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Classification: B

Drug products: alli, Beacita, Orlistat Ebb, Orlistat STADA, Xenical®

ATC code: A08AB01

Substances: orlistat


Published controlled studies on differences between men and women in effect of orlistat are lacking, besides a study with patients simultaneously treated with clozapine or olanzapin. However, this is a special combination which limits the generalizability.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.

Additional information

Pharmacokinetics and dosing

After a single dose of 360 mg orlistat in obese/overweight patients (5 men, 3 women) no difference in concentrations of orlistat metabolites in urine was found between men and women [1]. No studies with a clinically relevant sex analysis regarding the dosing of orlistat have been found.


The only study found with a sex-analysis of orlistat effects was in a randomized prospective study combining orlistat with clozapine or olanzapine (41 men, 22 women). The study showed that men had significant weight-loss over time but not women [2, 3].The effect of orlistat on eating behavior 17 and 33 months after initial weight loss among patients was evaluated in a randomized controlled trial (149 men, 157 women). There was no difference between the sexes with regard to change in dietary restraint, disinhibition and binge eating [4].

Adverse effects

Results from a large retrospective cohort study (43 295 men, 150 677 women) examining the risk of colorectal cancer associated with orlistat treatment, showed no evidence of an increased risk in analyses stratified according to sex [5].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Other information

In a Taiwanese study (269 men, 791 women), the one-year prevalence of orlistat use was higher among men than women [6].

In a review the rates of dropouts from large randomized controlled trials of weight loss drugs with adult participants and at least a 1-year duration were summarized. Study groups with a high percentage of women had a higher dropout, compared to groups with low-percentage of women [7].

Updated: 2020-08-28

Date of litterature search: 2014-05-15


  1. Zhi J, Melia AT, Funk C, Viger-Chougnet A, Hopfgartner G, Lausecker B et al. Metabolic profiles of minimally absorbed orlistat in obese/overweight volunteers. J Clin Pharmacol. 1996;36:1006-11. PubMed
  2. Joffe G, Takala P, Tchoukhine E, Hakko H, Raidma M, Putkonen H et al. Orlistat in clozapine- or olanzapine-treated patients with overweight or obesity: a 16-week randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2008;69:706-11. PubMed
  3. Tchoukhine E, Takala P, Hakko H, Raidma M, Putkonen H, Räsänen P et al. Orlistat in clozapine- or olanzapine-treated patients with overweight or obesity: a 16-week open-label extension phase and both phases of a randomized controlled trial. J Clin Psychiatry. 2011;72:326-30. PubMed
  4. Svendsen M, Rissanen A, Richelsen B, Rössner S, Hansson F, Tonstad S. Effect of orlistat on eating behavior among participants in a 3-year weight maintenance trial. Obesity (Silver Spring). 2008;16:327-33. PubMed
  5. Hong JL, Meier CR, Sandler RS, Jick SS, Stürmer T. Risk of colorectal cancer after initiation of orlistat: matched cohort study. BMJ. 2013;347:f5039. PubMed
  6. Liou TH, Wu CH, Chien HC, Lin WY, Lee WJ, Chou P. Anti-obesity drug use before professional treatment in Taiwan. Asia Pac J Clin Nutr. 2007;16:580-6. PubMed
  7. Fabricatore AN, Wadden TA, Moore RH, Butryn ML, Gravallese EA, Erondu NE et al. Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis. Obes Rev. 2009;10:333-41. PubMed
  8. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson