Drug Safety Information for PREDNISOLONE ACETATE (Prednisolone acetate)

Safety-related Labeling Changes for BLEPHAMIDE (PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for PRED FORTE (PREDNISOLONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for PRED MILD (PREDNISOLONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for OMNIPRED (PREDNISOLONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for FLO-PRED (PREDNISOLONE ACETATE) Discontinued Drug: FDA Link

Adverse Drug Reactions for PREDNISOLONE ACETATE* (Prednisolone acetate)

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 PREDNISOLONE ACETATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Visual acuity reduced127
2Vision blurred107
3Eye pain100
4Intraocular pressure increased83
5Drug ineffective82
6Eye irritation78
7Pneumonia76
8Dyspnoea74
9Headache67
10Cataract64
11Fatigue63
12Ocular hyperaemia63
13Endophthalmitis62
14Pyrexia62
15Diarrhoea58
16Off label use57
17Nausea54
18Pain*54
19Dizziness52
20Visual impairment52

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

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

Reason # of FDA Reports
1Product used for unknown indication868
2Postoperative care393
3Cataract operation341
4Uveitis170
5Iritis108
6Eye disorder95
7Prophylaxis against graft versus host disease84
8Cataract71
9Corneal transplant67
10Glaucoma66

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


Types of Adverse Events for PREDNISOLONE ACETATE

Total Reports Filed with FDA: 10108


Number of FDA Adverse Event Reports by Patient Age for PREDNISOLONE ACETATE

Total Reports Filed with FDA: 10108*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Prednisolone acetate (Omnipred, Econopred, Meticortelone, Flo-pred, Pred mild, Pred forte, Prednisolone acetate)

Charts are based on 10108 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 PREDNISOLONE ACETATE 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.