Drug Safety Information for LUCENTIS (Ranibizumab)

FDA Safety-related Labeling Changes for LUCENTIS (RANIBIZUMAB) Rx Drug: Safety Information Link

Adverse Drug Reactions for LUCENTIS* (Ranibizumab)

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 LUCENTIS
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death2444
2Visual acuity reduced1950
3Cerebrovascular accident954
4Eye haemorrhage589
5Visual impairment586
6Myocardial infarction560
7Retinal haemorrhage471
8Vision blurred468
9Drug ineffective443
10Eye pain440
11Fall431
12Blindness419
13Malaise370
14Cataract365
15Pneumonia255
16Blindness unilateral254
17Retinal pigment epithelial tear251
18Vitreous floaters246
19Endophthalmitis242
20Hypertension240

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

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

Reason # of FDA Reports
1Age-related macular degeneration10743
2Macular degeneration7105
3Product used for unknown indication6812
4Diabetic retinal oedema2151
5Retinal vein occlusion1045
6Maculopathy804
7Choroidal neovascularisation670
8Macular oedema369
9Diabetic retinopathy360
10Diabetic eye disease286

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


Types of Adverse Events for LUCENTIS

Total Reports Filed with FDA: 33575


Number of FDA Adverse Event Reports by Patient Age for LUCENTIS

Total Reports Filed with FDA: 33575*


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

Charts are based on 33575 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 LUCENTIS 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.