Drug Safety Information for SANDIMMUNE (Cyclosporine)

Safety-related Labeling Changes for RESTASIS (CYCLOSPORINE) Rx Drug: FDA Link

Adverse Drug Reactions for SANDIMMUNE* (Cyclosporine)

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 SANDIMMUNE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
2Eye irritation2085
3Drug ineffective1589
4Blood creatinine increased1435
7Cytomegalovirus infection1064
11Renal impairment1006
12Graft versus host disease1002
14Vision blurred*944
15Renal failure941
16Renal failure acute917
18Drug interaction883
19Eye pain843

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

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

Reason # of FDA Reports
1Renal transplant*19951
2Dry eye*12277
3Product used for unknown indication9023
5Prophylaxis against graft versus host disease5774
6Stem cell transplant5021
7Liver transplant*4748
8Heart transplant*4488
9Prophylaxis against transplant rejection3716
10Aplastic anaemia3539

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

Types of Adverse Events for SANDIMMUNE

Total Reports Filed with FDA: 157488

Number of FDA Adverse Event Reports by Patient Age for SANDIMMUNE

Total Reports Filed with FDA: 157488*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cyclosporine (Sandimmun neoral, Sandimmun, Cyslosporine, Gengraf, Sandimmune, Neoral, Cyclosporine, Restasis)

Charts are based on 157488 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 SANDIMMUNE Reviews and Review Summary .

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.

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