General Information
Manufacturer: AbbVie and Ironwood Pharmaceuticals
Medical Name: Linaclotide
Purpose: Linzess is s a prescription medication for treating:
- Irritable bowel syndrome with constipation (IBS-C) and
- Chronic idiopathic constipation (CIC) in adults and
- Functional constipation (FC) in children aged 6 to 17
Possible Side Effects
| Side Effect | Incidence with Linzess | Incidence with Placebo |
|---|---|---|
| Diarrhea | 16-22% | 3-7% |
| Abdominal pain | 7% | 5-6% |
| Flatulence (gas) | 4-6% | 2-5% |
| Abdominal distension (bloating) | 2-3% | 1-2% |
| Headache | 4% | 3% |
| Viral gastroenteritis | 3% | 1% |
| Upper respiratory tract infection | 5% (CIC patients only) | 4% (CIC patients only) |
| Sinusitis | 3% (CIC patients only) | 2% (CIC patients only) |
Serious but Less Common Side Effects
| Severe Diarrhea | This occurred in about 2% of patients taking 145 mcg or 290 mcg doses of Linzess, and in less than 1% of patients taking the 72 mcg dose. Severe diarrhea can lead to dehydration and electrolyte imbalances, in rare cases requiring hospitalization. |
| Defecation Urgency and Fecal Incontinence | These were reported in less than 2% of patients in clinical trials. |
| Hypersensitivity Reactions | Rare cases of serious allergic reactions (anaphylaxis, hives, rash, swelling of the face, tongue, or throat) have been reported in post-marketing experience. |
| Rectal Bleeding/Bloody Stools | This has been reported in post-marketing experience. |
Preconditions
- Known or suspected mechanical gastrointestinal (GI) obstruction (bowel blockage).
- Age less than 2 years old, due to the risk of serious dehydration. Linzess carries a boxed warning from the FDA for this risk.
- Use in pediatric patients 6 through 17 years of age with irritable bowel syndrome with constipation (IBS-C) is not established and should be avoided.
- Linzess should be used with caution in patients with a history of severe diarrhea, as this is the most common side effect and can lead to dehydration and electrolyte abnormalities.
Warnings
- Diarrhea usually starts within the first two weeks of treatment.
- Higher doses are associated with a higher incidence of diarrhea.
- Linzess should not be used in children under 2 years of age due to the risk of severe dehydration.
- If you experience severe or unusual abdominal pain, bloody/black stools, dizziness, or signs of dehydration (excessive thirst, dry mouth, fast heartbeat), stop taking Linzess and contact your doctor immediately or seek emergency medical attention.