Drug Safety Information for EPIDUO (Adapalene; benzoyl peroxide)

FDA Safety-related Labeling Changes for EPIDUO FORTE (ADAPALENE; BENZOYL PEROXIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for EPIDUO* (Adapalene; benzoyl peroxide)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with EPIDUO
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Erythema	126
2	Dry skin*	98
3	Skin burning sensation	92
4	Skin exfoliation	69
5	Acne*	65
6	Drug ineffective	55
7	Swelling face	49
8	Pruritus	45
9	Pain of skin	38
10	Skin irritation	34
11	Rash	16
12	Eyelid oedema	15
13	Pain	12
14	Dermatitis	12
15	Dermatitis allergic	11
16	Drug effect decreased	11
17	Off label use	11
18	Inappropriate schedule of drug administration	11
19	Condition aggravated	11
20	Chemical injury	10

* This side effect also appears in "Top 10 Side Effects of EPIDUO " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking EPIDUO
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Acne*	965
2	Product used for unknown indication	58
3	Rash papular	11
4	Rash	9
5	Antibiotic therapy	6
6	Rosacea	6
7	Dermatitis acneiform	5
8	Wrong drug administered	5
9	Prophylaxis	4
10	Acne cystic	4

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for EPIDUO

Total Reports Filed with FDA: 1363

Number of FDA Adverse Event Reports by Patient Age for EPIDUO

Total Reports Filed with FDA: 1363*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Adapalene; benzoyl peroxide (Epiduo forte, Epiduo)

Charts are based on 1363 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.