MedDRA preferred term · fluid around the heart

Pericardial effusion: adverse event reports recording this term

22,645 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.

22,645
reports recording the term: 0.1% of all reports; 1,533
reports, 12 months to June 2026: 1,390 in the 12 months before; 98.6%
marked serious by the reporter: 57.4% across all reports; 13.7%
record death among outcomes, as reported: 9.1% across all reports

22,645 reports in FDA's adverse event database record the MedDRA term "Pericardial effusion" (in plain words, fluid around the heart): 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

1,533 reports recorded it in the 12 months to June 2026, up 10% from 1,390 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, 98.6% are marked serious, 13.7% include death among the outcomes and 66.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Cyclophosphamide, Humira and Methotrexate. 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
Cyclophosphamide	Alkylating drug	554	0.4%
Humira	—	470	0.1%
Methotrexate	Folate analog metabolic inhibitor	449	0.2%
Prednisone	Corticosteroid	406	0.2%
Imbruvica	Kinase inhibitor	370	0.6%
Opsumit	Endothelin receptor antagonist	365	0.9%
Remodulin	Prostacycline vasodilator	365	0.8%
Carboplatin	Platinum-based drug	356	0.3%
Xarelto	Factor Xa inhibitor	329	0.2%
Tacrolimus	Calcineurin inhibitor immunosuppressant	327	0.3%
Entresto	Angiotensin 2 receptor blocker	317	0.3%
Ambrisentan	Endothelin receptor antagonist	315	0.6%
Sprycel	Kinase inhibitor	313	1.1%
Pradaxa	Direct thrombin inhibitor	304	0.5%
Clozapine	Atypical antipsychotic	295	0.4%
Revlimid	Thalidomide analog	278	0.1%
Nivolumab	Programmed death Receptor-1 blocking antibody	276	0.6%
Dexamethasone	Corticosteroid	272	0.2%
Aspirin	Nonsteroidal anti-inflammatory drug	271	0.4%
Rituximab	CD20-directed cytolytic antibody	266	0.2%
Mycophenolate mofetil	Antimetabolite immunosuppressant	262	0.3%
Cytarabine	Nucleoside metabolic inhibitor	250	0.5%
Avandia	—	240	0.3%
Tracleer	Endothelin receptor antagonist	237	0.7%
Etoposide	Topoisomerase inhibitor	233	0.4%

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
Kinase inhibitor	3,373	0.4%	0.3%
Corticosteroid	1,359	0.2%	0%
Nucleoside metabolic inhibitor	1,134	0.4%	0.3%
Endothelin receptor antagonist	1,125	0.6%	0.6%
Programmed death Receptor-1 blocking antibody	976	0.4%	0.4%
Alkylating drug	951	0.4%	0.1%
Prostacycline vasodilator	832	0.7%	0.6%
Atypical antipsychotic	804	0.1%	0%
Factor Xa inhibitor	705	0.2%	0.2%
Angiotensin 2 receptor blocker	704	0.3%	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 20.8%186

2 to 111.9%435

12 to 171.7%392

18 to 4412.7%2,867

45 to 6426.2%5,923

65 to 7415.9%3,608

75 and over11.6%2,618

Age not given29.2%6,616

Patient sex

Female51.5%11,651

Male39.8%9,010

Not given8.8%1,984

Grey bar: all 20,646,523 reports in the database. 50.1% of these reports give the United States as the country.

Questions about "Pericardial effusion"

What does "Pericardial effusion" mean in an adverse event report?

In plain language: fluid around the heart. 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 pericardial effusion?

22,645 reports through June 2026 (0.1% of all reports), 1,533 of them in the latest 12 months.

Which drugs appear most often in these reports?

Cyclophosphamide (554), Humira (470), Methotrexate (449), Prednisone (406) and Imbruvica (370). 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.