Trametinib adverse event reports that FDA received

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

Name type: Generic name
Class: Kinase inhibitor
Also reported as: Trametinib Tablet

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 2013 to June 2026, FDA received 6,043 adverse event reports that name Trametinib. In these reports the drug is a suspect or interacting product.

In the same period, 522 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 337 reports in the 12 months to June 2026 and 383 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 Trametinib 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 77 reports that name Trametinib.
In January to March 2026, FDA received 91.
In April to June 2025, FDA received 96.

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 556 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 6,043 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 556 terms.

Reaction terms in the reports that name Trametinib, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 6,043 reports
Pyrexiafever	1,192	19.7%
Malignant neoplasm progression	837	13.9%
Product use in unapproved indicationused for a purpose not on the label	359	5.9%
Diarrhoealoose or frequent stools	345	5.7%
Rashskin rash	313	5.2%
Nauseafeeling sick	311	5.1%
Vomitingbeing sick	298	4.9%
Off label useused for a purpose or in a way not on the label	277	4.6%
Fatiguetiredness	268	4.4%
Chillschills or shivering	252	4.2%
Drug ineffectivethe medicine did not work as expected	241	4%
Deaththe patient died; cause not stated by this term	226	3.7%
Astheniaweakness or lack of energy	200	3.3%
Metastatic malignant melanoma	179	3%
Anaemialow red blood cells	175	2.9%
Headachehead pain	169	2.8%
Disease progressionthe disease advanced	166	2.7%
Metastases to central nervous system	165	2.7%
General physical health deteriorationgeneral decline in health	158	2.6%
Ejection fraction decreased	148	2.4%
Neutropenialow neutrophils, a type of white blood cell	145	2.4%
Decreased appetitereduced appetite	141	2.3%
Abdominal painstomach or belly pain	139	2.3%
Pneumonialung infection	138	2.3%
Blood creatine phosphokinase increased	134	2.2%
Hypotensionlow blood pressure	134	2.2%
Arthralgiajoint pain	133	2.2%
Dehydration	127	2.1%
Dyspnoeashortness of breath	127	2.1%
Malignant melanomamelanoma, a skin cancer	127	2.1%
Acute kidney injurysudden loss of kidney function	123	2%
Aspartate aminotransferase increasedraised liver enzyme (AST)	115	1.9%
Thrombocytopenialow platelets	113	1.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	112	1.9%
Sepsisa severe body-wide response to infection	108	1.8%
C-reactive protein increased	99	1.6%
Confusional stateconfusion	99	1.6%
Uveitis	99	1.6%
Product use issuea problem in how the product was used	93	1.5%
Cough	87	1.4%
Hypertensionhigh blood pressure	86	1.4%
Constipation	84	1.4%
Dermatitis acneiform	84	1.4%
Painpain, site not specified	82	1.4%
Skin toxicity	81	1.3%
Weight decreasedweight loss	81	1.3%
Myalgiamuscle pain	80	1.3%
Pneumonitis	79	1.3%
Urinary tract infectionbladder or urinary infection	79	1.3%
Malaisegeneral feeling of being unwell	78	1.3%

Download all 556 terms of Trametinib (CSV)

The counts add to more than 6,043 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 Trametinib with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Trametinib (this page)	Generic name	6,043
Mekinist	Brand name	17,070

Sum of the separately reported names: 23,113. 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 Trametinib, 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
2013	235	235	5	6	150	4	0	91	0
2014	294	287	21	21	176	10	0	126	7
2015	624	617	54	13	311	15	0	455	7
2016	342	336	86	16	182	7	0	168	6
2017	434	426	72	21	250	16	0	222	8
2018	417	398	82	30	217	9	1	217	19
2019	566	545	99	28	268	11	0	334	21
2020	561	539	89	40	215	10	0	379	22
2021	596	564	111	29	232	11	0	425	32
2022	563	543	95	20	219	5	1	398	20
2023	448	431	81	27	155	5	0	317	17
2024	367	348	41	12	63	8	0	292	19
2025	401	390	73	21	115	10	0	309	11
2026	195	191	25	12	79	0	0	138	4

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 Trametinib, 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 Trametinib, by the year in which FDA received them
Year	Reports
2013	321
2014	332
2015	574
2016	435
2017	413
2018	521
2019	624
2020	519
2021	516
2022	525
2023	370
2024	363
2025	362
2026	168

Reports that name Trametinib, 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 Trametinib
Age	Reports	Share
Under 2	111	1.8%
2 to 11	264	4.4%
12 to 17	164	2.7%
18 to 44	782	12.9%
45 to 64	1,779	29.4%
65 to 74	998	16.5%
75 and over	529	8.8%
Age not given	1,416	23.4%

Sex of the patient in the reports that name Trametinib
Sex	Reports	Share
Female	2,643	43.7%
Male	2,657	44%
Unknown or not given	743	12.3%

Type of reporter in the reports that name Trametinib
Reporter	Reports	Share
Physician	3,543	58.6%
Pharmacist	93	1.5%
Other health professional	1,980	32.8%
Lawyer	0	0%
Consumer or non-health professional	417	6.9%
Not given	10	0.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 23% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Trametinib record
Indication as recorded (MedDRA)	Reports	Share
Metastatic malignant melanoma	1,459	24.1%
Malignant melanoma	1,408	23.3%
Non-small cell lung cancer	152	2.5%
Glioma	104	1.7%
Colorectal cancer	98	1.6%
Noonan syndrome	38	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 6,043 reports.

Drugs in the same reports

Other drugs that the reports of Trametinib name, in any role, in order of name
Drug	Reports that name the two
Carboplatin	122
Dabrafenib	4,068
Dexamethasone	186
Ipilimumab	241
Nivolumab	362
Paracetamol	139
Pembrolizumab	138
Prednisone	137
Tafinlar	397
Vemurafenib	123

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

Mekinist same ingredient
Tepmetko same class
Tucatinib same class
Tasigna same class
Tukysa same class
Tagrisso same class
Turalio same class
Tramcet next in the A to Z list
Trandate next in the A to Z list
Tramal next in the A to Z list
Trandolapril next in the A to Z list
Tramadol/Tramadol Hydrochloride 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 TrametinibThe 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. Trametinib: adverse event reports that FDA received. https://reportedreactions.com/drug/trametinib/ 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 Trametinib as a suspect or interacting product. The 522 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 Trametinib 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 Trametinib?

No. It is a count of what people reported to FDA: 6,043 reports from January 2013 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 (58.6%), other health professional (32.8%) and consumer or non-health professional (6.9%). 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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