Differin Lotion .1

Differin Lotion .1

Differin Lotion .1 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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 include mild burning, warmth, stinging, tingling, itching, redness, or irritation.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Differin Lotion .1 in Detail - Patient Information: Side Effects

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%) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Differin Lotion .1 FDA Prescribing Information: Side Effects
(Adverse Reactions)

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) 10.20% 4.60%
  Dry Skin 7.70% 3.00%
  Skin irritation 1.50% 0.70%
  Skin burning/skin discomfort 0.90% 0.00%
  Sunburn 0.60% 0.60%

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 Mild Moderate Severe
Erythema 21.80% 8.00% 0.20% 7.90% 2.60% 0.20%
Scaling 25.30% 6.50% 0.10% 5.30% 1.10% 0%
Dryness 36.10% 7.30% 0.30% 7.60% 2.00% 0%
Stinging/burning 22.10% 7.00% 0.90% 4.60% 1.00% 0.40%
* 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 event 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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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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