Orlistat
Orlistat is a fat-absorption blocker taken by mouth as a capsule for weight loss and weight maintenance, along with a reduced-calorie diet, and to help prevent weight regain after weight loss.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Orlistat (Xenical by prescription, Alli over the counter) is an older weight-loss medicine with a modest effect, used with a reduced-calorie diet for weight loss and maintenance; it blocks fat-digesting gut enzymes so some fat passes out in your stool, has been on the market since about 2007 and is available as a generic. Because it stays in the gut, whole-body side effects are uncommon, but most people notice oily spotting, gas with oily discharge or urgent bowel movements, worst after fatty meals. Watch for yellow skin or eyes, dark urine or upper right belly pain (rare signs of serious liver injury), and do not use it in pregnancy.
Clinical pearls
- Take it with each fat-containing meal or within an hour after; skip the dose when a meal has no fat.
- Take a daily multivitamin with vitamins A, D, E and K at bedtime, at least two hours away from orlistat.
- On levothyroxine, separate the two by at least four hours and get thyroid levels checked; cyclosporine goes three hours after orlistat.
- Tell your prescribers if you take warfarin, amiodarone, seizure or HIV medicines, since orlistat can change how well they work.
Patient information guide A plain-language walkthrough of Orlistat, written from its FDA label.
What Orlistat is used for
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Orlistat is used for weight management in these ways:
- Xenical and Orlistat capsules: obesity management, including weight loss and weight maintenance, with a reduced-calorie diet.
- Xenical and Orlistat capsules: reducing the risk of weight regain after weight loss.
- Xenical and Orlistat capsules: people with a BMI of 30 or higher, or 27 or higher with risk factors such as high blood pressure, diabetes or dyslipidemia (abnormal cholesterol).
- Alli capsules: weight loss in overweight adults 18 and older, with a reduced-calorie, low-fat diet.
How Orlistat works
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Orlistat blocks lipases, the digestive enzymes that break down dietary fat. It attaches to these enzymes in the stomach and small intestine and turns them off. Fat that is not broken down cannot be absorbed, so it leaves the body in stool. The resulting calorie deficit may help with weight control.
Orlistat dosage
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Orlistat is a capsule taken by mouth with meals that contain fat. How often you take it depends on the product, so follow your prescriber and the label.
- Xenical and Orlistat: three times a day with each main meal containing fat, during or up to 1 hour after.
- Alli: 1 capsule with each fat-containing meal, no more than 3 a day.
- If a meal is skipped or has no fat, you can skip that dose of Xenical or Orlistat.
- Use a reduced-calorie diet with about 30% of calories from fat, spread over three meals.
- Doses above the recommended amount have not been shown to help more.
Dosing details from the FDA-approved label
From the Orlistat prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Xenical/Orlistat (prescription): recommended dosing
- One 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal)
- Maximum: Doses above 120 mg three times a day have not been shown to provide additional benefit
- Use with a nutritionally balanced, reduced-calorie diet containing approximately 30% of calories from fat; if a meal is occasionally missed or contains no fat, the dose can be omitted
- Alli (overweight adults 18 years and older)
- Take 1 capsule with each meal containing fat
- Maximum: Do not take more than 3 capsules daily
- Use with a reduced-calorie, low-fat diet and exercise program; take a multivitamin once a day, at bedtime
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION One 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal). ( 2 ) Advise patients to take a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. ( 2 ) Distribute the daily intake of fat, carbohydrate, and protein over three main meals. ( 2 ) Advise patients to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. ( 2 ) Take the vitamin supplement at least 2 hours before or after the administration of ORLISTAT, such as at bedtime. ( 2 ) For patients receiving both ORLISTAT and cyclosporine therapy, administer cyclosporine 3 hours after ORLISTAT. ( 2 ) For patients receiving both ORLISTAT and levothyroxine therapy, administer levothyroxine and ORLISTAT at least 4 hours apart. ( 2 ) 2.1 Recommended Dosing The recommended dose of ORLISTAT is one 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal). The patient should be on a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. If a meal is occasionally missed or contains no fat, the dose of ORLISTAT can be omitted. Because ORLISTAT has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition [see Warnings and Precautions (5.1) ] . The vitamin supplement should be taken at least 2 hours before or after the administration of ORLISTAT, such as at bedtime. For patients receiving both ORLISTAT and cyclosporine therapy, administer cyclosporine 3 hours after ORLISTAT. For patients receiving both ORLISTAT and levothyroxine therapy, administer levothyroxine and ORLISTAT at least 4 hours apart. Patients treated concomitantly with ORLISTAT and levothyroxine should be monitored for changes in thyroid function. Doses above 120 mg three times a day have not been shown to provide additional benefit. Based on fecal fat measurements, the effect of ORLISTAT is seen as soon as 24 to 48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.
