Differin Lotion .1
"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
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 of Differin Lotion 0.1% include:
- skin burning
- 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.
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 Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Differin Lotion .1 Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: very red/irritated skin, an intense burning sensation, eye redness and watering (conjunctivitis), eyelid swelling, skin discoloration.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview 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
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/
|Adapalene lotion 0.1%
N = 1068
N = 1073
|Subjects with Related AR(s)||10,2%||4.6%|
|Skin burning/skin discomfort||0.9%||0.0%|
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
|Local Cutaneous Irritation (skin irritation||Mild||Moderate||Severe||MM||Moderate||Severe|
|*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%)
Additional Differin Lotion .1 Information
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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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