The following adverse reactions have been identified during post approval use of Diferin: 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.
Clinical studies of Diferin Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.
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What’s a retinoid?
Topical retinoids play a crucial role in the treatment of acne. When you have acne, your skin cell turnover is in overdrive — as new cells are being produced, old cells aren’t being discarded as they should. These old cells, along with sebum and bacteria, clog the pores. Diferin adjusts the speed of skin cell turnover to make sure your skin goes through the right process, creating a healthier environment for skin. Regulating skin cell turnover to a normal rate helps to keep the pores from clogging and target acne before it even starts. According to the American Academy of Dermatology’s (AAD) therapeutic treatment guidelines, topical retinoids are recommended as a primary therapy for initial treatment of mild, moderate and severe acne.
There are other topical retinoids — tretinoin and tazarotene — used to treat acne, but Diferin is the only one available over the counter. In clinical studies, Diferin has shown superior tolerability to other topical prescription retinoids, meaning Differin is gentler on your skin, while still effective.
- Diferin is more stable to light and oxygen, compared to tretinoin
- Stability to light means that it won’t lose effectiveness when exposed to sunlight
- Works deep in the pores where acne begins
What are the Advantages of Differin Diferin Gel?
- It is said to fight acne at its root cause, targeting acne-causing bacteria.
- It may regulate the oil production.
- It may clear the skin and prevents formation of breakouts.
- It claims to effectively eliminate acne after 12 weeks of regular use.
Not your parents’ acne treatment.
Take a different approach to clearing—and preventing—your acne. Non-comedogenic, fragrance-free Differin Gel contains the retinoid Diferin, the first over-the-counter active ingredient for acne in more than 30 years. It’s what you and your skin have been waiting for. Use daily. Live beautifully.
- Clears acne with the power of Rx
- Prevents breakouts, blackheads, whiteheads, blemishes and clogged pores
- Restores skin tone and texture by clearing acne
- Prescription no longer required
- Available in 15g (up to 30-day supply) and 45g (up to 90-day supply)
Active ingredient: Diferin 0.1% (retinoid) Inactive ingredients: carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH.
What Other Drugs Interact with Diferin?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Diferin has no known severe interactions with other drugs.
Diferin has no known serious interactions with other drugs.
Diferin has no known moderate interactions with other drugs.
Diferin has no known mild interactions with other drugs.
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.
How to use Diferin Gel
If you are using the over-the-counter product to self-treat, read and follow all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, use it as directed.
Use this medication as directed by your doctor or the product package, usually once daily at bedtime. Before using, gently clean the affected skin with a mild or soapless cleanser and pat dry.
If you are using the gel, cream, or lotion, wash your hands before and after applying this medication. Use your fingertips to apply a small amount of medication in a thin layer. If you are using the medicated swab, unwrap the swab and apply a thin layer to the affected area(s).
Use this medication on the skin only. Avoid getting this medication in your eyes or on your lips. Do not apply to the inner lip area or inside the nose/mouth. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Do not apply to cut, scraped, or sunburned areas, or to skin affected by eczema (a skin condition).
During the first few weeks of using Diferin, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take 8 to 12 weeks to notice results from this medication.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more often than directed. Your skin will not improve any faster, and your risk of developing side effects (such as redness, peeling, or pain) will increase.
This medication is available in different strengths and forms (such as gel, cream, lotion). The best type of medication for you to use will depend on the condition of your skin and your response to treatment. Tell your doctor if your condition does not get better or if it gets worse.
Since this drug is absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.
When to Call a Doctor
Call 911 or go to your nearest emergency room if you develop a severe rash, hives, shortness of breath, wheezing, rapid or irregular heartbeat, confusion, dizziness, or swelling of the face, tongue, or throat after using Diferin.
If left untreated, anaphylaxis can lead to shock, coma, cardiac or respiratory failure, asphyxiation, and death.
What’s Diferin and how does it work?
Diferin is the active ingredient in Differin ® Gel. It’s a multi-benefit, dermatologist-recommended retinoid specifically used for clearing acne. Diferin treats acne deep in the pores at the source, prevents new acne from forming and, as a result of reduced acne, restores your skin’s natural texture and tone. Diferin has been prescribed to more than 40 million people over the last 20 years. With Differin Gel, acne sufferers now have access to this effective treatment without a prescription.
- No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day Diferin representing up to 6 times the maximum recommended human dose (MRHD) based on mg/m 2 comparisons. Diferin has been shown to be teratogenic in rats and rabbits when administered orally at doses ≥ 25 mg/kg representing 32 and 65 times, respectively, the MRHD based on mg/m 2 comparisons. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in the rat and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in the rabbit.
