Polidocanol side effects: what 1,382 FDA adverse event reports show

Polidocanol · Asclera · 29 reaction terms · 964 drug–reaction co-reports · data 2026-09-14

Drug class

Sclerosing Agent

FDA label (Established Pharmacologic Class)

Brand names

Asclera

openFDA label

Who reports

1,382 reports · 34% serious · 15 with death outcome · 77% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Asclera ® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. Asclera has not been studied in varicose veins more than 3 mm in diameter.

FDA label, Indications and Usage

What it is

Asclera is a sterile, nonpyrogenic, and colorless to faintly greenish-yellow solution of polidocanol for intravenous use as a sclerosing agent. The active ingredient, polidocanol is a non-ioni.

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 19 strongest signals

Labeled adverse reaction 2Labeled (related wording) 5Reporting / coding artifact 7Not in label — unassessed 5

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.
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. 10 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
Deep vein thrombosis (leg blood clot)	340	79.4 72.4–87.1ROR 105.0 · χ² 26,183 / p <1e-300	78.6 EB05 71.9 · IC025 +6.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 52.8	no trial data cached
Therapy change	23	36.3 24.2–54.4ROR 36.9 · χ² 753 / p 5e-166	35.2 EB05 24.7 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	78% consumer	no trial data cached
Poor quality product administered	23	34.2 22.8–51.3ROR 34.8 · χ² 707 / p 4e-156	33.3 EB05 23.4 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Tenderness	16	23.3 14.3–37.9ROR 23.5 · χ² 319 / p 1e-71	22.6 EB05 14.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Skin discolouration	51	16.9 12.9–22.1ROR 17.5 · χ² 746 / p 2e-164	16.7 EB05 13.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Injection site extravasation	12	14.6 8.3–25.7ROR 14.7 · χ² 139 / p 3e-32	13.3 EB05 7.2 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Expired product administered	30	13.7 9.6–19.6ROR 14.0 · χ² 342 / p 1e-76	13.3 EB05 9.5 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=2 · 90% clinician	no trial data cached
Injection site discolouration	10	12.2 6.6–22.7ROR 12.3 · χ² 92 / p 4e-22	10.2 EB05 5.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Treatment noncompliance	31	8.7 6.1–12.3ROR 8.8 · χ² 203 / p 2e-46	8.0 EB05 5.8 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial data cached
Blister	31	8.4 5.9–11.9ROR 8.6 · χ² 195 / p 1e-44	7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
No adverse event	93	8.0 6.5–9.7ROR 8.5 · χ² 563 / p 7e-125	7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product availability issue	11	7.4 4.1–13.4ROR 7.5 · χ² 55 / p 6e-14	5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product quality issue	65	7.3 5.8–9.3ROR 7.6 · χ² 350 / p 2e-78	7.0 EB05 5.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	74% consumer	no trial data cached
Thrombosis	37	7.0 5.1–9.6ROR 7.1 · χ² 184 / p 4e-42	6.5 EB05 4.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial data cached
Burning sensation	32	6.9 4.9–9.8ROR 7.1 · χ² 157 / p 3e-36	6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Limb discomfort	13	6.4 3.7–11.0ROR 6.4 · χ² 54 / p 1e-13	5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Injection site urticaria	10	6.3 3.4–11.6ROR 6.3 · χ² 39 / p 2e-10	5.0 EB05 2.9 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Wrong technique in product usage process	65	4.9 3.9–6.2ROR 5.1 · χ² 199 / p 2e-45	4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 6.8	no trial data cached
Injection site swelling	11	2.2 1.2–4.0ROR 2.2 · χ² 6 / p 0.007	2.1 EB05 1.3 · IC025 +0.0	Labeled (related wording) related wording	serious PRR 6.5	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
Deep vein thrombosis (leg blood clot)	340	79.4 72.4–87.1ROR 105.0 · χ² 26,183 / p <1e-300	78.6 EB05 71.9 · IC025 +6.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 52.8	no trial data cached
No adverse event	93	8.0 6.5–9.7ROR 8.5 · χ² 563 / p 7e-125	7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Wrong technique in product usage process	65	4.9 3.9–6.2ROR 5.1 · χ² 199 / p 2e-45	4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 6.8	no trial data cached
Product quality issue	65	7.3 5.8–9.3ROR 7.6 · χ² 350 / p 2e-78	7.0 EB05 5.7 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	74% consumer	no trial data cached
Skin discolouration	51	16.9 12.9–22.1ROR 17.5 · χ² 746 / p 2e-164	16.7 EB05 13.2 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Thrombosis	37	7.0 5.1–9.6ROR 7.1 · χ² 184 / p 4e-42	6.5 EB05 4.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial data cached
Burning sensation	32	6.9 4.9–9.8ROR 7.1 · χ² 157 / p 3e-36	6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Blister	31	8.4 5.9–11.9ROR 8.6 · χ² 195 / p 1e-44	7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.8	no trial data cached
Treatment noncompliance	31	8.7 6.1–12.3ROR 8.8 · χ² 203 / p 2e-46	8.0 EB05 5.8 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial data cached
Expired product administered	30	13.7 9.6–19.6ROR 14.0 · χ² 342 / p 1e-76	13.3 EB05 9.5 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=2 · 90% clinician	no trial data cached
Poor quality product administered	23	34.2 22.8–51.3ROR 34.8 · χ² 707 / p 4e-156	33.3 EB05 23.4 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Therapy change	23	36.3 24.2–54.4ROR 36.9 · χ² 753 / p 5e-166	35.2 EB05 24.7 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	78% consumer	no trial data cached
Tenderness	16	23.3 14.3–37.9ROR 23.5 · χ² 319 / p 1e-71	22.6 EB05 14.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Limb discomfort	13	6.4 3.7–11.0ROR 6.4 · χ² 54 / p 1e-13	5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Injection site extravasation	12	14.6 8.3–25.7ROR 14.7 · χ² 139 / p 3e-32	13.3 EB05 7.2 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=3	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.

Skin discolouration — n=51, PRR 16.9
Blister — n=31, PRR 8.4
Burning sensation — n=32, PRR 6.9

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 Polidocanol?

In FDA FAERS, the most frequently co-reported reaction terms for Polidocanol are deep vein thrombosis, skin discolouration, thrombosis, burning sensation, blister, poor quality product administered. 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 Polidocanol have an FDA boxed warning?

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

Do FAERS signals prove that Polidocanol 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 bb1f342b-5352-4059-a0b2-e60fd652fd28, effective 20250716; matched on openfda.generic_name.exact:"POLIDOCANOL")
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, 29 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.