Restylane Adverse Reactions

Anticipated injection-related reactions: Injection-related reactions (including bruising, erythema, itching, swelling, pain or tenderness at the implant site) might occur after treatment.
Restylane: Typically resolution is spontaneous within a few days after injection into the skin, and within one week after injection of the lips.
Restylane Lyft: These injection-related reactions consist mainly of mild to moderate inflammatory symptoms that resolve spontaneously within a few days or up to 2 weeks.
Restylane Defyne/Restylane Kysse/Restylane Refyne/Restylane Volyme: Typically, resolution is spontaneous within one week after injection.
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, 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 ischemia or stroke have been reported following facial aesthetic treatments.
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.
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: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane or Restylane Lidocaine (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the products.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment, Mass/induration.
1/10 000 - 1/100 000: Short duration of effect, Erythema, Pain/tenderness, Bruising/bleeding, Deformity/asymmetry, Papules/nodules, Infection/abscess including pustule, cellulitis and purulent discharge, Discolouration/hyperpigmentation, Ischemia/necrosis including livedo reticularis, pallor and vascular occlusion, Other injection site reactions and skin reactions including burning sensation, exfoliation, irritation, discomfort, dryness and warmth, Inflammation, Hypersensitivity/angioedema, Eye disorders including dry eyes, eye irritation, eye pain, eye swelling, eyelid ptosis, increased lacrimation and visual impairment such as blindness, blurred vision and reduced visual acuity, Neurological symptoms including facial nerve paralysis, hypoaesthesia and paraesthesia, Pruritus, Extrusion of device, Scar/scab/skin atrophy.
<1/100 000: Device dislocation, Granuloma/foreign body reaction, Reactivation of herpes infection, Rash, Blisters/vesicles, Capillary disorders such as telangiectasia, Discharge/extravasation, Acne, Urticaria, Dermatitis, Muscle disorders including muscle twitching and muscular weakness, Encapsulation, Dermatophytosis, Other dermatological events including localised alopecia and skin wrinkling, Non-dermatological events including anxiety, arthralgia, asthenia, depression, dizziness, dysphagia, dyspnoea, fatigue, headache, malaise, pyrexia, influenza like illness, insomnia, sinusitis and nausea.
Restylane Defyne: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Defyne (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the product.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment, Mass/induration.
1/10 000 - 1/100 000: Papules/nodules, Erythema, Pain/tenderness, Device ineffective, Infection/abscess including pustule, cellulitis and purulent discharge, Bruising/bleeding, Inflammation, Discolouration, Other injection site reactions and skin reactions including burning sensation, exfoliation, irritation, discomfort, dryness and warmth, Ischemia/necrosis including livedo reticularis, pallor and vascular occlusion, Granuloma/foreign body reaction, Pruritus, Hypersensitivity/angioedema, Eye disorders including eye contusion, eye irritation, eye pain, eye swelling, eyelid ptosis, and visual impairment such as blurred vision, Device dislocation, Neurological symptoms including facial paralysis, hypoaesthesia and paraesthesia, Rash.
<1/100 000: Scar/skin atrophy, Blisters/vesicles, Reactivation of herpes infection, Deformity/asymmetry, Capillary disorders such as telangiectasia, Dermatitis, Discharge, Urticaria, Acne, Extrusion of device, Non-dermatological events including chills, cutaneous contour deformity, dizziness, headache, malaise, nausea, pyrexia and vomiting, Other dermatological events such as skin pain.
Restylane Kysse: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Kysse (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the product.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment, Mass/induration, Device ineffective.
1/10 000 - 1/100 000: Papules/nodules, Pain/tenderness, Bruising/bleeding, Ischemia/necrosis including arterial occlusive disease, pallor and ulcer, Erythema, Discolouration/hyperpigmentation, Inflammation, Hypersensitivity/angioedema, Blisters/vesicles, Infection/abscess including pustule and purulent discharge, Other injection site reactions and skin reactions including burning sensation, discomfort and warmth, Pruritus, Neurological symptoms including facial nerve paralysis, hypoaesthesia and paraesthesia.
