Gallbladder disorder 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 17,604 adverse event reports that record the MedDRA preferred term Gallbladder disorder. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 774 reports in the 12 months to June 2026 and 654 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 747 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, 774 (0.1%) record this term. Reports for female patients were 71.1% 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 130 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 Gallbladder disorder name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	88
Actemra	Interleukin-6 receptor antagonist	82
Adempas	Soluble guanylate cyclase stimulator	28
Afinitor	Kinase inhibitor	41
Alendronate sodium	Bisphosphonate	70
Alli	Intestinal lipase inhibitor	83
Ambrisentan	Endothelin receptor antagonist	84
Ampyra	Potassium channel blocker	48
Apixaban	Factor Xa inhibitor	30
Arava	Antirheumatic agent	57
Aredia		31
Atenolol	beta-Adrenergic blocker	45
Aubagio	Pyrimidine synthesis inhibitor	48
Avonex	Interferon beta	188
Benicar	Angiotensin 2 receptor blocker	61
Benicar HCT	Thiazide diuretic	42
Betaseron		26
Boniva		30
Byetta	GLP-1 receptor agonist	76
Cabometyx	Kinase inhibitor	74
Celebrex	Nonsteroidal anti-inflammatory drug	61
Certolizumab pegol	Tumor necrosis factor blocker	38
Chantix	Partial cholinergic nicotinic agonist	44
Cimzia	Tumor necrosis factor blocker	41
Cosentyx	Interleukin-17A antagonist	93
Creon		51
Crestor	HMG-CoA reductase inhibitor	47
Cyclosporine	Calcineurin inhibitor immunosuppressant	38
Cymbalta		29
Darbepoetin alfa	Erythropoiesis-stimulating agent	32
Dianeal		56
Dianeal Low Calcium		45
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		61
Dilaudid	Opioid agonist	40
Diovan	Angiotensin 2 receptor blocker	30
Drospirenone and ethinyl estradiol		776
Dupixent	Interleukin-4 receptor alpha antagonist	112
Eliquis	Factor Xa inhibitor	100
Enbrel	Tumor necrosis factor blocker	478
Entresto	Angiotensin 2 receptor blocker	53
Forteo	Parathyroid hormone analog	97
Fosamax	Bisphosphonate	235
Fosamax Plus D		45
Furosemide	Loop diuretic	49
Gabapentin	Anti-epileptic agent	41
Gilenya	Sphingosine 1-phosphate receptor modulator	43
Humalog	Insulin analog	34
Human immunoglobulin g	Human immunoglobulin G	41
Humira		913
Ibrance	Kinase inhibitor	56
Imbruvica	Kinase inhibitor	76
Indapamide	Thiazide-like diuretic	41
Inflectra	Tumor necrosis factor blocker	69
Infliximab	Tumor necrosis factor blocker	57
Insulin glargine	Insulin analog	25
Jakafi	Janus kinase inhibitor	37
Januvia	Dipeptidyl peptidase 4 inhibitor	89
Lantus	Insulin analog	28
Lantus Solostar	Insulin analog	26
Lenalidomide	Thalidomide analog	42
Lenvima	Kinase inhibitor	88
Letairis	Endothelin receptor antagonist	50
Lipitor	HMG-CoA reductase inhibitor	59
Lorazepam	Benzodiazepine	61
Lyrica		94
Metformin	Biguanide	28
Methotrexate	Folate analog metabolic inhibitor	145
Methotrexate sodium	Folate analog metabolic inhibitor	57
Morphine	Opioid agonist	34
Morphine sulfate	Opioid agonist	32
Mounjaro	GLP-1 receptor agonist	180
Nexium	Proton pump inhibitor	159
Nuvaring	Estrogen	57
Ocella		475
Ocrevus	CD20-directed cytolytic antibody	46
Ofev	Kinase inhibitor	43
Opsumit	Endothelin receptor antagonist	61
Orencia	Selective T cell costimulation modulator	121
Orenitram	Prostacycline vasodilator	29
Otezla	Phosphodiesterase 4 inhibitor	142
Oxycodone hydrochloride	Opioid agonist	25
OxyContin	Opioid agonist	35
Ozempic	GLP-1 receptor agonist	130
Plaquenil	Antimalarial	28
Pomalyst	Thalidomide analog	113
Prednisone	Corticosteroid	68
Premarin	Estrogen	57
Prempro	Estrogen	32
Prilosec	Proton pump inhibitor	41
Prolia	RANK ligand inhibitor	30
Ramipril	Angiotensin converting enzyme inhibitor	42
Rebif	Interferon beta	182
Remicade	Tumor necrosis factor blocker	178
Remodulin	Prostacycline vasodilator	57
Repatha	PCSK9 inhibitor	52
Revlimid	Thalidomide analog	703
Ribavirin	Nucleoside analog antiviral	26
Rinvoq	Janus kinase inhibitor	86
Rituxan	CD20-directed cytolytic antibody	31
Rituximab	CD20-directed cytolytic antibody	147
Sandostatin	Somatostatin analog	88
Sandostatin LAR Depot		87
Seroquel	Atypical antipsychotic	95
Simponi	Tumor necrosis factor blocker	41
Skyrizi	Interleukin-23 antagonist	103
Soliris	Complement inhibitor	56
Stelara	Interleukin-12 antagonist	57
Suboxone	Opioid antagonist	45
Sulfasalazine	Aminosalicylate	41
Sutent	Kinase inhibitor	42
Tecfidera		90
Teduglutide	GLP-2 analog	49
Tracleer	Endothelin receptor antagonist	67
Trulicity	GLP-1 receptor agonist	71
Tysabri	Integrin receptor antagonist	163
Uptravi	Prostacyclin receptor agonist	30
Vedolizumab	Integrin receptor antagonist	91
Veletri	Prostacycline vasodilator	34
Venclexta	BCL-2 inhibitor	29
Victoza	GLP-1 receptor agonist	58
Vioxx		314
Wegovy	GLP-1 receptor agonist	57
Xarelto	Factor Xa inhibitor	27
Xeljanz	Janus kinase inhibitor	147
Xyrem	Central nervous system depressant	95
Yasmin		2,619
Yaz		2,854
Zantac		34
Zepbound	GLP-1 receptor agonist	95
Zometa		47