Read the full Dosage and Administration section on DailyMed →
Orlistat side effects
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Most side effects are digestive and come from the fat that passes through your gut.
Common side effects
- Oily spotting
- Gas with oily discharge
- Urgent need to have a bowel movement
- Fatty or oily stools
- Oily bowel movements
- More frequent bowel movements
- Loss of bowel control (fecal incontinence)
- Abdominal pain or discomfort
- Oily evacuation
When to get medical help
- Itching, yellow skin or eyes, dark urine, light-colored stools, loss of appetite or pain in the upper right belly. These can be signs of rare but severe liver injury.
- Severe back or groin pain, painful urination, blood in urine, leg or foot swelling, or urinating much less. These can be signs of kidney problems.
- Severe or continuous abdominal pain.
- Signs of a serious allergic reaction such as rash, hives, swelling or trouble breathing.
- More frequent or worse seizures if you take seizure medicine.
- Rising HIV viral load if you take HIV medicine.
These usually start within 3 months. About half of episodes last less than a week, though some people have them for 6 months or longer. A low-fat diet lowers the chance of these effects. Call your doctor for signs of liver or kidney problems, severe belly pain or an allergic reaction.
Orlistat warnings and precautions
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- Liver injury: rare but severe cases have been reported. Stop and call your doctor for itching, yellow skin or eyes, dark urine, light stools, appetite loss or upper right belly pain.
- Kidney problems: orlistat can cause oxalate kidney stones and kidney damage, especially if you have kidney disease or a history of kidney stones.
- Low vitamin levels: orlistat can lower vitamins A, D, E, K and beta-carotene, so take a daily multivitamin.
- Gallstones: substantial weight loss can raise the risk.
- Diabetes: weight loss may mean your diabetes medicine dose needs lowering.
- Pancreatitis and bleeding: pancreatitis and lower gastrointestinal bleeding have been reported. Severe or persistent bleeding should be checked.
Orlistat interactions
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Orlistat can change how well some medicines work. Check with your pharmacist before starting it.
- Cyclosporine: lower levels, so it should not be taken at the same time. Take it 3 hours after orlistat.
- Levothyroxine: hypothyroidism has been reported, so separate by at least 4 hours.
- Warfarin and other blood thinners: clotting changes have been reported.
- Amiodarone: exposure is lowered, so it may work less well.
- Seizure medicines: convulsions have been reported.
- HIV medicines: loss of control of the virus has been reported.
- Fat-soluble vitamin supplements: absorption is reduced, so take your multivitamin at bedtime.
- Diabetes medicines: doses may need adjusting.
Interactions listed in the FDA-approved label
From the Orlistat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Cyclosporine: Reduction in cyclosporine plasma levels was observed when ORLISTAT was coadministered with cyclosporine. Do not coadminister simultaneously; administer cyclosporine 3 hours after ORLISTAT.
- Fat-soluble vitamin supplements and analogues: Absorption of beta-carotene supplement is reduced and absorption of a vitamin E acetate supplement was inhibited; the effect on supplemental vitamin D, vitamin A, and nutritionally-derived vitamin K is not known. Take a daily multivitamin containing vitamins A, D, E, K, and beta-carotene, at least 2 hours before or after ORLISTAT, such as at bedtime.
