Plecanatide side effects: what 1,994 FDA adverse event reports show
Drug class
Guanylate Cyclase-C Agonist
Brand names
Trulance Immediate Release
Who reports
1,994 reports · 36% serious · 76 with death outcome · 79% female
Used for
TRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C). TRULANCE is a guanylate cyclase-C agonist indicated in adults for treatment of: chronic idiopathic constipation (CIC). ( 1 ) irritable bowel syndrome with constipation (IBS-C). ( 1 )
What it is
TRULANCE (plecanatide) is a guanylate cyclase-C (GC-C) agonist. Plecanatide is a 16 amino acid peptide with the following chemical name: L-Leucine, L-asparaginyl-L-α-aspartyl-L-α-glutamyl-L-cy.
Boxed warning
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS TRULANCE is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice, administration of a single oral dose of plecanatide caused deaths due to dehydration [see Contraindications (4) , Use in Specific Populations (8.4) ] .
Causality screen of the 28 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 28 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Inability to afford medication | 25 | 26.8 18.1–39.6ROR 27.1 · χ² 594 / p 2e-131 | 26.3 EB05 18.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 · 84% consumer | no trial data cached |
| Insurance issue | 32 | 22.7 16.1–32.0ROR 23.0 · χ² 641 / p 1e-141 | 22.4 EB05 16.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 43.9 · 75% consumer | no trial data cached |
| Impaired gastric emptying | 27 | 22.3 15.3–32.4ROR 22.6 · χ² 527 / p 5e-117 | 21.9 EB05 15.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 39.6 · 75% consumer | no trial data cached |
| Gastrointestinal pain | 14 | 13.4 8.0–22.7ROR 13.5 · χ² 149 / p 1e-34 | 12.3 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Flatulence (gas) | 69 | 12.8 10.2–16.2ROR 13.3 · χ² 742 / p 1e-163 | 12.7 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Abdominal distension (bloating) | 117 | 11.8 9.9–14.1ROR 12.5 · χ² 1,155 / p 2e-253 | 11.7 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Therapeutic product effect decreased | 37 | 8.8 6.4–12.1ROR 8.9 · χ² 247 / p 5e-56 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 89% consumer | no trial data cached |
| Therapy interrupted | 55 | 8.4 6.5–10.9ROR 8.6 · χ² 351 / p 1e-78 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 14.3 · 78% consumer | no trial data cached |
| Thirst | 14 | 8.3 4.9–13.9ROR 8.3 · χ² 82 / p 6e-20 | 6.9 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Faeces discoloured | 17 | 8.2 5.1–13.2ROR 8.3 · χ² 101 / p 4e-24 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Constipation | 168 | 8.2 7.1–9.4ROR 8.8 · χ² 1,059 / p 1e-232 | 8.0 EB05 7.1 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.2 · 72% consumer | no trial data cached |
| Frequent bowel movements | 19 | 7.4 4.7–11.6ROR 7.5 · χ² 99 / p 1e-23 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Product prescribing error | 15 | 6.7 4.0–11.0ROR 6.7 · χ² 67 / p 2e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Diarrhoea (diarrhea) | 393 | 6.4 5.9–7.0ROR 7.8 · χ² 1,851 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.7 | no trial data cached |
| Sinus disorder | 12 | 6.4 3.6–11.2ROR 6.4 · χ² 49 / p 1e-12 | 5.2 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 | no trial data cached |
| Therapeutic product effect incomplete | 40 | 5.9 4.4–8.1ROR 6.0 · χ² 160 / p 5e-37 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 80% consumer | no trial data cached |
| Product physical issue | 11 | 5.8 3.2–10.5ROR 5.8 · χ² 39 / p 2e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Abdominal pain upper | 107 | 5.5 4.6–6.6ROR 5.7 · χ² 391 / p 3e-87 | 5.4 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 74% consumer | no trial data cached |
| Irritable bowel syndrome | 11 | 5.4 3.0–9.8ROR 5.4 · χ² 35 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.9 | no trial data cached |
| Intentional dose omission | 13 | 5.0 2.9–8.6ROR 5.0 · χ² 38 / p 4e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 | no trial data cached |
| Surgery | 27 | 4.9 3.4–7.1ROR 5.0 · χ² 80 / p 2e-19 | 4.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 | no trial data cached |
| Illness | 38 | 4.0 2.9–5.4ROR 4.0 · χ² 82 / p 7e-20 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 79% consumer | no trial data cached |
