MedDRA preferred term · black tarry stools

Melaena: adverse event reports recording this term

21,686 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.

21,686
reports recording the term: 0.1% of all reports; 908
reports, 12 months to June 2026: 1,051 in the 12 months before; 97.9%
marked serious by the reporter: 57.4% across all reports; 13.4%
record death among outcomes, as reported: 9.1% across all reports

"Melaena" (in plain words, black tarry stools) is a MedDRA preferred term recorded in 21,686 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.

908 reports recorded it in the 12 months to June 2026, down 14% from 1,051 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, 97.9% are marked serious, 13.4% include death among the outcomes and 71% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Aspirin, Xarelto and Pradaxa. 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
Aspirin	Nonsteroidal anti-inflammatory drug	1,816	2.5%
Xarelto	Factor Xa inhibitor	1,380	1%
Pradaxa	Direct thrombin inhibitor	1,196	1.9%
Clopidogrel	P2Y12 platelet inhibitor	1,100	3.7%
Ibuprofen	Nonsteroidal anti-inflammatory drug	959	1.2%
Eliquis	Factor Xa inhibitor	775	0.6%
Acetylsalicylic Acid	—	637	2.6%
Plavix	P2Y12 platelet inhibitor	634	2%
Warfarin	Vitamin K antagonist	569	2.4%
Apixaban	Factor Xa inhibitor	522	1.1%
Warfarin sodium	Vitamin K antagonist	492	2.5%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	477	0.9%
Coumadin	—	407	1.8%
Kardegic	—	372	4%
Rivaroxaban	Factor Xa inhibitor	343	2.1%
Clopidogrel bisulfate	P2Y12 platelet inhibitor	332	4.8%
Diclofenac	Nonsteroidal anti-inflammatory drug	330	1.2%
Naproxen	Nonsteroidal anti-inflammatory drug	321	1.3%
Prednisolone	Corticosteroid	317	0.4%
Furosemide	Loop diuretic	273	0.6%
Humira	—	241	0%
Prednisone	Corticosteroid	223	0.1%
Previscan	—	202	4.9%
Methotrexate	Folate analog metabolic inhibitor	185	0.1%
Allopurinol	Xanthine oxidase inhibitor	183	0.8%

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
Nonsteroidal anti-inflammatory drug	4,602	0.8%	0.1%
Factor Xa inhibitor	3,241	1%	1.1%
P2Y12 platelet inhibitor	2,301	2.3%	2.1%
Direct thrombin inhibitor	1,254	1.9%	1.9%
Vitamin K antagonist	1,061	2.5%	2.5%
Corticosteroid	921	0.1%	0%
Kinase inhibitor	917	0.1%	0%
Proton pump inhibitor	601	0.1%	0%
Serotonin reuptake inhibitor	533	0.2%	0.1%
Nucleoside metabolic inhibitor	472	0.2%	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 20.3%62

2 to 110.8%180

12 to 170.5%112

18 to 446.4%1,382

45 to 6418.8%4,084

65 to 7420.2%4,380

75 and over35.8%7,770

Age not given17.1%3,716

Patient sex

Female41.1%8,923

Male51.1%11,083

Not given7.7%1,680

Grey bar: all 20,646,523 reports in the database. 23.7% of these reports give the United States as the country.

Questions about "Melaena"

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

In plain language: black tarry stools. 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 melaena?

21,686 reports through June 2026 (0.1% of all reports), 908 of them in the latest 12 months.

Which drugs appear most often in these reports?

Aspirin (1,816), Xarelto (1,380), Pradaxa (1,196), Clopidogrel (1,100) and Ibuprofen (959). 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.