Note: This document contains side effect information about polidocanol. Some dosage forms listed on this page may not apply to the brand name Varithena.

Applies to polidocanol: intravenous foam, intravenous solution.

Serious side effects of Varithena

Along with its needed effects, polidocanol (the active ingredient contained in Varithena) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking polidocanol:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• collection of blood under the skin of the injection site
• deep, dark purple bruise at the injection site
• pain, discomfort, redness, or swelling in the arm or leg

Incidence not known

• Anxiety
• blue-green to black skin discoloration
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain or tightness
• cough
• darkening of the skin
• difficult or labored breathing
• difficulty with swallowing
• dizziness or lightheadedness
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• inability to speak
• increased hair growth in the treatment area
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of consciousness
• nerve injury
• no blood pressure or pulse
• noisy breathing
• pain, redness, or sloughing of the skin at the injection site
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness, soreness, or itching skin
• seizures
• severe or sudden headache
• skin rash
• slurred speech
• sores, welts, or blisters
• stopping of the heart
• temporary blindness
• trouble breathing
• unusual tiredness or weakness
• weakness in the arm or leg on one side of the body, sudden and severe

Get emergency help immediately if any of the following symptoms of overdose occur while taking polidocanol:

Symptoms of overdose

• Break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid

Other side effects of Varithena

Some side effects of polidocanol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Confusion
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• sudden sweating

For Healthcare Professionals

Applies to polidocanol: injectable foam, injectable kit, injectable solution.

Local

Very common (10% or more): Injection site hematoma (up to 42%), injection site irritation (up to 41%), injection site discoloration (up to 38%), injection site pain (up to 24%), injection site pruritus (up to 19%), injection site warmth (up to 16%)

Common (1% to 10%): Injection site thrombosis (local intravaricose blood clots)

Uncommon (0.1% to 1%): Injection site necrosis, induration, swelling^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic shock^[Ref]

Respiratory

Very rare (less than 0.01%): Asthma attack, dyspnea, chest discomfort, cough^[Ref]

Cardiovascular

Common (1% to 10%): Neovascularization, hematoma

Uncommon (0.1% to 1%): Thrombophlebitis superficial, phlebitis

Rare (0.01% to 0.1%): Deep vein thrombosis

Very rare (less than 0.01%): Cerebrovascular accident, migraine, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis, blood pressure abnormal, heart rate abnormal (tachycardia, bradycardia)

Frequency not reported: Cardiac arrest, palpitations, hot flush^[Ref]

Nervous system

Uncommon (0.1% to 1%): Nerve injury

Very rare (less than 0.01%): Headache, paresthesia (local), loss of consciousness, confusional state, dizziness, aphasia, ataxia, hemiparesis, hypoesthesia oral

Frequency not reported: Migraine^[Ref]

Dermatologic

Common (1% to 10%): Rash, ecchymosis, skin hyperpigmentation

Uncommon (0.1% to 1%): Allergic dermatitis, skin reaction, erythema

Very rare (less than 0.01%): Angioedema, generalized urticaria, hypertrichosis (in the area of sclerotherapy)^[Ref]

Gastrointestinal

Very rare (less than 0.01%): dysgeusia, nausea, vomiting^[Ref]

Musculoskeletal

Very common (10% or more): Pain in extremity (up to 65%), limb discomfort (up to 32%)^[Ref]

Other

Very rare (less than 0.01%): Pyrexia, asthenia, malaise^[Ref]