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Juvéderm Ultra XC

Last reviewed on RxList: 2/20/2019
Juvéderm Ultra XC Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/20/2019

Juvéderm Ultra XC (hyaluronic acid) injectable gel is a dermal filler indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Common side effects of Juvéderm Ultra XC include:

  • injection site reactions such as:
    • redness swelling,
    • tenderness,
    • firmness,
    • lumps/bumps,
    • discoloration, and
    • bruising

Juvéderm Ultra XC injectable gel is supplied in individual treatment syringes with 30-G needles for single-patient use and ready for injection (implantation). Juvéderm Ultra XC may interact with drugs that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], and warfarin). Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Juvéderm Ultra XC; it is unknown how it would affect a fetus. Consult your doctor before breastfeeding.

Our Juvéderm Ultra XC (hyaluronic acid) Injectable Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Juvéderm Ultra XC Professional Information

SIDE EFFECTS

Clinical Evaluation Of JUVEDERM® Ultra XC

A 2-week, randomized, controlled US clinical study for JUVEDERM® Ultra XC and Ultra Plus XC compared with JUVEDERM® Ultra and Ultra Plus without lidocaine showed a similar safety profile in all subjects (N = 72), with the exception of fewer reports of pain/tenderness with the product containing lidocaine. Common treatment-site responses (CTR), by severity and duration, are presented in Tables 1 and 2. Aside from injection-site responses, there were no adverse events related to the device, procedure, or anesthesia.

  • The most common injection-site responses for JUVEDERM® Ultra XC were redness, swelling, tenderness, firmness, lumps/bumps, discoloration, and bruising.

Table 1: Injection-Site Responses by Maximum Severity (Number/% of Subject Nasolabial Folds [NLFs])

Injection-Site Responses TOTALS JUVEDERM® Ultra XC
(Na= 36 NLFs)
JUVEDERM® Ultra
(Na= 36 NLFs)
JUVEDERM® Ultra XC
nc %
JUVEDERM® Ultra
nc %
Mild nc % Modb nc % Severe
nc %
Mild nc % Modb nc % Severe
nc %
Redness 29 30 22 7 0 21 9 0
81% 83% 61% 19% 0% 58% 25% 0%
Pain 17 22 12 5 0 16 5 1
47% 61% 33% 14% 0% 44% 14% 3%
Tenderness 22 29 18 3 1 22 6 1
61% 81% 50% 8% 3% 61% 17% 3%
Firmness 32 33 22 8 2 24 9 0
89% 92% 61% 22% 6% 67% 25% 0%
Swelling 30 29 23 6 1 17 12 0
83% 81% 64% 17% 3% 47% 33% 0%
Lumps/Bumps 20 22 13 6 1 17 4 1
56% 61% 36% 17% 3% 47% 11% 3%
Bruising 27 24 16 8 3 15 6 3
75% 67% 44% 22% 8% 42% 17% 8%
Itching 12 11 12 0 0 10 1 0
33% 31% 33% 0% 0% 28% 3% 0%
Discoloration 22 21 17 2 3 16 3 2
61% 58% 47% 6% 8% 44% 8% 6%
a Number of subject NLFs treated with the respective device
b Mod = Moderate
c Number of NLFs with any occurrence of a particular CTR (or severity for the overall percentages)

Table 2: Duration of Injection-Site Responses (Number/% of Subject NLFs)

Injection-Site Responses JUVEDERM® Ultra XC
(Na = 36 NLFs) nb %
JUVEDERM® Ultra
(Na = 36 NLFs) nb %
Durationc 1-3 Days 4-7 Days 8-14 Days > 14 Days 1-3 Days 4-7 Days 8-14 Days > 14 Days
Redness 22 4 1 2 22 4 2 2
61% 11% 3% 6% 61% 11% 6% 6%
Pain 15 0 1 1 18 3 0 1
42% 0% 3% 3% 50% 8% 0% 3%
Tenderness 14 3 3 2 23 5 0 1
39% 8% 8% 6% 64% 14% 0% 3%
Firmness 15 7 5 5 15 7 8 3
42% 19% 14% 14% 42% 19% 22% 8%
Swelling 19 7 2 2 17 7 3 2
53% 19% 6% 6% 47% 19% 8% 6%
Lumps/Bumps 10 4 2 4 11 5 3 3
28% 11% 6% 11% 31% 14% 8% 8%
Bruising 12 8 4 3 7 8 6 3
33% 22% 11% 8% 19% 22% 17% 8%
Itching 8 3 0 1 9 1 0 1
22% 8% 0% 3% 25% 3% 0% 3%
Discoloration 13 2 4 3 10 5 4 2
36% 6% 11% 8% 28% 14% 11% 6%
a Number of subject NLFs treated with the respective device
b Number of subject NLFs with each specific injection-site response by maximum duration
c Duration refers to number of days from symptom onset until resolution, irrespective of date of implantation

