Gastrointestinal pain 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 10,789 adverse event reports that record the MedDRA preferred term Gastrointestinal pain. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 787 reports in the 12 months to June 2026 and 707 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 729 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, 787 (0.1%) record this term. Reports for female patients were 62.5% of the reports that record this term and 52.7% 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 127 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 Gastrointestinal pain name as a suspect product, in order of name
Drug	Class	Reports with this term
Abemaciclib	Kinase inhibitor	43
Acetylsalicylic Acid		73
Actemra	Interleukin-6 receptor antagonist	44
Adalimumab	Tumor necrosis factor blocker	51
Aimovig		36
Alli	Intestinal lipase inhibitor	55
Amlodipine	Calcium channel blocker	29
Arava	Antirheumatic agent	218
Aspirin	Nonsteroidal anti-inflammatory drug	170
Atorvastatin		42
Boniva		34
Byetta	GLP-1 receptor agonist	52
Capecitabine	Nucleoside metabolic inhibitor	30
Carbamazepine	Mood stabilizer	31
Chantix	Partial cholinergic nicotinic agonist	44
Cimzia	Tumor necrosis factor blocker	43
Ciprofloxacin	Fluoroquinolone antibacterial	133
Clopidogrel	P2Y12 platelet inhibitor	27
Clozapine	Atypical antipsychotic	25
Cosentyx	Interleukin-17A antagonist	171
Creon		45
Crestor	HMG-CoA reductase inhibitor	30
Cymbalta		40
Dexamethasone	Corticosteroid	38
Diclofenac	Nonsteroidal anti-inflammatory drug	175
Diclofenac potassium	Nonsteroidal anti-inflammatory drug	98
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	85
Docetaxel	Microtubule inhibitor	27
Domperidone		40
Dupixent	Interleukin-4 receptor alpha antagonist	90
Eliquis	Factor Xa inhibitor	37
Enbrel	Tumor necrosis factor blocker	344
Entyvio	Integrin receptor antagonist	47
Ergocalciferol	Provitamin D2 compound	59
Esbriet	Pyridone	31
Etanercept	Tumor necrosis factor blocker	26
Exjade	Iron chelator	25
Fluorouracil	Nucleoside metabolic inhibitor	30
Folic acid		30
Forteo	Parathyroid hormone analog	48
Fosamax	Bisphosphonate	42
Gabapentin	Anti-epileptic agent	31
Gilenya	Sphingosine 1-phosphate receptor modulator	28
Gold	Standardized chemical allergen	155
Gold Sodium Thiomalate		59
Humira		1,151
Hydroxychloroquine	Antimalarial	105
Hydroxychloroquine sulfate	Antimalarial	82
Ibrance	Kinase inhibitor	39
Ibuprofen	Nonsteroidal anti-inflammatory drug	132
Imbruvica	Kinase inhibitor	30
Inflectra	Tumor necrosis factor blocker	57
Infliximab	Tumor necrosis factor blocker	89
Irbesartan	Angiotensin 2 receptor blocker	32
Kisqali	Kinase inhibitor	32
Lansoprazole	Proton pump inhibitor	67
Leflunomide	Antirheumatic agent	73
Letrozole	Aromatase inhibitor	36
Linzess	Guanylate Cyclase-C agonist	37
Lisinopril	Angiotensin converting enzyme inhibitor	27
Loperamide hydrochloride	Opioid agonist	27
Lyrica		46
Mesalamine	Aminosalicylate	28
Metformin	Biguanide	49
Methotrexate	Folate analog metabolic inhibitor	335
Methotrexate sodium	Folate analog metabolic inhibitor	95
MiraLAX	Osmotic laxative	81
Mirena	Progestin	28
Motrin	Nonsteroidal anti-inflammatory drug	171
Mounjaro	GLP-1 receptor agonist	135
Naprosyn		172
Naproxen	Nonsteroidal anti-inflammatory drug	95
Nexium	Proton pump inhibitor	74
Novothyrox		97
Ofev	Kinase inhibitor	95
Omeprazole	Proton pump inhibitor	88
Opsumit	Endothelin receptor antagonist	25
Orencia	Selective T cell costimulation modulator	27
Otezla	Phosphodiesterase 4 inhibitor	99
Oxaliplatin	Platinum-based drug	27
OxyContin	Opioid agonist	31
Ozempic	GLP-1 receptor agonist	130
Pantoprazole	Proton pump inhibitor	104
Pantoprazole sodium	Proton pump inhibitor	37
Paxlovid		62
Plaquenil	Antimalarial	140
Pradaxa	Direct thrombin inhibitor	32
Prednisone	Corticosteroid	71
Pregabalin		28
Prilosec OTC	Proton pump inhibitor	41
Prolia	RANK ligand inhibitor	47
Remicade	Tumor necrosis factor blocker	115
Repatha	PCSK9 inhibitor	64
Revlimid	Thalidomide analog	117
Rinvoq	Janus kinase inhibitor	106
Rituximab	CD20-directed cytolytic antibody	51
Rosuvastatin	HMG-CoA reductase inhibitor	25
Sandostatin LAR Depot		51
Sertraline	Serotonin reuptake inhibitor	51
Simvastatin	HMG-CoA reductase inhibitor	61
Skyrizi	Interleukin-23 antagonist	112
Sodium Aurothiomalate		60
Solifenacin		29
Stelara	Interleukin-12 antagonist	43
Sulfamethoxazole		38
Sulfamethoxazole and trimethoprim	Dihydrofolate reductase inhibitor antibacterial	34
Sulfamethoxazole, trimethoprim	Dihydrofolate reductase inhibitor antibacterial	35
Tecfidera		178
Teduglutide	GLP-2 analog	40
Tocilizumab	Interleukin-6 receptor antagonist	26
Tramadol		49
Tramadol hydrochloride	Opioid agonist	33
Trimethoprim	Dihydrofolate reductase inhibitor antibacterial	59
Trimipramine	Tricyclic antidepressant	30
Trulicity	GLP-1 receptor agonist	108
Tysabri	Integrin receptor antagonist	51
Ultram		25
Vedolizumab	Integrin receptor antagonist	232
Venlafaxine hydrochloride	Serotonin and norepinephrine reuptake inhibitor	25
Victoza	GLP-1 receptor agonist	40
Vitamin c	Vitamin C	58
Wegovy	GLP-1 receptor agonist	31
Xarelto	Factor Xa inhibitor	25
Xeljanz	Janus kinase inhibitor	109
Xyrem	Central nervous system depressant	25
Zejula	Poly(ADP-Ribose) polymerase inhibitor	26
Zepbound	GLP-1 receptor agonist	52

