MedDRA preferred term

Gallbladder disorder: adverse event reports recording this term

17,604 reports to FDA record it, 2004–2026; 0.1% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

17,604
reports recording the term: 0.1% of all reports; 774
reports, 12 months to June 2026: 654 in the 12 months before; 90.9%
marked serious by the reporter: 57.4% across all reports; 3.4%
record death among outcomes, as reported: 9.1% across all reports

"Gallbladder disorder" is a MedDRA preferred term recorded in 17,604 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

774 reports recorded it in the 12 months to June 2026, up 18% from 654 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 90.9% are marked serious, 3.4% include death among the outcomes and 56.1% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Yaz, Yasmin and Humira. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Yaz	—	2,854	10.4%
Yasmin	—	2,619	12.2%
Humira	—	913	0.1%
Drospirenone and ethinyl estradiol	—	776	21.1%
Revlimid	Thalidomide analog	703	0.2%
Enbrel	Tumor necrosis factor blocker	478	0.1%
Ocella	—	475	10.4%
Vioxx	—	314	0.8%
Fosamax	Bisphosphonate	235	0.7%
Avonex	Interferon beta	188	0.2%
Rebif	Interferon beta	182	0.4%
Mounjaro	GLP-1 receptor agonist	180	0.2%
Remicade	Tumor necrosis factor blocker	178	0.1%
Tysabri	Integrin receptor antagonist	163	0.1%
Nexium	Proton pump inhibitor	159	0.2%
Rituximab	CD20-directed cytolytic antibody	147	0.1%
Xeljanz	Janus kinase inhibitor	147	0.1%
Methotrexate	Folate analog metabolic inhibitor	145	0.1%
Otezla	Phosphodiesterase 4 inhibitor	142	0.1%
Ozempic	GLP-1 receptor agonist	130	0.2%
Orencia	Selective T cell costimulation modulator	121	0.1%
Pomalyst	Thalidomide analog	113	0.1%
Dupixent	Interleukin-4 receptor alpha antagonist	112	0%
Skyrizi	Interleukin-23 antagonist	103	0.1%
Eliquis	Factor Xa inhibitor	100	0.1%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Tumor necrosis factor blocker	937	0.1%	0%
Thalidomide analog	858	0.2%	0.1%
GLP-1 receptor agonist	715	0.2%	0.1%
Kinase inhibitor	597	0.1%	0%
Interferon beta	377	0.2%	0.1%
Bisphosphonate	333	0.3%	0%
Janus kinase inhibitor	308	0.1%	0.1%
Proton pump inhibitor	279	0.1%	0%
Endothelin receptor antagonist	269	0.1%	0.1%
Integrin receptor antagonist	263	0.1%	0.1%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.1%14

2 to 110.2%35

12 to 171.6%285

18 to 4426.1%4,593

45 to 6421.1%3,717

65 to 7410.1%1,774

75 and over6.3%1,106

Age not given34.5%6,080

Patient sex

Female71.1%12,523

Male23.8%4,186

Not given5.1%895

Grey bar: all 20,646,523 reports in the database. 80.3% of these reports give the United States as the country.

Questions about "Gallbladder disorder"

What does "Gallbladder disorder" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record gallbladder disorder?

17,604 reports through June 2026 (0.1% of all reports), 774 of them in the latest 12 months.

Which drugs appear most often in these reports?

Yaz (2,854), Yasmin (2,619), Humira (913), Drospirenone and ethinyl estradiol (776) and Revlimid (703). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.