Anorectal discomfort 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 November 2004 to June 2026, FDA received 5,279 adverse event reports that record the MedDRA preferred term Anorectal discomfort. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 172 reports in the 12 months to June 2026 and 147 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 1,341 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, 172 (under 0.1%) record this term. Reports for patients aged 45 to 64 were 34.6% of the reports that record this term and 20% 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 148 drug pages with 5 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 Anorectal discomfort name as a suspect product, in order of name
Drug	Class	Reports with this term
Abemaciclib	Kinase inhibitor	12
Abrilada		7
Acetaminophen		7
Adalimumab	Tumor necrosis factor blocker	26
Afinitor	Kinase inhibitor	6
Alli	Intestinal lipase inhibitor	23
Anakinra	Interleukin-1 receptor antagonist	5
Aubagio	Pyrimidine synthesis inhibitor	5
Avastin	Vascular endothelial growth factor inhibitor	13
Azathioprine	Purine antimetabolite	13
Azithromycin Anhydrous		6
Benadryl	Histamine-1 receptor antagonist	6
Benicar	Angiotensin 2 receptor blocker	7
Boceprevir		5
Cabometyx	Kinase inhibitor	29
Calcium carbonate	Blood coagulation factor	10
Canasa	Aminosalicylate	6
Cefuroxime axetil	Cephalosporin antibacterial	5
Cimzia	Tumor necrosis factor blocker	5
Ciprofloxacin	Fluoroquinolone antibacterial	38
Clenpiq	Anti-coagulant	5
Clindamycin	Lincosamide antibacterial	8
Colestid		10
Copegus		105
Cosentyx	Interleukin-17A antagonist	17
Cyclosporine	Calcineurin inhibitor immunosuppressant	6
Dexamethasone	Corticosteroid	5
Dexilant	Proton pump inhibitor	5
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	7
Diphenhydramine	Histamine-1 receptor antagonist	9
Dulcolax	Osmotic laxative	6
Dupixent	Interleukin-4 receptor alpha antagonist	6
Eligard	Gonadotropin releasing hormone receptor agonist	8
Eliquis	Factor Xa inhibitor	5
Emapalumab		6
Enbrel	Tumor necrosis factor blocker	18
Entresto	Angiotensin 2 receptor blocker	5
Entyvio	Integrin receptor antagonist	18
Ergocalciferol	Provitamin D2 compound	8
Esbriet	Pyridone	28
Etoposide	Topoisomerase inhibitor	6
Farxiga	Sodium-Glucose cotransporter 2 inhibitor	5
Fentanyl	Opioid agonist	7
Finasteride	5-alpha reductase inhibitor	5
Flagyl	Nitroimidazole antimicrobial	6
Fluorouracil	Nucleoside metabolic inhibitor	16
Folic acid		17
Forteo	Parathyroid hormone analog	5
Gabapentin	Anti-epileptic agent	11
Humira		195
Humira 40 Mg/0 8 Ml Pen		5
Hydrocortisone	Corticosteroid	13
Hydromorph Contin		5
Hyrimoz	Tumor necrosis factor blocker	8
Ibrance	Kinase inhibitor	7
Ibuprofen	Nonsteroidal anti-inflammatory drug	7
Imbruvica	Kinase inhibitor	7
Incivek		1,361
Incivo		51
Inflectra	Tumor necrosis factor blocker	77
Infliximab	Tumor necrosis factor blocker	81
Interferon		6
Iron		5
Jakafi	Janus kinase inhibitor	17
Jardiance	Sodium-Glucose cotransporter 2 inhibitor	13
Letrozole	Aromatase inhibitor	6
Levofloxacin	Fluoroquinolone antibacterial	5
Lidocaine	Amide local anesthetic	11
Linzess	Guanylate Cyclase-C agonist	28
Lyrica		9
Mesalamine	Aminosalicylate	15
Metformin	Biguanide	19
Methotrexate	Folate analog metabolic inhibitor	21
Methylprednisolone	Corticosteroid	5
Metoprolol	beta-Adrenergic blocker	13
Metronidazole	Nitroimidazole antimicrobial	8
Midazolam hydrochloride	Benzodiazepine	6
MiraLAX	Osmotic laxative	52
Mirena	Progestin	13
Naproxen	Nonsteroidal anti-inflammatory drug	12
Nexavar	Kinase inhibitor	7
Nexium	Proton pump inhibitor	9
Ofev	Kinase inhibitor	8
Omeprazole	Proton pump inhibitor	12
Orenitram	Prostacycline vasodilator	7
Orgovyx	Gonadotropin releasing hormone receptor antagonist	14
Otezla	Phosphodiesterase 4 inhibitor	8
Oxaliplatin	Platinum-based drug	10
Oxycodone	Opioid agonist	8
Ozempic	GLP-1 receptor agonist	11
Pantoprazole	Proton pump inhibitor	14
Pantoprazole sodium	Proton pump inhibitor	5
Paracetamol		7
Paxlovid		54
Peg Interferon		13
Peg-Interferon Alfa 2a		10
Peg-Intron		13
Pegasys	Interferon alpha	1,050
Peginterferon		21
Peginterferon Alfa		25
Peginterferon alfa-2a	Interferon alpha	7
Peginterferon Alfa-2b		35
Pegintron		46
Pegylated Interferon Alpha		6
Pentasa	Aminosalicylate	20
Pradaxa	Direct thrombin inhibitor	100
Prednisone	Corticosteroid	48
Prepopik		7
Proctofoam Hc		15
Rabeprazole	Proton pump inhibitor	20
Ranitidine	Histamine-2 receptor antagonist	6
Rebetol		31
Remicade	Tumor necrosis factor blocker	46
Revlimid	Thalidomide analog	35
Ribapak		64
Ribasphere		89
Ribasphere Ribapak		17
Ribavirin	Nucleoside analog antiviral	940
Rifampin	Rifamycin antibacterial	5
Rinvoq	Janus kinase inhibitor	12
Rituxan	CD20-directed cytolytic antibody	6
Rituximab	CD20-directed cytolytic antibody	5
Rosuvastatin	HMG-CoA reductase inhibitor	6
Sandostatin	Somatostatin analog	11
Sandostatin LAR Depot		25
Sertraline hydrochloride	Serotonin reuptake inhibitor	15
Skyrizi	Interleukin-23 antagonist	22
Stivarga	Kinase inhibitor	9
SUPREP Bowel Prep	Osmotic laxative	60
Sutab	Osmotic laxative	9
Sutent	Kinase inhibitor	40
Tasigna	Kinase inhibitor	7
Tecfidera		9
Telaprevir		175
Telotristat ethyl	Tryptophan hydroxylase inhibitor	8
Tykerb	Kinase inhibitor	6
Uptravi	Prostacyclin receptor agonist	5
Vancomycin hydrochloride	Glycopeptide antibacterial	9
Vedolizumab	Integrin receptor antagonist	141
Victrelis		22
Viekira Pak		8
Vitamin B12		13
Vx-950		630
Xeljanz	Janus kinase inhibitor	12
Xeloda	Nucleoside metabolic inhibitor	10
Xtandi	Androgen receptor inhibitor	5
Zantac		7
Zejula	Poly(ADP-Ribose) polymerase inhibitor	7

