Sculptra Adverse Reactions

The anticipated injection related reactions include transient bleeding from the needle stick, pain, localised redness, bruising, haematoma, or oedema, which generally resolve within 2-6 days.
Post-Marketing Surveillance: The following post marketing adverse events have been reported from worldwide sources after treatment with Sculptra (non-exhaustive list). The rate of reporting is based on the number of estimated treatments performed. (See table.)

Click on icon to see table/diagram/image

Subcutaneous papules, invisible but palpable, or visible nodules including periorbital nodules, or areas of induration have been noted in the injection area and may be due to over-correction. Nodules are occasionally associated with inflammation or discolouration.
The early occurrence of subcutaneous nodules at the injection site (within 3-6 weeks after treatment) may be minimised by adhering to proper dilution and injection techniques (see Treatment procedure under Cautions for Usage and Dosage & Administration).
Delayed occurrences of subcutaneous nodules at the injection site (within 1-14 months post-injection) have been reported with sometimes a prolonged duration of up to 2 years.
For nodular areas or late granuloma formation, in some cases, they resolved spontaneously or following treatment with multiple intralesional injections of corticosteroids and/or antineoplastic agents (e.g. 5-fluorouracil). Surgical excision of the nodules was sometimes required when they were larger in size, occurring in difficult anatomical regions (e.g. lower eyelid) or persisting after other treatments.
Vascular compromise may occur due to an inadvertent intravascular injection or as a result of vascular compression associated with implantation of any injectable product. This may manifest as blanching, discolouration, necrosis or ulceration at the implant site or in the area supplied by the blood vessels affected; or rarely as ischemic events in other organs due to embolisation. Rare but serious cases of ischemic events associated with temporary or permanent vision impairment, blindness, cerebral ischaemia or stroke have been reported following facial aesthetic treatments.
For patients who have experienced clinically significant reactions, a decision for retreatment should take into consideration the cause and significance of previous reactions.
For reporting of adverse events, contact the local Galderma representative or distributor for this product.