Differin Gel .3
"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 Gel .3%
Differin Gel .3 Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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 effects usually decrease with continued use.
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 breast-feeding.
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.
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 Gel .3 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 Gel .3 (Adapalene)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Differin Gel .3 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 Gel .3 (Adapalene)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Differin Gel .3 FDA Prescribing 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
|Incidence of Local Cutaneous Irritation with DIFFERIN Gel,
0.3% from Controlled Clinical Study (N = 253*)
Maximum Severity Scores Higher Than Baseline
|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|
|Related* Adverse Reactions||57(22.1%)||6 (4.5%)|
|Skin Discomfort||15(5.8%)||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.
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)
Additional Differin Gel .3% Information
Differin Gel .1% - User Reviews
Differin Gel .1% User Reviews
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Report Problems to the Food and Drug Administration
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