The last of these has no equivalent in the prescription label, and it exists because nobody checks eligibility at a shop counter.

05Written by us

What this page does not tell you

It does not say which one a person should use, and buying a product without a prescription does not make that decision unnecessary. The full lists of warnings, interactions and reported adverse reactions from each label are reproduced on the orlistat page.

06Written by us

Common questions

Is Alli just a lower dose of Xenical?
Both contain orlistat, and the Alli capsule contains less of it. They are separate FDA approvals with separate labels, one prescription and one over the counter, and the labels are worded for different readers.
Why is one available without a prescription?
They were approved through different routes. This page reports what each label states; it does not explain the FDA's reasoning, which is not in either document.
Can someone take two Alli capsules to match Xenical?
Neither label describes that. The Alli label gives directions for its own product, and taking more than a label directs is outside what these documents cover.
07

Sources

Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.

Each stripe is one section of the label, each division in a stripe one entry in that section.

08

Other comparisons in this category

Page last updated 23 August 2026

Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.