What the label lists and what reports show
Plecanatide side effects
Plecanatide's FDA label: “Most common adverse reaction (≥2%) is diarrhea.” FAERS holds 1,995 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (393 reports).
- No generic listed
- Boxed warning
Check it at the source: the plecanatide FDA label on DailyMed (effective April 4, 2024, Salix Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TRULANCE?TRULANCE can cause serious side effects, including: See “What is the most important information I should know about TRULANCE?” Diarrhea is the most common side effect of TRULANCE, and it can sometimes be severe. Diarrhea often begins within the first 4 weeks of TRULANCE treatment. Stop taking TRULANCE and call your doctor if you develop severe diarrhea. These are not all the possible side effects of TRULANCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Salix Pharmaceuticals Inc., effective April 4, 2024 (SPL set fe2895bf-71a6-493a-b0ca-e06b2dfefc82), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction (≥2%) is diarrhea.
From the label: adverse reactions, continuedMost common adverse reaction (≥2%) is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Demographic characteristics were comparable between the TRULANCE and placebo groups in all studies [see Clinical Studies (14) ]. Chronic Idiopathic Constipation (CIC) The safety data described below reflect data from 1,733 adult patients with CIC randomized in two double-blind, placebo-controlled clinical trials (Study 1 and Study 2) to receive placebo or 3 mg of TRULANCE once daily for 12 weeks. Most Common Adverse Reactions Table 1 provides the incidence of adverse reactions reported in at least 2% of CIC patients in the TRULANCE-treated group and at an incidence that was greater than in the placebo group.
Source: FDA drug label, Salix Pharmaceuticals Inc., effective April 4, 2024 (SPL set fe2895bf-71a6-493a-b0ca-e06b2dfefc82), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,995 reports list plecanatide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 76 are coded as a death and 281 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Plecanatide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions