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Differin Lotion .1

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

Last reviewed on RxList 3/28/2016

Differin (adapalene) Lotion 0.1% 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. Common side effects of Differin Lotion 0.1% include:

  • skin burning
  • warmth
  • stinging
  • tingling
  • itching
  • redness
  • dryness
  • scaling
  • irritation, or
  • worsening of acne, especially during the first 4 weeks of using this drug

Apply a thin film dose of Differin Lotion to the entire face and other affected areas of the skin once daily, after washing gently with a mild soapless cleanser. Dispense a nickel size amount of Differin Lotion (3-4 actuations of the pump) to cover the entire face. Avoid application to the areas of skin around eyes, lips and mucous membranes. Differin 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 during treatment with Differin. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Differin (adapalene) Lotion 0.1% 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.

Differin Lotion .1 Consumer Information

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

During your first 4 weeks of using adapalene topical, your skin may be dry, red, or scaly. You may also feel some burning or stinging. Call your doctor if these side effects are severe.

Less serious side effects are more likely to occur, such as mild burning, warmth, stinging, tingling, itching, redness, or irritation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Differin Lotion .1 (Adapalene Lotion .1%)

Differin Lotion .1 Professional Information

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction 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.

A total of 2141 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Of these, 1068 were exposed to DIFFERIN Lotion during the clinical trials. A total of 1057 subjects completed at least one post treatment evaluation.

Related adverse reactions that were reported in at least 1% of subjects treated with DIFFERIN Lotion or with the Vehicle Lotion are presented in Table 1.

The majority of cases were transient, mild to moderate in severity and were managed with moisturizers.

Table 1: Adverse Reactions Reported in Clinical Trials by At Least 1% of Subjects

System Organ Class/
Preferred Term
Adapalene lotion 0.1%
N = 1068
Vehicle Lotion
N = 1073
Subjects with Related AR(s) 10,2% 4.6%
  Dry Skin 7.7% 3.0%
  Skin Irritation 1,5% 0.7%
  Skin burning/skin discomfort 0.9% 0.0%
  Sunburn 0.6% 0.6%

Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials. Erythema, scaling, dryness, burning/stinging were assessed:

Table 2: Incidence of Local Cutaneous Irritation, for Subjects Whose Irritation Score was Higher than at Baseline, in Controlled Clinical Trials Adverse Reactions (DIFFERIN Lotion Group N = 1057*)

Combined Trial 1 and Trial 2 Maximum Severity During Treatment
(N = 1057)
Week 12 Treatment Severity
(N =950)
Local Cutaneous Irritation (skin irritation Mild Moderate Severe MM Moderate Severe
Erythema 21.8% 8.0% 0.2% 7.9% 2.6% 0.2%
Scaling 25.3% 6.5% 0.1% 5.3% 1.1% 0%
Dryness 36.1% 7.3% 0.3% 7.6% 2.0% 0%
Stinging/burning 22.1% 7.0% 0.9% 4.6% 1.0% 0.4%
*Data from 11 subjects with missing data are not included

Local tolerability scores for erythema, scaling, dryness, burning/stinging rose during the first two weeks of treatment and generally decreased thereafter.

In an open label postmarketing pharmacokinetic trial of 13 adolescent subjects, the adverse reaction of pruritus was reported in 8 out of 13 subjects.

Read the entire FDA prescribing information for Differin Lotion .1 (Adapalene Lotion .1%)

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© Differin Lotion .1 Patient Information is supplied by Cerner Multum, Inc. and Differin Lotion .1 Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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