Date published: DATE
Restylane is a range of hyaluronic acid (HA) dermal fillers with decades of unmatched safety profile.1,2,3 The first to be introduced to the European market in 1996, Restylane has been used in more than 77 million treatments worldwide, and its safety profile has been evaluated in scientific studies covering approximately 407,000 patients.2,3
Restylane at a glance4
First introduced in EU | 1996 |
Material | Stabilised HA3,4 |
Source | Non-animal4 |
Dissolvable? | Yes, with hyaluronidase5 |
Regulation | CE-marked, EU MDR6,28 |
Where made | Uppsala, Sweden7 |
User satisfaction | 96% of people would do the treatment again8 |
What Are the Typical Results of Restylane?
Restylane® OBT™ and NASHA™ are associated with low risk of late-onset complications compared to a competitor.9-12
Closest to skin’s own
Restylane fillers use highly purified, long-chain hyaluronic acid (HA)13,14 that is minimally modified during manufacturing,12 helping it remain close to the HA naturally found in your body15 and contributing to a lower incidence of delayed-onset reaction9,16 and optimize injection safety for the best treatment outcomes* 9,14,16
*Always consult a healthcare professional for individualized treatment recommendations and to discuss important safety information and risks associated with the use of the products.
Natural Looking Results
Restylane® help achieve desired aesthetic outcomes with lower injection volumes compared to some other HA fillers.17,18,19
Low Water Uptake
For predictable results, Restylane® Eyelight is designed to help reduce unwanted swelling or puffiness after treatment and support more predictable, natural-looking results.20,21
How Is Restylane’s Safety Profile Studied?
Restylane is one of the most extensively researched HA filler ranges.3 Its safety profile and performance have been examined in more than 80 clinical trials and 182 total publications.3
Galderma also runs a large practitioner-training and safety-education programme, GAIN. This program has trained over 100,000 Healthcare Professionals around the world in 2025.22
Who Should Not Have Restylane?
Restylane is not suitable for everyone. Restylane is not recommended for patients with a known allergy to hyaluronic acid or to any component of the product (for example, lidocaine in some formulations, or the streptococcal proteins used to make the HA), if you have a bleeding disorder or are prone to bleeding, or if there is active skin disease, inflammation or infection near the treatment area.4 Safety of use during pregnancy or breastfeeding has not been established.4 Safety of use has also not been established for patients under 18 years.4 Always discuss your full medical history with your practitioner, who will confirm whether treatment is appropriate for you.
How is Restylane Regulated and Manufactured?
In the European Union, fillers are CE-marked medical devices under the EU Medical Device Regulation (MDR 2017/745).6
Restylane is developed and produced in Galderma's own state-of-the-art facility in Uppsala, Sweden.1 Manufacturing in-house lets Galderma control the purity, high molecular weight, long chains, and consistency of every product; with its unique structure and manufacturing methodology, Restylane is designed for optimized injection safety for the best treatment outcomes. 9,13,14,16
Restylane has a well-established safety profile over nearly three decades, based on a large body of clinical evidence and real-world use.1,3 Injection-related reactions (including bruising, erythema, itching, swelling, pain or tenderness at the implant site, might occur after treatment.4 Typically, resolution is spontaneous within a few days after injection into the skin, and within one week after injection of the lips.4 Post-marketing adverse effects may include swelling/oedema and mass/induration.4 Treatment should always be done by a qualified practitioner.
Most side effects are injection-related and short-lived: redness, swelling, bruising, tenderness and itching, usually resolving within about two weeks.4 Rare, more serious risks exist, which is why a trained practitioner is essential. All potential risks are outlined in the Patient Information leaflet, which is provided by your practitioner or accessible online.
No. Restylane uses non-animal stabilized hyaluronic acid produced by fermentation, which reduces the risk of allergic reactions associated with animal-derived materials.1,4,23
Since 1996, making it one of the longest-established HA fillers, with more than 77 million treatments worldwide.1,2
In the EU, Restylane Eyelight fillers are CE-marked medical devices regulated under MDR 2017/745.6
To prepare for your Restylane treatment:
- Choose a qualified, medically trained and experienced healthcare practitioner;
- Have a proper consultation and share your medical history; ask to confirm you are receiving genuine, CE-marked Restylane product if receiving treatment in the EU;
- Follow the aftercare advice you're given. A good practitioner will explain the benefits, limitations, possible side effects and costs, and answer your questions before you go ahead.
1. Galderma. Data on file. MA-39680. Global 55 million Restylane® treatments, update 2022.
2. Galderma. Data on file. MA-57232. Restylane® global treatments.
3. Galderma. Data on file. MA-55607 (2023). Restylane® 27 years data publications analysis.
4. Restylane® EU Instructions for Use (relevant product IFU).
5. Park KE, et al. Plast Reconstr Surg Glob Open. 2023;11:e5457.
6. Regulation (EU) 2017/745 (Medical Device Regulation); Common Specifications (EU) 2022/2346 (Annex XVI).
7. Galderma. "Manufacturing." galderma.com/manufacturing
8. Andriopoulos B, et al. Facial augmentation with hyaluronic acid fillers in an Asian population. Poster AMWC 2019.
9. Sadeghpour M, et al. Dermatol Surg. 2019;45(8):1085–94.
10. Faivre J, et al. Aesthetic Surg J. 2024;44(6):402–10.
11. Cohen JL, et al. Dermatol Surg. 2022;48(2):220–4.
12. Nikolis A, et al. Manuscript in progress. (v1.0)
13. Galderma. "Hyaluronic acid fillers – how are they made?" galdermaaesthetics.com.
14. Edsman K, et al. Dermatol Surg. 2012;38:1170–79.
15. Faivre J, et al. Dermatol Surg. 2021;47(5):e159–e167
16. Kokoska RE et al. Dermatol Surg. 2022; 48(7): 752–7
17. Jones D, et al. J Drugs Dermatol. 2021;20:949–56.
18. Weiss R, et al. Dermatol Surg. 2021;47(4):527–32.
19. Hilton S, et al. Dermatol Surg. 2018;44(2):261–9.
20. de la Guardia C, et al. Facial Plast Surg. 2022;38(2):116–23.
21. Kablik J, et al. Dermatol Surg. 2009;35(Suppl 1):302–12.
22. 2025 GAIN Global Training Numbers Data on File (v0.1).
23. Galderma. Data on file. MA 1400-01
24. Restylane® KYSSE™ IFU (EU)
25. Restylane® VOLYME™ IFU (EU)
26. Restylane® DEFYNE™ IFU (EU)
27. Restylane® REFYNE™ IFU (EU)
28. Restylane® CLASSYC™ IFU (EU)
29. Restylane® EYELIGHT™ IFU (EU)
30. Restylane® LYFT™ IFU (EU)
31. Restylane® SHAYPE™ IFU (EU)