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 10 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 Anorectal discomfort name, in order of name
Class	Reports with this term
Amide local anesthetic	11
Aminosalicylate	37
Angiotensin 2 receptor blocker	17
Anti-epileptic agent	11
Benzodiazepine	10
beta-Adrenergic blocker	20
Biguanide	23
Blood coagulation factor	10
CD20-directed cytolytic antibody	15
Corticosteroid	83
Direct thrombin inhibitor	102
Fluoroquinolone antibacterial	43
Folate analog metabolic inhibitor	21
GLP-1 receptor agonist	17
Gonadotropin releasing hormone receptor antagonist	14
Guanylate Cyclase-C agonist	28
Histamine-1 receptor antagonist	15
HMG-CoA reductase inhibitor	12
Integrin receptor antagonist	159
Interferon alpha	1,057
Interleukin-17A antagonist	17
Interleukin-23 antagonist	22
Intestinal lipase inhibitor	23
Janus kinase inhibitor	43
Kinase inhibitor	158
Nitroimidazole antimicrobial	14
Nonsteroidal anti-inflammatory drug	35
Nucleoside analog antiviral	942
Nucleoside metabolic inhibitor	34
Opioid agonist	32
Osmotic laxative	134
Phosphodiesterase 4 inhibitor	10
Platinum-based drug	12
Progestin	13
Prostacycline vasodilator	14
Proton pump inhibitor	73
Purine antimetabolite	15
Pyridone	30
Serotonin reuptake inhibitor	20
Sodium-Glucose cotransporter 2 inhibitor	18
Somatostatin analog	14
Thalidomide analog	35
Tryptophan hydroxylase inhibitor	10
Tumor necrosis factor blocker	265
Vascular endothelial growth factor inhibitor	17

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

Reports by month

Reports that record Anorectal discomfort, 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 Anorectal discomfort
Age	Reports	Share
Under 2	10	0.2%
2 to 11	14	0.3%
12 to 17	9	0.2%
18 to 44	502	9.5%
45 to 64	1,826	34.6%
65 to 74	580	11%
75 and over	348	6.6%
Age not given	1,990	37.7%

Sex of the patient in the reports that record Anorectal discomfort
Sex	Reports	Share
Female	2,413	45.7%
Male	2,423	45.9%
Unknown or not given	443	8.4%

Age and sex are as the report gives them. 73.1% 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. Anorectal discomfort: adverse event reports that record this term. https://reportedreactions.com/reaction/anorectal-discomfort/ 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 Anorectal discomfort 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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