Sandimmune (cyclosporine) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Sandimmune
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Cyclosporine
Class: Calcineurin inhibitor immunosuppressant

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 1,871 adverse event reports that name Sandimmune. In these reports the drug is a suspect or interacting product.

In the same period, 678 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 7 reports in the 12 months to June 2026 and 18 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 7 (under 0.1%) name Sandimmune. Reports from consumers or other non-health professionals were 18.7% of the reports that name Sandimmune and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Sandimmune is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 2 reports that name Sandimmune.
In January to March 2026, FDA received 2.
In April to June 2025, FDA received 2.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 273 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,856 of the 1,871 reports (99.2%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 273 terms.

Reaction terms in the reports that name Sandimmune, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,871 reports
Pyrexiafever	159	8.5%
Blood creatinine increasedraised creatinine, a kidney test	139	7.4%
Deaththe patient died; cause not stated by this term	101	5.4%
Renal failurekidney failure	82	4.4%
Renal impairmentreduced kidney function	80	4.3%
Drug interactionan interaction between medicines	68	3.6%
Cytomegalovirus infection	65	3.5%
Hypertensionhigh blood pressure	65	3.5%
Sepsisa severe body-wide response to infection	64	3.4%
Renal failure acute	62	3.3%
Diarrhoealoose or frequent stools	61	3.3%
Dyspnoeashortness of breath	61	3.3%
Vomitingbeing sick	59	3.2%
Nauseafeeling sick	55	2.9%
Graft versus host disease	51	2.7%
Pneumonialung infection	51	2.7%
Headachehead pain	49	2.6%
Respiratory failurethe lungs could not supply enough oxygen	45	2.4%
Abdominal painstomach or belly pain	43	2.3%
Alanine aminotransferase increasedraised liver enzyme (ALT)	43	2.3%
Cough	40	2.1%
Aspartate aminotransferase increasedraised liver enzyme (AST)	39	2.1%
C-reactive protein increased	39	2.1%
Blood bilirubin increased	38	2%
Confusional stateconfusion	38	2%
Convulsion	37	2%
Rashskin rash	37	2%
General physical health deteriorationgeneral decline in health	36	1.9%
Malaisegeneral feeling of being unwell	35	1.9%
Nephropathy toxic	35	1.9%
Urinary tract infectionbladder or urinary infection	35	1.9%
Multi-organ failure	34	1.8%
Fatiguetiredness	33	1.8%
Thrombotic microangiopathy	33	1.8%
Immunosuppressant drug level increased	32	1.7%
Blood urea increased	31	1.7%
Depressed level of consciousness	30	1.6%
Infectionan infection, type not specified	30	1.6%
Pancytopenialow counts of all blood cells	30	1.6%
Platelet count decreasedlow platelet count	30	1.6%
Somnolencedrowsiness	30	1.6%
Kidney transplant rejection	29	1.5%
Transplant rejection	29	1.5%
Tremorshaking	29	1.5%
Cardiac failureheart failure	28	1.5%
Drug level increaseda raised blood level of the medicine	28	1.5%
Blood creatine phosphokinase increased	27	1.4%
Gamma-glutamyltransferase increased	27	1.4%
Leukopenialow white blood cells	27	1.4%
Myalgiamuscle pain	27	1.4%

Download all 273 terms of Sandimmune (CSV)

The counts add to more than 1,871 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Cyclosporine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Cyclosporine	Generic name	38,688
Cequa	Brand name	3,041
Cyclosporine Modified	Brand name	444
Gengraf	Brand name	543
Neoral	Brand name	11,363
Restasis	Brand name	18,243
Sandimmune (this page)	Brand name	1,871
Vevye	Brand name	4,794

Sum of the separately reported names: 78,987. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Sandimmune, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	152	151	31	11	85	8	0	78	1
2005	147	146	37	14	72	8	1	77	1
2006	98	98	18	9	50	2	1	52	0
2007	104	104	24	5	49	6	0	66	0
2008	229	229	50	22	138	10	1	89	0
2009	163	163	42	18	95	8	0	88	0
2010	194	193	29	17	123	2	1	106	1
2011	199	199	45	20	111	4	0	107	0
2012	69	69	14	7	31	2	0	36	0
2013	13	13	3	0	7	0	0	6	0
2014	55	54	12	7	31	4	0	22	1
2015	76	60	20	12	30	3	0	33	16
2016	33	23	11	3	7	1	0	15	10
2017	40	29	8	0	12	0	0	15	11
2018	40	25	5	1	13	0	0	7	15
2019	62	39	14	2	20	2	0	10	23
2020	60	45	10	1	14	0	0	28	15
2021	36	30	11	0	12	0	0	14	6
2022	33	21	15	1	3	0	0	6	12
2023	29	20	9	2	12	0	0	6	9
2024	24	15	6	0	4	0	0	5	9
2025	11	8	2	1	6	0	0	5	3
2026	4	2	1	0	1	0	0	0	2

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Sandimmune, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Sandimmune, by the year in which FDA received them
Year	Reports
2004	123
2005	155
2006	114
2007	105
2008	225
2009	164
2010	189
2011	215
2012	79
2013	12
2014	55
2015	69
2016	36
2017	38
2018	50
2019	63
2020	49
2021	31
2022	33
2023	31
2024	21
2025	10
2026	4

Reports that name Sandimmune, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Sandimmune
Age	Reports	Share
Under 2	18	1%
2 to 11	80	4.3%
12 to 17	51	2.7%
18 to 44	240	12.8%
45 to 64	374	20%
65 to 74	152	8.1%
75 and over	55	2.9%
Age not given	901	48.2%

Sex of the patient in the reports that name Sandimmune
Sex	Reports	Share
Female	783	41.8%
Male	996	53.2%
Unknown or not given	92	4.9%

Type of reporter in the reports that name Sandimmune
Reporter	Reports	Share
Physician	821	43.9%
Pharmacist	138	7.4%
Other health professional	385	20.6%
Lawyer	4	0.2%
Consumer or non-health professional	350	18.7%
Not given	173	9.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 27.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Sandimmune record
Indication as recorded (MedDRA)	Reports	Share
Renal transplant	338	18.1%
Heart transplant	105	5.6%
Liver transplant	74	4%
Bone marrow transplant	56	3%
Stem cell transplant	53	2.8%
Psoriasis	35	1.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,871 reports.

Pages near this one

Cyclosporine same ingredient
Cequa same ingredient
Cyclosporine Modified same ingredient
Gengraf same ingredient
Neoral same ingredient
Restasis same ingredient
Tacrolimus same class
Prograf same class
Vevye same class
Pimecrolimus same class
Sandimmun Neoral next in the A to Z list
Sandostatin next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for SandimmuneThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Sandimmune: adverse event reports that FDA received. https://reportedreactions.com/drug/sandimmune/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Sandimmune as a suspect or interacting product. The 678 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Sandimmune was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Sandimmune?

No. It is a count of what people reported to FDA: 1,871 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (43.9%), other health professional (20.6%) and consumer or non-health professional (18.7%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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