Hepatomegaly adverse event reports that record this term

Kind of term: MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 9,652 adverse event reports that record the MedDRA preferred term Hepatomegaly. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 330 reports in the 12 months to June 2026 and 353 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 139 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Hepatomegaly name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		107
Acetylsalicylic Acid		25
Actemra	Interleukin-6 receptor antagonist	35
Adalimumab	Tumor necrosis factor blocker	32
Afinitor	Kinase inhibitor	54
Alcohol		29
Allopurinol	Xanthine oxidase inhibitor	30
Alprazolam	Benzodiazepine	31
Amlodipine	Calcium channel blocker	54
Amoxicillin	Penicillin-class antibacterial	48
Aredia		39
Aripiprazole	Atypical antipsychotic	27
Aspirin	Nonsteroidal anti-inflammatory drug	37
Atorvastatin		72
Augmentin '125		27
Avonex	Interferon beta	54
Azathioprine	Purine antimetabolite	36
Azithromycin	Macrolide antimicrobial	29
Betaseron		28
Bisoprolol	beta-Adrenergic blocker	32
Busulfan	Alkylating drug	68
Carbamazepine	Mood stabilizer	51
Carboplatin	Platinum-based drug	53
Ceftriaxone	Cephalosporin antibacterial	42
Ciclosporin		25
Ciprofloxacin	Fluoroquinolone antibacterial	35
Cisplatin	Platinum-based drug	40
Clozapine	Atypical antipsychotic	31
Cosentyx	Interleukin-17A antagonist	81
Crestor	HMG-CoA reductase inhibitor	39
Cyclophosphamide	Alkylating drug	215
Cyclosporine	Calcineurin inhibitor immunosuppressant	64
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	64
Cytarabine	Nucleoside metabolic inhibitor	140
Dexamethasone	Corticosteroid	141
Diazepam	Benzodiazepine	36
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	25
Didanosine		46
Digoxin	Cardiac glycoside	28
Doxorubicin	Anthracycline topoisomerase inhibitor	50
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	42
Efavirenz	Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	55
Enbrel	Tumor necrosis factor blocker	113
Entresto	Angiotensin 2 receptor blocker	30
Etoposide	Topoisomerase inhibitor	82
Exjade	Iron chelator	84
Femara	Aromatase inhibitor	27
Fentanyl	Opioid agonist	52
Fludarabine	Nucleoside metabolic inhibitor	44
Fludarabine phosphate	Nucleoside metabolic inhibitor	30
Fluorouracil	Nucleoside metabolic inhibitor	25
Folic acid		28
Fulvestrant	Estrogen receptor antagonist	33
Furosemide	Loop diuretic	46
Gilenya	Sphingosine 1-phosphate receptor modulator	38
Gleevec	Kinase inhibitor	31
Glivec		40
Humira		270
Ibrance	Kinase inhibitor	28
Ibuprofen	Nonsteroidal anti-inflammatory drug	73
Imbruvica	Kinase inhibitor	33
Infliximab	Tumor necrosis factor blocker	28
Isoniazid	Antimycobacterial	36
Jakafi	Janus kinase inhibitor	139
Jakavi		40
Kaletra	Cytochrome P450 3A inhibitor	34
Kisqali	Kinase inhibitor	54
Lamictal	Anti-epileptic agent	33
Lamivudine	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	113
Lamotrigine	Anti-epileptic agent	43
Letrozole	Aromatase inhibitor	45
Lipitor	HMG-CoA reductase inhibitor	37
Lyrica		39
Mabthera		32
Melphalan	Alkylating drug	35
Mercaptopurine	Nucleoside metabolic inhibitor	30
Meropenem	Penem antibacterial	38
Metformin	Biguanide	62
Methotrexate	Folate analog metabolic inhibitor	325
Methotrexate sodium	Folate analog metabolic inhibitor	46
Methylprednisolone	Corticosteroid	55
Metoprolol	beta-Adrenergic blocker	28
Morphine	Opioid agonist	31
Mycophenolate mofetil	Antimetabolite immunosuppressant	77
Mylotarg	CD33-directed immunoconjugate	31
Nevirapine	Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	47
Nexium	Proton pump inhibitor	28
Norvir	Cytochrome P450 3A inhibitor	30
Omeprazole	Proton pump inhibitor	40
Oncaspar	Asparagine-specific enzyme	56
Opsumit	Endothelin receptor antagonist	38
Oxaliplatin	Platinum-based drug	54
Oxycodone hydrochloride	Opioid agonist	38
OxyContin	Opioid agonist	36
Paclitaxel	Microtubule inhibitor	31
Palbociclib	Kinase inhibitor	38
Pantoprazole	Proton pump inhibitor	57
Paracetamol		74
Pegasys	Interferon alpha	45
Prednisolone	Corticosteroid	86
Prednisone	Corticosteroid	159
Ramipril	Angiotensin converting enzyme inhibitor	51
Rebif	Interferon beta	53
Remicade	Tumor necrosis factor blocker	83
Revlimid	Thalidomide analog	44
Ribavirin	Nucleoside analog antiviral	46
Ribociclib	Kinase inhibitor	30
Rifampicin		34
Ritonavir	Cytochrome P450 3A inhibitor	26
Rituximab	CD20-directed cytolytic antibody	86
Ruxolitinib	Janus kinase inhibitor	45
Sandostatin LAR Depot		83
Seroquel	Atypical antipsychotic	30
Simvastatin	HMG-CoA reductase inhibitor	98
Skyrizi	Interleukin-23 antagonist	36
Soliris	Complement inhibitor	40
Spironolactone	Aldosterone antagonist	35
Stavudine		41
Sutent	Kinase inhibitor	25
Tacrolimus	Calcineurin inhibitor immunosuppressant	79
Tasigna	Kinase inhibitor	54
Tecfidera		37
Tracleer	Endothelin receptor antagonist	73
Tramadol		27
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	33
Tysabri	Integrin receptor antagonist	32
Valproic acid	Anti-epileptic agent	29
Valsartan	Angiotensin 2 receptor blocker	37
Vancomycin	Glycopeptide antibacterial	35
Velcade	Proteasome inhibitor	32
Vincristine		90
Vincristine sulfate	Vinca alkaloid	118
Vioxx		35
Viramune		27
Viread	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	25
Xeljanz	Janus kinase inhibitor	32
Zidovudine	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	60
Zometa		69
Zyprexa	Atypical antipsychotic	46

