Drug Safety Information for ZIOPTAN (Tafluprost)

Adverse Drug Reactions for ZIOPTAN* (Tafluprost)

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 ZIOPTAN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Ocular hyperaemia	64
2	Eye irritation	52
3	Eye pain	48
4	Vision blurred	40
5	Headache	29
6	Eye pruritus	25
7	Dry eye	21
8	Drug ineffective	21
9	Drug dose omission	20
10	Dizziness	20
11	Product quality issue	18
12	Urinary tract infection	16
13	Pruritus	16
14	Photophobia	15
15	Pain	15
16	Dyspnoea	15
17	Cough	15
18	Incorrect storage of drug	15
19	Pemphigoid	15
20	Rash	13

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

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

	Reason	# of FDA Reports
1	Glaucoma	569
2	Product used for unknown indication	82
3	Open angle glaucoma	77
4	Intraocular pressure increased	58
5	Intraocular pressure test	44
6	Ocular hypertension	40
7	Normal tension glaucoma	18
8	Intraocular pressure decreased	10
9	Prophylaxis	10
10	Intraocular pressure test abnormal	8

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

Types of Adverse Events for ZIOPTAN

Total Reports Filed with FDA: 1449

Number of FDA Adverse Event Reports by Patient Age for ZIOPTAN

Total Reports Filed with FDA: 1449*

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

Charts are based on 1449 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.