MedDRA preferred term · gallstones

Cholelithiasis: adverse event reports recording this term

32,223 reports to FDA record it, 2004–2026; 0.2% 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.

32,223
reports recording the term: 0.2% of all reports; 1,986
reports, 12 months to June 2026: 1,508 in the 12 months before; 94.6%
marked serious by the reporter: 57.4% across all reports; 5.5%
record death among outcomes, as reported: 9.1% across all reports

"Cholelithiasis" (in plain words, gallstones) is a MedDRA preferred term recorded in 32,223 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

1,986 reports recorded it in the 12 months to June 2026, up 32% from 1,508 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, 94.6% are marked serious, 5.5% include death among the outcomes and 64.6% 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	—	2,893	10.5%
Yasmin	—	2,672	12.4%
Humira	—	1,583	0.2%
Drospirenone and ethinyl estradiol	—	672	18.3%
Enbrel	Tumor necrosis factor blocker	598	0.1%
Mounjaro	GLP-1 receptor agonist	508	0.6%
Ocella	—	505	11.1%
Ozempic	GLP-1 receptor agonist	475	0.9%
Sandostatin LAR Depot	—	452	2.7%
Methotrexate	Folate analog metabolic inhibitor	444	0.2%
Avonex	Interferon beta	433	0.4%
Rebif	Interferon beta	386	0.9%
Revlimid	Thalidomide analog	371	0.1%
Prednisone	Corticosteroid	353	0.2%
Byetta	GLP-1 receptor agonist	337	0.7%
Diazepam	Benzodiazepine	320	0.8%
Remicade	Tumor necrosis factor blocker	312	0.2%
Olanzapine	Atypical antipsychotic	297	0.6%
Acetaminophen	Nonsteroidal anti-inflammatory drug	293	0.3%
Skyrizi	Interleukin-23 antagonist	288	0.4%
Clonazepam	Benzodiazepine	285	0.8%
Risperidone	Atypical antipsychotic	285	0.6%
Tysabri	Integrin receptor antagonist	283	0.2%
Tegretol	Mood stabilizer	281	1.7%
Benicar	Angiotensin 2 receptor blocker	263	3.1%

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 0.2% 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
GLP-1 receptor agonist	2,457	0.6%	0.8%
Atypical antipsychotic	1,524	0.2%	0%
Tumor necrosis factor blocker	1,398	0.1%	0.1%
Kinase inhibitor	1,188	0.1%	0%
Corticosteroid	1,119	0.1%	0%
Interferon beta	845	0.5%	0.2%
Nonsteroidal anti-inflammatory drug	756	0.1%	0%
Angiotensin 2 receptor blocker	735	0.3%	0.2%
Benzodiazepine	698	0.3%	0%
Proton pump inhibitor	571	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 20.2%65

2 to 110.8%266

12 to 171.4%465

18 to 4421.8%7,009

45 to 6424.5%7,908

65 to 7412.2%3,928

75 and over8.6%2,786

Age not given30.4%9,796

Patient sex

Female65.4%21,080

Male28.4%9,154

Not given6.2%1,989

Grey bar: all 20,646,523 reports in the database. 55.7% of these reports give the United States as the country.

Questions about "Cholelithiasis"

What does "Cholelithiasis" mean in an adverse event report?

In plain language: gallstones. 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 cholelithiasis?

32,223 reports through June 2026 (0.2% of all reports), 1,986 of them in the latest 12 months.

Which drugs appear most often in these reports?

Yaz (2,893), Yasmin (2,672), Humira (1,583), Drospirenone and ethinyl estradiol (672) and Enbrel (598). 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.