Abacavir adverse event reports that FDA received

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

Name type: Generic name
Class: Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor
Also reported as: Abacavir Tablets Usp, Abacavir Tab 300mg

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 3,867 adverse event reports that name Abacavir. In these reports the drug is a suspect or interacting product.

In the same period, 2,133 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 108 reports in the 12 months to June 2026 and 145 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, 108 (under 0.1%) name Abacavir. Reports from other health professionals were 58% of the reports that name Abacavir 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 Abacavir 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 38 reports that name Abacavir.
In January to March 2026, FDA received 21.
In April to June 2025, FDA received 29.

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 488 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 3,850 of the 3,867 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 488 terms.

Reaction terms in the reports that name Abacavir, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,867 reports
Virologic failure	411	10.6%
Pyrexiafever	372	9.6%
Treatment failurethe treatment did not work	326	8.4%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	320	8.3%
Viral mutation identified	311	8%
Pathogen resistance	307	7.9%
Exposure during pregnancythe medicine was taken during pregnancy	290	7.5%
Rashskin rash	286	7.4%
Drug resistance	254	6.6%
Drug ineffectivethe medicine did not work as expected	210	5.4%
Thrombocytopenialow platelets	210	5.4%
Fatiguetiredness	196	5.1%
Treatment noncompliancethe treatment was not taken as directed	188	4.9%
Drug interactionan interaction between medicines	179	4.6%
Hypersensitivityan allergic-type reaction	179	4.6%
Upper respiratory tract infectiona cold or similar infection	178	4.6%
Immune reconstitution inflammatory syndrome	177	4.6%
Hypertensionhigh blood pressure	173	4.5%
Rash erythematousa red rash	173	4.5%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	173	4.5%
Asthma	172	4.4%
Headachehead pain	172	4.4%
Diarrhoealoose or frequent stools	148	3.8%
Infectionan infection, type not specified	143	3.7%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	140	3.6%
Lipodystrophy acquiredchanges in body fat distribution	137	3.5%
Off label useused for a purpose or in a way not on the label	137	3.5%
Nauseafeeling sick	136	3.5%
Painpain, site not specified	128	3.3%
Vomitingbeing sick	128	3.3%
Immunodeficiency	124	3.2%
Hepatic enzyme increasedraised liver enzymes	122	3.2%
Product use issuea problem in how the product was used	119	3.1%
Foetal death	116	3%
Anaemialow red blood cells	115	3%
Drug intolerancethe medicine was not tolerated	115	3%
Hyperhidrosisexcessive sweating	114	2.9%
Intentional product misusedeliberate use not as intended	113	2.9%
Infusion related reactiona reaction during or soon after an infusion	112	2.9%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	111	2.9%
Prescribed overdose	110	2.8%
Back pain	109	2.8%
Overdosea dose above the recommended amount	109	2.8%
Deaththe patient died; cause not stated by this term	108	2.8%
Food allergy	105	2.7%
Joint swellinga swollen joint	104	2.7%
Psoriasispsoriasis, a skin condition	101	2.6%
Constipation	99	2.6%
Fluid retentionthe body holding extra fluid	99	2.6%
Temperature regulation disorder	99	2.6%

Download all 488 terms of Abacavir (CSV)

The counts add to more than 3,867 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 Abacavir with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Abacavir (this page)	Generic name	3,867
Abacavir sulfate	Generic name	840
Abacavir sulphate	Generic name	248
Ziagen	Brand name	1,554

Sum of the separately reported names: 6,509. 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 Abacavir, 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	95	84	11	10	42	3	0	39	11
2005	67	60	9	2	26	2	0	32	7
2006	98	93	10	9	42	2	2	53	5
2007	70	63	8	2	18	6	8	35	7
2008	68	65	5	9	34	2	2	41	3
2009	98	89	8	13	40	2	2	45	9
2010	74	71	9	7	35	1	3	36	3
2011	53	51	4	5	27	1	4	31	2
2012	52	51	5	7	23	3	0	32	1
2013	79	76	15	3	34	5	0	51	3
2014	140	136	24	7	42	0	23	79	4
2015	262	247	60	2	32	0	13	202	15
2016	281	271	34	3	34	0	14	249	10
2017	253	243	18	13	53	3	9	225	10
2018	249	230	26	16	43	0	8	209	19
2019	240	215	12	18	56	0	41	191	25
2020	372	361	18	8	90	0	45	302	11
2021	217	211	27	12	49	7	9	196	6
2022	302	300	40	4	84	2	26	275	2
2023	269	258	33	20	19	6	25	240	11
2024	220	210	24	7	37	0	12	196	10
2025	205	198	41	7	31	0	2	186	7
2026	103	103	27	3	16	3	1	101	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 Abacavir, 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 Abacavir, by the year in which FDA received them
Year	Reports
2004	75
2005	63
2006	118
2007	69
2008	68
2009	105
2010	86
2011	54
2012	66
2013	77
2014	149
2015	270
2016	288
2017	275
2018	274
2019	296
2020	367
2021	225
2022	260
2023	303
2024	190
2025	130
2026	59

Reports that name Abacavir, 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 Abacavir
Age	Reports	Share
Under 2	79	2%
2 to 11	120	3.1%
12 to 17	100	2.6%
18 to 44	786	20.3%
45 to 64	799	20.7%
65 to 74	107	2.8%
75 and over	18	0.5%
Age not given	1,858	48%

Sex of the patient in the reports that name Abacavir
Sex	Reports	Share
Female	1,012	26.2%
Male	1,563	40.4%
Unknown or not given	1,292	33.4%

Type of reporter in the reports that name Abacavir
Reporter	Reports	Share
Physician	864	22.3%
Pharmacist	110	2.8%
Other health professional	2,244	58%
Lawyer	0	0%
Consumer or non-health professional	455	11.8%
Not given	194	5%

Age and sex are as the report gives them. The reporter is the primary source in the report. 20.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Abacavir record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	2,361	61.1%
Antiretroviral therapy	234	6.1%
Acquired immunodeficiency syndrome	39	1%
Perinatal HIV infection	31	0.8%
Hiv test positive	23	0.6%
Hiv infection who clinical stage iii	16	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,867 reports.

Drugs in the same reports

Other drugs that the reports of Abacavir name, in any role, in order of name
Drug	Reports that name the two
Didanosine	567
Dolutegravir	573
Efavirenz	877
Emtricitabine	412
Lamivudine	2,643
Nevirapine	714
Ritonavir	839
Stavudine	556
Tenofovir	428
Zidovudine	994

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

Abacavir sulfate same ingredient
Abacavir sulphate same ingredient
Ziagen same ingredient
Abacavir sulfate, dolutegravir sodium, lamivudine same class
Biktarvy same class
6-Mp next in the A to Z list
Abacavir and lamivudine next in the A to Z list
6-Mercaptopurine Monohydrate next in the A to Z list
Abacavir Lamivudine next in the A to Z list
6-Mercaptopurine next in the A to Z list
5-Fu Fluorouracil next in the A to Z list
Abacavir Sulfate + Lamivudine 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 AbacavirThe 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. Abacavir: adverse event reports that FDA received. https://reportedreactions.com/drug/abacavir/ 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 Abacavir as a suspect or interacting product. The 2,133 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 Abacavir 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 Abacavir?

No. It is a count of what people reported to FDA: 3,867 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 (58%), physician (22.3%) and consumer or non-health professional (11.8%). 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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