Lamivudine adverse event reports that FDA received

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

Name type: Generic name
Class: Hepatitis B virus nucleoside analog reverse transcriptase inhibitor
Also reported as: Tab Lamivudine, Lamivudine Tablet, Lamivudine Tablets

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 June 2026, FDA received 17,966 adverse event reports that name Lamivudine. In these reports the drug is a suspect or interacting product.

In the same period, 7,551 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 271 reports in the 12 months to June 2026 and 480 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 271 (under 0.1%) name Lamivudine. Reports from other health professionals were 60.4% of the reports that name Lamivudine and 19.7% 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 Lamivudine 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.

In April to June 2026, FDA received 109 reports that name Lamivudine.
In January to March 2026, FDA received 41.
In April to June 2025, FDA received 141.

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 1,254 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 17,907 of the 17,966 reports (99.7%).

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 1,254 terms.

Reaction terms in the reports that name Lamivudine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 17,966 reports
Virologic failure	1,829	10.2%
Drug resistance	1,766	9.8%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	1,718	9.6%
Pathogen resistance	1,683	9.4%
Viral mutation identified	1,612	9%
Drug interactionan interaction between medicines	1,242	6.9%
Treatment failurethe treatment did not work	959	5.3%
Depressionlow mood	930	5.2%
Exposure during pregnancythe medicine was taken during pregnancy	819	4.6%
Drug ineffectivethe medicine did not work as expected	746	4.2%
Immune reconstitution inflammatory syndrome	643	3.6%
Pyrexiafever	592	3.3%
Treatment noncompliancethe treatment was not taken as directed	566	3.2%
Anaemialow red blood cells	495	2.8%
Immune reconstitution syndrome	478	2.7%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	471	2.6%
Deaththe patient died; cause not stated by this term	466	2.6%
Lipodystrophy acquiredchanges in body fat distribution	429	2.4%
Hepatitis Bhepatitis B infection	403	2.2%
Vomitingbeing sick	398	2.2%
Condition aggravatedthe condition being treated got worse	395	2.2%
Nauseafeeling sick	385	2.1%
Blood HIV RNA increased	377	2.1%
Alanine aminotransferase increasedraised liver enzyme (ALT)	373	2.1%
Diarrhoealoose or frequent stools	371	2.1%
Fatiguetiredness	348	1.9%
Renal impairmentreduced kidney function	346	1.9%
Premature babya baby born early	338	1.9%
Headachehead pain	300	1.7%
Rashskin rash	298	1.7%
Hepatitis B reactivation	297	1.7%
Drug exposure during pregnancythe medicine was taken during pregnancy	296	1.6%
Off label useused for a purpose or in a way not on the label	290	1.6%
Abortion spontaneousmiscarriage	288	1.6%
Aspartate aminotransferase increasedraised liver enzyme (AST)	263	1.5%
Loss of personal independence in daily activities	263	1.5%
Hepatic failureliver failure	262	1.5%
Weight decreasedweight loss	258	1.4%
Drug-induced liver injury	238	1.3%
Renal failurekidney failure	232	1.3%
Lactic acidosisa build-up of lactic acid in the blood	231	1.3%
Abdominal painstomach or belly pain	228	1.3%
HIV infection	226	1.3%
Astheniaweakness or lack of energy	222	1.2%
Lymphadenopathyswollen lymph nodes	207	1.2%
Hypertensionhigh blood pressure	204	1.1%
Mitochondrial toxicity	201	1.1%
Thrombocytopenialow platelets	198	1.1%
Eyelid ptosis	196	1.1%
Decreased appetitereduced appetite	186	1%

Download all 1,254 terms of Lamivudine (CSV)

The counts add to more than 17,966 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.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Lamivudine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Lamivudine (this page)	Generic name	17,966
Epivir	Brand name	3,208

Sum of the separately reported names: 21,174. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

