Drug Safety Information for NEO-RX (Neomycin sulfate)

Adverse Drug Reactions for NEO-RX* (Neomycin 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 NEO-RX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Eye irritation88
2Drug hypersensitivity74
3Medication error50
4Rash44
5Pain44
6Incorrect route of drug administration40
7Drug dispensing error38
8Nausea36
9Wrong drug administered35
10Back pain31
11Diarrhoea31
12Asthenia31
13Toxic anterior segment syndrome30
14Ear pain30
15Pyrexia29
16Dyspnoea29
17Drug ineffective29
18Ocular hyperaemia27
19Headache27
20Dizziness26

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

Top 10 Reasons for Taking NEO-RX
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication344
2Ear infection158
3Gastrointestinal disorder111
4Otitis externa40
5Postoperative care40
6Conjunctivitis37
7Infection prophylaxis32
8Gastric bypass23
9Ear disorder21
10Blepharitis21

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


Types of Adverse Events for NEO-RX

Total Reports Filed with FDA: 4472


Number of FDA Adverse Event Reports by Patient Age for NEO-RX

Total Reports Filed with FDA: 4472*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Neomycin sulfate (Neo-rx, Neo-fradin, Vitacilina, Neomycin sulfate, Pomada de sulfa, Antibiotic ointment, Baclezene, Neomycin, Neobiotic, Mycifradin)

Charts are based on 4472 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 NEO-RX 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.

Visit   DrugInformer.com more on NEO-RX's side effects.