RADIESSE® and BELOTERO® - Safety Overview

Important Safety Information for BELOTERO BALANCE®, RADIESSE®, and RADIESSE® (+)

Who Should Avoid These Treatments?

  • Individuals with severe allergies, anaphylaxis history, or known sensitivities to any components in these products should not receive treatment.
  • RADIESSE® and RADIESSE® (+) are not recommended for those with bleeding disorders or allergies to product ingredients.
  • Patients with lidocaine allergies should avoid RADIESSE® (+).
  • BELOTERO BALANCE® is not suitable for individuals allergic to gram-positive bacterial proteins.
  • These treatments are not advised during pregnancy or while breastfeeding.

Potential Risks & Safety Considerations

Blood Vessel Injection Risks

Accidental injection into a blood vessel is a rare but serious risk that can cause permanent complications. If injected incorrectly, facial filler may lead to vision issues, blindness, stroke, skin damage, or tissue scarring.

Seek immediate medical attention if you experience:

  • Sudden vision changes or blindness
  • Stroke-like symptoms, including difficulty speaking, weakness or numbness in the face or limbs, dizziness, severe headache, or confusion
  • Skin blanching or unusual pain at or near the injection site

General Treatment Considerations

  • As with all injectable procedures, infection risks exist.
  • These products are only approved for use in facial wrinkles and folds—treatment for other areas is unapproved and untested for safety.
  • Avoid treatment if experiencing active skin infections, cold sores, or inflammation at the injection site.
  • Patients with a history of herpes simplex virus may experience an outbreak post-treatment.
  • RADIESSE® and RADIESSE® (+) microspheres are visible on X-rays and CT scans—inform medical providers if you’ve had prior injections.
  • After hand injections, some patients may experience temporary limitations in hand function, and small lumps or nodules may persist for up to a year.

Post-Treatment Guidelines

  • Minimize intense activity and avoid direct sun or heat exposure for at least 24 hours or until swelling and redness have diminished.
  • Some patients may notice temporary swelling, redness, or sensitivity at the treatment site, which generally resolves within a few days.
  • For BELOTERO BALANCE®, disclose any history of frequent sore throats or immunosuppressive therapy, as these may impact treatment outcomes.

Pre-Treatment Disclosures

Before receiving treatment, inform your provider if you have:

  • A history of excessive scarring or keloids
  • Previous skin treatments or facial procedures
  • Current use of blood-thinning medications such as aspirin or warfarin
  • Existing hand conditions, injuries, or disabilities (for hand treatments)

Common Side Effects

RADIESSE® for Hand Rejuvenation

Patients may experience:

  • Bruising, redness, swelling, and itching at the injection site
  • Temporary sensation changes or activity limitations
  • Localized lumps or nodules

RADIESSE® and RADIESSE® (+) for Facial Wrinkles

Typical reactions include:

  • Mild to moderate swelling, bruising, or redness
  • Localized discomfort or sensitivity
  • Itching or small lumps at the injection site

BELOTERO BALANCE® for Facial Wrinkles and Volume Loss

Common side effects include:

  • Swelling, bruising, redness, pain, and itching
  • Temporary skin hardening or discoloration
  • Cold sore reactivation in patients with a history of herpes simplex
  • Lip dryness or mild numbness (for lip treatments)
  • Nasal swelling and occasional headaches

These effects typically resolve within 7 days.


This list does not cover all potential side effects. Merz continuously monitors patient experiences post-approval, with documented details available in the Patient Information Guides at:

www.radiesse.com

www.belotero.com

If you experience persistent or concerning side effects, contact your healthcare provider immediately.

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