linaclotide
Constella · ATC code A06AX04
Also known as: Linaclotid
- Key facts
- Active substance
- linaclotide
- ATC code
- A06AX04
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Constella 290 micrograms hard capsules
- Marketing authorisation holder
- AbbVie Deutschland GmbH & Co. KG
- Information as of
- 2026-10-27
Key facts
Linaclotide is a guanylate cyclase-C agonist that acts locally in the gut. It is used for the symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults.
What it is used for
- Symptomatic treatment of moderate to severe irritable bowel syndrome with constipation (IBS-C) in adults
Dosing
- One capsule (290 micrograms) once daily, at least 30 minutes before a meal
- If no improvement after 4 weeks, re-examine and reconsider continuing; periodically assess the need for treatment
- No dose adjustment in renal or hepatic impairment
- Elderly: no dose adjustment, but careful monitoring
- Not to be used in children and adolescents
Contraindications
- Hypersensitivity to the active substance or any excipient
- Known or suspected mechanical gastrointestinal obstruction
Important warnings
- Use only after organic disease is ruled out and the diagnosis is established
- Diarrhoea and lower gastrointestinal bleeding may occur; seek advice for severe or prolonged diarrhoea
- Extra caution in patients prone to water or electrolyte disturbances (e.g. elderly, cardiovascular disease, diabetes, hypertension)
- Cases of intestinal perforation; discontinue with severe, persistent or worsening abdominal pain
- Not recommended in chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
Side effects
- Most frequent: diarrhoea, mainly mild to moderate
- Common: abdominal pain, abdominal distension, flatulence, viral gastroenteritis
- Rarely with severe diarrhoea: dehydration, hypokalaemia, dizziness, orthostatic hypotension; anaphylactic reaction possible
Interactions
- Taking it with food produces more frequent and looser stools
- Proton pump inhibitors, laxatives or NSAIDs may increase the risk of diarrhoea
Pregnancy and breastfeeding
- As a precaution, avoid use during pregnancy
- Can be used during breast-feeding; linaclotide was not detected in breast milk
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- ConstellaAbbVie Deutschland GmbH & Co. KG · EMEA/H/C/002490
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Constella
- Liechtenstein
- Constella
- Norway
- Constella
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Constella – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/constella-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.