Alli (orlistat 60 mg): the over-the-counter weight-loss pill

Key takeaways

• Alli (orlistat 60 mg) is the only FDA-approved over-the-counter weight-loss medicine, for overweight adults 18 and older with a reduced-calorie, low-fat diet.^[1]
• The label says that for every 5 lb lost by diet alone, orlistat can help you lose 2 to 3 lb more, and that most people in studies lost 5 to 10 lb over 6 months.^[1]
• In a 16-week trial, orlistat 60 mg led to 3.05 kg of weight loss vs 1.90 kg on placebo.^[4]
• Do not use it after an organ transplant, with cyclosporine, with food-absorption problems, if not overweight, or if pregnant or breastfeeding; ask a pharmacist first if you take other medicines.^[1]
• Gas with oily spotting and urgent loose stools are common; a low-fat diet and a bedtime multivitamin are part of the label directions.^[1]

In short: Alli is orlistat 60 mg, the only weight-loss medicine the FDA has approved for sale without a prescription (since February 7, 2007). Its Drug Facts label says it is for weight loss in overweight adults 18 and older, used with a reduced-calorie, low-fat diet: one capsule with each meal that contains fat, no more than three a day, plus a daily multivitamin at bedtime. It works by blocking some of the fat you eat, so bowel changes such as gas with oily spotting are common, and some people, including anyone who has had an organ transplant or takes cyclosporine, should not use it (label checked on DailyMed on 2026-10-06).

Because Alli sits on a store shelf, it is easy to forget that it is a real medicine with real interactions. This page walks through its Drug Facts label line by line, what studies of the 60 mg dose found, how it compares with prescription orlistat, and the questions worth asking a pharmacist or doctor first. It is general education, not personal medical advice. Even for an over-the-counter product, please read the full label, talk with a pharmacist or doctor about your other medicines and health conditions, and get evaluated if you have significant weight to lose or a weight-related condition.

What Alli is and how it works

Alli contains orlistat, the same ingredient as prescription Xenical, at 60 mg instead of 120 mg. The Drug Facts label explains it simply: orlistat “works by preventing the absorption of some of the fat you eat,” and that fat “passes out of your body.” It does not suppress appetite or act on the brain, and it is not a stimulant. Our orlistat page explains the mechanism in more depth, including the prescription label’s finding that the 120 mg dose blocks about 30% of dietary fat.

Alli is not a dietary supplement. Supplements sold for weight loss are not FDA approved for that purpose; Alli went through FDA review as a drug and is sold under an FDA-approved application (NDA 021887, held by Haleon). Our weight-loss pills guide explains the difference and why it matters.

Who the label says it is for

The label’s use is “for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet.” It says diet and exercise are the starting points and to try them first, and to check with a doctor before starting an exercise program. To help people decide whether they are overweight, the label includes a height-and-weight chart: you may consider orlistat if your weight is at or above the weight shown for your height. Selected rows:

129 lb4 ft 10 in

138 lb5 ft 0 in

147 lb5 ft 2 in

157 lb5 ft 4 in

167 lb5 ft 6 in

177 lb5 ft 8 in

188 lb5 ft 10 in

199 lb6 ft 0 in

210 lb6 ft 2 in

221 lb6 ft 4 in

Starting weight on the Alli label chart, by height

Item	Value
4 ft 10 in	129 lb
5 ft 0 in	138 lb
5 ft 2 in	147 lb
5 ft 4 in	157 lb
5 ft 6 in	167 lb
5 ft 8 in	177 lb
5 ft 10 in	188 lb
6 ft 0 in	199 lb
6 ft 2 in	210 lb
6 ft 4 in	221 lb

The label says you may consider a program with orlistat if your weight is the same as or more than the weight shown for your height. These weights correspond roughly to a BMI of 27.

Source: Alli Drug Facts, height and weight chart (DailyMed) (checked on October 6, 2026)

You can check your own number with our BMI calculator. If your BMI is well above this range, or you have conditions such as type 2 diabetes, high blood pressure or sleep apnea, it is worth seeing a clinician: prescription options, explained on our medications hub and in medical weight loss, may be more suitable, and your other conditions may need attention too.

Who should not use Alli

The Drug Facts label says do not use Alli:

• if you have had an organ transplant (“orlistat interferes with the medicines used to prevent transplant rejection”),
• if you are taking cyclosporine,
• if you have been diagnosed with problems absorbing food,
• if you are not overweight,
• if you are allergic to any of its ingredients, or
• if you are pregnant or breastfeeding.

