Colon cancer adverse event reports that record this term

Kind of term: MedDRA preferred term

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 14,708 adverse event reports that record the MedDRA preferred term Colon cancer. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 760 reports in the 12 months to June 2026 and 867 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 758 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 760 (0.1%) record this term. Reports for male patients were 43.2% of the reports that record this term and 34.6% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 120 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

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.

Drugs that the reports with the term Colon cancer name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	35
Accutane	Retinoid	27
Aclasta		31
Actemra	Interleukin-6 receptor antagonist	60
Adalimumab	Tumor necrosis factor blocker	45
Advair Diskus	Corticosteroid	30
Ambrisentan	Endothelin receptor antagonist	47
Apixaban	Factor Xa inhibitor	75
Aspirin	Nonsteroidal anti-inflammatory drug	45
Avastin	Vascular endothelial growth factor inhibitor	138
Avonex	Interferon beta	198
Azathioprine	Purine antimetabolite	28
Bevacizumab	Vascular endothelial growth factor inhibitor	38
Braftovi		26
Byetta	GLP-1 receptor agonist	28
Calcium Levofolinate		25
Camptosar	Topoisomerase inhibitor	36
Capecitabine	Nucleoside metabolic inhibitor	74
Cimzia	Tumor necrosis factor blocker	29
Clozapine	Atypical antipsychotic	29
Clozaril	Atypical antipsychotic	56
Cosentyx	Interleukin-17A antagonist	88
Crestor	HMG-CoA reductase inhibitor	41
Cyclophosphamide	Alkylating drug	85
Cyclosporine	Calcineurin inhibitor immunosuppressant	28
Dexamethasone	Corticosteroid	71
Digoxin	Cardiac glycoside	26
Diovan	Angiotensin 2 receptor blocker	53
Doxorubicin	Anthracycline topoisomerase inhibitor	25
Duodopa		27
Dupixent	Interleukin-4 receptor alpha antagonist	66
Eligard	Gonadotropin releasing hormone receptor agonist	27
Eliquis	Factor Xa inhibitor	175
Enbrel	Tumor necrosis factor blocker	423
Entresto	Angiotensin 2 receptor blocker	66
Entyvio	Integrin receptor antagonist	46
Etanercept	Tumor necrosis factor blocker	41
Fluorouracil	Nucleoside metabolic inhibitor	99
Forteo	Parathyroid hormone analog	114
Fosamax	Bisphosphonate	40
Fruquintinib		243
Fruzaqla		127
Furosemide	Loop diuretic	28
Gilenya	Sphingosine 1-phosphate receptor modulator	42
Gleevec	Kinase inhibitor	46
Glivec		55
Humalog	Insulin analog	63
Human immunoglobulin g	Human immunoglobulin G	25
Humira		568
Imbruvica	Kinase inhibitor	43
Inflectra	Tumor necrosis factor blocker	31
Infliximab	Tumor necrosis factor blocker	72
Irinotecan hydrochloride	Topoisomerase inhibitor	33
Januvia	Dipeptidyl peptidase 4 inhibitor	42
Keytruda	Programmed death Receptor-1 blocking antibody	27
Lantus	Insulin analog	42
Lantus Solostar	Insulin analog	28
Lenalidomide	Thalidomide analog	37
Levoleucovorin calcium	Folate analog	26
Lipitor	HMG-CoA reductase inhibitor	57
Lonsurf	Nucleoside analog antiviral	33
Lupron Depot		25
Lyrica		61
Metformin	Biguanide	29
Methotrexate	Folate analog metabolic inhibitor	130
Methotrexate sodium	Folate analog metabolic inhibitor	42
Mycophenolate mofetil	Antimetabolite immunosuppressant	81
Nexium	Proton pump inhibitor	101
Ocrevus	CD20-directed cytolytic antibody	28
Ofev	Kinase inhibitor	40
Opsumit	Endothelin receptor antagonist	46
Orencia	Selective T cell costimulation modulator	57
Otezla	Phosphodiesterase 4 inhibitor	59
Oxaliplatin	Platinum-based drug	125
Ozempic	GLP-1 receptor agonist	31
Panitumumab	Epidermal growth factor receptor antagonist	35
Plavix	P2Y12 platelet inhibitor	37
Pradaxa	Direct thrombin inhibitor	140
Prazaxa		33
Prednisolone	Corticosteroid	42
Prednisone	Corticosteroid	73
Prolia	RANK ligand inhibitor	90
Ranitidine	Histamine-2 receptor antagonist	701
Ranitidine Hci		40
Ranitidine hydrochloride	Histamine-2 receptor antagonist	435
Rebif	Interferon beta	69
Remicade	Tumor necrosis factor blocker	356
Repatha	PCSK9 inhibitor	25
Revlimid	Thalidomide analog	282
Rheumatrex		70
Rinvoq	Janus kinase inhibitor	142
Rituximab	CD20-directed cytolytic antibody	142
Rivaroxaban	Factor Xa inhibitor	27
Sandostatin LAR Depot		27
Simponi	Tumor necrosis factor blocker	80
Skyrizi	Interleukin-23 antagonist	194
Soliris	Complement inhibitor	32
Stelara	Interleukin-12 antagonist	108
Stivarga	Kinase inhibitor	331
Tacrolimus	Calcineurin inhibitor immunosuppressant	46
Tecfidera		76
Tiotropium bromide	Anticholinergic	59
Tocilizumab	Interleukin-6 receptor antagonist	25
Tracleer	Endothelin receptor antagonist	48
Trulicity	GLP-1 receptor agonist	33
Tysabri	Integrin receptor antagonist	132
Valsartan	Angiotensin 2 receptor blocker	83
Vectibix	Epidermal growth factor receptor antagonist	218
Vedolizumab	Integrin receptor antagonist	116
Venclexta	BCL-2 inhibitor	26
Viagra	Phosphodiesterase 5 inhibitor	25
Vincristine		27
Vioxx		47
Xarelto	Factor Xa inhibitor	110
Xeljanz	Janus kinase inhibitor	151
Xeloda	Nucleoside metabolic inhibitor	80
Xolair	Anti-IgE	42
Xtandi	Androgen receptor inhibitor	27
Zantac		1,461
Zometa		32

