Drug Safety Information for DIFFERIN (Adapalene)

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

Adverse Drug Reactions for DIFFERIN* (Adapalene)

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 DIFFERIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*58
2Dry skin*53
3Erythema*50
4Anxiety48
5Injury40
6Nausea40
7Depression39
8Skin exfoliation*38
9Dyspnoea36
10Dizziness36
11Pulmonary embolism35
12Abdominal pain35
13Headache32
14Drug ineffective31
15Paraesthesia30
16Rash29
17Acne*28
18Emotional distress27
19Deep vein thrombosis27
20Vomiting26

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

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

Reason # of FDA Reports
1Acne*1044
2Product used for unknown indication187
3Acne cystic*32
4Rash22
5Prophylaxis20
6Acne conglobata10
7Chloasma8
8Skin discolouration7
9Off label use7
10Headache7

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


Types of Adverse Events for DIFFERIN

Total Reports Filed with FDA: 3499


Number of FDA Adverse Event Reports by Patient Age for DIFFERIN

Total Reports Filed with FDA: 3499*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Adapalene (Adapalene, Differin)

Charts are based on 3499 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.

Click to go back to search results and DIFFERIN Reviews and Review Summary .

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.