Anal fissure 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 5,253 adverse event reports that record the MedDRA preferred term Anal fissure. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 383 reports in the 12 months to June 2026 and 348 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 1,120 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, 383 (under 0.1%) record this term. Reports for patients aged 18 to 44 were 25.2% of the reports that record this term and 12.3% 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 97 drug pages with 10 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 Anal fissure name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	11
Abemaciclib	Kinase inhibitor	20
Abrilada		45
Accutane	Retinoid	321
Acetaminophen		20
Actemra	Interleukin-6 receptor antagonist	18
Adalimumab	Tumor necrosis factor blocker	29
Amnesteem	Retinoid	14
Apixaban	Factor Xa inhibitor	10
Arava	Antirheumatic agent	27
Atorvastatin calcium	HMG-CoA reductase inhibitor	10
Avastin	Vascular endothelial growth factor inhibitor	30
Azacitidine	Nucleoside metabolic inhibitor	10
Azathioprine	Purine antimetabolite	35
Benicar	Angiotensin 2 receptor blocker	30
Benicar HCT	Thiazide diuretic	19
Bevacizumab	Vascular endothelial growth factor inhibitor	39
Budesonide	Corticosteroid	12
Cabometyx	Kinase inhibitor	17
Calcium		14
Carboplatin	Platinum-based drug	27
Ceftriaxone sodium	Cephalosporin antibacterial	16
Cimzia	Tumor necrosis factor blocker	11
Ciprofloxacin	Fluoroquinolone antibacterial	29
Codeine		11
Cosentyx	Interleukin-17A antagonist	30
Cyclophosphamide	Alkylating drug	27
Cytarabine	Nucleoside metabolic inhibitor	14
Dexamethasone	Corticosteroid	11
Dexilant	Proton pump inhibitor	11
Docetaxel	Microtubule inhibitor	11
Doxorubicin	Anthracycline topoisomerase inhibitor	11
Enbrel	Tumor necrosis factor blocker	53
Entyvio	Integrin receptor antagonist	35
Etoposide	Topoisomerase inhibitor	10
Filgrastim	Leukocyte growth factor	10
Flagyl	Nitroimidazole antimicrobial	17
Fluorouracil	Nucleoside metabolic inhibitor	47
Folic acid		27
Folinic Acid		18
Fosamax	Bisphosphonate	14
Gabapentin	Anti-epileptic agent	29
Hulio		19
Humira		463
Hydrochlorothiazide	Thiazide diuretic	15
Hydroxychloroquine sulfate	Antimalarial	16
Hyrimoz	Tumor necrosis factor blocker	49
Imuran	Purine antimetabolite	15
Incivek		20
Inflectra	Tumor necrosis factor blocker	1,009
Infliximab	Tumor necrosis factor blocker	822
Infliximab Recombinant		22
Infliximab-dyyb	Tumor necrosis factor blocker	20
Irinotecan		16
Isotretinoin	Retinoid	30
Ixifi		37
Kisqali	Kinase inhibitor	13
Letrozole	Aromatase inhibitor	21
Leucovorin calcium	Folate analog	12
Mesalamine	Aminosalicylate	13
Methotrexate	Folate analog metabolic inhibitor	122
Methotrexate sodium	Folate analog metabolic inhibitor	37
Metronidazole	Nitroimidazole antimicrobial	42
Mounjaro	GLP-1 receptor agonist	14
Omeprazole	Proton pump inhibitor	15
Orencia	Selective T cell costimulation modulator	27
Oxaliplatin	Platinum-based drug	20
OxyContin	Opioid agonist	15
Ozempic	GLP-1 receptor agonist	17
Paclitaxel	Microtubule inhibitor	24
Palbociclib	Kinase inhibitor	10
Pantoprazole sodium	Proton pump inhibitor	16
Pegasys	Interferon alpha	15
Pertuzumab	HER2/neu receptor antagonist	13
Plaquenil	Antimalarial	16
Prednisolone	Corticosteroid	18
Prednisone	Corticosteroid	49
Remicade	Tumor necrosis factor blocker	260
Revlimid	Thalidomide analog	25
Ribavirin	Nucleoside analog antiviral	19
Rinvoq	Janus kinase inhibitor	24
Rituxan	CD20-directed cytolytic antibody	19
Rituximab	CD20-directed cytolytic antibody	30
Skyrizi	Interleukin-23 antagonist	30
Stelara	Interleukin-12 antagonist	40
Sulfasalazine	Aminosalicylate	36
Sutent	Kinase inhibitor	16
Tasigna	Kinase inhibitor	10
Teduglutide	GLP-2 analog	12
Vedolizumab	Integrin receptor antagonist	394
Venetoclax	BCL-2 inhibitor	10
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	15
Vincristine		20
Vincristine sulfate	Vinca alkaloid	11
Vioxx		18
Xeljanz	Janus kinase inhibitor	29
Xyrem	Central nervous system depressant	11

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 54 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 Anal fissure name, in order of name
Class	Reports with this term
5-alpha reductase inhibitor	16
Alkylating drug	34
Aminosalicylate	49
Angiotensin 2 receptor blocker	38
Anthracycline topoisomerase inhibitor	23
Anti-epileptic agent	29
Antimalarial	34
Antirheumatic agent	36
Aromatase inhibitor	25
Atypical antipsychotic	25
BCL-2 inhibitor	14
Biguanide	15
Bisphosphonate	30
CD20-directed cytolytic antibody	54
Central nervous system depressant	11
Cephalosporin antibacterial	24
Corticosteroid	104
Factor Xa inhibitor	22
Fluoroquinolone antibacterial	33
Folate analog	12
Folate analog metabolic inhibitor	165
GLP-1 receptor agonist	42
GLP-2 analog	12
HER2/neu receptor antagonist	28
HMG-CoA reductase inhibitor	34
Integrin receptor antagonist	433
Interferon alpha	18
Interleukin-12 antagonist	47
Interleukin-17A antagonist	35
Interleukin-23 antagonist	30
Interleukin-6 receptor antagonist	18
Janus kinase inhibitor	59
Kinase inhibitor	154
Leukocyte growth factor	10
Microtubule inhibitor	35
Nitroimidazole antimicrobial	59
Nonsteroidal anti-inflammatory drug	10
Nucleoside analog antiviral	19
Nucleoside metabolic inhibitor	82
Opioid agonist	71
Platinum-based drug	52
Programmed death Receptor-1 blocking antibody	20
Proton pump inhibitor	51
Purine antimetabolite	50
Retinoid	370
Selective T cell costimulation modulator	38
Serotonin and norepinephrine reuptake inhibitor	32
Thalidomide analog	27
Thiazide diuretic	34
Topoisomerase inhibitor	13
Tumor necrosis factor blocker	2,262
Vascular endothelial growth factor inhibitor	71
Vinca alkaloid	11
Vitamin K antagonist	13

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

Reports by month

Reports that record Anal fissure, 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 Anal fissure
Age	Reports	Share
Under 2	7	0.1%
2 to 11	37	0.7%
12 to 17	143	2.7%
18 to 44	1,324	25.2%
45 to 64	1,125	21.4%
65 to 74	389	7.4%
75 and over	135	2.6%
Age not given	2,093	39.8%

Sex of the patient in the reports that record Anal fissure
Sex	Reports	Share
Female	2,227	42.4%
Male	1,699	32.3%
Unknown or not given	1,327	25.3%

Age and sex are as the report gives them. 26.3% 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. Anal fissure: adverse event reports that record this term. https://reportedreactions.com/reaction/anal-fissure/ 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 Anal fissure 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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