Drug Safety Information for LATANOPROST (Latanoprost)

FDA Safety-related Labeling Changes for XALATAN (LATANOPROST) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for ROCKLATAN (LATANOPROST; NETARSUDIL DIMESYLATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for LATANOPROST* (Latanoprost)

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 LATANOPROST
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Intraocular pressure increased1117
2Eye irritation881
3Drug ineffective765
4Cataract690
5Ocular hyperaemia*553
6Glaucoma546
7Eye pain*534
8Visual acuity reduced534
9Dyspnoea529
10Vision blurred*516
11Dizziness515
12Headache*489
13Death483
14Nausea432
15Fall422
16Fatigue*421
17Eye disorder401
18Asthenia338
19Visual impairment334
20Pain*322

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

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

Reason # of FDA Reports
1Glaucoma*15515
2Product used for unknown indication2918
3Intraocular pressure increased1836
4Open angle glaucoma*1075
5Ocular hypertension*490
6Cataract345
7Intraocular pressure test316
8Ill-defined disorder277
9Intraocular pressure test abnormal236
10Eye disorder188

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


Types of Adverse Events for LATANOPROST

Total Reports Filed with FDA: 53181


Number of FDA Adverse Event Reports by Patient Age for LATANOPROST

Total Reports Filed with FDA: 53181*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Latanoprost (Latanoprost, Xalatan)

Charts are based on 53181 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 LATANOPROST 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.