JUVÉDERM® – Safety Information

Important Information About the JUVÉDERM® Collection of Fillers

APPROVED USES
  • JUVÉDERM VOLUMA® XC is designed for deep-layer injections (subcutaneous and/or supraperiosteal) to restore lost volume in the cheeks and address age-related mid-face volume loss in adults 21 and older.
  • JUVÉDERM® Ultra XC & JUVÉDERM® Ultra Plus XC are used for mid-to-deep dermal injections to improve moderate to severe facial wrinkles and folds, including nasolabial folds.
  • JUVÉDERM VOLLURE® XC is formulated for mid-to-deep dermal injections to smooth moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults 21 and older.
  • JUVÉDERM® Ultra XC is specifically approved for lip augmentation and perioral enhancement in adults 21 and older.
  • JUVÉDERM VOLBELLA® XC is used to enhance lips and correct perioral rhytids (lip lines) in adults 21 and older.

CRITICAL SAFETY INFORMATION

CONTRAINDICATIONS

JUVÉDERM® should not be used in individuals with severe allergic reactions, including a history of anaphylaxis or multiple severe allergies. Patients with known allergies to Gram-positive bacterial proteins or lidocaine should also avoid these products.

WARNINGS
Risk of Intravascular Injection
 
Injecting filler into blood vessels may lead to serious complications, including embolization, blocked blood flow, skin damage, and tissue death. Rare but severe adverse effects include:
  • Vision impairment or blindness
  • Stroke due to cerebral ischemia or hemorrhage
  • Skin necrosis and long-term facial damage
If symptoms such as vision changes, stroke-like symptoms, skin blanching, or severe pain occur during or after injection, immediate medical attention is required. Intravascular injection complications should be evaluated by a specialist as soon as possible.

Injection at Active Infection Sites
JUVÉDERM® should not be injected into areas with active skin infections, including acne breakouts, cysts, rashes, or hives, until the condition is fully resolved.
 
PRECAUTIONS
  • JUVÉDERM® fillers should only be administered by licensed medical professionals with proper training and expertise in facial anatomy.
  • Patients should be fully informed about potential risks, side effects, and warning signs before undergoing treatment.
  • The safety and effectiveness of:
    • JUVÉDERM VOLUMA® XC for mid-face treatment
    • JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE® XC for facial wrinkles and folds
    • JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC for lips and perioral areas beyond their indicated uses have not been clinically established.
  • Like all injectable treatments, dermal fillers carry a risk of infection. Proper sterilization protocols should always be followed.

Additional Considerations

  • Pregnancy & Nursing: Safety has not been evaluated in pregnant or breastfeeding women.
  • Scarring & Skin Conditions: Use caution in patients prone to keloid scars, hypertrophic scarring, or pigmentation disorders.
  • Age Restrictions:
    • JUVÉDERM VOLUMA® XC has not been studied in individuals under 35 or over 65.
    • JUVÉDERM® Ultra XC & JUVÉDERM® Ultra Plus XC are not approved for patients under 18.
    • JUVÉDERM VOLLURE® XC & JUVÉDERM VOLBELLA® XC have not been studied in patients under 22.
  • Autoimmune & Immune-Compromised Patients: Patients with weakened immune systems should proceed with caution.
  • Blood Thinners & Medications: Individuals taking aspirin, NSAIDs, warfarin, or other blood-thinning medications may experience increased bruising or bleeding at injection sites.

Additional Risks with Laser & Skin Procedures

If undergoing laser treatments, chemical peels, or other aggressive skin resurfacing procedures, an increased risk of inflammatory reactions may occur if done before or after JUVÉDERM® treatment.

ADVERSE EVENTS
Common side effects associated with JUVÉDERM® fillers include:
  • Redness, swelling, tenderness, and pain at the injection site
  • Lumps, bumps, bruising, and mild discoloration
  • Itching and temporary dryness (specifically with JUVÉDERM VOLBELLA® XC)

Duration of side effects varies:

  • JUVÉDERM VOLUMA® XC side effects are typically moderate, lasting 2 to 4 weeks.
  • JUVÉDERM® Ultra XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM VOLLURE® XC reactions tend to be mild to moderate, lasting up to 14 days.
  • JUVÉDERM VOLBELLA® XC side effects are generally mild to moderate, resolving in 30 days.
If you experience severe or prolonged side effects, contact your healthcare provider immediately.
For any adverse reactions, report concerns to Allergan at 1-800-433-8871 or visit JuvedermDFU.com for more information.

IMPORTANT SAFETY REMINDER

JUVÉDERM® products are prescription-only treatments and should be administered by qualified medical professionals. If you have any concerns or questions about your treatment, speak with your provider before proceeding.

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