MedDRA preferred term

Hepatic encephalopathy: adverse event reports recording this term

9,191 reports to FDA record it, 2004–2026; 0% 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.

9,191
reports recording the term: 0% of all reports; 352
reports, 12 months to June 2026: 455 in the 12 months before; 99.4%
marked serious by the reporter: 57.4% across all reports; 31.5%
record death among outcomes, as reported: 9.1% across all reports

9,191 reports in FDA's adverse event database record the MedDRA term "Hepatic encephalopathy": 0% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

352 reports recorded it in the 12 months to June 2026, down 23% from 455 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, 99.4% are marked serious, 31.5% include death among the outcomes and 72.5% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Acetaminophen, Xifaxan and Ribavirin. 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
Acetaminophen	Nonsteroidal anti-inflammatory drug	482	0.6%
Xifaxan	Rifamycin antibacterial	479	3.4%
Ribavirin	Nucleoside analog antiviral	444	0.9%
Lenvima	Kinase inhibitor	395	1.8%
Nexavar	Kinase inhibitor	386	2.5%
Sofosbuvir	Hepatitis C virus nucleotide analog NS5B polymerase inhibitor	239	3.2%
Paracetamol	—	212	0.8%
Furosemide	Loop diuretic	158	0.3%
Bevacizumab	Vascular endothelial growth factor inhibitor	147	0.3%
Prednisone	Corticosteroid	147	0.1%
Cyclophosphamide	Alkylating drug	143	0.1%
Aldactone	Aldosterone antagonist	130	1.9%
Prednisolone	Corticosteroid	126	0.1%
Avastin	Vascular endothelial growth factor inhibitor	124	0.2%
Oxaliplatin	Platinum-based drug	121	0.2%
Rituximab	CD20-directed cytolytic antibody	121	0.1%
Harvoni	Hepatitis C virus NS5A inhibitor	118	0.6%
Sorafenib	Kinase inhibitor	116	2.1%
Lenvatinib	Kinase inhibitor	109	1.2%
Isoniazid	Antimycobacterial	108	1.2%
Sovaldi	Hepatitis C virus nucleotide analog NS5B polymerase inhibitor	107	1%
Rebetol	—	103	0.8%
Atezolizumab	Programmed death Receptor-1 blocking antibody	101	0.5%
Dexamethasone	Corticosteroid	101	0.1%
Methotrexate	Folate analog metabolic inhibitor	101	0%

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% 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	1,313	0.2%	0%
Nonsteroidal anti-inflammatory drug	640	0.1%	0%
Rifamycin antibacterial	560	2.3%	2.8%
Corticosteroid	466	0.1%	0%
Nucleoside analog antiviral	444	0.7%	0.5%
Programmed death Receptor-1 blocking antibody	354	0.2%	0.1%
Hepatitis C virus nucleotide analog NS5B polymerase inhibitor	346	1.9%	2.1%
Nucleoside metabolic inhibitor	279	0.1%	0%
Vascular endothelial growth factor inhibitor	278	0.2%	0%
Aldosterone antagonist	232	0.7%	0.4%

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 20.7%62

2 to 111.5%138

12 to 171.1%105

18 to 4413.7%1,257

45 to 6431.5%2,892

65 to 7419.2%1,761

75 and over11%1,011

Age not given21.4%1,965

Patient sex

Female38.6%3,545

Male50.7%4,664

Not given10.7%982

Grey bar: all 20,646,523 reports in the database. 31% of these reports give the United States as the country.

Questions about "Hepatic encephalopathy"

What does "Hepatic encephalopathy" mean in an adverse event report?

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 hepatic encephalopathy?

9,191 reports through June 2026 (0% of all reports), 352 of them in the latest 12 months.

Which drugs appear most often in these reports?

Acetaminophen (482), Xifaxan (479), Ribavirin (444), Lenvima (395) and Nexavar (386). 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.