Hepsera adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Hepsera
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported

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.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to September 2024, FDA received 1,801 adverse event reports that name Hepsera. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 211 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 1 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports for male patients were 65% of the reports that name Hepsera and 34.6% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
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.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Hepsera is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
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.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

FDA received no report that names Hepsera in April to June 2026, in January to March 2026 or in April to June 2025.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 220 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,793 of the 1,801 reports (99.6%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 220 terms.

Reaction terms in the reports that name Hepsera, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,801 reports
Hypophosphataemia	295	16.4%
Fanconi syndrome acquired	275	15.3%
Osteomalacia	274	15.2%
Drug resistance	216	12%
Renal impairmentreduced kidney function	196	10.9%
Blood creatinine increasedraised creatinine, a kidney test	141	7.8%
Drug ineffectivethe medicine did not work as expected	138	7.7%
Arthralgiajoint pain	136	7.6%
Blood phosphorus decreased	133	7.4%
Bone pain	128	7.1%
Blood alkaline phosphatase increased	126	7%
Alanine aminotransferase increasedraised liver enzyme (ALT)	115	6.4%
Osteoporosisthinning of the bones	101	5.6%
Back pain	100	5.6%
Gait disturbancedifficulty walking	89	4.9%
Hepatitis Bhepatitis B infection	89	4.9%
Renal tubular disorder	84	4.7%
Hepatitis B DNA increased	80	4.4%
Fanconi syndrome	79	4.4%
Pain in extremitypain in an arm or leg	74	4.1%
Painpain, site not specified	73	4.1%
Hypouricaemia	63	3.5%
Viral load increased	63	3.5%
Muscular weaknessmuscle weakness	57	3.2%
Metabolic acidosistoo much acid in the body fluids	54	3%
Multiple fractures	54	3%
Aspartate aminotransferase increasedraised liver enzyme (AST)	53	2.9%
Hepatic cirrhosis	51	2.8%
Renal failurekidney failure	51	2.8%
Proteinuriaprotein in the urine	50	2.8%
Hepatic function abnormal	47	2.6%
Viral mutation identified	46	2.6%
Renal disorder	45	2.5%
Rib fracture	42	2.3%
Astheniaweakness or lack of energy	41	2.3%
Fracturea broken bone	41	2.3%
Hepatocellular carcinoma	40	2.2%
Hepatic neoplasm malignant	39	2.2%
Bone density decreased	37	2.1%
Chest pain	34	1.9%
Fatiguetiredness	34	1.9%
Femoral neck fracture	34	1.9%
Hepatic cancer	33	1.8%
Aminoaciduria	32	1.8%
Ascitesfluid in the abdomen	31	1.7%
Condition aggravatedthe condition being treated got worse	31	1.7%
Hepatitis	31	1.7%
Weight decreasedweight loss	31	1.7%
Blood bilirubin increased	29	1.6%
Hypokalaemialow blood potassium	27	1.5%

Download all 220 terms of Hepsera (CSV)

The counts add to more than 1,801 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. 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.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Hepsera, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	40	25	3	1	12	1	0	15	15
2005	73	73	15	4	24	5	0	43	0
2006	70	69	7	2	20	5	0	43	1
2007	94	93	7	4	24	4	1	58	1
2008	84	83	11	7	22	2	3	55	1
2009	82	82	4	6	25	3	2	60	0
2010	51	51	2	1	21	4	0	31	0
2011	53	52	0	0	14	2	0	40	1
2012	65	65	3	1	24	7	0	44	0
2013	79	77	2	0	26	6	0	60	2
2014	109	105	2	1	34	5	1	96	4
2015	174	140	0	0	46	4	1	130	34
2016	202	196	10	3	90	4	1	181	6
2017	169	165	4	1	74	10	0	158	4
2018	105	104	1	0	46	2	0	93	1
2019	81	81	2	0	33	8	0	75	0
2020	32	30	0	0	9	2	0	30	2
2021	191	188	21	0	82	2	0	163	3
2022	20	20	0	0	6	2	0	18	0
2023	19	18	3	0	10	0	0	13	1
2024	6	6	0	0	0	0	0	6	0
2025	2	2	0	0	1	1	0	2	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

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.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Hepsera, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Hepsera, by the year in which FDA received them
Year	Reports
2004	39
2005	62
2006	84
2007	96
2008	82
2009	85
2010	53
2011	56
2012	77
2013	105
2014	121
2015	174
2016	182
2017	162
2018	116
2019	72
2020	26
2021	176
2022	8
2023	19
2024	6

Reports that name Hepsera, 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.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Hepsera
Age	Reports	Share
Under 2	1	0.1%
2 to 11	3	0.2%
12 to 17	5	0.3%
18 to 44	220	12.2%
45 to 64	624	34.6%
65 to 74	231	12.8%
75 and over	63	3.5%
Age not given	654	36.3%

Sex of the patient in the reports that name Hepsera
Sex	Reports	Share
Female	461	25.6%
Male	1,171	65%
Unknown or not given	169	9.4%

Type of reporter in the reports that name Hepsera
Reporter	Reports	Share
Physician	677	37.6%
Pharmacist	71	3.9%
Other health professional	321	17.8%
Lawyer	0	0%
Consumer or non-health professional	602	33.4%
Not given	130	7.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 7.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Hepsera record
Indication as recorded (MedDRA)	Reports	Share
Hepatitis b	781	43.4%
Chronic hepatitis b	354	19.7%
Hepatic cirrhosis	68	3.8%
Hepatitis b virus	11	0.6%
Chronic hepatitis	5	0.3%
Hepatitis	5	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,801 reports.

Drugs in the same reports

Other drugs that the reports of Hepsera name, in any role, in order of name
Drug	Reports that name the two
Adefovir dipivoxil	28
Aldactone	26
Entecavir	175
Furosemide	26
Lamivudine	227
Omeprazole	24
Tenofovir disoproxil fumarate	49
Ursodeoxycholic acid	27
Viread	203
Zeffix	159

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

Pages near this one

Heparin Sodium in Dextrose next in the A to Z list
Heptodin next in the A to Z list
Heparin Sodium 5 000 Units in Dextrose 5% next in the A to Z list
Herbals next in the A to Z list
Heparin Sodium 1 000 Units and Sodium Chloride 0 9% next in the A to Z list
Herbals Mitragynine next in the A to Z list
Heparin sodium next in the A to Z list
Herbals Paullinia Cupana Seed next in the A to Z list
Heparin Calcium next in the A to Z list
Herbals Plantago Ovata Leaf next in the A to Z list
Heparin next in the A to Z list
Herbals Tetrahydrocannabinol next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for HepseraThe labels (prescribing information) that have this name, at the National Library of Medicine.
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. Hepsera: adverse event reports that FDA received. https://reportedreactions.com/drug/hepsera/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 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 29 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 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Hepsera as a suspect or interacting product. The 211 reports that name it only as a concomitant medicine are not in the count. 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

Do these reports show that Hepsera was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
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.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Hepsera?

No. It is a count of what people reported to FDA: 1,801 reports from January 2004 to September 2024. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (37.6%), consumer or non-health professional (33.4%) and other health professional (17.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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