Prucalopride side effects: what 2,284 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,284 reports · 45% serious · 55 with death outcome · 79% female
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)
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.
Boxed warning
None in the current label
Causality screen of the 31 strongest signals
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.
- 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. 43 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 | 135 | 127.7 108.3–150.6ROR 135.6 · χ² 16,616 / p <1e-300 | 123.8 EB05 107.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=19 · 83% consumer | no trial data cached |
| Insurance issue | 105 | 65.3 54.1–78.8ROR 68.4 · χ² 6,540 / p <1e-300 | 64.1 EB05 54.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.4 · 74% consumer | no trial data cached |
| Impaired gastric emptying | 47 | 33.9 25.6–45.0ROR 34.6 · χ² 1,465 / p <1e-300 | 33.4 EB05 26.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 47.5 | no trial data cached |
| Product availability issue | 45 | 18.4 13.8–24.6ROR 18.8 · χ² 725 / p 7e-160 | 18.3 EB05 14.2 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 17.3 | no trial data cached |
| Vitamin d deficiency | 17 | 16.0 10.0–25.7ROR 16.1 · χ² 224 / p 5e-51 | 15.4 EB05 9.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.6 | no trial data cached |
| Product prescribing issue | 29 | 13.1 9.1–18.8ROR 13.2 · χ² 312 / p 5e-70 | 12.6 EB05 8.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Adrenal insufficiency | 16 | 12.3 7.5–20.0ROR 12.4 · χ² 154 / p 9e-36 | 11.1 EB05 6.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
| No adverse event | 175 | 9.1 7.9–10.4ROR 9.7 · χ² 1,256 / p 2e-275 | 8.9 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Flatulence (gas) | 49 | 7.9 6.0–10.5ROR 8.1 · χ² 291 / p 1e-65 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 71% consumer | no trial data cached |
| Drug effect less than expected | 12 | 7.8 4.4–13.7ROR 7.8 · χ² 65 / p 5e-16 | 6.3 EB05 3.8 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Product dispensing error | 17 | 7.2 4.5–11.5ROR 7.2 · χ² 84 / p 2e-20 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Abdominal distension (bloating) | 81 | 7.2 5.8–8.9ROR 7.4 · χ² 424 / p 1e-94 | 6.9 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Seasonal allergy | 10 | 6.5 3.5–12.1ROR 6.5 · χ² 41 / p 7e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Constipation | 138 | 5.9 5.0–6.9ROR 6.2 · χ² 556 / p 3e-123 | 5.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.6 | no trial data cached |
| Product use issue | 116 | 5.7 4.8–6.8ROR 5.9 · χ² 448 / p 1e-99 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 75% consumer | no trial data cached |
| Product prescribing error | 14 | 5.4 3.2–9.1ROR 5.5 · χ² 46 / p 5e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Intestinal obstruction | 22 | 5.4 3.6–8.2ROR 5.4 · χ² 74 / p 3e-18 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | no trial data cached |
| Therapeutic product effect decreased | 26 | 5.4 3.7–7.9ROR 5.4 · χ² 88 / p 3e-21 | 4.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 · ♀ 48% (drug 79%) · 77% consumer | no trial data cached |
| Migraine | 52 | 5.0 3.8–6.6ROR 5.1 · χ² 165 / p 6e-38 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Loss of personal independence in daily activities | 26 | 5.0 3.4–7.4ROR 5.1 · χ² 80 / p 2e-19 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Frequent bowel movements | 14 | 4.8 2.8–8.1ROR 4.8 · χ² 38 / p 3e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Limb injury | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 43 | 4.3 3.2–5.8ROR 4.4 · χ² 106 / p 3e-25 | 4.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Head injury | 14 | 4.1 2.4–6.9ROR 4.1 · χ² 29 / p 3e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Therapy interrupted | 30 | 4.0 2.8–5.7ROR 4.0 · χ² 64 / p 5e-16 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Nightmare | 15 | 4.0 2.4–6.6ROR 4.0 · χ² 30 / p 2e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Dyskinesia (involuntary movements) | 17 | 3.8 2.4–6.2ROR 3.9 · χ² 33 / p 4e-9 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Illness | 40 | 3.7 2.7–5.0ROR 3.7 · χ² 75 / p 3e-18 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 70% consumer | no trial data cached |
| Inappropriate schedule of product administration | 60 | 3.1 2.4–4.0ROR 3.2 · χ² 85 / p 2e-20 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Wrong technique in product usage process | 61 | 2.8 2.2–3.5ROR 2.8 · χ² 68 / p 9e-17 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 70% consumer | no trial data cached |
| Surgery | 17 | 2.7 1.7–4.3ROR 2.7 · χ² 16 / p 2e-5 | 2.6 EB05 1.7 · IC025 +0.5 | Reporting / coding artifact | serious PRR 3.2 | 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 |
|---|---|---|---|---|---|---|
| No adverse event | 175 | 9.1 7.9–10.4ROR 9.7 · χ² 1,256 / p 2e-275 | 8.9 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Constipation | 138 | 5.9 5.0–6.9ROR 6.2 · χ² 556 / p 3e-123 | 5.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.6 | no trial data cached |
| Inability to afford medication | 135 | 127.7 108.3–150.6ROR 135.6 · χ² 16,616 / p <1e-300 | 123.8 EB05 107.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=19 · 83% consumer | no trial data cached |
| Product use issue | 116 | 5.7 4.8–6.8ROR 5.9 · χ² 448 / p 1e-99 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 75% consumer | no trial data cached |
| Insurance issue | 105 | 65.3 54.1–78.8ROR 68.4 · χ² 6,540 / p <1e-300 | 64.1 EB05 54.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.4 · 74% consumer | no trial data cached |
| Abdominal distension (bloating) | 81 | 7.2 5.8–8.9ROR 7.4 · χ² 424 / p 1e-94 | 6.9 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Wrong technique in product usage process | 61 | 2.8 2.2–3.5ROR 2.8 · χ² 68 / p 9e-17 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 70% consumer | no trial data cached |
| Inappropriate schedule of product administration | 60 | 3.1 2.4–4.0ROR 3.2 · χ² 85 / p 2e-20 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Migraine | 52 | 5.0 3.8–6.6ROR 5.1 · χ² 165 / p 6e-38 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Flatulence (gas) | 49 | 7.9 6.0–10.5ROR 8.1 · χ² 291 / p 1e-65 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 71% consumer | no trial data cached |
| Impaired gastric emptying | 47 | 33.9 25.6–45.0ROR 34.6 · χ² 1,465 / p <1e-300 | 33.4 EB05 26.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 47.5 | no trial data cached |
| Product availability issue | 45 | 18.4 13.8–24.6ROR 18.8 · χ² 725 / p 7e-160 | 18.3 EB05 14.2 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 17.3 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 43 | 4.3 3.2–5.8ROR 4.4 · χ² 106 / p 3e-25 | 4.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Illness | 40 | 3.7 2.7–5.0ROR 3.7 · χ² 75 / p 3e-18 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 70% consumer | no trial data cached |
| Therapy interrupted | 30 | 4.0 2.8–5.7ROR 4.0 · χ² 64 / p 5e-16 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | 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=135, PRR 127.7
- Insurance issue — n=105, PRR 65.3
- Impaired gastric emptying — n=47, PRR 33.9
- Loss of personal independence in daily activities — n=26, PRR 5.0
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 constipation, inability to afford medication, insurance issue, abdominal distension, migraine, flatulence. 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, fieldpatient.drug.openfda.generic_name.exact, 74 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.