Orlistat
Metabolic Health · Lipase inhibitor
Also known as: Xenical ·Alli
Tier B
Bottom line
Read Off Label grades Orlistat as B (6.9/10) based on strong evidence, low-med benefit magnitude, and a low-med-risk safety profile.
XENDOS trial: modest weight loss (~3% above placebo at 4 years) and ~37% reduction in progression to T2D.
Studied, labeled, or reported-use context: 60 mg (OTC) or 120 mg TID with meals — OTC (Alli) / Rx; not individualized guidance.
Citation correction in progress
1 PubMed link was found to be unrelated to this entry and removed from public output. The remaining sources are shown below, but this row's claims and score still need a full source-by-source revalidation.
What the evidence says
XENDOS trial: modest weight loss (~3% above placebo at 4 years) and ~37% reduction in progression to T2D. Steatorrhea and "anal leakage" are common and notorious. Now largely displaced by GLP-1 era drugs.
Mechanism
Inhibits pancreatic/gastric lipases — prevents absorption of ~30% of dietary fat; unabsorbed fat excreted in stool
Studied, labeled, or reported dose & route
60 mg (OTC) or 120 mg TID with meals
This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.
Citations
- PubMed · PMID 14693982
- cochranelibrary.com
- ClinicalTrials.gov · NCT01755676
- ClinicalTrials.gov · NCT00212199
A link means the source informed this entry; it does not mean every claim on the page comes from that source. If a citation looks wrong or you want a claim re-checked, send a correction.
Common questions
- What does the evidence show about Orlistat's effects?
- Read Off Label rates the evidence for Orlistat as Strong and the benefit magnitude as low-med, producing an overall grade of B (6.9/10). XENDOS trial: modest weight loss (~3% above placebo at 4 years) and ~37% reduction in progression to T2D.
- What safety findings are reported for Orlistat?
- Orlistat has a low-med risk profile in the database. Low-Med (GI side effects are severe and common; fat-soluble vitamin malabsorption) Legal status: OTC (Alli) / Rx (Xenical).
- What doses or routes are reported for Orlistat?
- 60 mg (OTC) or 120 mg TID with meals This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
- How does Orlistat work?
- Inhibits pancreatic/gastric lipases — prevents absorption of ~30% of dietary fat; unabsorbed fat excreted in stool
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.