Drug Safety Information for BENZACLIN (Benzoyl peroxide; clindamycin phosphate)

Safety-related Labeling Changes for ONEXTON (BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE) Rx Drug: FDA Link

Adverse Drug Reactions for BENZACLIN* (Benzoyl peroxide; clindamycin phosphate)

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 BENZACLIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Erythema54
2Drug ineffective53
3Pain*49
4Pruritus*46
5Pulmonary embolism42
6Injury35
7Deep vein thrombosis35
8Anxiety35
9Rash*32
10Dry skin*29
11Product quality issue28
12Acne25
13Swelling face24
14Burning sensation*20
15Urticaria19
16Nausea19
17Diarrhoea19
18Dyspnoea19
19Colitis ulcerative19
20Headache18

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

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

Reason # of FDA Reports
1Acne*1104
2Product used for unknown indication185
3Rosacea22
4Rash pustular13
5Rash8
6Scar6
7Prophylaxis5
8Ingrown hair5
9Furuncle4
10Self esteem decreased3

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


Types of Adverse Events for BENZACLIN

Total Reports Filed with FDA: 2466


Number of FDA Adverse Event Reports by Patient Age for BENZACLIN

Total Reports Filed with FDA: 2466*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Benzoyl peroxide; clindamycin phosphate (Acanya, Duac, Neuac, Benzaclin, Onexton)

Charts are based on 2466 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 BENZACLIN Reviews and Review Summary .

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.

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