Prucalopride Succinate side effects: what 339 FDA adverse event reports show

Prucalopride Succinate · 25 reaction terms · 285 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

339 reports · 96% serious · 24 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablets are serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. (1)

FDA label, Indications and Usage

What it is

Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT4) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide butanedioate.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 18 strongest signals

Labeled adverse reaction 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 15

What the badges mean

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.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 7 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Intervertebral disc degeneration	15	99.8 60.9–163.8ROR 104.4 · χ² 1,369 / p 6e-300	88.8 EB05 57.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 68.6	no trial data cached
Vasculitis	15	79.7 48.6–130.7ROR 83.3 · χ² 1,087 / p 1e-238	72.5 EB05 46.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 51.4	no trial data cached
Wrist fracture	15	77.5 47.2–127.1ROR 81.0 · χ² 1,056 / p 5e-232	70.7 EB05 45.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 54.6	no trial data cached
Blood pressure systolic increased	22	69.5 46.4–104.2ROR 74.3 · χ² 1,418 / p <1e-300	65.7 EB05 45.7 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 45.5	no trial data cached
Feeling jittery	15	48.6 29.6–79.8ROR 50.8 · χ² 653 / p 3e-144	45.9 EB05 29.6 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Rotator cuff syndrome	10	48.0 26.1–88.4ROR 49.4 · χ² 414 / p 2e-92	44.2 EB05 25.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 33.5	no trial data cached
Joint range of motion decreased	10	46.3 25.1–85.3ROR 47.7 · χ² 399 / p 4e-89	42.8 EB05 24.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 35.4	no trial data cached
Rib fracture	15	45.2 27.6–74.2ROR 47.3 · χ² 605 / p 5e-134	42.9 EB05 27.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 29.6	no trial data cached
Sciatica	10	39.0 21.2–71.9ROR 40.2 · χ² 333 / p 9e-75	36.5 EB05 21.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 31.5	no trial data cached
Muscle tightness	10	38.3 20.8–70.5ROR 39.4 · χ² 327 / p 3e-73	35.8 EB05 20.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 44.3	no trial data cached
Unresponsive to stimuli	15	36.1 22.0–59.2ROR 37.7 · χ² 478 / p 4e-106	34.6 EB05 22.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.1	no trial data cached
Wound	16	35.6 22.1–57.5ROR 37.3 · χ² 505 / p 5e-112	34.3 EB05 22.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 25.5	no trial data cached
Anger	15	27.3 16.7–44.8ROR 28.5 · χ² 355 / p 2e-79	26.5 EB05 17.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 27.0	no trial data cached
Crying	16	27.1 16.8–43.8ROR 28.4 · χ² 378 / p 2e-84	26.4 EB05 17.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.8	no trial data cached
Intentional dose omission	11	24.9 13.9–44.5ROR 25.7 · χ² 229 / p 5e-52	23.8 EB05 13.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 30.7	no trial data cached
Mental disorder	16	22.7 14.1–36.6ROR 23.8 · χ² 311 / p 6e-70	22.1 EB05 14.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.6	no trial data cached
Hypoacusis	15	21.6 13.2–35.4ROR 22.6 · χ² 275 / p 5e-62	21.0 EB05 13.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.5	no trial data cached
Suicide attempt	15	15.3 9.3–25.0ROR 15.9 · χ² 187 / p 9e-43	14.4 EB05 8.6 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.2	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Blood pressure systolic increased	22	69.5 46.4–104.2ROR 74.3 · χ² 1,418 / p <1e-300	65.7 EB05 45.7 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 45.5	no trial data cached
Mental disorder	16	22.7 14.1–36.6ROR 23.8 · χ² 311 / p 6e-70	22.1 EB05 14.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.6	no trial data cached
Crying	16	27.1 16.8–43.8ROR 28.4 · χ² 378 / p 2e-84	26.4 EB05 17.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.8	no trial data cached
Wound	16	35.6 22.1–57.5ROR 37.3 · χ² 505 / p 5e-112	34.3 EB05 22.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 25.5	no trial data cached
Suicide attempt	15	15.3 9.3–25.0ROR 15.9 · χ² 187 / p 9e-43	14.4 EB05 8.6 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.2	no trial data cached
Hypoacusis	15	21.6 13.2–35.4ROR 22.6 · χ² 275 / p 5e-62	21.0 EB05 13.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.5	no trial data cached
Anger	15	27.3 16.7–44.8ROR 28.5 · χ² 355 / p 2e-79	26.5 EB05 17.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 27.0	no trial data cached
Unresponsive to stimuli	15	36.1 22.0–59.2ROR 37.7 · χ² 478 / p 4e-106	34.6 EB05 22.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.1	no trial data cached
Rib fracture	15	45.2 27.6–74.2ROR 47.3 · χ² 605 / p 5e-134	42.9 EB05 27.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 29.6	no trial data cached
Feeling jittery	15	48.6 29.6–79.8ROR 50.8 · χ² 653 / p 3e-144	45.9 EB05 29.6 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=15	no trial data cached
Wrist fracture	15	77.5 47.2–127.1ROR 81.0 · χ² 1,056 / p 5e-232	70.7 EB05 45.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 54.6	no trial data cached
Vasculitis	15	79.7 48.6–130.7ROR 83.3 · χ² 1,087 / p 1e-238	72.5 EB05 46.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 51.4	no trial data cached
Intervertebral disc degeneration	15	99.8 60.9–163.8ROR 104.4 · χ² 1,369 / p 6e-300	88.8 EB05 57.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 68.6	no trial data cached
Intentional dose omission	11	24.9 13.9–44.5ROR 25.7 · χ² 229 / p 5e-52	23.8 EB05 13.9 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 30.7	no trial data cached
Muscle tightness	10	38.3 20.8–70.5ROR 39.4 · χ² 327 / p 3e-73	35.8 EB05 20.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 44.3	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Prucalopride?

In FDA FAERS, the most frequently co-reported reaction terms for Prucalopride are blood pressure systolic increased, mental disorder, crying, wound, suicide attempt, hypoacusis. 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 Prucalopride have an FDA boxed warning?

No. The FDA label retrieved for Prucalopride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Prucalopride 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 6325308c-4b0f-4926-bb85-b63db614533d, effective 20250902; matched on openfda.generic_name.exact:"PRUCALOPRIDE")
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, field patient.drug.openfda.generic_name.exact, 25 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.