Temsirolimus adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Temsirolimus
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 May 2006 to June 2026, FDA received 2,007 adverse event reports that name Temsirolimus. In these reports the drug is a suspect or interacting product.

In the same period, 127 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 6 reports in the 12 months to June 2026 and 12 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, 6 (under 0.1%) name Temsirolimus. Reports from physicians were 65.4% of the reports that name Temsirolimus and 21.9% 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 Temsirolimus 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 3 reports that name Temsirolimus.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 1.

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 173 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 1,985 of the 2,007 reports (98.9%).

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 173 terms.

Reaction terms in the reports that name Temsirolimus, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,007 reports
Disease progressionthe disease advanced	134	6.7%
Pneumonialung infection	121	6%
Diarrhoealoose or frequent stools	116	5.8%
Dehydration	113	5.6%
Anaemialow red blood cells	109	5.4%
Vomitingbeing sick	104	5.2%
Febrile neutropeniafever with low white blood cells	103	5.1%
Fatiguetiredness	101	5%
Pyrexiafever	100	5%
Stomatitissore mouth	100	5%
Thrombocytopenialow platelets	94	4.7%
Neutropenialow neutrophils, a type of white blood cell	90	4.5%
Nauseafeeling sick	85	4.2%
Dyspnoeashortness of breath	82	4.1%
Pneumonitis	68	3.4%
Hypokalaemialow blood potassium	67	3.3%
Hyperglycaemiahigh blood sugar	62	3.1%
Mucosal inflammation	58	2.9%
Off label useused for a purpose or in a way not on the label	57	2.8%
Deaththe patient died; cause not stated by this term	55	2.7%
Sepsisa severe body-wide response to infection	54	2.7%
Astheniaweakness or lack of energy	53	2.6%
Abdominal painstomach or belly pain	50	2.5%
Pleural effusionfluid around the lung	50	2.5%
Renal cell carcinoma	47	2.3%
Hypertensionhigh blood pressure	46	2.3%
Renal failurekidney failure	43	2.1%
Decreased appetitereduced appetite	42	2.1%
Headachehead pain	37	1.8%
Hyponatraemialow blood sodium	37	1.8%
Platelet count decreasedlow platelet count	37	1.8%
Respiratory failurethe lungs could not supply enough oxygen	37	1.8%
Hypertriglyceridaemia	35	1.7%
Epistaxisnosebleed	34	1.7%
Hypophosphataemia	33	1.6%
Blood bilirubin increased	32	1.6%
Myocardial infarctionheart attack	31	1.5%
Aspartate aminotransferase increasedraised liver enzyme (AST)	30	1.5%
Interstitial lung diseasescarring or inflammation of lung tissue	29	1.4%
Lymphocyte count decreased	29	1.4%
Blood creatinine increasedraised creatinine, a kidney test	28	1.4%
Malignant neoplasm progression	28	1.4%
Renal failure acute	28	1.4%
Hypotensionlow blood pressure	27	1.3%
Neutrophil count decreased	27	1.3%
White blood cell count decreasedlow white cell count	27	1.3%
Alanine aminotransferase increasedraised liver enzyme (ALT)	25	1.2%
Acute kidney injurysudden loss of kidney function	24	1.2%
Neoplasm progression	23	1.1%
Constipation	22	1.1%

Download all 173 terms of Temsirolimus (CSV)

The counts add to more than 2,007 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 Temsirolimus with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Temsirolimus (this page)	Generic name	2,007
Torisel	Brand name	2,270

Sum of the separately reported names: 4,277. 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 Temsirolimus, 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	Other Serious (Important Medical Events)	Not serious
2006	10	10	1	1	7	0	9	0
2007	35	35	3	5	26	1	13	0
2008	91	90	24	12	71	1	23	1
2009	140	136	23	7	95	6	45	4
2010	185	183	33	12	132	0	53	2
2011	198	198	68	15	128	3	62	0
2012	202	202	61	19	130	11	62	0
2013	185	183	35	14	126	4	53	2
2014	120	116	21	9	66	0	53	4
2015	123	117	24	9	65	0	58	6
2016	150	145	23	11	70	2	113	5
2017	76	74	27	12	31	0	47	2
2018	67	65	8	2	46	0	21	2
2019	43	42	11	8	28	0	18	1
2020	48	46	8	1	18	0	34	2
2021	53	49	6	3	23	0	30	4
2022	190	190	15	18	137	1	105	0
2023	50	50	10	4	17	0	39	0
2024	29	29	4	0	4	0	24	0
2025	9	8	0	2	1	0	8	1
2026	3	2	1	1	2	0	0	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 Temsirolimus, 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 Temsirolimus, by the year in which FDA received them
Year	Reports
2006	10
2007	35
2008	90
2009	144
2010	188
2011	225
2012	238
2013	190
2014	118
2015	115
2016	125
2017	60
2018	67
2019	60
2020	73
2021	62
2022	123
2023	47
2024	27
2025	7
2026	3

Reports that name Temsirolimus, 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 Temsirolimus
Age	Reports	Share
Under 2	36	1.8%
2 to 11	187	9.3%
12 to 17	69	3.4%
18 to 44	102	5.1%
45 to 64	460	22.9%
65 to 74	363	18.1%
75 and over	168	8.4%
Age not given	622	31%

Sex of the patient in the reports that name Temsirolimus
Sex	Reports	Share
Female	584	29.1%
Male	1,177	58.6%
Unknown or not given	246	12.3%

Type of reporter in the reports that name Temsirolimus
Reporter	Reports	Share
Physician	1,313	65.4%
Pharmacist	30	1.5%
Other health professional	510	25.4%
Lawyer	0	0%
Consumer or non-health professional	101	5%
Not given	53	2.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 49.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Temsirolimus record
Indication as recorded (MedDRA)	Reports	Share
Renal cell carcinoma	304	15.1%
Metastatic renal cell carcinoma	145	7.2%
Embryonal rhabdomyosarcoma	110	5.5%
Mantle cell lymphoma	104	5.2%
Rhabdomyosarcoma	43	2.1%
Metastatic malignant melanoma	35	1.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,007 reports.

Pages near this one

Torisel same ingredient
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for TemsirolimusThe 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. Temsirolimus: adverse event reports that FDA received. https://reportedreactions.com/drug/temsirolimus/ 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 Temsirolimus as a suspect or interacting product. The 127 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 Temsirolimus 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 Temsirolimus?

No. It is a count of what people reported to FDA: 2,007 reports from May 2006 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 (65.4%), other health professional (25.4%) and consumer or non-health professional (5%). 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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