Lamivudine and zidovudine adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Lamivudine and zidovudine
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: Lamivudine/Zidovudine, Lamivudine And Zidovudine Tablets, Lamivudine 150mg/Zidovudine 300mg Tablet

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 April 2004 to June 2026, FDA received 1,432 adverse event reports that name Lamivudine and zidovudine. In these reports the drug is a suspect or interacting product.

In the same period, 228 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 8 reports in the 12 months to June 2026 and 16 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, 8 (under 0.1%) name Lamivudine and zidovudine. Reports from other health professionals were 52.1% of the reports that name Lamivudine and zidovudine 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 and zidovudine 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 6 reports that name Lamivudine and zidovudine.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 2.

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 111 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 1,369 of the 1,432 reports (95.6%).

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 111 terms.

Reaction terms in the reports that name Lamivudine and zidovudine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,432 reports
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	273	19.1%
Virologic failure	193	13.5%
Exposure during pregnancythe medicine was taken during pregnancy	157	11%
Drug resistance	117	8.2%
Viral mutation identified	116	8.1%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	111	7.8%
Pathogen resistance	94	6.6%
Exposure during breast feeding	73	5.1%
Lipodystrophy acquiredchanges in body fat distribution	59	4.1%
Abortion spontaneousmiscarriage	50	3.5%
HIV infection	50	3.5%
Low birth weight baby	50	3.5%
Foetal exposure during delivery	49	3.4%
Treatment noncompliancethe treatment was not taken as directed	48	3.4%
Premature babya baby born early	46	3.2%
No adverse eventno adverse event was reported	43	3%
Anaemialow red blood cells	39	2.7%
Premature delivery	32	2.2%
Renal impairmentreduced kidney function	31	2.2%
Dandy-Walker syndrome	28	2%
Deaththe patient died; cause not stated by this term	26	1.8%
Drug interactionan interaction between medicines	26	1.8%
Stillbirth	25	1.7%
Drug ineffectivethe medicine did not work as expected	24	1.7%
Congenital central nervous system anomaly	21	1.5%
Renal failurekidney failure	21	1.5%
Diarrhoealoose or frequent stools	20	1.4%
Nauseafeeling sick	20	1.4%
Sleep disordera sleep problem	20	1.4%
Ataxia	19	1.3%
Gastrointestinal disorder	19	1.3%
Macrocephaly	19	1.3%
Live birth	18	1.3%
Neurodevelopmental disorder	18	1.3%
Speech disorder developmental	18	1.3%
Attention deficit hyperactivity disorder	15	1%
Drug exposure during pregnancythe medicine was taken during pregnancy	15	1%
Immune reconstitution inflammatory syndrome	15	1%
Maternal drugs affecting foetus	15	1%
Plagiocephaly	15	1%
Treatment failurethe treatment did not work	15	1%
Astheniaweakness or lack of energy	14	1%
Osteonecrosis	13	0.9%
Small for dates baby	13	0.9%
Anxiety	12	0.8%
Dizzinesslight-headedness or unsteadiness	12	0.8%
Nervous system disorder	12	0.8%
Diabetes mellitusdiabetes	11	0.8%
Pneumonialung infection	11	0.8%
Abdominal distensiona bloated abdomen	10	0.7%

Download all 111 terms of Lamivudine and zidovudine (CSV)

The counts add to more than 1,432 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 and zidovudine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Lamivudine and zidovudine (this page)	Generic name	1,432
Combivir	Brand name	4,367

Sum of the separately reported names: 5,799. 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 and zidovudine, 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	18	18	3	0	11	0	3	6	0
2005	24	24	2	3	12	0	5	8	0
2006	9	9	0	0	6	0	2	4	0
2008	8	8	0	0	3	0	1	4	0
2009	17	16	1	0	5	0	2	9	1
2010	4	4	0	0	2	0	1	2	0
2011	4	4	2	0	0	0	0	2	0
2012	12	11	4	1	0	0	7	3	1
2013	15	14	1	0	2	0	12	0	1
2014	59	53	18	5	8	0	13	17	6
2015	124	80	15	3	10	0	13	65	44
2016	239	206	54	6	27	14	3	167	33
2017	210	189	15	1	18	0	8	168	21
2018	184	111	2	0	7	0	25	103	73
2019	125	110	8	1	9	0	25	107	15
2020	127	121	5	0	12	0	36	103	6
2021	102	82	1	0	8	0	3	79	20
2022	61	60	6	4	10	1	14	56	1
2023	17	17	3	0	1	0	9	11	0
2024	33	33	6	0	2	0	13	27	0
2025	32	29	3	0	4	1	9	22	3
2026	8	7	3	0	0	0	4	7	1

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 and zidovudine, 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 and zidovudine, by the year in which FDA received them
Year	Reports
2004	10
2005	30
2006	12
2008	9
2009	19
2010	6
2011	6
2012	16
2013	23
2014	73
2015	126
2016	241
2017	219
2018	171
2019	133
2020	115
2021	105
2022	48
2023	20
2024	35
2025	8
2026	7

Reports that name Lamivudine and zidovudine, 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 and zidovudine
Age	Reports	Share
Under 2	93	6.5%
2 to 11	14	1%
12 to 17	2	0.1%
18 to 44	400	27.9%
45 to 64	144	10.1%
65 to 74	23	1.6%
75 and over	12	0.8%
Age not given	744	52%

Sex of the patient in the reports that name Lamivudine and zidovudine
Sex	Reports	Share
Female	505	35.3%
Male	362	25.3%
Unknown or not given	565	39.5%

Type of reporter in the reports that name Lamivudine and zidovudine
Reporter	Reports	Share
Physician	331	23.1%
Pharmacist	16	1.1%
Other health professional	746	52.1%
Lawyer	0	0%
Consumer or non-health professional	281	19.6%
Not given	58	4.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 39% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lamivudine and zidovudine record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	784	54.7%
Antiretroviral therapy	61	4.3%
Hiv infection cdc category c	28	2%
Prophylaxis against HIV infection	22	1.5%
Maternal exposure timing unspecified	18	1.3%
Acquired immunodeficiency syndrome	14	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,432 reports.

Drugs in the same reports

Other drugs that the reports of Lamivudine and zidovudine name, in any role, in order of name
Drug	Reports that name the two
Darunavir	89
Efavirenz	121
Isentress	127
Kaletra	113
Lamivudine	112
Lopinavir Ritonavir	81
Nevirapine	116
Norvir	66
Ritonavir	137
Zidovudine	123

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

Combivir same ingredient
Lamivudine same class
Tenofovir alafenamide same class
Epivir same class
Tenofovir disoproxil fumarate same class
Entecavir same class
Triumeq same class
Lamivudine + Zidovudine next in the A to Z list
Lamivudine Zidovudine next in the A to Z list
Lamotrigin next in the A to Z list
Lamisil next in the A to Z list
Lamotrigine 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 Lamivudine and zidovudineThe 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. Lamivudine and zidovudine: adverse event reports that FDA received. https://reportedreactions.com/drug/lamivudine-and-zidovudine/ 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 and zidovudine as a suspect or interacting product. The 228 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 and zidovudine 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 and zidovudine?

No. It is a count of what people reported to FDA: 1,432 reports from April 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 (52.1%), physician (23.1%) and consumer or non-health professional (19.6%). 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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