It says to ask a doctor first if you have ever had gallbladder problems, kidney disease or kidney stones, or pancreatitis, and to ask a doctor or pharmacist first if you take blood thinners, amiodarone (a heart medicine), diabetes medicine, thyroid medicine, seizure medicine, HIV medicines (antiretrovirals) or any other weight-loss product, because some doses may need adjusting or some medicines may not work as well.

How to take it, according to the label

The Starter Pack contains 60 capsules, which the box describes as up to a 20-day supply. Check the tamper-evident seals before use: the label lists a seal on both ends of the carton, a foil seal under the bottle cap and a dark blue band around each capsule, and says not to use the product if any are missing or broken. The FDA regularly warns about tainted weight-loss products sold online, so buy from established pharmacies or retailers.

What results to expect

The label sets modest expectations: “for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more,” and “in studies, most people lost 5-10 pounds over 6 months.”

Published trials of the 60 mg dose agree. In a 16-week U.S. trial of 391 mildly to moderately overweight adults (Anderson and colleagues, Annals of Pharmacotherapy, 2006), people on orlistat 60 mg three times a day lost 3.05 kg (about 6.7 lb) versus 1.90 kg on placebo, with a reduced-calorie diet and self-help materials. Among people who completed the study, weight loss was 4.8% versus 3.1%. Cholesterol and blood pressure also improved slightly more, and digestive side effects were more common on orlistat.

1.90 kgPlacebo with diet

3.05 kgOrlistat 60 mg with diet

Average weight lost in 16 weeks: orlistat 60 mg vs placebo

Item	Value
Placebo with diet	1.90 kg
Orlistat 60 mg with diet	3.05 kg

391 overweight adults at 20 U.S. centers, intent-to-treat analysis. Completers lost 4.8% vs 3.1% of starting weight.

Source: Anderson JW et al., Annals of Pharmacotherapy 2006 (checked on October 6, 2026)

A two-year European trial (Rossner and colleagues, Obesity Research, 2000) compared both strengths with placebo in adults with a BMI of 28 to 43. After the first year, average weight loss was 8.6% on 60 mg, 9.7% on 120 mg and 6.6% on placebo, all with a reduced-calorie diet, and both strengths reduced regain during the second year. The diet did most of the work; orlistat added a few percentage points.

6.6%Placebo with diet

8.6%Orlistat 60 mg (Alli strength)

9.7%Orlistat 120 mg (Xenical strength)

Average weight loss after one year: placebo vs 60 mg vs 120 mg

Item	Value
Placebo with diet	6.6%
Orlistat 60 mg (Alli strength)	8.6%
Orlistat 120 mg (Xenical strength)	9.7%

Adults with a BMI of 28 to 43 on a hypocaloric diet in year 1. Both orlistat groups lost significantly more than placebo.

Source: Rossner S et al., Obesity Research 2000 (European Orlistat Obesity Study) (checked on October 6, 2026)

What the longer-term evidence shows

Alli itself was studied for months, not years, but orlistat as a molecule has some of the longest follow-up of any weight-loss medicine. In the four-year XENDOS trial of the 120 mg prescription strength, weight loss averaged 5.17% versus 2.75% on placebo, and fewer people developed type 2 diabetes (5.5% vs 8.3%), mostly among those who started with impaired glucose tolerance. In three studies of keeping weight off, people on prescription orlistat regained about a quarter to a third of the weight they had lost over a year, compared with about half or more on placebo. These results come from the higher dose under medical supervision, so they show what the ingredient can do rather than exactly what Alli will do.

If you have diabetes or take other daily medicines

The Drug Facts label asks people who take diabetes medicine to talk with a doctor or pharmacist before using Alli, because doses may need to change as weight comes down. In a one-year trial of prescription orlistat in adults with type 2 diabetes on sulfonylureas, 31.5% lowered their sulfonylurea dose, compared with 21.4% on placebo. The same advice applies to thyroid, seizure, heart-rhythm, HIV and blood-thinning medicines: the timing of doses and extra monitoring can matter, and a pharmacist can usually sort this out in a few minutes at the counter.

Side effects

Because the unabsorbed fat has to leave the body, the label warns you may get “gas with oily spotting,” “loose stools” and “more frequent stools that may be hard to control.” It says eating a low-fat diet lowers the chance of these bowel changes. In the prescription-strength (120 mg) trials, oily spotting affected about 27% of people in the first year and fecal urgency about 22%, mostly in the first three months; the lower Alli dose has been studied less, and the 16-week 60 mg trial reported digestive events as significantly more common than on placebo without changing the overall safety profile.

Orlistat can also reduce absorption of fat-soluble vitamins (A, D, E, K and beta-carotene), which is why the label asks for a daily multivitamin at bedtime, away from the capsules.

