Gangrene adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: death of tissue

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 5,977 adverse event reports that record the MedDRA preferred term Gangrene. In plain words, the term means: death of tissue. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 217 reports in the 12 months to June 2026 and 247 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 1,312 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, 217 (under 0.1%) record this term. Reports for male patients were 55.4% 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.

Plain meaning

Death of tissue. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

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

Drugs in these reports

The table has the 91 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 Gangrene name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		203
Aliskiren	Renin inhibitor	65
Aliskiren hemifumarate	Renin inhibitor	139
Altace		190
Amlodipine	Calcium channel blocker	121
Amlodipine Besilate		30
Amlodipine besylate	Dihydropyridine calcium channel blocker	123
Aspirin	Nonsteroidal anti-inflammatory drug	150
Atacand	Angiotensin 2 receptor blocker	156
Atorvastatin		27
Bisoprolol	beta-Adrenergic blocker	165
Bisoprolol fumarate	beta-Adrenergic blocker	31
Calcium carbonate	Blood coagulation factor	143
Candesartan	Angiotensin 2 receptor blocker	107
Candesartan cilexetil	Angiotensin 2 receptor blocker	80
Cosentyx	Interleukin-17A antagonist	181
Dapagliflozin	Sodium-Glucose cotransporter 2 inhibitor	28
Diamicron		33
Dianeal		233
Dianeal Low Calcium		206
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		245
Diphenhydramine	Histamine-1 receptor antagonist	57
Diphenhydramine hydrochloride	Histamine-1 receptor antagonist	159
Eliquis	Factor Xa inhibitor	25
Enbrel	Tumor necrosis factor blocker	76
Entresto	Angiotensin 2 receptor blocker	32
Epinephrine	Catecholamine	30
Ergocalciferol	Provitamin D2 compound	170
Esomeprazole	Proton pump inhibitor	120
Esomeprazole magnesium	Proton pump inhibitor	76
Esomeprazole Magnesium Naproxen		76
Esomeprazole sodium	Proton pump inhibitor	38
Extraneal	Osmotic laxative	235
Farxiga	Sodium-Glucose cotransporter 2 inhibitor	32
Gliclazide		184
Glucophage		33
Gravol	Histamine-1 receptor antagonist	203
Heparin		51
Heparin sodium	Anti-coagulant	91
Humalog	Insulin analog	74
Humira		107
Insulin glargine	Insulin analog	32
Invokamet	Biguanide	79
Invokana	Sodium-Glucose cotransporter 2 inhibitor	1,069
Irbesartan	Angiotensin 2 receptor blocker	175
Januvia	Dipeptidyl peptidase 4 inhibitor	148
Jardiance	Sodium-Glucose cotransporter 2 inhibitor	100
Lantus	Insulin analog	54
Levothyroxine		47
Levothyroxine sodium	l-Thyroxine	132
Lipitor	HMG-CoA reductase inhibitor	152
Lisinopril	Angiotensin converting enzyme inhibitor	201
Lyrica		57
Metformin	Biguanide	186
Metformin hydrochloride	Biguanide	69
Methotrexate	Folate analog metabolic inhibitor	211
Methylprednisolone	Corticosteroid	47
Methylprednisolone sodium succinate	Corticosteroid	191
Morphine	Opioid agonist	106
Morphine sulfate	Opioid agonist	142
Naproxen	Nonsteroidal anti-inflammatory drug	35
Nexium	Proton pump inhibitor	81
Nexium 24HR	Proton pump inhibitor	40
Norepinephrine	Catecholamine	35
Omeprazole	Proton pump inhibitor	38
Ondansetron	Serotonin-3 receptor antagonist	142
Ondansetron hydrochloride	Serotonin-3 receptor antagonist	62
Prednisolone sodium phosphate	Corticosteroid	26
Prednisone	Corticosteroid	242
Prochlorperazine	Phenothiazine	180
Prochlorperazine maleate	Phenothiazine	27
Ramipril	Angiotensin converting enzyme inhibitor	92
Regranex		35
Revlimid	Thalidomide analog	36
Rituxan	CD20-directed cytolytic antibody	49
Rituximab	CD20-directed cytolytic antibody	240
Sitagliptin phosphate	Dipeptidyl peptidase 4 inhibitor	27
Skyrizi	Interleukin-23 antagonist	29
Stelara	Interleukin-12 antagonist	33
Synthroid	l-Thyroxine	164
Tacrolimus	Calcineurin inhibitor immunosuppressant	26
Tasigna	Kinase inhibitor	58
Tracleer	Endothelin receptor antagonist	41
Trulicity	GLP-1 receptor agonist	26
Tums Ultra		27
Vasopressin		27
Warfarin	Vitamin K antagonist	43
Warfarin sodium	Vitamin K antagonist	31
Zestril	Angiotensin converting enzyme inhibitor	66
Zofran		72
Zolpidem	gamma-Aminobutyric acid A receptor positive modulator	86

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 49 pharmacologic classes with 25 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 Gangrene name, in order of name
Class	Reports with this term
Alkylating drug	26
Angiotensin 2 receptor blocker	559
Angiotensin converting enzyme inhibitor	359
Anti-coagulant	100
Anti-epileptic agent	45
Antimetabolite immunosuppressant	36
Aromatase inhibitor	25
Atypical antipsychotic	72
beta-Adrenergic blocker	226
Biguanide	343
Blood coagulation factor	151
Calcineurin inhibitor immunosuppressant	58
Calcium channel blocker	123
Catecholamine	86
CD20-directed cytolytic antibody	298
Corticosteroid	566
Dihydropyridine calcium channel blocker	127
Dipeptidyl peptidase 4 inhibitor	193
Endothelin receptor antagonist	73
Erythropoiesis-stimulating agent	34
Factor Xa inhibitor	42
Folate analog metabolic inhibitor	233
gamma-Aminobutyric acid A receptor positive modulator	95
GLP-1 receptor agonist	47
Histamine-1 receptor antagonist	440
HMG-CoA reductase inhibitor	180
Insulin	69
Insulin analog	248
Interferon beta	39
Interleukin-12 antagonist	33
Interleukin-17A antagonist	183
Interleukin-23 antagonist	29
Kinase inhibitor	130
l-Thyroxine	296
Nonsteroidal anti-inflammatory drug	229
Nucleoside metabolic inhibitor	47
Opioid agonist	293
Osmotic laxative	256
Phenothiazine	196
Platinum-based drug	46
Proton pump inhibitor	442
Provitamin D2 compound	170
Renin inhibitor	65
Serotonin reuptake inhibitor	28
Serotonin-3 receptor antagonist	204
Sodium-Glucose cotransporter 2 inhibitor	1,244
Thalidomide analog	45
Tumor necrosis factor blocker	104
Vitamin K antagonist	74

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

Reports by month

Reports that record Gangrene, 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 Gangrene
Age	Reports	Share
Under 2	33	0.6%
2 to 11	18	0.3%
12 to 17	15	0.3%
18 to 44	432	7.2%
45 to 64	2,012	33.7%
65 to 74	1,128	18.9%
75 and over	626	10.5%
Age not given	1,713	28.7%

Sex of the patient in the reports that record Gangrene
Sex	Reports	Share
Female	2,353	39.4%
Male	3,310	55.4%
Unknown or not given	314	5.3%

Age and sex are as the report gives them. 61.7% 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. Gangrene: adverse event reports that record this term. https://reportedreactions.com/reaction/gangrene/ 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 Gangrene mean in an adverse event report?

In plain words: death of tissue. 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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