Asclera
Asclera Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Asclera in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; sneezing, runny nose, difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- severe pain, burning, or other irritation in your leg;
- discoloration or skin changes where an injection was given;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- severe numbness that does not go away;
- pain, swelling, warmth, or redness in one or both legs;
- trouble breathing, pounding heartbeats or fluttering in your chest; or
- confusion, feeling like you might pass out.
Less serious side effects may include:
- mild numbness or tingling;
- mild headache, dizziness;
- increased hair growth on the treated leg; or
- mild pain or warmth, mild itching, or slight bruising where an injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Asclera (Polidocanol Injection) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Asclera FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Study Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In 5 controlled randomized clinical trials, Asclera (polidocanol injection) has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo. Patients were 18 to 70 years old. The patient population was predominately female and consisted of Caucasian and Asian patients.
Table 1 shows adverse events more common with Asclera (polidocanol injection) or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo- controlled EASI study (see Clinical Studies). All of these were injection site reactions and most were mild.
Table 1: Adverse Reactions in EASI-study
| ASCLERA (180 patients) |
STS 1% (105 patients) |
Placebo (53 patients) |
|
| Injection site haematoma | 42% | 65% | 19% |
| Injection site irritation | 41% | 73% | 30% |
| Injection site discoloration | 38% | 74% | 4% |
| Injection site pain | 24% | 31% | 9% |
| Injection site pruritus | 19% | 27% | 4% |
| Injection site warmth | 16% | 21% | 6% |
| Neovascularisation | 8% | 20% | 4% |
| Injection site thrombosis | 6% | 1% | 0% |
Ultrasound examinations at one week (±3 days) and 12 weeks (±2 weeks) after treatment did not reveal deep vein thrombosis in any treatment group.
Post-marketing Safety Experience
The following adverse reactions have been reported during use of polidocanol in world-wide experience; in some of these cases these adverse events have been serious or troublesome. Because these reactions are reported voluntarily from a population of uncertain size and without a control group, it is not possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Immune system disorders: Anaphylactic shock, angioedema, urticaria generalized, asthma
Nervous system disorders: Cerebrovascular accident, migraine, paresthesia (local), loss of consciousness, confusional state, dizziness
Cardiac disorders: Cardiac arrest, palpitations
Vascular disorders. Deep vein thrombosis, pulmonary embolism, syncope vasovagal, circulatory collapse, vasculitis
Respiratory, thoracic and mediastinal disorders: Dyspnea
Skin and subcutaneous tissue disorders: Skin hyperpigmentation, dermatitis allergic, hypertrichosis (in the area of sclerotherapy)
General disorders and injection site conditions: Injection site necrosis, pyrexia, hot flush
Injury, poisoning and procedural complications: Nerve injury
Read the entire FDA prescribing information for Asclera (Polidocanol Injection) »
Additional Asclera Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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