When to stop and ask a doctor

The FDA has approved Alli labeling that specifically warns about kidney stones and kidney injury, telling people with a history of kidney disease or kidney stones to ask a health care provider before use. The prescription Xenical label describes the underlying problem as increased urinary oxalate, which can lead to oxalate kidney stones and, rarely, kidney damage, and reports rare cases of severe liver injury, some leading to transplant or death.

Alli vs prescription orlistat

	Alli (OTC)	Xenical (Rx)
Dose per capsule	60 mg	120 mg
Who	Overweight adults 18+	BMI 30+, or 27+ with risk factors; studied in teens 12 to 16
How often	With each fat-containing meal, max 3 a day	With each fat-containing main meal, up to 3 a day
One-year weight loss in the Rossner trial	8.6% (with diet)	9.7% (with diet)
Supervision	Self-selected; ask a pharmacist or doctor	Prescribed and monitored by a clinician
Insurance	Not usually; bought off the shelf	Depends on the plan

Prescription orlistat comes with clinical follow-up, which can help with interactions and side effects. For a broader comparison of pills, including prescription combinations such as Qsymia and Contrave and GLP-1 pills such as the Wegovy pill, see injections vs pills and our weight-loss pills guide.

Which eating styles fit with Alli

Because Alli works on dietary fat, the way you eat changes both the results and the side effects. The Drug Facts label asks for a well-balanced, reduced-calorie, low-fat diet, and the prescription orlistat label explains that digestive side effects increase when a meal is very high in fat, recommending that about 30% of daily calories come from fat, spread over three meals. That makes very-high-fat approaches such as keto or carnivore a poor match: more fat per meal means more unabsorbed fat and more bowel urgency. Patterns built around vegetables, fruit, whole grains, beans and lean protein, such as DASH or a plant-based style, fit more easily. Our diets hub compares the evidence for each approach.

Cost

Alli is sold at retail without a prescription, and prices vary by store and pack size; we could not find an official price list from the manufacturer to quote, so we do not give a number here. Remember to budget for the daily multivitamin. Because it is bought off the shelf, insurance usually does not apply. Our weight-loss costs hub compares the typical costs of different approaches.

Making the most of it

The label is clear that Alli is an add-on to diet and exercise, not a replacement. The plan that makes it work, and makes its side effects milder, is a reduced-calorie, lower-fat way of eating. Our guides to a sustainable calorie deficit, nutrition basics and healthy snacks, plus the calorie calculator, can help you plan meals. When you stop, the strategies in keeping weight off help protect your progress. And if Alli is not giving the results you hoped for after a few months, that is a good moment to talk with a clinician about other options on the medications hub.

FDA status and approved uses

Indication	Labeled population	For weight	Approved	Source
Weight loss aid, used along with a reduced-calorie and low-fat diet	Overweight adults 18 years and older	Yes	February 7, 2007	Source

From the FDA label. Who a medicine is labeled for is not the same as whether it fits you; only a clinician can decide that.

How it is taken (in general)

Drug Facts: for overweight adults 18 and older, take 1 capsule with each meal containing fat, no more than 3 capsules daily, with a reduced-calorie, low-fat diet and exercise. Take a multivitamin once a day at bedtime. Most weight loss occurs in the first 6 months. Read the enclosed brochure; ask a pharmacist or doctor about your other medicines.

This is what the label describes in general, never a personal dose or schedule. Follow your prescriber.

What studies showed

Trial	Population	Duration	Outcome as reported
Anderson 2006 (orlistat 60 mg)	391 mildly to moderately overweight adults, 20 U.S. centers	16 weeks	Weight -3.05 kg vs -1.90 kg with placebo (ITT); completers -4.8% vs -3.1%.[4]
European Orlistat Obesity Study (60 mg and 120 mg)	Adults with BMI 28 to 43	2 years	Year-1 weight loss 8.6% (60 mg) and 9.7% (120 mg) vs 6.6% (placebo); less regain in year 2.[5]

Average results from trials; individual results vary. Results from different trials cannot be compared directly.

Side effects

Common side effect	How often (label)
Gas with oily spotting	Listed on the Drug Facts label (no percentage); about 27% at the 120 mg prescription dose in year 1
Loose stools	Listed on the Drug Facts label (no percentage)
More frequent stools that may be hard to control	Listed on the Drug Facts label; fecal urgency about 22% at 120 mg in year 1

Serious risks

• Rare liver injury
• Rare kidney injury, including kidney stones
• Reduced absorption of some vitamins
• Interactions with anticoagulants, amiodarone, diabetes, thyroid, seizure and HIV medicines; contraindicated with cyclosporine

Warnings and who should not use it

Who should not use it (per the label)

• Organ transplant (orlistat interferes with anti-rejection medicines)
• Taking cyclosporine
• Diagnosed problems absorbing food
• Not overweight
• Allergy to any ingredient
• Pregnancy or breastfeeding

