Neoral (cyclosporine) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Neoral
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.

Reports on file

From January 2004 to June 2026, FDA received 11,363 adverse event reports that name Neoral. In these reports the drug is a suspect or interacting product.

In the same period, 3,369 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 133 reports in the 12 months to June 2026 and 200 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Neoral 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 23 reports that name Neoral.
In January to March 2026, FDA received 47.
In April to June 2025, FDA received 44.

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 957 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 all 11,363 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 957 terms.

Reaction terms in the reports that name Neoral, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 11,363 reports
Drug ineffectivethe medicine did not work as expected	1,312	11.5%
Pneumonialung infection	770	6.8%
Deaththe patient died; cause not stated by this term	712	6.3%
Pyrexiafever	678	6%
Blood creatinine increasedraised creatinine, a kidney test	559	4.9%
Renal impairmentreduced kidney function	536	4.7%
Alopeciahair loss	534	4.7%
Transplant rejection	530	4.7%
Pain in extremitypain in an arm or leg	509	4.5%
Condition aggravatedthe condition being treated got worse	502	4.4%
Product use in unapproved indicationused for a purpose not on the label	501	4.4%
Painpain, site not specified	494	4.3%
Transplant dysfunction	447	3.9%
Treatment failurethe treatment did not work	439	3.9%
Off label useused for a purpose or in a way not on the label	433	3.8%
Acne	428	3.8%
Drug intolerancethe medicine was not tolerated	425	3.7%
Ovarian cysta cyst on an ovary	415	3.7%
Hypersensitivityan allergic-type reaction	402	3.5%
Hepatic function abnormal	399	3.5%
Nauseafeeling sick	397	3.5%
Fatiguetiredness	388	3.4%
Diarrhoealoose or frequent stools	383	3.4%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	383	3.4%
Urticariahives	377	3.3%
Vomitingbeing sick	351	3.1%
Product use issuea problem in how the product was used	336	3%
Renal failurekidney failure	333	2.9%
Drug interactionan interaction between medicines	323	2.8%
Malaisegeneral feeling of being unwell	315	2.8%
Hypertensionhigh blood pressure	312	2.7%
Rashskin rash	312	2.7%
Dyspnoeashortness of breath	306	2.7%
Headachehead pain	306	2.7%
Psoriasispsoriasis, a skin condition	298	2.6%
Arthralgiajoint pain	292	2.6%
Stomatitissore mouth	288	2.5%
Muscle spasmsmuscle cramps	285	2.5%
Drug eruption	281	2.5%
Pruritusitching	280	2.5%
Epistaxisnosebleed	264	2.3%
Platelet count decreasedlow platelet count	264	2.3%
Cytomegalovirus infection	245	2.2%
Sepsisa severe body-wide response to infection	245	2.2%
Contraindicated product administered	242	2.1%
Acute kidney injurysudden loss of kidney function	241	2.1%
Kidney transplant rejection	239	2.1%
Anaemialow red blood cells	225	2%
Insomniadifficulty sleeping	206	1.8%
C-reactive protein increased	205	1.8%

Download all 957 terms of Neoral (CSV)

The counts add to more than 11,363 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 (this page)	Brand name	11,363
Restasis	Brand name	18,243
Sandimmune	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 Neoral, 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	303	301	86	35	175	16	1	131	2
2005	226	225	62	22	132	8	0	95	1
2006	243	238	40	19	134	12	1	127	5
2007	289	281	44	25	176	19	0	134	8
2008	520	515	104	42	375	26	2	184	5
2009	409	405	87	36	242	11	0	205	4
2010	447	442	77	28	269	15	1	222	5
2011	573	571	123	25	319	18	2	279	2
2012	510	505	90	41	244	12	0	273	5
2013	441	424	82	33	233	10	0	237	17
2014	554	544	113	26	274	17	0	286	10
2015	592	522	96	35	270	26	2	292	70
2016	613	556	156	29	212	8	4	306	57
2017	782	721	139	26	299	10	3	436	61
2018	729	652	68	57	242	7	1	417	77
2019	883	790	70	66	267	15	3	554	93
2020	1,068	1,013	101	109	239	6	2	739	55
2021	676	625	147	43	196	6	1	396	51
2022	533	489	106	33	180	9	7	282	44
2023	368	336	47	24	122	9	2	221	32
2024	299	286	64	27	98	14	5	174	13
2025	203	196	22	27	98	26	16	130	7
2026	102	99	17	11	47	6	6	78	3

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 Neoral, 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 Neoral, by the year in which FDA received them
Year	Reports
2004	242
2005	245
2006	273
2007	296
2008	521
2009	423
2010	484
2011	553
2012	673
2013	436
2014	561
2015	572
2016	658
2017	839
2018	751
2019	931
2020	1,015
2021	563
2022	516
2023	324
2024	261
2025	153
2026	70

Reports that name Neoral, 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 Neoral
Age	Reports	Share
Under 2	64	0.6%
2 to 11	262	2.3%
12 to 17	201	1.8%
18 to 44	1,634	14.4%
45 to 64	3,117	27.4%
65 to 74	1,273	11.2%
75 and over	667	5.9%
Age not given	4,145	36.5%

Sex of the patient in the reports that name Neoral
Sex	Reports	Share
Female	4,989	43.9%
Male	5,529	48.7%
Unknown or not given	845	7.4%

Type of reporter in the reports that name Neoral
Reporter	Reports	Share
Physician	3,833	33.7%
Pharmacist	1,150	10.1%
Other health professional	3,622	31.9%
Lawyer	6	0.1%
Consumer or non-health professional	2,087	18.4%
Not given	665	5.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 18.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Neoral record
Indication as recorded (MedDRA)	Reports	Share
Renal transplant	1,927	17%
Psoriasis	662	5.8%
Aplastic anaemia	430	3.8%
Prophylaxis against transplant rejection	388	3.4%
Heart transplant	285	2.5%
Transplant	276	2.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 11,363 reports.

Drugs in the same reports

Other drugs that the reports of Neoral name, in any role, in order of name
Drug	Reports that name the two
CellCept	1,303
Enbrel	1,320
Humira	867
Methotrexate	1,252
Mycophenolate mofetil	946
Myfortic	614
Prednisolone	1,219
Prednisone	835
Prograf	638
Remicade	1,266

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

Cyclosporine same ingredient
Cequa same ingredient
Cyclosporine Modified same ingredient
Gengraf same ingredient
Restasis same ingredient
Sandimmune same ingredient
Lupkynis same class
Pimecrolimus same class
Prograf same class
Envarsus same class
Neoprofen next in the A to Z list
Neorecormon 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 NeoralThe 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. Neoral: adverse event reports that FDA received. https://reportedreactions.com/drug/neoral/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Neoral as a suspect or interacting product. The 3,369 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 Neoral 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 Neoral?

No. It is a count of what people reported to FDA: 11,363 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 (33.7%), other health professional (31.9%) and consumer or non-health professional (18.4%). 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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