Gastric ulcer haemorrhage 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 5,471 adverse event reports that record the MedDRA preferred term Gastric ulcer haemorrhage. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 155 reports in the 12 months to June 2026 and 191 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 1,353 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, 155 (under 0.1%) record this term. Reports for patients 75 and over were 27.7% of the reports that record this term and 9.5% 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 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 Gastric ulcer haemorrhage name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		17
Acetylsalicylic Acid		193
Acetylsalicylic Acid Srt		13
Advil	Nonsteroidal anti-inflammatory drug	48
Alendronic Acid		23
Aleve	Nonsteroidal anti-inflammatory drug	156
Apixaban	Factor Xa inhibitor	36
Arixtra	Factor Xa inhibitor	21
Arthrotec	Prostaglandin E1 analog	17
Aspirin	Nonsteroidal anti-inflammatory drug	583
Avastin	Vascular endothelial growth factor inhibitor	37
Avonex	Interferon beta	44
Bayaspirin		29
Bayer aspirin extra strength	Nonsteroidal anti-inflammatory drug	32
Bayer genuine aspirin	Nonsteroidal anti-inflammatory drug	13
Bayer Low Dose	Nonsteroidal anti-inflammatory drug	58
Benicar	Angiotensin 2 receptor blocker	10
Bevacizumab	Vascular endothelial growth factor inhibitor	19
Bextra		16
Brilinta	P2Y12 platelet inhibitor	20
Byetta	GLP-1 receptor agonist	10
Cabometyx	Kinase inhibitor	18
Carboplatin	Platinum-based drug	18
Cardioaspirin		11
Celebrex	Nonsteroidal anti-inflammatory drug	83
Celecox		16
Celecoxib	Nonsteroidal anti-inflammatory drug	21
Ciclosporin		11
Cisplatin	Platinum-based drug	16
Citalopram hydrobromide	Serotonin reuptake inhibitor	12
Clopidogrel	P2Y12 platelet inhibitor	80
Clopidogrel bisulfate	P2Y12 platelet inhibitor	17
Coumadin		65
Cyclophosphamide	Alkylating drug	38
Cyclosporine	Calcineurin inhibitor immunosuppressant	10
Cytarabine	Nucleoside metabolic inhibitor	12
Dexamethasone	Corticosteroid	28
Dianeal Low Calcium		12
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		13
Diclofenac	Nonsteroidal anti-inflammatory drug	60
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	98
Digoxin	Cardiac glycoside	10
Diovan	Angiotensin 2 receptor blocker	13
Docetaxel	Microtubule inhibitor	12
Doxorubicin	Anthracycline topoisomerase inhibitor	10
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	11
Doxycycline	Tetracycline-class drug	17
Effient	P2Y12 platelet inhibitor	16
Eliquis	Factor Xa inhibitor	88
Enbrel	Tumor necrosis factor blocker	52
Etoposide	Topoisomerase inhibitor	18
Excedrin	Central nervous system stimulant	15
Forteo	Parathyroid hormone analog	32
Fosamax	Bisphosphonate	43
Furosemide	Loop diuretic	25
Heparin		10
Humira		137
Ibuprofen	Nonsteroidal anti-inflammatory drug	271
Ifosfamide	Alkylating drug	13
Imbruvica	Kinase inhibitor	14
Indapamide	Thiazide-like diuretic	11
Jakafi	Janus kinase inhibitor	11
Kardegic		21
Ketoprofen	Nonsteroidal anti-inflammatory drug	11
Keytruda	Programmed death Receptor-1 blocking antibody	18
Lansoprazole	Proton pump inhibitor	12
Leflunomide	Antirheumatic agent	16
Lenvima	Kinase inhibitor	22
Lovenox	Low molecular weight heparin	19
Loxonin		24
Lyrica		10
Meloxicam	Nonsteroidal anti-inflammatory drug	21
Methotrexate	Folate analog metabolic inhibitor	74
Methotrexate sodium	Folate analog metabolic inhibitor	10
Methylprednisolone	Corticosteroid	28
Mobic		27
Mycophenolate mofetil	Antimetabolite immunosuppressant	31
Naprosyn		10
Naproxen	Nonsteroidal anti-inflammatory drug	121
Naproxen sodium	Nonsteroidal anti-inflammatory drug	18
Nexavar	Kinase inhibitor	16
Nexium	Proton pump inhibitor	77
Ofev	Kinase inhibitor	22
Omeprazole	Proton pump inhibitor	24
Opdivo	Programmed death Receptor-1 blocking antibody	20
Orencia	Selective T cell costimulation modulator	20
Oxaliplatin	Platinum-based drug	10
Oxycodone hydrochloride	Opioid agonist	10
Pantoprazole	Proton pump inhibitor	10
Plavix	P2Y12 platelet inhibitor	182
Pletal		20
Pradaxa	Direct thrombin inhibitor	87
Prednisolone	Corticosteroid	67
Prednisone	Corticosteroid	101
Predonine		11
Previscan		11
Ramipril	Angiotensin converting enzyme inhibitor	10
Rebif	Interferon beta	38
Remicade	Tumor necrosis factor blocker	12
Revlimid	Thalidomide analog	22
Ribavirin	Nucleoside analog antiviral	11
Rinvoq	Janus kinase inhibitor	19
Rituximab	CD20-directed cytolytic antibody	45
Rivaroxaban	Factor Xa inhibitor	32
Rosuvastatin	HMG-CoA reductase inhibitor	11
Simponi	Tumor necrosis factor blocker	23
Sulfasalazine	Aminosalicylate	19
Sutent	Kinase inhibitor	19
Tacrolimus	Calcineurin inhibitor immunosuppressant	21
Tecentriq	Programmed death Receptor-1 blocking antibody	11
Tecfidera		14
Ticagrelor	P2Y12 platelet inhibitor	10
Tracleer	Endothelin receptor antagonist	17
Tylenol	Expectorant	17
Tysabri	Integrin receptor antagonist	10
Vincristine		22
Vioxx		39
Warfarin	Vitamin K antagonist	50
Warfarin sodium	Vitamin K antagonist	58
Xarelto	Factor Xa inhibitor	817