Interactions, pregnancy and breastfeeding

Drug or class	What the label says
Cyclosporine and transplant anti-rejection medicines	Do not use: orlistat interferes with them.
Anticoagulants (blood thinners)	Ask a doctor or pharmacist first; doses may need adjusting.
Amiodarone	Ask a doctor or pharmacist first.
Diabetes medicine	Ask a doctor or pharmacist first; doses may need adjusting.
Thyroid medicine	Ask a doctor or pharmacist first.
Seizure medicine	Ask first; stop and ask a doctor if seizures become more frequent or worse.
Antiretrovirals (HIV medicine)	Ask a doctor or pharmacist first; they may not work as well.
Other weight-loss products	Ask a doctor or pharmacist first.

Pregnancy and breastfeeding

Drug Facts: if pregnant or breast-feeding, do not use.

Questions to ask your doctor or pharmacist

• Is Alli safe with my current medicines, and how should I time them?
• Given my weight and health conditions, would a prescription option suit me better?
• Which multivitamin should I take with it?
• Do I have any history of kidney stones, gallbladder, pancreas or liver problems that makes it a poor fit?
• What eating plan will help me get results and keep side effects mild?

Frequently asked questions

Does Alli really work?

Modestly. The label says that for every 5 lb lost by diet alone, orlistat can help you lose 2 to 3 lb more, and most people in studies lost 5 to 10 lb over 6 months. In a 16-week trial, people on 60 mg lost 3.05 kg vs 1.90 kg on placebo.

Is Alli the same as Xenical?

Both contain orlistat. Alli is 60 mg and sold over the counter for overweight adults; Xenical is 120 mg and requires a prescription. In a two-year trial, first-year weight loss was 8.6% on 60 mg and 9.7% on 120 mg vs 6.6% on placebo, all with diet.

How do I take Alli?

The label says to take 1 capsule with each meal containing fat, no more than 3 a day, with a reduced-calorie, low-fat diet, and a multivitamin once a day at bedtime.

What are the side effects of Alli?

Bowel changes such as gas with oily spotting, loose stools and more frequent stools that may be hard to control. A low-fat diet lowers the chance of these. Rare liver and kidney injury have been reported.

Who should not take Alli?

People who have had an organ transplant, take cyclosporine, have been diagnosed with problems absorbing food, are not overweight, are allergic to an ingredient, or are pregnant or breastfeeding.

Can I take Alli with my other medicines?

Ask a doctor or pharmacist first if you take blood thinners, amiodarone, diabetes, thyroid, seizure or HIV medicines, or other weight-loss products, because doses may need adjusting or the medicines may not work as well.

Why do I need a multivitamin with Alli?

Orlistat can reduce absorption of some vitamins. The label says to take a multivitamin once a day at bedtime.

Is Alli a supplement?

No. Alli is an FDA-approved drug sold over the counter under NDA 021887. Products sold as weight-loss supplements are not FDA approved for weight loss.

Can teenagers use Alli?

No. The Drug Facts label is for adults 18 and older. Teens should see a clinician, who can discuss options approved for adolescents.

Official sources

• Prescribing information (FDA label)
• FDA approval letter or page

References

1. ALLI (orlistat 60 mg) capsules: Drug Facts. Haleon, via DailyMed, 2026. (accessed October 6, 2026) Drug label
2. Drugs@FDA: Alli, NDA 021887 (original approval 2007-02-07). U.S. Food and Drug Administration. (accessed October 6, 2026) Government page
3. XENICAL (orlistat) capsules: prescribing information. H2-Pharma / CHEPLAPHARM, via DailyMed, 2026. (accessed October 6, 2026) Drug label
4. Anderson JW, Schwartz SM, Hauptman J, et al.. Low-dose orlistat effects on body weight of mildly to moderately overweight individuals: a 16 week, double-blind, placebo-controlled trial. Annals of Pharmacotherapy, 2006. doi:10.1345/aph.1H234 · PMID 16940406 (accessed October 6, 2026) Randomized trial
5. Rossner S, Sjostrom L, Noack R, Meinders AE, Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. Obesity Research, 2000. doi:10.1038/oby.2000.8 · PMID 10678259 (accessed October 6, 2026) Randomized trial
6. FDA Approves Labeling Changes for OTC Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury. U.S. Food and Drug Administration. (accessed October 6, 2026) Government page
7. Weight loss product notifications (tainted products). U.S. Food and Drug Administration. (accessed October 7, 2026) Government page

Facts checked on October 6, 2026

Educational information, not medical advice. Talk with a qualified healthcare professional about your own situation. In an emergency call 911.