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 44 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 Gastrointestinal pain name, in order of name
Class	Reports with this term
Aminosalicylate	54
Angiotensin 2 receptor blocker	100
Anti-epileptic agent	53
Antimalarial	329
Antirheumatic agent	291
Atypical antipsychotic	121
Benzodiazepine	68
Biguanide	65
Bisphosphonate	103
CD20-directed cytolytic antibody	75
Corticosteroid	211
Dihydrofolate reductase inhibitor antibacterial	141
Factor Xa inhibitor	64
Fluoroquinolone antibacterial	155
Folate analog metabolic inhibitor	432
GLP-1 receptor agonist	587
Guanylate Cyclase-C agonist	54
HMG-CoA reductase inhibitor	154
Integrin receptor antagonist	330
Interleukin-17A antagonist	187
Interleukin-23 antagonist	119
Interleukin-4 receptor alpha antagonist	94
Interleukin-6 receptor antagonist	74
Intestinal lipase inhibitor	58
Janus kinase inhibitor	242
Kinase inhibitor	439
Microtubule inhibitor	51
Nonsteroidal anti-inflammatory drug	1,015
Nucleoside metabolic inhibitor	87
Opioid agonist	241
Osmotic laxative	110
Parathyroid hormone analog	51
PCSK9 inhibitor	74
Phosphodiesterase 4 inhibitor	99
Poly(ADP-Ribose) polymerase inhibitor	52
Prostacycline vasodilator	57
Proton pump inhibitor	473
Provitamin D2 compound	59
Serotonin and norepinephrine reuptake inhibitor	55
Serotonin reuptake inhibitor	128
Standardized chemical allergen	155
Thalidomide analog	158
Tumor necrosis factor blocker	762
Vitamin C	80

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

Reports by month

Reports that record Gastrointestinal pain, 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 Gastrointestinal pain
Age	Reports	Share
Under 2	14	0.1%
2 to 11	78	0.7%
12 to 17	99	0.9%
18 to 44	1,479	13.7%
45 to 64	2,897	26.9%
65 to 74	1,445	13.4%
75 and over	954	8.8%
Age not given	3,823	35.4%

Sex of the patient in the reports that record Gastrointestinal pain
Sex	Reports	Share
Female	6,738	62.5%
Male	3,199	29.7%
Unknown or not given	852	7.9%

Age and sex are as the report gives them. 60.7% 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. Gastrointestinal pain: adverse event reports that record this term. https://reportedreactions.com/reaction/gastrointestinal-pain/ 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 Gastrointestinal pain 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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