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 50 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 Gallbladder disorder name, in order of name
Class	Reports with this term
Angiotensin 2 receptor blocker	201
Angiotensin converting enzyme inhibitor	65
Anti-epileptic agent	68
Antirheumatic agent	59
Atypical antipsychotic	157
Benzodiazepine	93
beta-Adrenergic blocker	80
Biguanide	61
Bisphosphonate	333
Calcineurin inhibitor immunosuppressant	51
CD20-directed cytolytic antibody	253
Central nervous system depressant	118
Complement inhibitor	72
Corticosteroid	171
Dipeptidyl peptidase 4 inhibitor	91
Endothelin receptor antagonist	269
Estrogen	155
Factor Xa inhibitor	157
Folate analog metabolic inhibitor	205
GLP-1 receptor agonist	715
GLP-2 analog	71
HMG-CoA reductase inhibitor	134
Human immunoglobulin G	53
Insulin analog	129
Integrin receptor antagonist	263
Interferon beta	377
Interleukin-12 antagonist	59
Interleukin-17A antagonist	120
Interleukin-23 antagonist	108
Interleukin-4 receptor alpha antagonist	112
Interleukin-6 receptor antagonist	84
Intestinal lipase inhibitor	92
Janus kinase inhibitor	308
Kinase inhibitor	597
Loop diuretic	52
Nonsteroidal anti-inflammatory drug	123
Opioid agonist	249
Parathyroid hormone analog	99
PCSK9 inhibitor	66
Phosphodiesterase 4 inhibitor	144
Phosphodiesterase 5 inhibitor	53
Potassium channel blocker	54
Progestin	77
Prostacycline vasodilator	169
Proton pump inhibitor	279
Pyrimidine synthesis inhibitor	54
Selective T cell costimulation modulator	209
Somatostatin analog	126
Thalidomide analog	858
Tumor necrosis factor blocker	937

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

Reports by month

Reports that record Gallbladder disorder, 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 Gallbladder disorder
Age	Reports	Share
Under 2	14	0.1%
2 to 11	35	0.2%
12 to 17	285	1.6%
18 to 44	4,593	26.1%
45 to 64	3,717	21.1%
65 to 74	1,774	10.1%
75 and over	1,106	6.3%
Age not given	6,080	34.5%

Sex of the patient in the reports that record Gallbladder disorder
Sex	Reports	Share
Female	12,523	71.1%
Male	4,186	23.8%
Unknown or not given	895	5.1%

Age and sex are as the report gives them. 80.3% 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. Gallbladder disorder: adverse event reports that record this term. https://reportedreactions.com/reaction/gallbladder-disorder/ 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 Gallbladder disorder 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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