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

Outcomes in the reports that name Lamivudine, 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	384	370	57	30	168	23	9	174	14
2005	423	415	92	14	154	14	12	234	8
2006	380	377	74	22	104	8	14	239	3
2007	430	425	86	18	118	11	26	237	5
2008	448	439	93	26	155	14	20	259	9
2009	531	522	85	22	162	10	24	336	9
2010	367	363	89	26	120	15	20	226	4
2011	365	359	41	23	102	4	45	234	6
2012	288	284	35	17	114	8	6	194	4
2013	281	269	63	12	84	8	11	170	12
2014	437	434	88	20	124	8	42	290	3
2015	1,032	985	149	19	163	2	43	836	47
2016	1,594	1,576	267	28	189	9	101	1,322	18
2017	1,488	1,454	119	23	180	11	57	1,342	34
2018	1,324	1,285	119	69	220	14	90	1,200	39
2019	1,286	1,232	105	36	199	7	158	1,154	54
2020	1,676	1,637	138	43	217	4	234	1,457	39
2021	1,211	1,160	163	13	184	13	56	1,036	51
2022	1,344	1,325	167	20	307	10	104	1,201	19
2023	1,158	1,133	117	38	220	19	66	1,075	25
2024	612	602	90	24	164	5	37	532	10
2025	669	654	99	17	183	2	17	599	15
2026	238	232	64	3	63	2	27	218	6

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 Lamivudine, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Lamivudine, by the year in which FDA received them
Year	Reports
2004	328
2005	418
2006	441
2007	435
2008	471
2009	519
2010	420
2011	383
2012	330
2013	312
2014	461
2015	1,059
2016	1,619
2017	1,553
2018	1,452
2019	1,456
2020	1,713
2021	1,223
2022	1,236
2023	1,101
2024	495
2025	389
2026	150

Reports that name Lamivudine, 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 Lamivudine
Age	Reports	Share
Under 2	506	2.8%
2 to 11	425	2.4%
12 to 17	296	1.6%
18 to 44	3,797	21.1%
45 to 64	3,419	19%
65 to 74	443	2.5%
75 and over	142	0.8%
Age not given	8,938	49.7%

Sex of the patient in the reports that name Lamivudine
Sex	Reports	Share
Female	4,403	24.5%
Male	7,085	39.4%
Unknown or not given	6,478	36.1%

Type of reporter in the reports that name Lamivudine
Reporter	Reports	Share
Physician	3,940	21.9%
Pharmacist	220	1.2%
Other health professional	10,847	60.4%
Lawyer	2	under 0.1%
Consumer or non-health professional	1,764	9.8%
Not given	1,193	6.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 15.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lamivudine record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	10,182	56.7%
Antiretroviral therapy	904	5%
Hepatitis b	664	3.7%
Chronic hepatitis b	646	3.6%
Antiviral prophylaxis	320	1.8%
Prophylaxis against HIV infection	263	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 17,966 reports.

Drugs in the same reports

Other drugs that the reports of Lamivudine name, in any role, in order of name
Drug	Reports that name the two
Abacavir	2,681
Dolutegravir	1,709
Efavirenz	4,380
Kaletra	1,656
Nevirapine	3,752
Ritonavir	2,426
Stavudine	2,890
Tenofovir	1,949
Tenofovir disoproxil fumarate	2,889
Zidovudine	5,579

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

Epivir same ingredient
Lamivudine and zidovudine same class
Entecavir same class
Tenofovir alafenamide same class
Dovato same class
Tenofovir disoproxil fumarate same class
Lamisil next in the A to Z list
Lamivudine + Zidovudine next in the A to Z list
Lamira Nebulizer System next in the A to Z list
Lamictal Cd next in the A to Z list
Lamivudine Zidovudine next in the A to Z list
Lamictal next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for LamivudineThe 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.

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Reported Reactions. Lamivudine: adverse event reports that FDA received. https://reportedreactions.com/drug/lamivudine/ 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 Lamivudine as a suspect or interacting product. The 7,551 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 Lamivudine 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 Lamivudine?

No. It is a count of what people reported to FDA: 17,966 reports from January 2004 to June 2026. 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?

Other health professional (60.4%), physician (21.9%) and consumer or non-health professional (9.8%). 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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