Prescription and over-the-counter medicine
Orlistat Brand names: Alli, Xenical
Orlistat (Alli) is a prescription and over-the-counter medicine with an FDA approval on record since 1999. No generic is listed; pharmacies paid $7.00 per orlistat 120 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the orlistat FDA label on DailyMed (effective March 18, 2026, Haleon US Holdings LLC); the NDA 20766 record on Drugs@FDA; every orlistat label on DailyMed.
Highlights of the record
FDA label of March 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagefor weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
Forms and strengths
- 60 mg
- 120 mg
Capsule.
On the market
- Earliest approval on file
- April 23, 1999 Xenical, Cheplapharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $7.00 per capsule Orlistat 120 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 25,755 through July 30, 2026
What is orlistat used for?
From the label: indications and usagefor weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
Conditions named in the indications of orlistat's FDA labels, with every medicine labeled for each:
From other orlistat labelsWeight management: XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet.
FDA pharmacologic class: Intestinal Lipase Inhibitor.
Source: FDA drug label (ALLI), Haleon US Holdings LLC, effective March 18, 2026 (SPL set a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f), via openFDA; the full label on DailyMed
Is there a generic for orlistat (Alli)?
No generic orlistat is approved (Drugs@FDA, October 8, 2026).
- 1999 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for orlistat (Alli)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.00 per Orlistat 120 mg capsule, up 1% from $6.93 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Orlistat 120 mg capsule (generic)
- Xenical 120 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Orlistat 120 mg capsule | Generic | $7.00 per capsule | $209.97 | +1% |
| Xenical 120 mg capsule | Brand | $4.60 per capsule | $137.94 | -0.4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the orlistat label say about other medicines?
The orlistat label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name orlistat. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions (prescription label) | A reduction in exposure to amiodarone was observed when XENICAL was co-administered. |
| Atazanavir | drug interactions (prescription label) | Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs such as atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, and with the combinations lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. |
| Cyclosporine | drug interactions (prescription label) | DRUG INTERACTIONS Cyclosporine: Reduction in cyclosporine plasma levels was observed when XENICAL was coadministered with cyclosporine. ( 7.1 ) Fat-soluble Vitamin Supplements and Analogues: |
| Efavirenz | drug interactions (prescription label) | Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs such as atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, and with the combinations lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. |
| Emtricitabine | drug interactions (prescription label) | Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs such as atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, and with the combinations lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. |
| Levothyroxine | drug interactions (prescription label) | Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function. |
| Lopinavir and ritonavir | drug interactions (prescription label) | Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs such as atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, and with the combinations lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. |
| Ritonavir | drug interactions (prescription label) | Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs such as atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, and with the combinations lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. |
| Tenofovir disoproxil | drug interactions (prescription label) | Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs such as atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, and with the combinations lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. |
| Vitamin a | drug interactions (prescription label) | The effect of XENICAL 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) ]. |
| Warfarin | drug interactions (prescription label) | Patients on chronic stable doses of warfarin who are prescribed XENICAL should be monitored closely for changes in coagulation parameters. |
Other labels that name orlistat
Source: FDA drug label (ALLI), Haleon US Holdings LLC, effective March 18, 2026 (SPL set a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f), via openFDA; the full label on DailyMed
What do FAERS reports show for orlistat?
The FDA Adverse Event Reporting System holds 25,755 reports that list orlistat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 230 are coded as a death and 2,124 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as orlistat?
7 other medicines are given the same way (oral) and in the same FDA class as orlistat or labeled mainly for the same use (weight management), the same class first. Weight management lists all 12 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Phentermine | Weight management | 27 labelers | $0.0727 per tablet 37.5 mg tablet | No current entry |
| Diethylpropion | Weight management | 13 labelers | $0.238 per tablet 25 mg tablet | No current entry |
| Phendimetrazine | Weight management | 11 labelers | $0.132 per tablet 35 mg tablet | No current entry |
| Phentermine and topiramate | Weight management | 2 labelers | $3.06 per capsule 7.5-46 mg capsule | No current entry |
| Benzphetamine | Weight management | 6 labelers | n/a | No current entry |
| Orforglipron | Weight management | none listed | $20.89 per tablet 0.8 mg tablet | No current entry |
| Bupropion and naltrexone | Weight management | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to orlistat
- 7 medicines for the same use
- Orlistat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other