| Therapy cessation | 18 | 3.7 2.3–5.9ROR 3.7 · χ² 33 / p 5e-9 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Product quality issue | 40 | 3.1 2.3–4.2ROR 3.2 · χ² 56 / p 4e-14 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 90% consumer | no trial data cached |
| Drug effect decreased | 14 | 2.7 1.6–4.5ROR 2.7 · χ² 13 / p 1e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Extra dose administered | 10 | 2.6 1.4–4.9ROR 2.6 · χ² 9 / p 0.002 | 2.4 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious n=2 | no trial data cached |
| Multiple sclerosis | 10 | 2.2 1.2–4.1ROR 2.2 · χ² 5 / p 0.011 | 2.1 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Wrong technique in product usage process | 39 | 2.0 1.5–2.8ROR 2.1 · χ² 20 / p 5e-6 | 2.0 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 4.5 · 71% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 393 | 6.4 5.9–7.0ROR 7.8 · χ² 1,851 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.7 | no trial data cached |
| Constipation | 168 | 8.2 7.1–9.4ROR 8.8 · χ² 1,059 / p 1e-232 | 8.0 EB05 7.1 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.2 · 72% consumer | no trial data cached |
| Abdominal distension (bloating) | 117 | 11.8 9.9–14.1ROR 12.5 · χ² 1,155 / p 2e-253 | 11.7 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Abdominal pain upper | 107 | 5.5 4.6–6.6ROR 5.7 · χ² 391 / p 3e-87 | 5.4 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 74% consumer | no trial data cached |
| Flatulence (gas) | 69 | 12.8 10.2–16.2ROR 13.3 · χ² 742 / p 1e-163 | 12.7 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Therapy interrupted | 55 | 8.4 6.5–10.9ROR 8.6 · χ² 351 / p 1e-78 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 14.3 · 78% consumer | no trial data cached |
| Product quality issue | 40 | 3.1 2.3–4.2ROR 3.2 · χ² 56 / p 4e-14 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 90% consumer | no trial data cached |
| Therapeutic product effect incomplete | 40 | 5.9 4.4–8.1ROR 6.0 · χ² 160 / p 5e-37 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 80% consumer | no trial data cached |
| Wrong technique in product usage process | 39 | 2.0 1.5–2.8ROR 2.1 · χ² 20 / p 5e-6 | 2.0 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 4.5 · 71% consumer | no trial data cached |
| Illness | 38 | 4.0 2.9–5.4ROR 4.0 · χ² 82 / p 7e-20 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 79% consumer | no trial data cached |
| Therapeutic product effect decreased | 37 | 8.8 6.4–12.1ROR 8.9 · χ² 247 / p 5e-56 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 89% consumer | no trial data cached |
| Insurance issue | 32 | 22.7 16.1–32.0ROR 23.0 · χ² 641 / p 1e-141 | 22.4 EB05 16.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 43.9 · 75% consumer | no trial data cached |
| Surgery | 27 | 4.9 3.4–7.1ROR 5.0 · χ² 80 / p 2e-19 | 4.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 | no trial data cached |
| Impaired gastric emptying | 27 | 22.3 15.3–32.4ROR 22.6 · χ² 527 / p 5e-117 | 21.9 EB05 15.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 39.6 · 75% consumer | no trial data cached |
| Inability to afford medication | 25 | 26.8 18.1–39.6ROR 27.1 · χ² 594 / p 2e-131 | 26.3 EB05 18.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 · 84% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Inability to afford medication — n=25, PRR 26.8
- Insurance issue — n=32, PRR 22.7
- Impaired gastric emptying — n=27, PRR 22.3
- Abdominal pain upper — n=107, PRR 5.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Plecanatide?
In FDA FAERS, the most frequently co-reported reaction terms for Plecanatide are diarrhoea, constipation, abdominal distension, abdominal pain upper, flatulence, insurance issue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Plecanatide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS TRULANCE is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice, administration of a single oral dose of plecanatide caused deaths due to dehydration [see Contraindications (4) , Use in Specific Populations (8.4) ] .
Do FAERS signals prove that Plecanatide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID fe2895bf-71a6-493a-b0ca-e06b2dfefc82, effective 20240404; matched on
openfda.generic_name.exact:"PLECANATIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 56 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.