Upper gastrointestinal 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 16,607 adverse event reports that record the MedDRA preferred term Upper gastrointestinal haemorrhage. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 686 reports in the 12 months to June 2026 and 743 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 815 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, 686 (0.1%) record this term. Reports for patients 75 and over were 33% 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 140 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 Upper gastrointestinal haemorrhage name as a suspect product, in order of name
Drug	Class	Reports with this term
Abraxane	Microtubule inhibitor	66
Acetaminophen		69
Acetylsalicylic Acid		937
Adempas	Soluble guanylate cyclase stimulator	33
Advil	Nonsteroidal anti-inflammatory drug	47
Alendronate sodium	Bisphosphonate	37
Alendronic Acid		48
Aleve	Nonsteroidal anti-inflammatory drug	129
Alteplase		40
Ambrisentan	Endothelin receptor antagonist	44
Amiodarone		29
Apixaban	Factor Xa inhibitor	420
Arixtra	Factor Xa inhibitor	32
Asa		59
Aspirin	Nonsteroidal anti-inflammatory drug	2,355
Asprin		86
Atezolizumab	Programmed death Receptor-1 blocking antibody	87
Atorvastatin		53
Avastin	Vascular endothelial growth factor inhibitor	66
Azacitidine	Nucleoside metabolic inhibitor	30
Baby Aspirin		41
Bayaspirin		30
Bayer aspirin extra strength	Nonsteroidal anti-inflammatory drug	58
Bayer Low Dose	Nonsteroidal anti-inflammatory drug	257
Bevacizumab	Vascular endothelial growth factor inhibitor	127
Brilinta	P2Y12 platelet inhibitor	64
Budesonide	Corticosteroid	27
Capecitabine	Nucleoside metabolic inhibitor	58
Carboplatin	Platinum-based drug	85
Celebrex	Nonsteroidal anti-inflammatory drug	83
Celecoxib	Nonsteroidal anti-inflammatory drug	73
Ciprofloxacin	Fluoroquinolone antibacterial	36
Cisplatin	Platinum-based drug	120
Citalopram	Serotonin reuptake inhibitor	53
Clarithromycin	Macrolide antimicrobial	42
Clexane		26
Clopidogrel	P2Y12 platelet inhibitor	662
Clopidogrel bisulfate	P2Y12 platelet inhibitor	196
Coumadin		198
Cyclophosphamide	Alkylating drug	170
Cytarabine	Nucleoside metabolic inhibitor	63
Dabigatran		60
Dexamethasone	Corticosteroid	175
Diclofenac	Nonsteroidal anti-inflammatory drug	185
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	198
Digoxin	Cardiac glycoside	39
Docetaxel	Microtubule inhibitor	43
Donepezil		31
Doxorubicin	Anthracycline topoisomerase inhibitor	65
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	27
Doxycycline	Tetracycline-class drug	26
Durvalumab	Programmed death Ligand-1 blocker	45
Ecotrin	Nonsteroidal anti-inflammatory drug	26
Edoxaban		74
Edoxaban tosylate	Factor Xa inhibitor	31
Effient	P2Y12 platelet inhibitor	30
Eliquis	Factor Xa inhibitor	343
Enalapril	Angiotensin converting enzyme inhibitor	26
Enoxaparin		29
Enoxaparin sodium	Low molecular weight heparin	85
Escitalopram	Serotonin reuptake inhibitor	53
Etoposide	Topoisomerase inhibitor	67
Exviera		39
Fluorouracil	Nucleoside metabolic inhibitor	65
Fluoxetine	Serotonin reuptake inhibitor	58
Fosamax	Bisphosphonate	71
Fragmin	Anti-coagulant	48
Furosemide	Loop diuretic	32
Gemcitabine	Nucleoside metabolic inhibitor	70
Gemcitabine hydrochloride	Nucleoside metabolic inhibitor	33
Harvoni	Hepatitis C virus NS5A inhibitor	31
Heparin		84
Heparin sodium	Anti-coagulant	114
Humira		97
Ibrutinib (form s4)	Kinase inhibitor	42
Ibuprofen	Nonsteroidal anti-inflammatory drug	841
Ibuprofeno		41
Imbruvica	Kinase inhibitor	51
Januvia	Dipeptidyl peptidase 4 inhibitor	36
Kisqali	Kinase inhibitor	32
Leflunomide	Antirheumatic agent	33
Lenvatinib	Kinase inhibitor	64
Lenvima	Kinase inhibitor	29
Letrozole	Aromatase inhibitor	27
Linezolid	Oxazolidinone antibacterial	35
Lorazepam	Benzodiazepine	25
Lovenox	Low molecular weight heparin	98
Meloxicam	Nonsteroidal anti-inflammatory drug	44
Meropenem	Penem antibacterial	40
Metformin	Biguanide	30
Methotrexate	Folate analog metabolic inhibitor	137
Methylprednisolone	Corticosteroid	109
Methylprednisolone sodium succinate	Corticosteroid	30
Metoprolol	beta-Adrenergic blocker	26
Mobic		42
Motrin	Nonsteroidal anti-inflammatory drug	28
Mycophenolate mofetil	Antimetabolite immunosuppressant	86
Naprosyn		29
Naproxen	Nonsteroidal anti-inflammatory drug	368
Naproxen sodium	Nonsteroidal anti-inflammatory drug	32
Nexavar	Kinase inhibitor	26
Nexium	Proton pump inhibitor	28
Nivolumab	Programmed death Receptor-1 blocking antibody	62
Omeprazole	Proton pump inhibitor	93
Opsumit	Endothelin receptor antagonist	57
Oxaliplatin	Platinum-based drug	91
Paclitaxel	Microtubule inhibitor	58
Pantoprazole	Proton pump inhibitor	46
Paracetamol		71
Pembrolizumab	Programmed death Receptor-1 blocking antibody	45
Plavix	P2Y12 platelet inhibitor	696
Pradaxa	Direct thrombin inhibitor	1,204
Prazaxa		26
Prednisolone	Corticosteroid	225
Prednisone	Corticosteroid	218
Remodulin	Prostacycline vasodilator	32
Revlimid	Thalidomide analog	61
Ribavirin	Nucleoside analog antiviral	68
Rituximab	CD20-directed cytolytic antibody	141
Rivaroxaban	Factor Xa inhibitor	201
Sertraline	Serotonin reuptake inhibitor	226
Simvastatin	HMG-CoA reductase inhibitor	38
Sintrom		104
Solu-medrol	Corticosteroid	25
Spironolactone	Aldosterone antagonist	27
Tacrolimus	Calcineurin inhibitor immunosuppressant	81
Tecentriq	Programmed death Receptor-1 blocking antibody	28
Ticagrelor	P2Y12 platelet inhibitor	83
Torsemide	Loop diuretic	32
Tramadol		44
Tylenol	Expectorant	31
Velcade	Proteasome inhibitor	30
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	27
Viekirax		40
Vincristine		50
Vincristine sulfate	Vinca alkaloid	33
Vioxx		90
Warfarin	Vitamin K antagonist	333
Warfarin sodium	Vitamin K antagonist	346
Xarelto	Factor Xa inhibitor	4,260

