After the injection of Restylane®, some common injection-related
reactions might occur. These reactions include erythema, swelling,
pain, itching, bruising or tenderness at the implant site. Typically, resolution is spontaneous within a few days after injection into the skin, within a week after injection into the lips and up to two weeks after a treatment with Restylane SubQ .
The most common adverse events reported post marketing for the Restylane range of products are swelling, bruising, erythema, mass, pain and tenderness. Their reporting frequencies are about 1 in 10,000 to 1 in 20,000.
Less common adverse events with reporting frequencies about 1 in 50,000 treatments are infection, inflammatory reactions, discolouration, nodules and papules. Symptoms of inflammation including a combination of redness, swelling, tenderness and induration at the implant site have been reported. These reactions may commence either shortly after injection or after a delay of 2-4 weeks. Infections should be excluded or treated if necessary. In
pronounced cases a short course of oral corticosteroids may prove effective.
For patients who have experienced clinically significant reactions, a decision for retreatment should take into consideration the cause and significance of previous reactions. For further information, please see instructions for use for each product.