BELOTERO® Important Safety Information
Indication:
BELOTERO BALANCE® (+) is FDA-approved for injection into the mid-to-deep dermis for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds and for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21.
BELOTERO VOLUME® (+) is FDA-approved for deep (subcutaneous and/or supraperiosteal) injection to improve volume deficit in the mid-face or to correct mid-face contour deficiencies in adults 22 years of age or older.
BELOTERO INTENSE® (+) is FDA-approved for submucosal and/or subcutaneous implantation for lip augmentation in adults over the age of 21.
Contraindications:
Do not use BELOTERO BALANCE® (+), BELOTERO VOLUME® (+), or BELOTERO INTENSE® (+) in patients with severe allergies, including a history of anaphylaxis or multiple severe allergies, or known hypersensitivity to any product component, including trace gram-positive bacterial proteins. The lidocaine-containing formulations — BELOTERO BALANCE® (+), BELOTERO VOLUME® (+), and BELOTERO INTENSE® (+) — are contraindicated in patients with known hypersensitivity to lidocaine or anesthetics of the amide type. These products must not be implanted into blood vessels.
Warnings:
Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example, injecting the product slowly and applying the least amount of pressure necessary. Rare but serious adverse events associated with intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possible evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.
Use at sites with an active inflammatory process (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection should be deferred until the underlying process has been controlled.
Common treatment site responses consist mainly of short-term inflammatory symptoms and typically resolve within 2 to 4 weeks, though the reported range varies by product and treatment area (for example, up to 17 days for BELOTERO BALANCE® (+) infraorbital hollow treatment and 15-28 days for BELOTERO INTENSE® (+) lip augmentation). The following have also been reported following use of dermal fillers generally: inflammatory reaction, anaphylactic reaction, edema, implant migration, acne, blisters, scarring, papules, and delayed-onset granulomas.
Do not use BELOTERO INTENSE® (+) in patients with a history of developing scars or keloids.
Precautions:
In order to minimize the risk of potential complications, these products should only be used by health care practitioners who have appropriate training, experience, and knowledge of the anatomy at and around the injection site. Health care practitioners should discuss all potential risks of soft tissue injection with patients prior to treatment.
These products are packaged for single-patient use. Do not resterilize. Discard any unused or partially used product. Do not use if the package is open, damaged, or beyond the expiration date.
Safety and effectiveness have not been established for: use during pregnancy or breastfeeding; use in patients under 21 years old (BELOTERO BALANCE® (+) infraorbital hollow and BELOTERO INTENSE® (+)) or under 22 years old (BELOTERO VOLUME® (+)); treatment of anatomic regions other than those studied for each product (nasolabial folds and infraorbital hollow for BELOTERO BALANCE® (+); mid-face for BELOTERO VOLUME® (+); lips for BELOTERO INTENSE® (+)); use in the lips with products other than BELOTERO INTENSE® (+); concomitant treatment with dermal therapies such as epilation, UV irradiation, or laser, mechanical, or chemical peeling procedures; and use of BELOTERO BALANCE® (+) beyond 96 weeks.
Health care practitioners are encouraged to conduct vision assessments — including visual acuity, extraocular motility, and visual field testing — before and after treatment with these products, and to identify a local ophthalmologist or ophthalmology subspecialist who can be made available in the event of an ophthalmic adverse event related to a hyaluronic acid dermal filler injection. Practitioners should also be prepared to conduct a basic neurologic examination in the event of an adverse event with central nervous system deficits.
The safety of BELOTERO BALANCE® (+) in patients with known susceptibility to recurrent sore throat, or Osler-Rendu endocarditis, has not been studied.
Patients using medications that prolong bleeding, such as aspirin, NSAIDs, or warfarin, may experience increased bruising or bleeding at the injection site. Patients with a history of previous herpetic eruption may experience reactivation of herpes. These products should be used with caution in patients on immunosuppressive therapy. Patients should minimize exposure of the treated area to excessive sun, heat, UV lamp exposure, Turkish baths, or extreme cold weather until initial swelling and redness have resolved and puncture sites have healed.
Care should be taken to determine the risk versus benefit of BELOTERO BALANCE® (+), specifically, in patients with congenital methemoglobinemia, glucose-6-phosphate dehydrogenase deficiency, or those receiving concomitant treatment with a methemoglobin-inducing agent, per its Instructions for Use.
