Drug Safety Information for ZYLET (Loteprednol etabonate; tobramycin)

Safety-related Labeling Changes for ZYLET (LOTEPREDNOL ETABONATE; TOBRAMYCIN) Rx Drug: FDA Link

Adverse Drug Reactions for ZYLET* (Loteprednol etabonate; tobramycin)

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 ZYLET
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Eye irritation30
2Ocular hyperaemia30
3Eye pain24
4Lacrimation increased14
5Headache14
6Condition aggravated13
7Eye pruritus13
8Drug ineffective13
9Vision blurred12
10Drug hypersensitivity12
11Eyelid oedema12
12Hypersensitivity9
13Dry eye8
14Eye swelling8
15Dizziness7
16Rash5
17Dyspnoea5
18Photophobia5
19Ocular discomfort5
20Intraocular pressure increased5

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

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

Reason # of FDA Reports
1Eye infection71
2Conjunctivitis36
3Product used for unknown indication33
4Blepharitis32
5Eye inflammation15
6Eye allergy12
7Chalazion11
8Corneal abrasion10
9Postoperative care10
10Eye infection bacterial9

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


Types of Adverse Events for ZYLET

Total Reports Filed with FDA: 566


Number of FDA Adverse Event Reports by Patient Age for ZYLET

Total Reports Filed with FDA: 566*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Loteprednol etabonate; tobramycin (Zylet)

Charts are based on 566 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 ZYLET 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.