Rapamune adverse event reports that FDA received

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

Name type: Product name as reported

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 6,381 adverse event reports that name Rapamune. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,400 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 42 reports in the 12 months to June 2026 and 43 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, 42 (under 0.1%) name Rapamune. Reports from consumers or other non-health professionals were 27.9% of the reports that name Rapamune 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 Rapamune 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 16 reports that name Rapamune.
In January to March 2026, FDA received 8.
In April to June 2025, FDA received 5.

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 543 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 6,381 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 543 terms.

Reaction terms in the reports that name Rapamune, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 6,381 reports
Off label useused for a purpose or in a way not on the label	889	13.9%
Transplant rejection	540	8.5%
Alopeciahair loss	468	7.3%
Transplant dysfunction	455	7.1%
Acne	436	6.8%
Ovarian cysta cyst on an ovary	417	6.5%
Product use in unapproved indicationused for a purpose not on the label	401	6.3%
Pneumonialung infection	386	6%
Product use issuea problem in how the product was used	354	5.5%
Deaththe patient died; cause not stated by this term	344	5.4%
Condition aggravatedthe condition being treated got worse	324	5.1%
Drug ineffectivethe medicine did not work as expected	320	5%
Kidney transplant rejection	305	4.8%
Painpain, site not specified	265	4.2%
Pyrexiafever	259	4.1%
Diarrhoealoose or frequent stools	257	4%
Blood creatinine increasedraised creatinine, a kidney test	237	3.7%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	181	2.8%
Liver function test abnormal	180	2.8%
Dyspnoeashortness of breath	179	2.8%
Malaisegeneral feeling of being unwell	178	2.8%
Sleep disorder due to general medical condition, insomnia type	172	2.7%
Renal impairmentreduced kidney function	163	2.6%
Renal failurekidney failure	158	2.5%
Drug interactionan interaction between medicines	145	2.3%
Haemoglobin decreasedlow haemoglobin	142	2.2%
Anaemialow red blood cells	135	2.1%
Nauseafeeling sick	134	2.1%
Complications of transplanted kidney	129	2%
Vomitingbeing sick	129	2%
Oedema peripheralswelling of the legs, ankles or hands	128	2%
Astheniaweakness or lack of energy	125	2%
Weight decreasedweight loss	125	2%
Dehydration	118	1.8%
Fatiguetiredness	117	1.8%
Headachehead pain	116	1.8%
Hypertensionhigh blood pressure	116	1.8%
Renal failure acute	109	1.7%
Interstitial lung diseasescarring or inflammation of lung tissue	108	1.7%
Immunosuppressant drug level increased	104	1.6%
Loss of personal independence in daily activities	99	1.6%
Diabetes mellitusdiabetes	96	1.5%
Infectionan infection, type not specified	96	1.5%
Nasopharyngitisa cold	95	1.5%
Overdosea dose above the recommended amount	95	1.5%
Cerebrovascular accidentstroke	92	1.4%
Sepsisa severe body-wide response to infection	90	1.4%
Cough	87	1.4%
Drug level increaseda raised blood level of the medicine	87	1.4%
Myocardial infarctionheart attack	87	1.4%

Download all 543 terms of Rapamune (CSV)

The counts add to more than 6,381 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 Rapamune, 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	416	416	61	44	272	15	0	205	0
2005	587	580	44	36	392	19	0	359	7
2006	463	461	32	32	330	15	0	300	2
2007	209	207	29	21	125	6	3	106	2
2008	252	247	33	13	137	7	1	121	5
2009	149	144	23	14	83	3	1	65	5
2010	167	154	30	13	79	13	0	75	13
2011	149	140	38	4	50	5	0	81	9
2012	205	168	54	4	56	2	0	92	37
2013	252	209	58	3	95	10	3	97	43
2014	254	191	39	3	78	8	0	111	63
2015	303	237	53	1	114	4	0	142	66
2016	360	273	52	8	157	3	0	146	87
2017	369	288	52	14	125	2	2	175	81
2018	369	279	35	29	136	5	0	162	90
2019	427	324	42	48	146	1	0	208	103
2020	542	450	56	87	151	3	0	295	92
2021	242	211	42	25	70	2	0	148	31
2022	446	295	56	4	115	5	0	210	151
2023	90	70	8	4	34	0	0	49	20
2024	54	48	9	8	24	1	0	31	6
2025	42	41	11	8	21	1	0	29	1
2026	34	33	2	3	27	1	0	22	1

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 Rapamune, 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 Rapamune, by the year in which FDA received them
Year	Reports
2004	375
2005	580
2006	480
2007	215
2008	266
2009	145
2010	178
2011	163
2012	227
2013	276
2014	279
2015	352
2016	446
2017	424
2018	392
2019	483
2020	457
2021	180
2022	284
2023	72
2024	39
2025	43
2026	24

Reports that name Rapamune, 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 Rapamune
Age	Reports	Share
Under 2	68	1.1%
2 to 11	237	3.7%
12 to 17	106	1.7%
18 to 44	860	13.5%
45 to 64	2,410	37.8%
65 to 74	813	12.7%
75 and over	219	3.4%
Age not given	1,668	26.1%

Sex of the patient in the reports that name Rapamune
Sex	Reports	Share
Female	2,667	41.8%
Male	3,228	50.6%
Unknown or not given	486	7.6%

Type of reporter in the reports that name Rapamune
Reporter	Reports	Share
Physician	1,574	24.7%
Pharmacist	311	4.9%
Other health professional	1,552	24.3%
Lawyer	6	0.1%
Consumer or non-health professional	1,782	27.9%
Not given	1,156	18.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 50.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Rapamune record
Indication as recorded (MedDRA)	Reports	Share
Prophylaxis against transplant rejection	1,711	26.8%
Renal transplant	611	9.6%
Liver transplant	321	5%
Immunosuppressant drug therapy	202	3.2%
Transplant	200	3.1%
Heart transplant	198	3.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 6,381 reports.

Drugs in the same reports

Other drugs that the reports of Rapamune name, in any role, in order of name
Drug	Reports that name the two
Aspirin	314
CellCept	816
Enbrel	475
Mycophenolate mofetil	912
Neoral	576
Prednisolone	312
Prednisone	846
Prograf	935
Remicade	377
Tacrolimus	670

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

Rapaflo next in the A to Z list
Rapamycin next in the A to Z list
Ranolazine next in the A to Z list
Rapiacta next in the A to Z list
Ranmark next in the A to Z list
Raptiva next in the A to Z list
Ranitidine hydrochloride next in the A to Z list
Rasagiline next in the A to Z list
Ranitidine Hci next in the A to Z list
Rasagiline mesylate next in the A to Z list
Ranitidine next in the A to Z list
Rasburicase next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for RapamuneThe 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. Rapamune: adverse event reports that FDA received. https://reportedreactions.com/drug/rapamune/ 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 Rapamune as a suspect or interacting product. The 1,400 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 Rapamune 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 Rapamune?

No. It is a count of what people reported to FDA: 6,381 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?

Consumer or non-health professional (27.9%), physician (24.7%) and other health professional (24.3%). 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.

To the top of the page