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Eskata

Last reviewed on RxList: 2/21/2019
Eskata Side Effects Center

Last reviewed on RxList 2/21/2019

Eskata (hydrogen peroxide) is indicated for the treatment of seborrheic keratoses that are raised. Common side effects of Eskata include:

  • skin redness,
  • stinging,
  • swelling,
  • scaling,
  • crusting,
  • itching,
  • blistering,
  • discoloration, and
  • ulceration.

Eskata is administered by a healthcare provider. Apply a dose of Eskata 4 times, approximately 1 minute apart, to the targeted lesion(s) during a single in-office treatment session. Eskata may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Eskata. Hydrogen peroxide is not absorbed systemically following topical administration, and maternal use of Eskata is not expected to result in fetal exposure to the drug. Hydrogen peroxide is not absorbed systemically following topical administration of Eskata, and breastfeeding is not expected to result in exposure of the child to hydrogen peroxide. Consult your doctor before breastfeeding.

Our Eskata (hydrogen peroxide) Topical Solution 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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Eskata Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to ESKATA or vehicle in a total of 937 subjects with seborrheic keratoses that are raised. Overall, 42% of the subjects were male and 58% were female. Ninety-eight (98) percent of the subjects were Caucasian and the mean age was 68.7 years.

At each visit, local skin reactions were graded for severity to determine the maximum severity after treatment. Table 1 presents the percentage of subjects with the local adverse reactions by the most severe grade reported during the course of the trials.

Table 1: Percentage of Subjects with Local Skin Reactions by Severity

  ESKATA
N=467
Vehicle
N=470
Mild Moderate Severe Total Mild Moderate Severe Total
Erythema 13 67 19 99 29 5 <1 34
Stinging 34 49 15 97 9 1 <1 10
Edema 28 48 15 91 6 1 0 6
Scaling 49 36 5 90 28 5 1 33
Crusting 34 38 8 81 13 5 1 19
Pruritus 34 18 5 58 7 1 <1 8
Hyperpigmentation 32 7 <1 39 1 <1 0 1
Vesicles 21 3 1 24 <1 0 0 <1
Hypopigmentation 16 3 <1 19 1 <1 0 1
Erosion 12 2 1 15 <1 0 0 1
Ulceration 6 2 <1 9 1 1 0 2
Atrophy 4 0 0 4 0 0 0 0
Scarring 3 <1 <1 3 0 0 0 0

Common local skin reactions observed 10 minutes after treatment include: erythema (98%), stinging (93%), edema (85%), pruritus (32%), and vesiculation (18%).

Common local skin reactions observed 1 week after treatment are scaling (72%), erythema (66%), crusting (67%), pruritus (18%), erosion (9%), and ulceration (4%).

Common local skin reactions observed 15 weeks after the initial treatment are erythema (21%), hyperpigmentation (18%), scaling (16%), crusting (12%), and hypopigmentation (7%).

Less common adverse reactions occurring in ≥ 0.5% of subjects treated with ESKATA include eyelid edema (0.6%) and herpes zoster (0.6%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ESKATA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissues disorders: crepitus

Read the entire FDA prescribing information for Eskata (Hydrogen Peroxide Topical Solution)

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

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