Clinical Evaluation Of JUVEDERM® Ultra (Without Lidocaine)

In the initial randomized, controlled clinical trial to evaluate safety and effectiveness, 146 subjects were injected with JUVEDERM® Ultra in one NLF and ZYPLAST® dermal filler in the contralateral NLF. Preprinted diary forms were used by subjects to record specific signs and symptoms experienced during each of the first14 days (day 0 through day 13) after initial and touch-up treatments. Subjects were instructed to rate each common treatment response listed on the diary as “Mild,” “Moderate,” “Severe,” or “None.” Injection-site responses reported by > 5% of subjects in either treatment group are summarized in Tables 3 and 4.

Table 3: Injection-Site Responses by Maximum Severity Occurring in > 5% of Treated Subjects (Number/% of Subject NLFs)

Injection-Site Responses TOTALS JUVEDERM® Ultra
(Na = 146 NLFs)
ZYPLAST®
(Na = 146 NLFs)
JUVEDERM® Ultra
nc %
ZYPLAST® nc % Mild nc % Modb nc % Severe
nc %
Milld nc % Modb nc % Severe
nc %
Redness 136 130 72 48 16 69 45 16
93% 89% 49% 33% 11% 47% 31% 11%
Pain/ Tenderness 131 128 74 45 12 87 34 7
90% 88% 51% 31% 8% 60% 23% 5%
Firmness 129 127 66 53 10 60 56 11
88% 87% 45% 36% 7% 41% 38% 8%
Swelling 125 122 60 54 11 77 37 8
86% 84% 41% 37% 8% 53% 25% 5%
Lumps/Bumps 115 122 61 45 9 66 42 14
79% 84% 42% 31% 6% 45% 29% 10%
Bruising 86 80 43 29 14 47 27 6
59% 55% 29% 20% 10% 32% 18% 4%
Itching 52 53 42 5 5 43 7 3
36% 36% 29% 3% 3% 29% 5% 2%
Discoloration 48 49 31 11 6 31 15 3
33% 34% 21% 8% 4% 21% 10% 2%
a Number of subject NLFs treated with the respective device
b Mod = Moderate
c Number of subject NLFs with each specific injection-site response

Table 4: Duration of Injection-Site Responses Occurring in > 5% of Treated Subjects(Number/% of Subject NLFs)

Injection-Site Responses JUVEDERM® Ultra
(Na = 146 NLFs) nb %
ZYPLAST®
(Na = 146 NLFs) nb %
Durationc ≤ 3 Days 4-7 Days 8-14 Days > 14 Days ≤3 Days 4-7 Days 8-14 Days > 14 Days
Redness 60 50 8 18 46 46 10 28
41% 34% 5% 12% 32% 32% 7% 19%
Pain /Tenderness 61 46 18 6 49 53 14 12
42% 32% 12% 4% 34% 36% 10% 8%
Firmness 29 34 20 46 25 28 20 54
20% 23% 14% 32% 17% 19% 14% 37%
Swelling 38 48 22 17 54 38 20 10
26% 33% 15% 12% 37% 26% 14% 7%
Lumps/Bumps 26 32 18 39 16 18 19 69
18% 22% 12% 27% 11% 12% 13% 47%
Bruising 29 28 24 5 35 27 10 8
20% 19% 16% 3% 24% 18% 7% 5%
Itching 25 15 7 5 21 17 4 11
17% 10% 5% 3% 14% 12% 3% 8%
Discoloration 22 12 4 10 26 9 3 11
15% 8% 3% 7% 18% 6% 2% 8%
a Number of subject NLFs treated with the respective device
b Number of subject NLFs with each specific injection-site response by maximum duration
c Duration refers to number of days from symptom onset until resolution, irrespective of date of implantation

Local injection-site responses were recorded in subjects’ diaries one or more times for 99% of JUVEDERM® Ultra treated NLFs and 98% of ZYPLAST® treated NLFs. Subjects’ scores for both products were predominantly Mild or Moderate in intensity, and their duration was short lasting (7 days or less). JUVEDERM® Ultra injection-site responses reported by greater than 1% of subjects and not noted in the above tables were skin dryness and peeling. No clinically meaningful differences in the safety profiles of JUVEDERM® Ultra and ZYPLAST® were found during the study.

Other Safety Data

Other Clinical Studies

In 2 additional randomized US clinical studies of other JUVEDERM® formulations (without lidocaine) in a total of 293 subjects, the safety profile was similar to that described above for JUVEDERM® Ultra.