Based on clinical studies, patients should be limited to 6.0 mL of BELOTERO BALANCE® (+) per year; the safety of injecting greater amounts has not been established. For BELOTERO INTENSE® (+), the maximum volume evaluated in clinical studies was 3.0 mL per treatment session (1.5 mL per lip), and total annual treatment volume should not exceed 6.0 mL; these are separate, product-specific limits.
Adverse Events:
Common adverse events observed in clinical studies of these products include swelling, bruising, redness, pain/tenderness, induration (firmness), itching, and lumps/bumps at the injection site; soreness was also commonly reported with BELOTERO INTENSE® (+). In the infraorbital hollow pivotal study, common treatment responses particularly bruising and visible lumps and in the BELOTERO INTENSE® (+) pivotal lip study, overall common treatment responses (88.4%), were reported at a numerically higher incidence than in the nasolabial fold or mid-face studies. No serious treatment-related adverse events, retinal artery occlusion, or vision loss were reported in the infraorbital hollow (pilot or pivotal) or lip augmentation pivotal studies; abnormal visual acuity findings recorded during screening were assessed as non-serious and unrelated to treatment.
Delayed-onset inflammation has been reported to occur at the dermal filler treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.
Information on adverse events from post-market surveillance is included in the Instructions for Use (IFU) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to these products. Please see the IFU and PIG available at www.belotero.com for a complete list of these events.
To report a problem with BELOTERO BALANCE® (+), BELOTERO VOLUME® (+), or BELOTERO INTENSE® (+), please call Merz North America at 1-844-469-6379.
For complete Safety Information please refer to the Instructions for Use at www.belotero.com.
Rx only
References: 1. Sundaram H, et al. Plast Reconstr Surg. 2015;136(5 Suppl):149S-163S. 2. Micheels P, et al. Dermatol Surg. 2012;38(7 Pt 2):1162-1169. 3. Tran C, et al. Dermatology. 2014;228(1):47-54. 4. Borrell M, et al. J Cosmet Laser Ther. 2011;13(1):21-27. 5. Micheels P, et al. J Cosmet Dermatol. 2019;18(1):36-44. 6. Lorenc ZP, et al. Plast Reconstr Surg. 2013;132(4 Suppl 2):33S-40S. 7. Belotero Balance (+) [Instructions for Use]. IN00201-01. Merz North America, Inc; 2023. 8. Merz Aesthetics. Published September 26, 2023. Accessed October 18, 2023. https://us.merzaesthetics.com/news/merz-aesthetics-continues-to-fuel-confidence-by-expanding-belotero-balance-filler-treatment-areas/ 9. Sundaram H, et al. Dermatol Surg. 2010;36 Suppl 3:1859-1865. 10. Sundaram H, et al. Plast Reconstr Surg. 2015;136(4):678-686. 11. Sundaram H, et al. Poster presented at: American Academy of Dermatology 74th Annual Meeting; March 4-8, 2016; Washington, DC. Abstract 3940. 12. Sundaram H, et al. Poster presented at: 23rd World Congress of Dermatology; June 8-13, 2015; Vancouver, Canada. 13. Prasetyo AD, et al. Clin Cosmet Investig Dermatol. 2016;9:257-280. 14. Hermitte L, Benoit O, inventors; Anteis SA, assignee. European patent WO/2005/085329. September 15, 2005. 15. Narins RS, et al. Dermatol Surg. 2010;36(s1):730-740. 16. Casabona G, et al. Dermatol Surg. Published online May 15, 2026. doi:10.1097/DSS.0000000000005152 17. Hermitte L, Benoit O, inventors; Anteis SA, assignee. Biocompatible crosslinked gel. US patent 8,052,990. November 8, 2011. 18. Belotero Volume (+) [Prescribing Information and Instructions for Use]. IN00241-00. Merz North America, Inc; 2026. 19. Belotero Intense (+) [Prescribing Information and Instructions for Use]. IN00262-00. Merz North America, Inc; 2026. 20. Biesman BS, et al. Aesthet Surg J. 2024;44(9):976-986. 21. Micheels P, et al. Plast Reconstr Surg Glob Open. 2017;5(2):e1222. 22. Micheels P, et al. J Clin Aesthet Dermatol. 2015;8(3):28-34. 23. Gerber PA, et al. Aesthet Surg J Open Forum. 2026;8:ojag031. 24. Choi MS, et al. Clin Cosmet Investig Dermatol. 2021;14:765-778. 25. Lee S, et al. Clin Cosmet Investig Dermatol. 2026;19:584595.
for cheek volume and contour, and 
for lip fullness and enhancement.
