Sandimmunecyclosporine
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.
56,405 adverse event reports submitted to the FDA (1994–2026)
Top Reported Adverse Events
The most frequently reported events in association with Sandimmune 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.
Show these terms with plain-language definitions
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Drug Ineffective 7,367 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 7,121 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 3,537 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 2,886 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 2,216 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 2,024 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 2,009 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 1,978 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Cytomegalovirus Infection 1,947 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 1,706 reports
Sepsis 1,705 reports
A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Full definition in the glossary →Fatigue 1,646 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Rash 1,636 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Graft Versus Host Disease 1,598 reports
A complication that can occur after a transplant, where donated cells attack the recipient's body.
Full definition in the glossary →Headache 1,566 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 | 24,368 |
| Female | 22,965 |
| Unknown | 496 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 8,066 |
| 18-34 | 6,362 |
| 35-49 | 7,684 |
| 50-64 | 11,238 |
| 65-74 | 4,786 |
| 75+ | 1,685 |
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 Sandimmune. 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 | 38,249 |
| Hospitalization | 17,850 |
| Death | 11,055 |
| Non-Serious | 4,952 |
| Life-Threatening | 3,818 |
| Disability | 1,132 |
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 Sandimmune. 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 | 1 |
| 2003 | 4 |
| 2004 | 1,059 |
| 2005 | 1,096 |
| 2006 | 1,184 |
| 2007 | 1,149 |
| 2008 | 1,941 |
| 2009 | 2,162 |
| 2010 | 1,897 |
| 2011 | 2,564 |
| 2012 | 1,717 |
| 2013 | 757 |
| 2014 | 877 |
| 2015 | 861 |
| 2016 | 1,001 |
| 2017 | 1,274 |
| 2018 | 1,793 |
| 2019 | 2,491 |
| 2020 | 3,615 |
| 2021 | 3,667 |
| 2022 | 5,356 |
| 2023 | 5,488 |
| 2024 | 6,905 |
| 2025 | 6,065 |
| 2026 (partial) | 1,480 |
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 Sandimmune
In FDA adverse event reports that mention Sandimmune, these medications appeared most often in the same report.
- Mycophenolate Mofetil (15,422 reports)
- Methotrexate (12,034 reports)
- Prednisone (10,577 reports)
- Prednisolone (8,016 reports)
- Cyclophosphamide (7,543 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