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 57 pharmacologic classes with 50 or more reports that record this term. The rows are in order of name.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Hepatomegaly name, in order of name
Class	Reports with this term
Aldosterone antagonist	54
Alkylating drug	364
Angiotensin 2 receptor blocker	119
Angiotensin converting enzyme inhibitor	77
Anthracycline topoisomerase inhibitor	104
Anti-epileptic agent	156
Antimetabolite immunosuppressant	96
Antimycobacterial	79
Aromatase inhibitor	97
Asparagine-specific enzyme	72
Atypical antipsychotic	224
Azole antifungal	51
Benzodiazepine	122
beta-Adrenergic blocker	95
Biguanide	102
Calcineurin inhibitor immunosuppressant	176
Calcium channel blocker	54
CD20-directed cytolytic antibody	123
Cephalosporin antibacterial	62
Corticosteroid	487
Cytochrome P450 3A inhibitor	96
Endothelin receptor antagonist	166
Fluoroquinolone antibacterial	58
Folate analog metabolic inhibitor	390
GLP-1 receptor agonist	77
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	193
HER2/neu receptor antagonist	60
HMG-CoA reductase inhibitor	224
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	108
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	166
Insulin analog	54
Interferon alpha	50
Interferon beta	107
Interleukin-17A antagonist	95
Interleukin-6 receptor antagonist	50
Iron chelator	94
Janus kinase inhibitor	241
Kinase inhibitor	577
Loop diuretic	62
Macrolide antimicrobial	61
Microtubule inhibitor	61
Mood stabilizer	72
Nonsteroidal anti-inflammatory drug	199
Nucleoside analog antiviral	52
Nucleoside metabolic inhibitor	331
Opioid agonist	281
Penicillin-class antibacterial	78
Platinum-based drug	147
Programmed death Receptor-1 blocking antibody	63
Prostacycline vasodilator	58
Proton pump inhibitor	143
Serotonin and norepinephrine reuptake inhibitor	94
Serotonin reuptake inhibitor	83
Thalidomide analog	68
Topoisomerase inhibitor	101
Tumor necrosis factor blocker	287
Vinca alkaloid	122

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Hepatomegaly, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Hepatomegaly
Age	Reports	Share
Under 2	250	2.6%
2 to 11	529	5.5%
12 to 17	268	2.8%
18 to 44	1,955	20.3%
45 to 64	2,506	26%
65 to 74	914	9.5%
75 and over	450	4.7%
Age not given	2,780	28.8%

Sex of the patient in the reports that record Hepatomegaly
Sex	Reports	Share
Female	5,029	52.1%
Male	3,820	39.6%
Unknown or not given	803	8.3%

Age and sex are as the report gives them. 39.1% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Hepatomegaly: adverse event reports that record this term. https://reportedreactions.com/reaction/hepatomegaly/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Hepatomegaly mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

To the top of the page