Drug Safety Information for NEOSPORIN (Bacitracin zinc; neomycin sulfate; polymyxin b sulfate)

Safety-related Labeling Changes for NEOSPORIN (BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE) Rx Drug: FDA Link

Adverse Drug Reactions for NEOSPORIN* (Bacitracin zinc; neomycin sulfate; polymyxin b sulfate)

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 NEOSPORIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug hypersensitivity142
2Rash67
3Pruritus57
4Pain55
5Drug ineffective48
6Off label use47
7Dyspnoea38
8Erythema37
9Blister36
10Hypersensitivity36
11Nausea30
12Condition aggravated30
13Infection27
14Anxiety26
15Fatigue26
16Headache25
17Diarrhoea24
18Urticaria24
19Dizziness23
20Pain in extremity22

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

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

Reason # of FDA Reports
1Product used for unknown indication561
2Laceration113
3Scratch79
4Wound72
5Facial pain66
6Rash61
7Pruritus52
8Excoriation48
9Thermal burn46
10Chapped lips44

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


Types of Adverse Events for NEOSPORIN

Total Reports Filed with FDA: 4506


Number of FDA Adverse Event Reports by Patient Age for NEOSPORIN

Total Reports Filed with FDA: 4506*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Bacitracin zinc; neomycin sulfate; polymyxin b sulfate (Sunmark, Neo-polycin, Shopko, Medi-first, Neocidin, Our family, Tribiotic, Neosporin, Neo-poly-bac, Makesense, Cvp)

Charts are based on 4506 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 NEOSPORIN 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.