- Levothyroxine: Hypothyroidism has been reported postmarketing in patients treated concomitantly with ORLISTAT and levothyroxine. Monitor for changes in thyroid function; administer levothyroxine and ORLISTAT at least 4 hours apart.
- Warfarin and other anticoagulants: Vitamin K absorption may be decreased; decreased prothrombin, increased INR and unbalanced anticoagulant treatment changing hemostatic parameters have been reported. Monitor closely for changes in coagulation parameters in patients on chronic stable doses of warfarin or other anticoagulants.
- Amiodarone: Reduction in exposure to amiodarone and its metabolite desethylamiodarone was demonstrated; a reduced therapeutic effect of amiodarone is possible. The effect of commencing orlistat in patients on stable amiodarone therapy has not been studied.
- Antiepileptic drugs: Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs. Monitor for possible changes in the frequency and/or severity of convulsions.
- Antiretroviral drugs (e.g., atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir/ritonavir, emtricitabine/efavirenz/tenofovir disoproxil fumarate): Loss of virological control has been reported in HIV-infected patients taking orlistat with antiretroviral drugs. Frequently monitor HIV RNA levels; if there is a confirmed increase in HIV viral load, discontinue ORLISTAT.
Read the label’s full interactions text
7 DRUG INTERACTIONS Cyclosporine: Reduction in cyclosporine plasma levels was observed when ORLISTAT was coadministered with cyclosporine. ( 7.1 ) Fat-soluble Vitamin Supplements and Analogues: All patients should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene. ( 7.2 ) Levothyroxine: Patients treated concomitantly with ORLISTAT and levothyroxine should be monitored for changes in thyroid function. ( 7.3 ) Warfarin: Patients on chronic stable doses of warfarin who are prescribed ORLISTAT should be monitored closely for changes in coagulation parameters. ( 7.4 ) Amiodarone: A reduction in exposure to amiodarone was observed when ORLISTAT was co-administered. ( 7.5 ) Antiepileptic Drugs: Convulsions have been reported in patients taking ORLISTAT with antiepileptic drugs. Patients should be monitored for possible changes in frequency or severity of convulsions. ( 7.6 ) Antiretroviral Drugs: Loss of virological control has been reported in HIV-infected patients. Patients should be monitored frequently for changes in HIV RNA levels. ( 7.7 ) 7.1 Cyclosporine Data from a ORLISTAT and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when ORLISTAT was coadministered with cyclosporine. ORLISTAT and cyclosporine should not be simultaneously coadministered. Cyclosporine should be administered 3 hours after the administration of ORLISTAT [see Dosage and Administration (2) , and Warnings and Precautions (5.1) ] . 7.2 Fat-soluble Vitamin Supplements and Analogues Data from a pharmacokinetic interaction study showed that the absorption of beta-carotene supplement is reduced when concomitantly administered with ORLISTAT. ORLISTAT inhibited absorption of a vitamin E acetate supplement. The effect of ORLISTAT on the absorption of supplemental vitamin D, vitamin A, and nutritionally-derived vitamin K is not known at this time [see Clinical Pharmacology (12.3) , and Warnings and Precautions (5.1) ] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Orlistat
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- Pregnancy: do not use.
- Breastfeeding: use caution. Alli says not to use it if breastfeeding.
- Chronic malabsorption syndrome or cholestasis: do not use.
- Allergy to orlistat or its ingredients: do not use.
- Alli: not for people who have had an organ transplant or who are not overweight.
- Gallbladder problems, kidney disease, kidney stones or pancreatitis: ask a doctor first.
- Children under 12: safety and effectiveness have not been established.
- Adults 65 and older: not enough studied to know if they respond differently.
Orlistat overdose
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Single doses much larger than usual were studied without significant harmful findings. If a significant overdose happens, the label recommends observing the person for 24 hours. Effects from blocking fat digestion should reverse quickly. Get medical help or call Poison Control right away.