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 43 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 Upper gastrointestinal haemorrhage name, in order of name
Class	Reports with this term
Alkylating drug	224
Angiotensin 2 receptor blocker	141
Angiotensin converting enzyme inhibitor	67
Anthracycline topoisomerase inhibitor	106
Anti-coagulant	183
Antimetabolite immunosuppressant	110
Atypical antipsychotic	64
Benzodiazepine	57
beta-Adrenergic blocker	58
Biguanide	52
Bisphosphonate	163
Calcineurin inhibitor immunosuppressant	103
CD20-directed cytolytic antibody	148
Corticosteroid	840
Direct thrombin inhibitor	1,225
Endothelin receptor antagonist	149
Factor Xa inhibitor	5,292
Fluoroquinolone antibacterial	58
Folate analog metabolic inhibitor	186
Hepatitis C virus NS5A inhibitor	56
HMG-CoA reductase inhibitor	89
Janus kinase inhibitor	69
Kinase inhibitor	463
Loop diuretic	76
Low molecular weight heparin	183
Microtubule inhibitor	167
Nonsteroidal anti-inflammatory drug	4,801
Nucleoside analog antiviral	74
Nucleoside metabolic inhibitor	368
Opioid agonist	67
P2Y12 platelet inhibitor	1,752
Platinum-based drug	296
Programmed death Receptor-1 blocking antibody	261
Prostacycline vasodilator	59
Proteasome inhibitor	66
Proton pump inhibitor	209
Serotonin and norepinephrine reuptake inhibitor	64
Serotonin reuptake inhibitor	476
Thalidomide analog	98
Topoisomerase inhibitor	83
Tumor necrosis factor blocker	70
Vascular endothelial growth factor inhibitor	199
Vitamin K antagonist	679

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

Reports by month

Reports that record Upper gastrointestinal 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 Upper gastrointestinal haemorrhage
Age	Reports	Share
Under 2	45	0.3%
2 to 11	95	0.6%
12 to 17	88	0.5%
18 to 44	829	5%
45 to 64	3,570	21.5%
65 to 74	4,002	24.1%
75 and over	5,487	33%
Age not given	2,491	15%

Sex of the patient in the reports that record Upper gastrointestinal haemorrhage
Sex	Reports	Share
Female	6,418	38.6%
Male	8,923	53.7%
Unknown or not given	1,266	7.6%

Age and sex are as the report gives them. 49.9% 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. Upper gastrointestinal haemorrhage: adverse event reports that record this term. https://reportedreactions.com/reaction/upper-gastrointestinal-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 Upper gastrointestinal 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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