Epiduo Forte

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Adapalene is similar to vitamin A. It helps the skin renew itself.

Adapalene and benzoyl peroxide topical (for the skin) is a combination medicine used to treat acne in adults and children who are at least 9 years old.

Adapalene and benzoyl peroxide topical may also be used for purposes not listed in this medication guide.

Benzoyl peroxide can cause a rare but serious allergic reaction or severe skin irritation. Stop using this medicine and get emergency medical help if you have: hives, itching; difficult breathing, feeling light-headed; or swelling of your face, lips, tongue, or throat.

You should not use this medicine if you are allergic to adapalene (Differin) or benzoyl peroxide.

To make sure adapalene and benzoyl peroxide topical is safe for you, tell your doctor about all your medical conditions.

It is not known whether adapalene and benzoyl peroxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether adapalene and benzoyl peroxide topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Adapalene and benzoyl peroxide topical should not be used on a child younger than 9 years old.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Using more of this medicine or applying it more often than prescribed will not make it work any faster, and may increase side effects.

Benzoyl peroxide topical can cause a rare but serious allergic reaction or severe skin irritation. Before you start using this medicine, you may choose to apply a "test dose" to see if you have a reaction. Apply a very small amount of the medicine to 1 or 2 small acne areas every day for 3 days in a row. If there is no reaction, begin using the full prescribed amount on the 4th day.

Wash your hands before and after applying this medicine.

Adapalene and benzoyl peroxide topical is usually applied one time per day. Follow your doctor's instructions.

Clean and pat dry the skin to be treated. Use a pea-sized amount of the gel for each treatment area (chin, forehead, and each cheek). Apply the medicine in a thin layer and rub in gently.

Call your doctor if your symptoms do not improve, or if they get worse while using this medicine.

Do not apply any other skin products unless your doctor has told you to.

Store at room temperature away from moisture, heat, and light.

An overdose of adapalene and benzoyl peroxide topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you use other potentially irritating skin products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes). 

This is not a complete list of Epiduo Forte drug interactions. Ask your doctor or pharmacist for more information. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Epiduo Forte falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Epiduo Forte should be given to a pregnant woman only if clearly needed. 

If you use too much Epiduo Forte, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. 

• Store Epiduo Forte at room temperature, 68° to 77° F (20° to 25° C).
• Keep Epiduo Forte inside its container and out of light and away from heat.
• Keep this and all medicines out of the reach of children. 

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Epiduo Forte, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Epiduo Forte (adapalene and benzoyl peroxide). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Epiduo Forte.

Review Date: October 4, 2017

Applies to adapalene / benzoyl peroxide topical: topical gel

General

The most commonly reported side effects include irritative contact dermatitis, burning sensation, and dry skin.[Ref]

Dermatologic

Common (1% to 10%): Irritative contact dermatitis, dry skin/dryness, skin irritation, erythema, skin exfoliation/scaling
Uncommon (0.1% to 1%): Sunburn, pruritus, atopic dermatitis, eczema
Frequency not reported: Skin pain/stinging pain
Postmarketing reports: Allergic contract dermatitis, blisters/vesicles, skin discoloration, rash[Ref]

Local

Common (1% to 10%): Application site burning, application site irritation[Ref]

Nervous system

Common (1% to 10%): Burning sensation/skin burning sensation[Ref]

Ocular

Postmarketing reports: Eyelid edema, conjunctivitis[Ref]

Respiratory

Postmarketing reports: Throat tightness[Ref]

Other

Postmarketing reports: Swelling face[Ref]

Some side effects of Epiduo Forte may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.