Restylane

Restylane Adverse Reactions

Manufacturer:

Galderma

Distributor:

Forewide
/
DCH Auriga - Healthcare
Full Prescribing Info
Adverse Reactions
Anticipated injection-related reactions: Injection-related reactions might occur. These reactions include bruising, erythema, itching, swelling, pain or tenderness at the implant site. Typically resolution is spontaneous within a few days after injection into the skin, and within one week after injection of the lips.
Post marketing adverse event reporting: 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, discoloration, ischemia, 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. Following facial aesthetic treatments isolated rare cases have been reported regarding ischemic events affecting the eye leading to visual loss, and the brain resulting in cerebral infarction. After injections of the nose ischemia/necrosis may occur, especially in patients who had prior rhinoplasty.
Symptoms of inflammation at the implant site commencing either shortly after injection or after a delay of up to several weeks have been reported. In case of unexplained inflammatory reactions infections should be excluded and treated if necessary, since inadequately treated infections may progress into complications such as abscess formation. Treatment using only oral corticosteroids without concurrent antibiotic treatment is not recommended.
The prolonged use of any medication, e.g., corticosteroids or antibiotics in treatment of adverse events has to be carefully assessed, since this may carry a risk for the patient. In case of persistent or recurrent inflammatory symptoms, consider removal of the product by aspiration/drainage, extrusion or enzymatic degradation (use of hyaluronidase has been described in scientific publications). Before any removal procedure is performed, the swelling may be reduced by using, e.g., NSAID for 2-7 days or a short course of corticosteroids for less than 7 days, in order to more easily palpate any remaining product.
Post inflammatory pigmentation changes have been observed in clinical studies in people with dark skin (Fitzpatrick Type IV-VI).
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.
Restylane/Restylane Lyft: The following post marketing adverse events have been reported (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the Restylane fillers range of products.
1/1 000 - 1/10 000: Swelling.
1/10 000 - 1/50 000: Bruising, discoloration, erythema, infection, inflammation, ischemia/necrosis, mass, pain/tenderness, papules/nodules.
1/50 000 - 1/100 000: Hypersensitivity, induration, neurological symptoms such as paresthesia, pruritus, short duration of effect.
<1/100 000: Abscess, acne, angioedema, atrophy/scarring, blisters, capillary disorders such as telangiectasia, dermatitis, device dislocation, fistula, granuloma, rash, reactivation of herpes infection, urticaria, visual disturbance.
Isolated rare cases of ischemic events affecting the eye leading to visual loss, and the brain resulting in cerebral infarction, following facial aesthetic treatments have been reported.
Isolated rare cases of ischemia/necrosis affecting the nose have been reported after injection, especially in patients who had prior rhinoplasty.
Restylane Defyne/Restylane Refyne/Restylane Volyme: The following post market adverse events have been reported (non-exhaustive list): angioedema, atrophy/scaring, blisters, bruising, capillary disorders such as telangiectasia, dermatitis, discoloration, erythema, hypersensitivity, induration, infection, inflammation, ischemia/necrosis, mass, neurological symptoms such as paraesthesia, pain/tenderness, papules/nodules, pruritus, reactivation of herpes infection, short duration of effect, swelling and urticaria.
Other potential adverse events that have been reported following injection of hyaluronic acid gels in general and may occur when using the product include the following: abscess, acne, device dislocation, fistula, granuloma, rash and visual disturbance.
Restylane Kysse: The following post marketing adverse events have been reported (non-exhaustive list): angioedema, atrophy/scaring, blisters, bruising, erythema, hypersensitivity, infection, mass, neurological symptoms such as paraesthesia, pain/tenderness, papules/nodules, pruritus, reactivation of herpes infection, short duration of effect, and swelling.
Other potential adverse events, that have been reported following treatment of lips with hyaluronic acid gels in general and may occur when using the product include the following: abscess, acne, capillary disorders such as telangiectasia, dermatitis, device dislocation, discoloration, granuloma, induration, inflammation, and ischemia/necrosis.
Restylane Lyps Lidocaine: The following post marketing adverse events have been reported (non-exhaustive list): abscess, angioedema, bruising, discolouration, erythema, inflammation, mass, pain/tenderness, papules/nodules, pruritus, short duration of effect, and swelling.
Other potential adverse events, that have been reported following treatment of lips with other Restylane fillers, are: acne, atrophy/scaring, blisters, capillary disorders such as telangiectasia, dermatitis, device dislocation, granuloma, hypersensitivity, induration, infection, ischemia/necrosis, neurological symptoms such as paraesthesia, and reactivation of herpes infection.
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