MedDRA preferred term · the patient died; cause not stated by this term

Death: adverse event reports recording this term

847,572 reports to FDA record it, 2004–2026; 4.1% 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.

847,572
reports recording the term: 4.1% of all reports; 48,702
reports, 12 months to June 2026: 51,622 in the 12 months before; 99.6%
marked serious by the reporter: 57.4% across all reports; 99.5%
record death among outcomes, as reported: 9.1% across all reports

847,572 reports in FDA's adverse event database record the MedDRA term "Death" (in plain words, the patient died; cause not stated by this term): 4.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

48,702 reports recorded it in the 12 months to June 2026, close to the 51,622 of 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, 99.6% are marked serious, 99.5% include death among the outcomes and 9.5% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Revlimid, OxyContin and Eliquis. 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
Revlimid	Thalidomide analog	23,204	6.5%
OxyContin	Opioid agonist	20,721	14.2%
Eliquis	Factor Xa inhibitor	17,207	13.8%
Oxycodone hydrochloride	Opioid agonist	16,702	14.8%
Prolia	RANK ligand inhibitor	15,175	11%
Percocet	Opioid agonist	15,162	26.2%
Aranesp	Erythropoiesis-stimulating agent	14,876	39.9%
Dilaudid	Opioid agonist	13,454	21%
MS Contin	Opioid agonist	13,019	25%
Opana	—	12,909	41.2%
Opana Er	—	12,563	41%
Percodan	—	12,071	49.6%
Hydromorphone	—	11,950	32.9%
Duragesic	—	11,776	38.1%
Butrans	Partial opioid agonist	11,668	19.4%
Hysingla ER	Opioid agonist	11,663	38%
Fentora	—	11,487	47.2%
Nucynta	Opioid agonist	11,461	41.6%
Actiq	—	11,423	46.2%
Glivec	—	11,368	53.8%
Humira	—	11,161	1.7%
Hydrocodone bitartrate and acetaminophen	Opioid agonist	10,912	18.5%
Nuplazid	Atypical antipsychotic	10,624	19.8%
Tarceva	—	10,373	37.9%
Avastin	Vascular endothelial growth factor inhibitor	9,540	15.8%

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 4.1% 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
Opioid agonist	155,890	16.2%	6.5%
Kinase inhibitor	97,719	11.5%	7.6%
Thalidomide analog	33,269	6.4%	6.4%
Atypical antipsychotic	31,480	4.6%	1.3%
Vascular endothelial growth factor inhibitor	24,881	14.1%	6.8%
Endothelin receptor antagonist	24,556	12.7%	12.5%
Factor Xa inhibitor	22,583	6.9%	2.3%
Programmed death Receptor-1 blocking antibody	20,993	9.3%	6.1%
RANK ligand inhibitor	18,859	11.2%	11%
Erythropoiesis-stimulating agent	18,853	28.4%	8.5%

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%2,347

2 to 110.4%2,988

12 to 170.3%2,438

18 to 444.7%39,414

45 to 6414.2%120,397

65 to 7413%109,810

75 and over19.5%165,532

Age not given47.7%404,646

Patient sex

Female39.3%333,474

Male45.1%382,675

Not given15.5%131,423

Grey bar: all 20,646,523 reports in the database. 61.4% of these reports give the United States as the country.

Questions about "Death"

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

In plain language: the patient died; cause not stated by this term. 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 death?

847,572 reports through June 2026 (4.1% of all reports), 48,702 of them in the latest 12 months.

Which drugs appear most often in these reports?

Revlimid (23,204), OxyContin (20,721), Eliquis (17,207), Oxycodone hydrochloride (16,702) and Prolia (15,175). 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.