July 31, 2016
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(linaclotide) Capsules



LINZESS is contraindicated in pediatric patients up to 6 years of age; in nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. Avoid use of LINZESS in pediatric patients 6 through 17 years of age. The safety and efficacy of LINZESS has not been established in pediatric patients under 18 years of age [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, Use in Specific Populations and Nonclinical Toxicology].


LINZESS (linaclotide) is a guanylate cyclase-C agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide).

The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below:

LINZESS (linaclotide) Structural Formula Illustration

Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 145 mcg and 290 mcg capsules for oral administration.

The inactive ingredients of LINZESS capsules include: calcium chloride dihydrate, L-leucine, hypromellose, microcrystalline cellulose, gelatin, and titanium dioxide. Page 9 of 20

What are the possible side effects of linaclotide (Linzess)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using linaclotide and call your doctor at once if you have a serious side effect such as:

  • severe or ongoing diarrhea;
  • severe stomach pain; or
  • black, bloody, or tarry stools.

Other common side effects may include:

  • mild diarrhea;
  • mild stomach discomfort;
  • heartburn, vomiting, gas, bloating;
  • headache; or
  • cold symptoms such as stuffy nose,...

Read All Potential Side Effects and See Pictures of Linzess »

Last reviewed on RxList: 6/1/2016
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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