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Linaclotide oral

Updated 2 Feb 2023 | Other laxatives


Oral formulation of linaclotide.

Drugs List

  • CONSTELLA 290microgram capsules
  • linaclotide 290microgram capsules
  • Therapeutic Indications


    Moderate to severe Irritable Bowel Syndrome with constipation: treatment


    Efficacy of linaclotide has been established for up to 6 months.

    If patients have not experienced improvement in their symptoms after 4 weeks of treatment, the patient should be re-examined and the benefit and risks of continuing treatment reconsidered.


    290 micrograms once daily, taken at least 30 minutes before a meal.


    Children under 18 years
    Inflammatory bowel disease
    Mechanical gastrointestinal obstruction

    Precautions and Warnings

    Predisposition towards electrolyte imbalance

    Contains propylene glycol
    Advise patient to take at least 30 minutes before a meal
    Advise patient to stop and contact Dr if severe/persistent abdominal pain
    Advise patient to inform physician if severe diarrhoea occurs
    Advise patients to report lower gastrointestinal bleeding
    Discontinue if severe and persistent abdominal pain occurs
    Discontinue if severe and persistent diarrhoea develops
    Female:Additional contraception method advised in cases of severe diarrhoea
    Advise patient to consult doctor if no improvement after 4 weeks

    The treatment should be carefully monitored and periodically re-assessed in the elderly.

    Intestinal perforation has been reported after use of linaclotide in patients with conditions that may be associated with localised or diffuse weakness of the intestinal wall.

    Pregnancy and Lactation


    Linaclotide is contraindicated during pregnancy.

    The manufacturer notes that as a precautionary measure, it is preferable to avoid the use of linaclotide during pregnancy due to the limited amount of data available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.


    Linaclotide is considered safe for use during breastfeeding.

    The manufacturer states that linaclotide may be used during breastfeeding. Linaclotide absorption is considered minimal following oral administration. Neither linaclotide or its metabolite were detected in a study conducted on 7 breastfeeding women taking linaclotide, hence exposure to infants is not expected.

    Side Effects

    Abdominal distension
    Abdominal pain
    Decrease in blood bicarbonate
    Decreased appetite
    Faecal incontinence
    Faecal urgency
    Gastro-intestinal perforation
    Gastrointestinal bleeding
    Haemorrhoidal bleeding
    Orthostatic hypotension
    Rectal bleeding


    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: June 2021

    Reference Sources

    Summary of Product Characteristics: Constella 290 micrograms hard capsules. Allergan Pharmaceuticals International Ltd. Revised December 2021.

    NICE Evidence Services Available at: Last accessed: 18 June 2021

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

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