Drug Safety Information for NEORAL (Cyclosporine)
FDA Safety-related Labeling Changes for SANDIMMUNE (CYCLOSPORINE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for NEORAL (CYCLOSPORINE) Rx Drug: Safety Information Link
FDA Safety-related Labeling Changes for RESTASIS (CYCLOSPORINE) Rx Drug: Safety Information Link
Adverse Drug Reactions for NEORAL* (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 NEORAL
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Pyrexia | 2183 |
2 | Eye irritation | 2085 |
3 | Drug ineffective | 1589 |
4 | Blood creatinine increased | 1435 |
5 | Diarrhoea | 1186 |
6 | Nausea* | 1093 |
7 | Cytomegalovirus infection | 1064 |
8 | Dyspnoea | 1018 |
9 | Sepsis | 1015 |
10 | Pneumonia | 1012 |
11 | Renal impairment | 1006 |
12 | Graft versus host disease | 1002 |
13 | Headache* | 985 |
14 | Vision blurred* | 944 |
15 | Renal failure | 941 |
16 | Renal failure acute | 917 |
17 | Vomiting | 910 |
18 | Drug interaction | 883 |
19 | Eye pain | 843 |
20 | Anaemia | 824 |
* This side effect also appears in "Top 10 Side Effects of NEORAL " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking NEORAL
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Renal transplant* | 19951 |
2 | Dry eye* | 12277 |
3 | Product used for unknown indication | 9023 |
4 | Immunosuppression | 5876 |
5 | Prophylaxis against graft versus host disease | 5774 |
6 | Stem cell transplant | 5021 |
7 | Liver transplant* | 4748 |
8 | Heart transplant* | 4488 |
9 | Prophylaxis against transplant rejection | 3716 |
10 | Aplastic anaemia | 3539 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for NEORAL
Total Reports Filed with FDA: 157488
Number of FDA Adverse Event Reports by Patient Age for NEORAL
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 NEORAL 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.