Neoralcyclosporine
According to the FDA label: Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate.
68,272 adverse event reports submitted to the FDA (1994–2026)
Top Reported Adverse Events
The most frequently reported events in association with Neoral in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 8,577 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Off Label Use 7,566 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Product Use in Unapproved Indication 4,012 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Pyrexia 3,602 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 2,761 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Diarrhoea 2,632 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 2,488 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Nausea 2,408 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Cytomegalovirus Infection 2,171 reports
An infection with a common virus, often called CMV, that can be serious for people with weakened immune systems.
Full definition in the glossary →Hypertension 1,983 reports
Fatigue 1,977 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Renal Impairment 1,970 reports
Reduced kidney function. Renal means related to the kidneys. This is a broad term for kidneys not working as well as normal.
Full definition in the glossary →Pain 1,952 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Sepsis 1,932 reports
A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Full definition in the glossary →Headache 1,893 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 30,211 |
| Female | 28,078 |
| Unknown | 569 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 8,608 |
| 18-34 | 7,348 |
| 35-49 | 9,412 |
| 50-64 | 13,760 |
| 65-74 | 6,268 |
| 75+ | 2,481 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Neoral. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 44,660 |
| Hospitalization | 23,264 |
| Death | 12,972 |
| Non-Serious | 5,618 |
| Life-Threatening | 4,675 |
| Disability | 1,436 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Neoral. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1994 | 1 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 1,339 |
| 2005 | 1,287 |
| 2006 | 1,416 |
| 2007 | 1,387 |
| 2008 | 2,314 |
| 2009 | 2,478 |
| 2010 | 2,263 |
| 2011 | 3,027 |
| 2012 | 2,467 |
| 2013 | 1,351 |
| 2014 | 1,556 |
| 2015 | 1,530 |
| 2016 | 1,822 |
| 2017 | 2,268 |
| 2018 | 2,673 |
| 2019 | 3,502 |
| 2020 | 4,667 |
| 2021 | 4,280 |
| 2022 | 5,857 |
| 2023 | 5,834 |
| 2024 | 7,164 |
| 2025 | 6,253 |
| 2026 (partial) | 1,526 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Neoral
In FDA adverse event reports that mention Neoral, these medications appeared most often in the same report.
- Mycophenolate Mofetil (17,873 reports)
- Methotrexate (13,153 reports)
- Prednisone (11,512 reports)
- Prednisolone (9,403 reports)
- Methylprednisolone (7,722 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026