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About Safety

JUVÉDERM® injectable gel is a dermal filler made from hyaluronic acid—a naturally occurring substance in your skin. JUVÉDERM® is the first FDA-approved hyaluronic acid dermal filler that has demonstrated its safety and effectiveness in persons of color.

Before you decide on treatment with JUVÉDERM® injectable gel, you'll want to find an experienced healthcare professional—someone who is familiar with the injection process. You can use our simple tool to find an experienced doctor near you.

Download the JUVÉDERM®
Patient Safety Information PDFs:

Talking to your healthcare professional about treatment with JUVÉDERM®

If you're considering treatment with JUVÉDERM® injectable gel, your healthcare professional should ask about your medical history to determine if you are an appropriate candidate for treatment. JUVÉDERM® injectable gel should not be used in patients who have:

  • Severe allergies marked by a history of anaphylaxis or presence of multiple
    severe allergies
     
  • A history of allergies to gram-positive bacterial proteins

  • JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC should not be used in patients with a history of allergies to lidocaine.

Your healthcare professional should also warn you that the safety and effectiveness of JUVÉDERM® injectable gel for the treatment of areas other than facial wrinkles and folds (such as lips) have not been established in controlled clinical studies.

In addition, you and your healthcare professional should discuss the following important treatment considerations in order to help avoid unsatisfactory results and complications:

  • Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at the injection site. You should inform your healthcare professional before treatment if you are using these types of substances.
     
  • If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with JUVÉDERM® injectable gel, there is a possible risk of an inflammatory reaction at the treatment site.
     
  • JUVÉDERM® injectable gel should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body's immune response, as there may be an increased risk of infection.
     
  • The safety of JUVÉDERM® injectable gel for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established.
     
  • The safety of JUVÉDERM® in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied.

Other treatment options to consider

Other treatments for dermal soft tissue augmentation include bovine-based collagen and other hyaluronic acid-based dermal fillers. Aside from these treatments, additional options for the correction of lines and wrinkles do exist, including facial creams, chemical peels, and laser skin surface treatments, and may be discussed with your healthcare professional.

You may also download these helpful materials:

JUVÉDERM® Ultra XC Patient Safety Information

JUVÉDERM® Ultra Plus XC Patient Safety Information

JUVÉDERM® Ultra Patient Safety Information

JUVÉDERM® Ultra Plus Patient Safety Information

get adobe reader Note: These documents are provided in Adobe® Reader® format (PDF). To view PDF documents, you must have the Adobe® Reader® software installed on your computer. If you do not have Adobe® Reader®, download it from the Adobe Web site.

JUVÉDERM® is part of the Allergan portfolio of products and this is the JUVÉDERM® website. For information on BOTOX® Cosmetic, visit www.botoxcosmetic.com.

JUVÉDERM® Safety Information

*JUVÉDERM® is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

Important JUVÉDERM® Safety Information

JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Side effects were usually mild to moderate, lasting 7 days or less, and included temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps. JUVÉDERM® is not for people with severe allergies. For more information, please click on the About Safety link at www.juvederm.com or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM® injectable gel is available by prescription only.

BOTOX® Cosmetic Important Information

Indication

BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary).

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.

  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing.

There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines.

Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® or Dysport™; have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions such as such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.

Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (It is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breastfeed (It is not known if BOTOX® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products.

BOTOX® Cosmetic may cause loss of strength or general muscle weakness, or vision problems. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see BOTOX® Cosmetic Full Product Information including Medication Guide.