MedDRA preferred term · a sudden death

Sudden death: adverse event reports recording this term

10,465 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.

10,465
reports recording the term: 0.1% of all reports; 336
reports, 12 months to June 2026: 310 in the 12 months before; 99.8%
marked serious by the reporter: 57.4% across all reports; 99.2%
record death among outcomes, as reported: 9.1% across all reports

10,465 reports in FDA's adverse event database record the MedDRA term "Sudden death" (in plain words, a sudden death): 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

336 reports recorded it in the 12 months to June 2026, close to the 310 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, 99.8% are marked serious, 99.2% include death among the outcomes and 11.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Bevacizumab, Olanzapine and Dexamethasone. 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
Bevacizumab	Vascular endothelial growth factor inhibitor	183	0.3%
Olanzapine	Atypical antipsychotic	170	0.4%
Dexamethasone	Corticosteroid	168	0.1%
Clozapine	Atypical antipsychotic	163	0.2%
Diazepam	Benzodiazepine	163	0.4%
Fluorouracil	Nucleoside metabolic inhibitor	136	0.2%
Oxaliplatin	Platinum-based drug	135	0.2%
Clozaril	Atypical antipsychotic	132	0.3%
Entresto	Angiotensin 2 receptor blocker	131	0.1%
Cisplatin	Platinum-based drug	130	0.2%
Revlimid	Thalidomide analog	130	0%
Cyclophosphamide	Alkylating drug	122	0.1%
Abilify	Atypical antipsychotic	117	0.2%
Tracleer	Endothelin receptor antagonist	114	0.3%
Carboplatin	Platinum-based drug	112	0.1%
Humira	—	112	0%
Nivolumab	Programmed death Receptor-1 blocking antibody	112	0.2%
Risperidone	Atypical antipsychotic	111	0.2%
Prednisone	Corticosteroid	107	0.1%
Quetiapine	Atypical antipsychotic	104	0.2%
Furosemide	Loop diuretic	103	0.2%
Eliquis	Factor Xa inhibitor	102	0.1%
Xarelto	Factor Xa inhibitor	100	0.1%
Capecitabine	Nucleoside metabolic inhibitor	99	0.2%
Mirtazapine	—	99	0.3%

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
Atypical antipsychotic	1,209	0.2%	0%
Kinase inhibitor	528	0.1%	0%
Benzodiazepine	466	0.2%	0.1%
Platinum-based drug	377	0.2%	0.2%
Nucleoside metabolic inhibitor	375	0.1%	0%
Corticosteroid	374	0%	0%
Serotonin reuptake inhibitor	325	0.1%	0.1%
Programmed death Receptor-1 blocking antibody	314	0.1%	0.1%
Vascular endothelial growth factor inhibitor	297	0.2%	0.1%
Opioid agonist	275	0%	0%

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 21%106

2 to 111.5%159

12 to 171.3%138

18 to 4413.5%1,415

45 to 6423%2,403

65 to 7415.4%1,616

75 and over16.7%1,750

Age not given27.5%2,878

Patient sex

Female34.6%3,619

Male53.6%5,606

Not given11.8%1,240

Grey bar: all 20,646,523 reports in the database. 20.2% of these reports give the United States as the country.

Questions about "Sudden death"

What does "Sudden death" mean in an adverse event report?

In plain language: a sudden death. 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 sudden death?

10,465 reports through June 2026 (0.1% of all reports), 336 of them in the latest 12 months.

Which drugs appear most often in these reports?

Bevacizumab (183), Olanzapine (170), Dexamethasone (168), Clozapine (163) and Diazepam (163). 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.