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Oral formulations of orlistat.

Drugs List

  • ALLI 60mg capsules
  • orlistat 120mg capsules
  • orlistat 60mg capsules
  • ORLOS 60mg capsules
  • XENICAL 120mg capsules
  • Therapeutic Indications


    Treatment with a hypocaloric diet for obese or overweight patients

    Treatment in conjunction with a mildly hypocaloric diet for:
    Obese patients (body mass index greater than or equal to 30kg per square metre)
    Overweight patients (body mass index greater than or equal to 28kg per square metre) with associated risk factors such as type 2 diabetes, hypertension or hypercholesterolaemia.

    Pharmacy only product: Only licensed for overweight patients with BMI greater than or equal to 28kg per square metre.


    Diet and exercise should be undertaken as part of the weight loss programme and continued once treatment with orlistat is stopped.

    Pharmacy only product: Treatment should not exceed 6 months.


    Prescription only product:
    120mg three times a day, taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose is omitted. Doses above 120mg three times a day have not shown any additional benefit.

    Pharmacy only product:
    60mg three times a day.

    The patient should be on a nutritionally balanced, mildly hypocaloric diet containing approximately 30% of calories from fat. Meals with very high fat content may increase gastrointestinal adverse effects. The diet should be rich in fruit and vegetables with a daily intake of fat, carbohydrate and protein distributed over three main meals. The use of a multivitamin supplement could be considered, which should be taken at least 2 hours after orlistat or at bedtime.

    The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. On discontinuation of treatment faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.


    Children aged 12 to 18 years (unlicensed)
    120mg up to three times a day, taken immediately before, during, or up to 1 hour after each main meal. If a meal is missed or contains no fat, the dose is omitted.


    Children under 12 years
    Malabsorption syndrome

    Precautions and Warnings

    Children aged 12 to 18 years
    Chronic renal disorder
    Diabetes mellitus
    Positive HIV status

    May reduce absorption of antiretroviral HIV drugs
    Discontinue after 12 weeks of treatment if weight loss less than 5%
    Monitor anticoagulant drug treatment
    Monitor antidiabetic drug treatment
    Monitor antiepileptic drug treatment
    Monitor hypercholesterolaemia drug treatment
    Monitor hypertension drug treatment
    Advise patient to contact prescriber if rectal bleeding occurs
    Supplements of fat-soluble vitamins A,D,E and K may be required
    Not licensed for use in children under 18 years
    Diet high in fat increases possibility of gastro-intestinal adverse effects
    Dietary restrictions should be maintained
    Female:Additional contraception method advised in cases of severe diarrhoea
    Advise patient on AED to consult Dr before taking OTC product
    Advise patient with diabetes to consult Dr before taking OTC product
    Advise patient with high cholesterol to consult Dr before taking OTCproduct
    Advise patient with HIV to consult Dr before taking OTC product
    Advise patient with hypertension to consult Dr before taking OTC product
    Advise patient with hyperthyroidism to consult Dr before taking OTC product
    Advise patient with hypothyroidism to consult Dr before taking OTC product
    Advise patient with renal impairment to consult Dr before taking OTCproduct

    The possibility of gastrointestinal events may increase if a diet high in fat is taken, for example, above 67 g of fat equals more than 30% of the calories in a 2000 kcal/day diet. Patients should therefore be advised to adhere to dietary recommendations.

    Use with caution in hypertension and/or hypercholesterolaemia as weight loss may be accompanied by improved blood pressure and cholesterol and an adjustment in treatment may be required.

    Increased risk of hyperoxaluria and oxalate nephropathy in patients with chronic renal disease and or volume depletion.

    Pregnancy and Lactation


    Use orlistat with caution during pregnancy.

    The manufacturer advises caution if orlistat is used during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development. At the time of writing there is limited published information regarding the use of orlistat during pregnancy. Potential risks are unknown.

    Weight-loss medications may interfere with adequate nutrition for both the mother and foetus. Orlistat may cause a deficiency of fat soluble vitamins if a daily multivitamin supplement is not taken.


    Orlistat is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking orlistat. The presence of orlistat in human breast milk is unknown.


    Advise patient to follow a diet rich in fruit and vegetables and low in fat.

    If multivitamins are taken advise patients that these should be at least 2 hours after taking orlistat or at bedtime.

    Advise patients that additional non oral contraceptive methods are recommended, particularly if diarrhoea is severe.

    Advise patients with diabetes, hypertension or hypercholesterolaemia that weight loss may be accompanied by improved metabolic control, blood pressure and cholesterol, which may require treatment adjustment.

    Advise patient to consult a doctor before purchasing orlistat over the counter if they have renal impairment, are being treated for hypothyroidism, are taking anticonvulsant medication or are taking antiretroviral medication for HIV.

    Side Effects

    Abdominal discomfort
    Abdominal distension
    Abdominal pain
    Bullous eruption
    Faecal incontinence
    Faecal urgency
    Fatty/oily stool
    Flatus with discharge
    Gingival disorder
    Hypersensitivity reactions
    Increase in alkaline phosphatase
    Increase of liver transaminases
    Increased defecation
    Influenza-like symptoms
    Irregular menstruation
    Lower respiratory tract infection
    Oily evacuation
    Oily spotting from the rectum
    Rectal bleeding
    Rectal pain/discomfort
    Soft or liquid stools
    Tooth disorder
    Upper respiratory tract infection
    Urinary tract infections


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2020

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Alli 60mg hard capsules. GlaxoSmithKline Consumer Healthcare. Revised November 2018.

    Summary of Product Characteristics: Beacita 120mg. Actavis. Revised October 2017.

    Summary of Product Characteristics: Orlos 60 mg hard capsules. Crescent Pharma Ltd. Revised February 2017.

    Summary of Product Characteristics: Xenical 120mg hard capsules. Cheplapharm Arzneimittel GmbH. Revised May 2017.

    MHRA Drug Safety Update March 2014
    Available at:
    Last accessed: 24 February 2020

    NICE Evidence Services Available at: Last accessed: 24 February 2020

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.