Orlistat
/api/v1/drug/orlistatMechanism of action
Sourced from openFDAMechanism-of-action class: Lipase Inhibitors.
Indications
Sourced from openFDA- Use for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
Dosage & administration
Sourced from openFDADirections 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 Ht. / Wt. 4’10” 129 lbs. 4’11” 133 lbs. 5’0” 138 lbs. 5’1” 143 lbs. 5’2” 147 lbs. 5’3” 152 lbs. 5’4” 157 lbs. 5’5” 162 lbs. 5’6” 167 lbs. 5’7” 172 lbs. 5’8” 177 lbs. 5’9” 182 lbs. 5’10” 188 lbs. 5’11” 193 lbs. 6’0” 199 lbs. 6’1” 204 lbs. 6’2” 210 lbs. 6’3” 216 lbs. 6’4” 221 lbs. 6’5” 227 lbs.
Warnings & precautions
Sourced from openFDAOrgan transplant alert: do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection. Allergy alert: do not use if you are allergic to any of the ingredients in orlistat capsules Do not use if you are taking cyclosporine if you have been diagnosed with problems absorbing food if you are not overweight Ask a doctor before use if you have ever had gallbladder problems kidney stones pancreatitis Ask a doctor or pharmacist before use if you are taking any of the following prescription medications. Some prescription doses may need to be adjusted, or some medications may not work as well when used with orlistat. anticoagulants (blood thinning medicine) amiodarone (heart medicine) diabetes medicine thyroid disease medicine seizure medicine antiretrovirals (HIV medicine) taking any other weight loss products When using this product 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.
Approval history
Sourced from openFDA- Apr 23, 1999NDANDA020766Cheplapharm
- Feb 7, 2007NDANDA021887Haleon Us Holdings
FAERS reports
- 1Drug Ineffective4,52418%
- 2Rectal Discharge2,4329.5%
- 3Gastrointestinal Disorder2,1858.5%
- 4Constipation1,9917.8%
- 5Diarrhoea1,9527.6%
- 6Weight Increased1,9447.6%
- 7Steatorrhoea1,6476.4%
- 8Flatulence1,6176.3%
- 9Abdominal Pain Upper1,3665.3%
- 10Headache1,1134.3%
- 11Abdominal Distension1,0053.9%
- 12Nausea9473.7%
- 13Treatment Noncompliance8053.1%
- 14Malaise7823.0%
- 15Abdominal Pain6932.7%
Literature
Recent PubMed references pinned to Orlistat as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Orlistat targets NEDD8 conjugating enzyme UBC12 for cancer therapy.Pharmacological research · 2026 · Shen M, Li H, Xuan Y, et al.PMID 42067003DOI 10.1016/j.phrs.2026.108214
- Effect of orlistat and anti-androgen oral contraceptives on pregnancy outcomes in overweight or obese PCOS patients during comprehensive management.Archives of gynecology and obstetrics · 2026 · Zhang M, Ruan X, Jiang L, et al.PMID 41831044DOI 10.1007/s00404-026-08383-6
- Long-Term Effects of Orlistat on Lipid Metabolism and Anthropometric Indices: A Meta-Analysis of Clinical Trials.Journal of obesity · 2026 · Khodadadiyan A, Khazraei Y, Kamali M, et al.PMID 41737647DOI 10.1155/jobe/9068305
- Orlistat impairs Chlamydia trachomatis development by disrupting its developmental cycle.Microbial pathogenesis · 2026 · Gao J, Jiang M, Chen J, et al.PMID 41529804DOI 10.1016/j.micpath.2026.108301
- Orlistat Confers Neuroprotection in Traumatic Brain Injury by Modulating Microglial Lipid Metabolism.Cells · 2025 · Yu C, Ni Y, Xiong Y, et al.PMID 41002434DOI 10.3390/cells14181469
- Synergistic Combination of Tamoxifen-Tetraphenylethylene Co-Assembled Micelles and Orlistat-Induced Lipid Droplet Inhibition to Overcome Tamoxifen Resistance.Advanced healthcare materials · 2025 · Park JY, Lee J, Kim YY, et al.PMID 40801177DOI 10.1002/adhm.202502060
- The Supportive Effect of Acarbose to Orlistat in Weight Management-A Randomized, Double-Blind, Multiarm Phase 2 Trial.Obesity (Silver Spring, Md.) · 2025 · Holmbäck U, Grudén S, Kuusk S, et al.PMID 40769876DOI 10.1002/oby.24369
- Orlistat-dopamine conjugate micelles improve targeted delivery and therapeutic efficiency of camptothecin in combination chemotherapy.Journal of materials chemistry. B · 2025 · Chen S, Chou T, Zhou X, et al.PMID 40689711DOI 10.1039/d5tb01194a
Clinical trials
The 10 most recently updated of 83 ClinicalTrials.gov registrations naming Orlistat as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- A Study to Evaluate the Safety of Exposure to Wegovy During PregnancyEnrolling by invitation · Observational · 1,139 enrolled · Novo Nordisk A/SNCT05503927updated 2026-06-09
- Long Term Efficacy and Safety of Orlistat for Type 1 HyperlipoproteinemiaRecruiting · Phase 2 · Interventional · 28 enrolled · University of Texas Southwestern Medical CenterNCT05816343updated 2026-05-29
- RWS of of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients.Not yet recruiting · Phase 4 · Interventional · 120 enrolled · The Fourth Affiliated Hospital of Zhejiang University School of MedicineNCT07301437updated 2026-03-23
- Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With ObesityTerminated · Phase 2 · Interventional · 128 enrolled · University of IowaNCT01351753updated 2026-03-12
- Effect of Electroacupuncture on Central Obesity and Fatty Liver in Postmenopausal WomenNot yet recruiting · Interventional · 60 enrolled · Cairo UniversityNCT07437001updated 2026-02-27
- A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in AmericaCompleted · Phase 4 · Interventional · 500 enrolled · Novo Nordisk A/SNCT05579249updated 2026-01-14
- Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCTNot yet recruiting · Interventional · 120 enrolled · XueMei GuoNCT07326839updated 2026-01-08
- Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)Active not recruiting · Phase 4 · Interventional · 150 enrolled · The Cleveland ClinicNCT06854614updated 2025-12-12
- Weight Loss Management in Endometrial Cancer SurvivorsRecruiting · Observational · 50 enrolled · University of Kansas Medical CenterNCT06877572updated 2025-10-27
- Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)Active not recruiting · Observational · 23,280,000 enrolled · Ohio State UniversityNCT07188545updated 2025-09-23
Frequently asked questions
- How does Orlistat work?
- Mechanism-of-action class: Lipase Inhibitors.
- What is Orlistat used for?
- According to FDA labeling, Orlistat carries indications including: Use for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Orlistat?
- Orlistat is classified as Peripherally acting antiobesity products, Intestinal Lipase Inhibitor, Lipase Inhibitors, Inhibition Fat Digestion.
- What are the brand names for Orlistat?
- Orlistat is marketed under brand names including Alli, Xenical.
orlistat is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.