Ciclosporin adverse event reports that FDA received

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

Name type: Generic name

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 September 2021, FDA received 13,549 adverse event reports that name Ciclosporin. In these reports the drug is a suspect or interacting product.

In the same period, 3,157 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports from other health professionals were 65.9% of the reports that name Ciclosporin and 19.7% 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 Ciclosporin 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.

FDA received no report that names Ciclosporin in April to June 2026, in January to March 2026 or in April to June 2025.

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 1,304 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 13,522 of the 13,549 reports (99.8%).

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 1,304 terms.

Reaction terms in the reports that name Ciclosporin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 13,549 reports
Drug ineffectivethe medicine did not work as expected	2,298	17%
Product use in unapproved indicationused for a purpose not on the label	1,383	10.2%
Off label useused for a purpose or in a way not on the label	1,027	7.6%
Drug intolerancethe medicine was not tolerated	920	6.8%
Cytomegalovirus infection	690	5.1%
Pyrexiafever	650	4.8%
Treatment failurethe treatment did not work	620	4.6%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	571	4.2%
Diarrhoealoose or frequent stools	500	3.7%
Condition aggravatedthe condition being treated got worse	496	3.7%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	485	3.6%
Renal impairmentreduced kidney function	471	3.5%
Psoriasispsoriasis, a skin condition	440	3.2%
Graft versus host disease	438	3.2%
Nauseafeeling sick	437	3.2%
Dyspnoeashortness of breath	422	3.1%
Hypertensionhigh blood pressure	420	3.1%
Acute graft versus host disease	400	3%
Fatiguetiredness	387	2.9%
Headachehead pain	384	2.8%
Sepsisa severe body-wide response to infection	376	2.8%
Drug interactionan interaction between medicines	375	2.8%
Pneumonialung infection	365	2.7%
Product use issuea problem in how the product was used	363	2.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	363	2.7%
Post transplant lymphoproliferative disorder	355	2.6%
Pruritusitching	340	2.5%
Posterior reversible encephalopathy syndrome	338	2.5%
Rashskin rash	336	2.5%
Acute kidney injurysudden loss of kidney function	333	2.5%
Blood creatinine increasedraised creatinine, a kidney test	333	2.5%
Chronic graft versus host disease	324	2.4%
Arthralgiajoint pain	321	2.4%
Painpain, site not specified	311	2.3%
Infectionan infection, type not specified	307	2.3%
Graft versus host disease in gastrointestinal tract	301	2.2%
Acute graft versus host disease in skin	294	2.2%
Pain in extremitypain in an arm or leg	286	2.1%
Psoriatic arthropathy	265	2%
Weight decreasedweight loss	264	1.9%
Erythemaskin redness	261	1.9%
Epstein-Barr virus infection	254	1.9%
Blood iron abnormal	253	1.9%
Contraindicated product administered	253	1.9%
Deaththe patient died; cause not stated by this term	247	1.8%
Graft versus host disease in skin	244	1.8%
Vomitingbeing sick	241	1.8%
Bronchopulmonary aspergillosis	238	1.8%
Respiratory failurethe lungs could not supply enough oxygen	234	1.7%
Thrombocytopenialow platelets	233	1.7%

Download all 1,304 terms of Ciclosporin (CSV)

The counts add to more than 13,549 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.

Outcomes by year

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

Outcomes in the reports that name Ciclosporin, 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	16	7	4	0	1	0	0	5	9
2005	9	9	5	0	5	0	0	3	0
2006	2	2	0	0	0	0	0	2	0
2007	10	10	7	0	2	0	0	6	0
2008	1	1	1	0	1	0	0	1	0
2009	5	5	2	0	3	0	0	4	0
2010	20	20	8	1	6	1	1	13	0
2011	24	24	4	1	11	0	0	15	0
2012	397	397	209	14	73	5	1	219	0
2013	474	474	129	43	157	8	1	343	0
2014	915	910	302	24	184	1	4	712	5
2015	1,021	998	330	41	228	1	0	710	23
2016	1,008	982	256	47	241	8	4	757	26
2017	1,476	1,442	325	86	268	6	2	1,162	34
2018	2,030	1,941	409	165	465	37	5	1,506	89
2019	2,726	2,661	502	202	671	43	7	2,197	65
2020	2,314	2,294	360	123	500	46	9	1,972	20
2021	1,101	1,085	120	99	353	53	4	925	16

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 Ciclosporin, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Ciclosporin, by the year in which FDA received them
Year	Reports
2004	20
2005	12
2006	4
2007	19
2008	5
2009	20
2010	35
2011	59
2012	444
2013	464
2014	938
2015	1,047
2016	1,068
2017	1,631
2018	2,086
2019	2,739
2020	2,152
2021	803

Reports that name Ciclosporin, 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 Ciclosporin
Age	Reports	Share
Under 2	319	2.4%
2 to 11	1,136	8.4%
12 to 17	606	4.5%
18 to 44	2,743	20.2%
45 to 64	3,557	26.3%
65 to 74	996	7.4%
75 and over	323	2.4%
Age not given	3,869	28.6%

Sex of the patient in the reports that name Ciclosporin
Sex	Reports	Share
Female	5,410	39.9%
Male	5,657	41.8%
Unknown or not given	2,482	18.3%

Type of reporter in the reports that name Ciclosporin
Reporter	Reports	Share
Physician	3,066	22.6%
Pharmacist	108	0.8%
Other health professional	8,927	65.9%
Lawyer	6	under 0.1%
Consumer or non-health professional	1,237	9.1%
Not given	205	1.5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 10.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Ciclosporin record
Indication as recorded (MedDRA)	Reports	Share
Prophylaxis against graft versus host disease	1,845	13.6%
Immunosuppressant drug therapy	1,404	10.4%
Immunosuppression	900	6.6%
Rheumatoid arthritis	550	4.1%
Renal transplant	468	3.5%
Stem cell transplant	442	3.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 13,549 reports.

Drugs in the same reports

Other drugs that the reports of Ciclosporin name, in any role, in order of name
Drug	Reports that name the two
Azathioprine	1,596
Cyclophosphamide	1,672
Fludarabine	1,284
Methotrexate	3,665
Methylprednisolone	1,905
Mycophenolate mofetil	3,480
Prednisolone	2,354
Prednisone	2,585
Rituximab	1,231
Tacrolimus	1,368

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

Pages near this one

Ciclopirox olamine next in the A to Z list
Ciclosporine next in the A to Z list
Ciclopirox next in the A to Z list
Cidofovir (dihydrate) next in the A to Z list
Ciclesonide next in the A to Z list
Ciflox next in the A to Z list
Cibinqo next in the A to Z list
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Cialis next in the A to Z list
Cilazapril Anhydrous next in the A to Z list
Chorionic gonadotropin next in the A to Z list
Cilgavimab Tixagevimab next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for CiclosporinThe 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. Ciclosporin: adverse event reports that FDA received. https://reportedreactions.com/drug/ciclosporin/ 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 Ciclosporin as a suspect or interacting product. The 3,157 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 Ciclosporin 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 Ciclosporin?

No. It is a count of what people reported to FDA: 13,549 reports from January 2004 to September 2021. 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?

Other health professional (65.9%), physician (22.6%) and consumer or non-health professional (9.1%). 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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