Drug Safety Information for DUREZOL (Difluprednate)

Safety-related Labeling Changes for DUREZOL (DIFLUPREDNATE) Rx Drug: FDA Link

Adverse Drug Reactions for DUREZOL* (Difluprednate)

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 DUREZOL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Intraocular pressure increased	28
2	Cataract	27
3	Vision blurred	23
4	Off label use	20
5	Headache	18
6	Nausea	16
7	Pain*	14
8	Pyrexia	13
9	Endophthalmitis	13
10	Dyspnoea	13
11	Visual acuity reduced	12
12	Drug ineffective	11
13	Visual impairment	11
14	Fatigue	11
15	Eye pain	11
16	Ocular hyperaemia*	10
17	Corneal disorder	10
18	Fall	10
19	Eye irritation	10
20	Diarrhoea	10

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	189
2	Cataract operation	72
3	Iritis	69
4	Uveitis	61
5	Postoperative care	58
6	Bone marrow transplant	37
7	Psoriasis	34
8	Folliculitis	14
9	Pustular psoriasis	12
10	Ocular hypertension	10

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

Types of Adverse Events for DUREZOL

Total Reports Filed with FDA: 1492

Number of FDA Adverse Event Reports by Patient Age for DUREZOL

Total Reports Filed with FDA: 1492*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Difluprednate (Durezol)

Charts are based on 1492 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.

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.