Postmarket Surveillance

The following adverse events were received from postmarket surveillance for JUVEDERM® Ultra (without lidocaine), which were not observed in the clinical trials; this includes reports received globally from all sources including scientific journals and voluntary reports. Adverse events with a frequency of 5 or more events are listed in order of prevalence: allergic reaction, blister, inflammation at the injection site, paresthesia, infection at the injection site, bleeding at the injection site, skin rash, malaise, headache, blanching, vision abnormalities, abscess at the injection site, urticaria, herpes simplex, telangiectasis, angioedema, flu-like symptoms, nausea, vascular event, dyspnea, dermatitis, granuloma at the injection site, and scar.

Vision abnormalities, almost all of which were nonserious events, have been reported in association with edema and overcorrection. The reported events consisted of blurred, double vision, or watery eyes and were noted after treatment of the tear trough region under the eyes. Time to onset ranged from immediate to 2 weeks postinjection. Interventions reported by physicians were noted to range from none to oral steroids to injectable hyaluronidase. Outcomes included resolved, improving, or ongoing at last contact.

Scarring has mostly been reported after treatment in the forehead or glabellar region and associated with a vascular event, necrosis, skin discoloration, blister, nodule, allergic reaction, and infection. Time to onset ranged from 2 weeks to 4 months. Interventions prescribed by the physicians included topical steroidal cream, nitropaste, oral steroids, and antibiotics. Additional treatments noted were a laser procedure and surgical scar revision.

Serious adverse events have infrequently been reported for JUVEDERM® Ultra (reported with a frequency of 5 or more). The most commonly reported serious adverse events were edema, erythema, ecchymosis, pruritus, induration, and pain.

  • The onset of edema generally varied from immediate to 2 week spost-injection. The treatment prescribed included arnica, NSAIDs, antihistamines, antibiotics, steroids, and hyaluronidase. In most cases, edema resolved within a day to a month.
  • The onset of erythema generally varied from immediate to1 week post-injection. The treatment prescribed included arnica, antihistamines, antibiotics, steroids, hyaluronidase, and laser treatment. In most cases, erythema resolved within 1 to4 weeks.
  • The onset of ecchymosis generally varied from immediate to 5 days post-injection. The treatment prescribed included arnica, NSAIDs, antihistamines, antibiotics, steroids, and hyaluronidase. In most cases, ecchymosis resolved within 1 day to 4 weeks.
  • The onset of pruritus generally varied from immediate to 1 week post-injection. The treatment prescribed included NSAIDs, antihistamines, antibiotics, and steroids. In most cases, pruritus resolved within 3 days to 2 months.
  • The onset of induration generally varied from 1 day to 2 months post-injection. The treatment prescribed included antihistamines, antibiotics, steroids, and hyaluronidase. In most cases, induration resolved within 1 week.
  • The onset of pain generally varied from immediate to 8 days post-injection. The treatment prescribed included NSAIDs, antihistamines, antibiotics, steroids, and hyaluronidase. In most cases, pain resolved within 1 to 6 weeks.

Additionally there have been reports of nodules, infection, allergic reaction, inflammation, abscess, deeper wrinkle/scar, and displacement.

  • The onset of nodules generally varied from immediate to 2 weeks post-injection. The treatment prescribed included arnica, NSAIDs, antibiotics, steroids, hyaluronidase, and needle aspiration. In most cases, nodules resolved within 3 days to1 month.
  • The onset of infection generally varied from immediate to 1 week post-injection. The treatment prescribed included NSAIDs, antibiotics, and steroids. In most cases, infection resolved within 6 to10 days.
  • The onset of allergic reaction generally varied from immediate to 2 months post-injection. The treatment prescribed included antihistamines, antibiotics, steroids, and hyaluronidase. In most cases, allergic reactions resolved within 2 days to 4 months.
  • The onset of inflammation generally varied from immediate to 2 weeks post-injection. The treatment prescribed included antihistamines, antibiotics, steroids, and hyaluronidase. In most cases, inflammation resolved within 3 days to 2 months.
  • The onset of abscess generally varied from 2 days to 2 weeks post-injection. The treatment prescribed included antibiotics, steroids, and hyaluronidase. In most cases, abscess resolved within 4 to 6 weeks.
  • The onset of deeper wrinkle/scar generally varied from immediate to 2 weeks post-injection. The treatment prescribed included antibiotics, steroids, and surgical correction of the scar. Deeper wrinkle/scar has been reported infrequently but more commonly after treatment in the glabellar region.
  • The onset of displacement generally varied from immediate to 2 weeks post-injection. The treatment prescribed included antibiotics, steroids, hyaluronidase, and laser treatment.

Read the entire FDA prescribing information for Juvéderm Ultra XC (Hyaluronic Acid Injectable Gel)

Related Resources for Juvéderm Ultra XC

© Juvéderm Ultra XC Patient Information is supplied by Cerner Multum, Inc. and Juvéderm Ultra XC Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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