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 51 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 Gastric ulcer haemorrhage name, in order of name
Class	Reports with this term
Alkylating drug	57
Aminosalicylate	22
Angiotensin 2 receptor blocker	30
Angiotensin converting enzyme inhibitor	12
Anthracycline topoisomerase inhibitor	21
Antimetabolite immunosuppressant	40
Antirheumatic agent	18
Aromatic amino acid	14
Atypical antipsychotic	24
beta-Adrenergic blocker	16
Bisphosphonate	58
Calcineurin inhibitor immunosuppressant	33
Cardiac glycoside	10
CD20-directed cytolytic antibody	49
Central nervous system stimulant	22
Corticosteroid	240
Direct thrombin inhibitor	87
Endothelin receptor antagonist	30
Expectorant	21
Factor Xa inhibitor	1,002
Folate analog metabolic inhibitor	94
GLP-1 receptor agonist	19
HMG-CoA reductase inhibitor	33
Integrin receptor antagonist	15
Interferon beta	82
Interleukin-17A antagonist	11
Janus kinase inhibitor	39
Kinase inhibitor	176
Loop diuretic	32
Low molecular weight heparin	23
Microtubule inhibitor	20
Nonsteroidal anti-inflammatory drug	1,630
Nucleoside analog antiviral	13
Nucleoside metabolic inhibitor	34
Opioid agonist	43
P2Y12 platelet inhibitor	331
Parathyroid hormone analog	32
Platinum-based drug	44
Programmed death Receptor-1 blocking antibody	67
Prostaglandin E1 analog	17
Proton pump inhibitor	144
Selective T cell costimulation modulator	28
Serotonin reuptake inhibitor	36
Tetracycline-class drug	19
Thalidomide analog	24
Thiazide-like diuretic	11
Topoisomerase inhibitor	22
Tumor necrosis factor blocker	105
Vascular endothelial growth factor inhibitor	56
Vitamin K antagonist	108
Xanthine oxidase inhibitor	13

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

Reports by month

Reports that record Gastric ulcer haemorrhage, 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 Gastric ulcer haemorrhage
Age	Reports	Share
Under 2	4	0.1%
2 to 11	25	0.5%
12 to 17	19	0.3%
18 to 44	241	4.4%
45 to 64	1,153	21.1%
65 to 74	1,242	22.7%
75 and over	1,517	27.7%
Age not given	1,270	23.2%

Sex of the patient in the reports that record Gastric ulcer haemorrhage
Sex	Reports	Share
Female	2,487	45.5%
Male	2,629	48.1%
Unknown or not given	355	6.5%

Age and sex are as the report gives them. 48.1% 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. Gastric ulcer haemorrhage: adverse event reports that record this term. https://reportedreactions.com/reaction/gastric-ulcer-haemorrhage/ 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 Gastric ulcer haemorrhage 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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