- Cutaneous teratology studies in rats and rabbits at doses of 0.6,2.0, and 6.0 mg/kg/day exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. Systemic exposure (AUC0-24h) to Diferin 0.3% gel at topical doses of 6.0 mg/kg/day in rats and rabbits represented 5.7 and 28.7 times, respectively, the exposure in acne patients treated with Diferin 0.3% gel applied to the face, chest and back (2 grams applied to 1000 cm 2 of acne involved skin).
All retinoids are naturally a chemical component of vitamin A. They actually fill many significant roles within the human body. Aside from regulating cell growth, they also active genes that suppress tumors, improve vision and regulate bone tissue growth.
But it’s only for that first role that they are used primarily in medications designed to treat acne.
Retinoids are divided into three generations. Tretinoin is from the first generation. Diferin and tazarotene are both from the third generation.
Diferin is a topical retinoid that is FDA-approved for the treatment of acne vulgaris. Retinoids are used to treat a wide variety of skin disorders. Diferin is also useful for several non-FDA-approved indications, including the treatment of verruca, molluscum contagiosum, Darier disease, Fox-Fordyce disease, Dowling-Degos disease, photoaging, pigmentary disorders, actinic keratoses, and alopecia areata.
Diferin was initially FDA-approved in 1996 for acne in patients 12 years of age or older. Diferin is available as a 0.1% cream, gel, and lotion, and 0.3% gel. Diferin, 0.1% gel, was FDA-approved in 2016 as an over-the-counter acne treatment in patients 12 years of age or older. Diferin 0.1% lotion and cream and Diferin 0.3% gel are available by prescription only.
Retinoids are vitamin A derivatives. Topical retinoids used in the treatment of acne vulgaris include Diferin, tretinoin, and tazarotene. Topical retinoids are recommended as first-line therapy for the treatment of acne vulgaris, either alone or in combination with other acne medications. Topical retinoids target two pathogenic mechanisms of acne vulgaris: microcomedone formation, which is the precursor of all forms of acne lesions, and the inflammatory response.
Conventional teaching indicates that the retinoids used to treat acne have varying degrees of efficacy and tolerability. Diferin is perceived to be the least effective, but the best tolerated. Tretinoin is perceived to have moderate efficacy and tolerability. Tazarotene is perceived to be the most efficacious, but the least tolerated due to patient skin irritation.
Studies support that Diferin is efficacious in the treatment of acne vulgaris. A meta-analysis included five randomized controlled trials and suggested that Diferin 0.1% gel has similar efficacy but enhanced tolerability in the treatment of acne as compared to tretinoin 0.025% gel.
A vehicle formulation of microsphere gel was developed for tretinoin, which allows for the medication to be delivered primarily to the epidermis; this provides for decreased irritation and better tolerability. A randomized controlled trial of tolerability, safety, and efficacy of Diferin gel 0.1% and tretinoin 0.1% microsphere gel revealed that the efficacy was comparable in terms of total, non-inflammatory, and inflammatory lesions. However, the Diferin patient group exhibited significantly enhanced cutaneous tolerability.
Diferin also performs well when compared to tazarotene. In a 12-week randomized, evaluator-blinded study comparing Diferin 0.3% gel and tazarotene 0.1% gel, each group had a clinically significant reduction in total lesion counts. A 61% reduction in acne lesions occurred with the use of Diferin, with a 57% reduction in the tazarotene group. Diferin, 0.3% gel, was found to have equivalent efficacy as tazarotene 0.1% gel. However, patients using Diferin experienced less irritation than patients in the tazarotene treated group.
Diferin has additional advantages when compared to other retinoids. Diferin is a more stable molecule, which leads to less concern for molecular photodegradation, allowing for use during daylight hours. This stability is in contrast to both tretinoin and tazarotene, which are photolabile. Diferin also exhibits less chemical instability, allowing for use in combination with benzoyl peroxide.
COMMON BRAND(S): Differin
GENERIC NAME(S): Diferin
OTHER NAME(S): Diferin Solution
This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Diferin belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.
Diferin Side Effects
When first used, Diferin can cause dryness, redness and irritation for some individuals. This irritation usually lessens after the first 4 weeks of continued use, however. In some instances acne may appear worse for a short time. If this occurs, you can try a gentle, non-comedogenic moisturizer, preferably one with sunscreen protection, to counteract the dryness. If irritation becomes severe (overly bothersome), stop use and ask a doctor before using the product again.
Finally, women who are pregnant or breastfeeding should consult a doctor before using Diferin as an acne treatment.