Drug · FAERS side-effect profile with label screen

Picosulfate and Oxide and Citric Acid side effects: what 722 FDA adverse event reports show

Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid · 10 reaction terms · 170 drug–reaction co-reports · data 2026-09-14

Drug class

Calculi Dissolution Agent, Anti-coagulant

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid (Clenpiq)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

722 reports · 21% serious · 2 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

CLENPIQ is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. CLENPIQ ® is a combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric.

FDA label, Indications and Usage

What it is

CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton.

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 9 strongest signals

Reporting / coding artifact 5Not in label — unassessed 4

What the badges mean

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. 1 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
Product taste abnormal	34	73.6 53.0–102.2ROR 77.2 · χ² 2,358 / p <1e-300	70.6 EB05 52.9 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=4 · 97% consumer	no trial data cached
Product use complaint	16	30.0 18.5–48.7ROR 30.7 · χ² 420 / p 1e-93	29.0 EB05 18.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Electrolyte imbalance	9	22.7 11.9–43.5ROR 23.0 · χ² 166 / p 3e-38	21.3 EB05 11.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 56.6	no trial data cached
Retching	16	21.9 13.5–35.5ROR 22.3 · χ² 298 / p 4e-67	21.3 EB05 13.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 21.8	no trial data cached
Oral discomfort	8	16.7 8.4–33.3ROR 16.9 · χ² 103 / p 2e-24	14.5 EB05 6.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Product prescribing error	9	11.0 5.8–21.1ROR 11.2 · χ² 73 / p 8e-18	8.7 EB05 4.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Sleep disorder due to a general medical condition	6	10.8 4.9–23.9ROR 10.9 · χ² 44 / p 2e-11	7.4 EB05 3.2 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Incorrect dose administered	56	7.2 5.6–9.3ROR 7.8 · χ² 298 / p 5e-67	6.9 EB05 5.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.5 · 100% consumer	no trial data cached
Product storage error	12	4.0 2.3–7.1ROR 4.1 · χ² 24 / p 4e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	–	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
Incorrect dose administered	56	7.2 5.6–9.3ROR 7.8 · χ² 298 / p 5e-67	6.9 EB05 5.5 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 10.5 · 100% consumer	no trial data cached
Product taste abnormal	34	73.6 53.0–102.2ROR 77.2 · χ² 2,358 / p <1e-300	70.6 EB05 52.9 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=4 · 97% consumer	no trial data cached
Retching	16	21.9 13.5–35.5ROR 22.3 · χ² 298 / p 4e-67	21.3 EB05 13.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 21.8	no trial data cached
Product use complaint	16	30.0 18.5–48.7ROR 30.7 · χ² 420 / p 1e-93	29.0 EB05 18.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Product storage error	12	4.0 2.3–7.1ROR 4.1 · χ² 24 / p 4e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product prescribing error	9	11.0 5.8–21.1ROR 11.2 · χ² 73 / p 8e-18	8.7 EB05 4.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Electrolyte imbalance	9	22.7 11.9–43.5ROR 23.0 · χ² 166 / p 3e-38	21.3 EB05 11.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 56.6	no trial data cached
Oral discomfort	8	16.7 8.4–33.3ROR 16.9 · χ² 103 / p 2e-24	14.5 EB05 6.4 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Sleep disorder due to a general medical condition	6	10.8 4.9–23.9ROR 10.9 · χ² 44 / p 2e-11	7.4 EB05 3.2 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product complaint	4	4.7 1.8–12.4ROR 4.7 · χ² 8 / p 0.002	3.3 EB05 1.5 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	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.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.

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 Picosulfate and Oxide and Citric Acid?

In FDA FAERS, the most frequently co-reported reaction terms for Picosulfate and Oxide and Citric Acid are retching, electrolyte imbalance, oral discomfort, sleep disorder due to a general medical condition. 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 Picosulfate and Oxide and Citric Acid have an FDA boxed warning?

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

Do FAERS signals prove that Picosulfate and Oxide and Citric Acid 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 e95fff66-4ec0-4001-a727-33e66a5ec7d5, effective 20260415; matched on openfda.generic_name.exact:"SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID")
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, 10 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.