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 45 pharmacologic classes with 50 or more reports that record this term. The rows are in order of name.

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.

Pharmacologic classes of the drugs that the reports with the term Colon cancer name, in order of name
Class	Reports with this term
Alkylating drug	107
Angiotensin 2 receptor blocker	276
Anticholinergic	82
Antimetabolite immunosuppressant	91
Atypical antipsychotic	162
Biguanide	52
Bisphosphonate	53
Calcineurin inhibitor immunosuppressant	102
CD20-directed cytolytic antibody	210
Corticosteroid	300
Dipeptidyl peptidase 4 inhibitor	56
Direct thrombin inhibitor	140
Endothelin receptor antagonist	156
Epidermal growth factor receptor antagonist	276
Factor Xa inhibitor	398
Folate analog metabolic inhibitor	172
GLP-1 receptor agonist	152
Histamine-2 receptor antagonist	1,136
HMG-CoA reductase inhibitor	130
Insulin analog	195
Integrin receptor antagonist	294
Interferon beta	272
Interleukin-12 antagonist	114
Interleukin-17A antagonist	98
Interleukin-23 antagonist	222
Interleukin-4 receptor alpha antagonist	72
Interleukin-6 receptor antagonist	85
Janus kinase inhibitor	330
Kinase inhibitor	667
Nonsteroidal anti-inflammatory drug	94
Nucleoside metabolic inhibitor	278
Opioid agonist	124
P2Y12 platelet inhibitor	77
Parathyroid hormone analog	119
Phosphodiesterase 4 inhibitor	61
Phosphodiesterase 5 inhibitor	52
Platinum-based drug	147
Proton pump inhibitor	224
RANK ligand inhibitor	100
Selective T cell costimulation modulator	92
Sphingosine 1-phosphate receptor modulator	54
Thalidomide analog	346
Topoisomerase inhibitor	88
Tumor necrosis factor blocker	1,118
Vascular endothelial growth factor inhibitor	216

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Colon cancer, 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.

Patients in these reports

Age of the patient in the reports that record Colon cancer
Age	Reports	Share
Under 2	1	under 0.1%
2 to 11	2	under 0.1%
12 to 17	13	0.1%
18 to 44	575	3.9%
45 to 64	3,109	21.1%
65 to 74	2,449	16.7%
75 and over	2,266	15.4%
Age not given	6,293	42.8%

Sex of the patient in the reports that record Colon cancer
Sex	Reports	Share
Female	6,573	44.7%
Male	6,354	43.2%
Unknown or not given	1,781	12.1%

Age and sex are as the report gives them. 54.2% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

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. Colon cancer: adverse event reports that record this term. https://reportedreactions.com/reaction/colon-cancer/ 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.

The count has the reports with each spelling of one MedDRA preferred term. 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

What does Colon cancer mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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