What Orlistat does in the body
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At the usual prescription dose, orlistat blocks about 30% of dietary fat from being absorbed. Its effect on fecal fat shows up within 24 to 48 hours of dosing. After you stop, fecal fat usually returns to its prior level in 48 to 72 hours. Alcohol does not change how well orlistat blocks fat absorption.
How your body processes Orlistat
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Very little orlistat gets into your bloodstream. Blood levels of the intact drug were near the limits of detection in the label's study. That fits with it working mostly inside the gut.
How to store Orlistat
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Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Orlistat
18 supplements and herbal products have documented interactions with Orlistat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 8
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Orlistat has been associated with lower levels of 5 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 2
- Moderate · 3
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Orlistat: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Orlistat — the kind of thing our pharmacy team would talk through with you at the counter.
What is orlistat actually for?
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How do I take it?
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What side effects should I expect?
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Do I need to take anything else with it?
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Which of my medicines could be a problem?
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When should I call my doctor?
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Is Orlistat available over the counter?
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When was Orlistat first available?
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Who makes Orlistat?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Orlistat on HelloPharmacist
Orlistat forms and strengths (how it comes)
Orlistat is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Orlistat inactive ingredients by manufacturer.
Capsule
How this form is used
- Xenical and Orlistat are used for obesity management, including weight loss, weight maintenance and reducing weight regain, with a reduced-calorie diet.
- Alli is used for weight loss in overweight adults 18 and older, with a reduced-calorie, low-fat diet.
- Xenical and Orlistat are taken three times a day with each main meal containing fat, during or up to 1 hour after the meal.
- Alli is taken as 1 capsule with each meal containing fat, up to 3 capsules daily.
- Xenical, Orlistat and Alli all call for a daily multivitamin, taken at bedtime or at least 2 hours apart from the dose.
Orlistat on the U.S. market: products, makers and brands
How Orlistat appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
3 companies list 4 Orlistat product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1999. Brand names on the directory include Alli, Xenical; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Orlistat is used (Medicaid data)
A general measure of how commonly Orlistat is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Orlistat is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Orlistat prescribed? Of the 1,601 medications we measure, Orlistat ranks #1,040 by Medicaid prescriptions — more than 35% of them.
Utilization by Orlistat product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
orlistat 120 MG Oral Capsule
Summed across the 2 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314153
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Orlistat, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 14 listed Orlistat NDCs with Medicaid activity.
Compare Orlistat products
A representative set of FDA-listed product records for Orlistat — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 60 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | NDA | View NDC → |
| 120 mg | Oral | H2-Pharma LLC | NDA | View NDC → |
| 120 mg | Oral | H2-Pharma LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 60 mg | Oral | Haleon US Holdings LLC | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Orlistat NDCs →
Orlistat side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Orlistat — a signal of what to watch for, not proof the drug caused it.
The effects most often named in FDA reports that mention Orlistat are rectal discharge, gastrointestinal disorder, constipation; about 26% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Orlistat in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Orlistat FDA approval history
How Orlistat went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Orlistat was first approved by the FDA in 1999 (Brand: XENICAL · Cheplapharm). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Orlistat recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Orlistat recalls since July 2021.
✅No Orlistat recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 37925 1 dose form · 2 strengths
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Dose form (SCDF) Oral Capsule RxCUI 373151In current FDA listings
Look up RxCUI 37925 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Orlistat supply and shortage status
Whether Orlistat is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Orlistat costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Capsule · Oral | 120 mg | $4.60 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Orlistat brand names
Orlistat is sold under 2 brand names in the FDA directory — Alli, Xenical. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Orlistat: manufacturers and labelers
3 companies list Orlistat products with the FDA. By number of product records, the largest are H2-Pharma LLC, Aphena Pharma Solutions - Tennessee, LLC, Haleon US Holdings LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Orlistat drug class (RxNorm)
Orlistat belongs to the Intestinal Lipase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Orlistat page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. H2-Pharma LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →