Plecanatide Side Effects: Safety Signals and Warnings
Plecanatide safety concerns are compound-specific. The main listed side effects are Diarrhea (most common, 2-5%), Abdominal distension, and Flatulence. The main warning signals are Contraindicated in patients under 6 years of age (risk of serious dehydration), Avoid use in patients 6 to less than 18 years of age, and Discontinue if severe diarrhea occurs.
Direct Answer
Plecanatide (Trulance) is FDA-approved for chronic idiopathic constipation and IBS with constipation, with Phase 3 RCTs demonstrating consistent efficacy on validated endpoints. As a uroguanylin analog that works locally in the GI tract with minimal systemic absorption, it has an excellent safety profile. For guanylate cyclase-C agonist research and IBS-C/CIC treatment, it is a validated option alongside linaclotide.
- Evidence grade
- Level A
- Research status
- FDA Approved
- Category
- Healing & Recovery
- Best for
- IBS-C, chronic idiopathic constipation, guanylate cyclase-C agonism research
Reported Side Effects
- Diarrhea (most common, 2-5%)
- Abdominal distension
- Flatulence
- Abdominal tenderness
- Sinusitis
- Upper respiratory tract infection
Warnings
- Contraindicated in patients under 6 years of age (risk of serious dehydration)
- Avoid use in patients 6 to less than 18 years of age
- Discontinue if severe diarrhea occurs
- Minimal systemic absorption limits drug interactions but does not eliminate them
- Monitor for dehydration in elderly patients
Known or Plausible Interactions
- Minimal drug interactions due to local GI action and negligible systemic absorption
- PDE5 inhibitors (theoretical additive cGMP elevation)
- Other GC-C agonists (avoid concurrent use with linaclotide)
Regulatory Context
FDA-approved (Trulance) since January 2017 for CIC, and March 2018 for IBS-C. Prescription required. Available in the United States. Patent-protected.
Evidence Snapshot
| Evidence grade | Level A |
|---|---|
| Research status | FDA Approved |
| Best supported outcomes | Chronic Idiopathic Constipation Relief (Level A), IBS-C Symptom Improvement (Level A), and Diarrhea (Adverse) (Level A) |
| Primary citation count | 3 |
| Last reviewed | 2026-04-04 |
Related Guides
How to Cite This Page
ExaminePeptides. "Plecanatide Side Effects: Safety Signals and Warnings." Last reviewed 2026-04-04. https://examinepeptides.com/answers/plecanatide-side-effects-safety/
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