<1/100 000: Device dislocation, Eye disorders including dry eyes, eye irritation, eye oedema, brow ptosis and increased lacrimation, Rash, Scar/scab/skin atrophy, Capillary disorders such as telangiectasia, Reactivation of herpes infection, Urticaria, Acne, Dermatitis, Discharge/extravasation, Granuloma/foreign body reaction, Non-dermatological events including cutaneous contour deformity, dizziness, dyspnoea and headache, Other dermatological events including dry lips and skin tightness.
Restylane Lyft: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Lyft or Restylane Lyft Lidocaine (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the products.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment.
1/10 000 - 1/100 000: Short duration of effect, Mass/induration, Pain/tenderness, Erythema, Bruising/bleeding, Infection/abscess including pustule, cellulitis and purulent discharge, Papules/nodules, Inflammation, Other injection site reactions and skin reactions including burning sensation, exfoliation, irritation, discomfort, and warmth, Discolouration/hyperpigmentation, Neurological symptoms including facial nerve paralysis, hypoaesthesia and paraesthesia, Hypersensitivity/angioedema, Non-dermatological events including anxiety, dizziness, dyspnoea, headache, influenza like illness, insomnia, malaise, nausea, pyrexia, and sinusitis.
<1/100 000: Ischemia/necrosis, Eye disorders including dry eyes, eye irritation, eye pain, eye swelling, eyelid ptosis, increased lacrimation, and visual impairment such as blindness, blurred vision, and reduced visual acuity, Pruritus, Scar/scab/skin atrophy, Device dislocation, Rash, Discharge/extravasation, Granuloma/foreign body reaction, Acne, Blisters/vesicles, Reactivation of herpes infection, Urticaria, Capillary disorders such as telangiectasia, Extrusion of device, Dermatitis, Muscle disorders including muscle twitching and muscular weakness, Encapsulation, Other dermatological events including alopecia, chapped lips, dry skin, and skin wrinkling.
Restylane Refyne: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Refyne (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the product.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment.
1/10 000 - 1/100 000: Mass/induration, Erythema, Papules/nodules, Bruising/bleeding, Device ineffective, Discolouration/hyperpigmentation, Pain/tenderness, Infection/abscess including pustule and purulent discharge, Inflammation, Ischemia/necrosis including pallor and vascular occlusion, Eye disorders including dry eye, eye pain and visual impairment such as blurred vision, Other injection site reactions and skin reactions including burning sensation, exfoliation, irritation and warmth, Hypersensitivity/angioedema, Pruritus, Device dislocation.
<1/100 000: Blisters/vesicles, Neurological symptoms including hypoaesthesia and paraesthesia, Deformity/asymmetry, Scar/skin atrophy, Rash, Granuloma/foreign body reaction, Acne, Discharge/extravasation, Urticaria, Capillary disorders such as telangiectasia, Dermatitis, Reactivation of herpes infection, Muscle disorders such as muscle twitching, Non-dermatological events including chills, cutaneous contour deformity, dizziness, dyspnoea, headache and sinusitis, Other dermatological events such as chapped lips.
Restylane Volyme: The following post marketing adverse events have been reported from worldwide sources after treatment with Restylane Volyme (non-exhaustive list). The frequency of reporting is based on the number of estimated treatments performed with the product.
1/1 000 - 1/10 000: Swelling/oedema with immediate onset and onset up to several weeks after treatment.
1/10 000 - 1/100 000: Mass/induration, Pain/tenderness, Papules/nodules, Erythema, Device ineffective, Inflammation, Infection/abscess including pustule, cellulitis and purulent discharge, Bruising/bleeding, Hypersensitivity/angioedema including anaphylactic shock, Ischemia/necrosis including pallor, Neurological symptoms including facial nerve paralysis, hypoaesthesia and paraesthesia, Device dislocation, Other injection site reactions and skin reactions including burning sensation and warmth, Eye disorders including eye pain, eyelid oedema, eyelid ptosis and dry eyes, Granuloma/foreign body reaction.
<1/100 000: Discolouration, Deformity/asymmetry, Pruritus, Reactivation of herpes infection, Rash, Blisters/vesicles, Scar/scab/skin atrophy, Acne, Dermatitis, Encapsulation, Urticaria, Non-dermatological events including chills, cutaneous contour deformity, dizziness, feeling hot, headache, influenza like illness, migraine and presyncope, Other dermatological events such as chapped lips.