What the label lists and what reports show
Polidocanol side effects
Polidocanol's FDA label: “In clinical trials, the most common related adverse events (occurring in ≥3% of patients treated with VARITHENA) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial …” FAERS holds 1,382 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is deep vein thrombosis (340 reports).
- No generic listed
Check it at the source: the polidocanol FDA label on DailyMed (effective August 7, 2026, Boston Scientific Corporation); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsIn clinical trials, the most common related adverse events (occurring in ≥3% of patients treated with VARITHENA) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biocompatibles, Inc.
Table 1: Treatment-emergent adverse reactions (3% more on VARITHENA 1% than on placebo)…
| Adverse Reaction | Placebo (N=151) | VARITHENA 1.0% (N=149) |
|---|---|---|
| Pain in extremity | 14 (9.3) | 25 (16.8) |
| Infusion site thrombosis b | 0 | 24 (16.1) |
| Contusion/injection site hematoma | 9 (6.0) | 23 (15.4) |
| Limb discomfort | 5 (3.3) | 18 (12.1) |
| Tenderness/injection site pain | 5 (3.3) | 16 (10.7) |
| Venous thrombosis limb c | 0 | 12 (8.1) |
| Thrombophlebitis superficial | 2 (1.3) | 8 (5.4) |
| Deep vein thrombosis | 0 | 7 (4.7) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedIn clinical trials, the most common related adverse events (occurring in ≥3% of patients treated with VARITHENA) were pain/discomfort in extremity, infusion site thrombosis (retained coagulum), injection site hematoma or pain, thrombophlebitis superficial, and extravasation.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biocompatibles, Inc. at 1-855-971-VEIN (1-855-971-8346) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of VARITHENA cannot be directly compared to rates in the clinical trials of other drugs or procedures and may not reflect the rates observed in practice. A total of 1333 patients with GSVI in 12 clinical trials were evaluated for safety when treated with VARITHENA at dose concentrations of 0.125%, 0.5%, 1.0%, or 2.0%, including 437 patients treated with VARITHENA in placebo-controlled clinical trials. Adverse reactions occurring in 3% more patients receiving VARITHENA 1% than receiving placebo are shown in Table 1 . a Retained coagulum. b Common femoral vein thrombus extension (non-occlusive thrombi starting in the superficial vein and extending into the common femoral vein).
Source: FDA drug label, Boston Scientific Corporation, effective August 7, 2026 (SPL set dfd6b4a0-b0dc-11e2-9e96-0800200c9a66), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,382 reports list polidocanol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 137 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Polidocanol: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions