Drug Safety Information for FML (Fluorometholone)

FDA Safety-related Labeling Changes for FLAREX (FLUOROMETHOLONE ACETATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for FML* (Fluorometholone)

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 FML
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Eye irritation	33
2	Eye pain	32
3	Vision blurred	31
4	Nausea	23
5	Intraocular pressure increased	22
6	Drug ineffective	22
7	Dyspnoea	20
8	Keratitis	18
9	Fatigue	17
10	Asthenia	17
11	Headache	17
12	Ocular hyperaemia	16
13	Lacrimation increased	16
14	Pyrexia	15
15	Pneumonia	15
16	Arthralgia	14
17	Dizziness	14
18	Rash	14
19	Visual acuity reduced	13
20	Blindness	13

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	253
2	Dry eye*	50
3	Eye inflammation	36
4	Postoperative care	36
5	Antiinflammatory therapy	24
6	Iritis	23
7	Uveitis	22
8	Prophylaxis	22
9	Eye infection*	19
10	Eye injury	18

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

Types of Adverse Events for FML

Total Reports Filed with FDA: 2199

Number of FDA Adverse Event Reports by Patient Age for FML

Total Reports Filed with FDA: 2199*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluorometholone (Fml forte, Oxylone, Fluor-op, Efflumidex, Flucon, Fluorometholone, Fml, Fml liquifilm)

Charts are based on 2199 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.