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Differin Gel .3

Last reviewed on RxList: 1/24/2017
Differin Gel .3 Side Effects Center

Last reviewed on RxList 01/19/2017

Differin (adapalene) Gel 0.3% is a topical (applied to the skin) medication similar to vitamin A used to treat severe acne in people who are at least 12 years old. Differin Gel 0.3% is available in generic form. Common side effects of Differin Gel 0.3% include:

  • a brief sensation of warmth or stinging immediately after applying the medication.

Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2-4 weeks of using Differin Gel 0.3%. These side effects usually decrease with continued use Differin Gel 0.3%. Tell your doctor if you have unlikely but serious side effects of Differin Gel 0.3% including:

  • very red or irritated skin,
  • an intense burning sensation,
  • eye redness and watering (conjunctivitis),
  • eyelid swelling, or
  • skin discoloration.

Differin Gel 0.3% should be applied in a thin film to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. It is not likely that other drugs you take orally or inject will have an effect on topically applied Differin Gel 0.3%. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Differin Gel 0.3% should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Differin (adapalene) Gel 0.3% 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.

QUESTION

Acne is the result of an allergy. See Answer
Differin Gel .3 Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • skin redness, stinging, burning, or peeling after sun exposure.

Some side effects may occur during the first 4 weeks of using this medicine. These side effects should become less noticeable with continued use.

Common side effects may include:

  • dry, red, or scaly skin;
  • feeling of warmth and mild stinging or burning;
  • peeling skin; or
  • skin pain.

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.

Read the entire detailed patient monograph for Differin Gel .3 (Adapalene)

SLIDESHOW

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Differin Gel .3 Professional Information

SIDE EFFECTS

Clinical Studies Experience

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

In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne patients who used DIFFERIN Gel, 0.3% once daily for 12 weeks. Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with DIFFERIN Gel, 0.3% from the controlled clinical study is provided in the following table:

Table 1: Physician assessed local cutaneous irritation with DIPPERIN Gel

Incidence of Local Cutaneous Irritation with DIFFERIN Gel, 0.3% from Controlled Clinical Study (N = 253*)
Maximum Severity Scores Higher Than Baseline
  Mild Moderate Severe
Erythema 66 (26.1%) 33 (13.0%) 1 (0.4%)
Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%)
Dryness 113 (44.7%) 43 (17.0%) 2 (0.8%)
Burning/Stinging 72 (28.5%) 36 (142%) 9 (3.6%)
* Total number of subjects with local cutaneous data for at least one post-Baseline evaluation.

Table 2: Patient reported local cutaneous adverse reactions with DIFFERIN Gel

  DIFFERIN (adapalene) Gel, 0.3% Vehicle Gel
N=258 N=134
Related* Adverse Reactions 57(22.1%) 6 (4.5%)
  Dry Skin 36(14%) 2(1.5%)
  Skin Discomfort 15(5.8%) 0 (0.0%)
  Desquamation 4(1.6%) 0 (0.0%)
* Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related

Related adverse reactions from the controlled clinical trial that occurred in greater than 1% of patients who used DIFFERIN Gel, 0.3% once daily included: dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). The following selected adverse reactions occurred in less than 1% of patients: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

In a one-year, open-label safety study of 551 patients with acne who received DIFFERIN Gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of adapalene: skin irritation, application site pain, face edema, eyelid edema, lip swelling, and angioedema. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drag exposure.

Read the entire FDA prescribing information for Differin Gel .3 (Adapalene)

Related Resources for Differin Gel .3

Related Health

Read the Differin Gel .3 User Reviews »

© Differin Gel .3 Patient Information is supplied by Cerner Multum, Inc. and Differin Gel .3 Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Acne is the result of an allergy. See Answer

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