Tenofovir disoproxil fumarate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Tenofovir disoproxil fumarate
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: Tenofovir Disoproxil Fumarate 300mg, Tenofovir Disoproxil Fumarate 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 February 2004 to June 2026, FDA received 7,400 adverse event reports that name Tenofovir disoproxil fumarate. In these reports the drug is a suspect or interacting product.

In the same period, 1,293 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 150 reports in the 12 months to June 2026 and 236 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, 150 (under 0.1%) name Tenofovir disoproxil fumarate. Reports from consumers or other non-health professionals were 13.8% of the reports that name Tenofovir disoproxil fumarate and 45.8% 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 Tenofovir disoproxil fumarate 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 45 reports that name Tenofovir disoproxil fumarate.
In January to March 2026, FDA received 46.
In April to June 2025, FDA received 46.

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 571 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 7,385 of the 7,400 reports (99.8%).

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 571 terms.

Reaction terms in the reports that name Tenofovir disoproxil fumarate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 7,400 reports
Virologic failure	718	9.7%
Pathogen resistance	700	9.5%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	699	9.4%
Viral mutation identified	663	9%
Drug resistance	445	6%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	379	5.1%
Drug ineffectivethe medicine did not work as expected	286	3.9%
Treatment failurethe treatment did not work	269	3.6%
Abortion spontaneousmiscarriage	262	3.5%
Exposure during pregnancythe medicine was taken during pregnancy	236	3.2%
Osteoporosisthinning of the bones	232	3.1%
Deaththe patient died; cause not stated by this term	220	3%
Drug interactionan interaction between medicines	219	3%
Immune reconstitution inflammatory syndrome	212	2.9%
Nephropathy toxic	201	2.7%
Hepatitis Bhepatitis B infection	191	2.6%
Treatment noncompliancethe treatment was not taken as directed	190	2.6%
Renal impairmentreduced kidney function	187	2.5%
Acute kidney injurysudden loss of kidney function	157	2.1%
Premature babya baby born early	152	2.1%
Fanconi syndrome acquired	147	2%
Diarrhoealoose or frequent stools	138	1.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	137	1.9%
Blood creatinine increasedraised creatinine, a kidney test	137	1.9%
Nauseafeeling sick	136	1.8%
Anaemialow red blood cells	134	1.8%
Condition aggravatedthe condition being treated got worse	131	1.8%
Pyrexiafever	131	1.8%
Off label useused for a purpose or in a way not on the label	121	1.6%
Chronic kidney diseaselong-term kidney disease	120	1.6%
Vomitingbeing sick	116	1.6%
Fatiguetiredness	104	1.4%
Aspartate aminotransferase increasedraised liver enzyme (AST)	102	1.4%
Renal failurekidney failure	101	1.4%
Blood HIV RNA increased	98	1.3%
Fanconi syndrome	94	1.3%
Lipodystrophy acquiredchanges in body fat distribution	92	1.2%
Astheniaweakness or lack of energy	90	1.2%
Drug-induced liver injury	89	1.2%
Hepatitis B reactivation	86	1.2%
Renal failure acute	84	1.1%
Premature delivery	83	1.1%
Hypophosphataemia	82	1.1%
Stillbirth	82	1.1%
Renal tubular disorder	78	1.1%
Headachehead pain	74	1%
Viral load increased	74	1%
Weight decreasedweight loss	74	1%
Hepatic failureliver failure	73	1%
Proteinuriaprotein in the urine	71	1%

Download all 571 terms of Tenofovir disoproxil fumarate (CSV)

The counts add to more than 7,400 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 Tenofovir disoproxil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Tenofovir disoproxil	Generic name	1,430
Tenofovir disoproxil fumarate (this page)	Generic name	7,400
Viread	Brand name	22,033

Sum of the separately reported names: 30,863. 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 Tenofovir disoproxil fumarate, 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	61	59	6	4	38	3	1	29	2
2005	63	63	6	4	33	10	4	29	0
2006	38	38	7	4	20	2	2	18	0
2007	142	141	22	3	47	2	5	84	1
2008	112	112	27	5	49	7	5	48	0
2009	93	92	9	7	48	6	0	48	1
2010	94	89	13	12	35	2	6	50	5
2011	180	175	8	12	73	1	12	91	5
2012	129	129	18	8	55	4	9	67	0
2013	155	154	27	5	48	4	13	102	1
2014	316	311	53	4	67	9	17	280	5
2015	686	673	100	11	94	9	22	597	13
2016	663	657	67	19	165	5	47	549	6
2017	736	725	111	7	130	2	23	652	11
2018	779	713	54	21	95	9	62	672	66
2019	592	578	49	3	105	11	70	537	14
2020	627	610	41	16	81	4	74	550	17
2021	352	346	19	3	73	7	28	314	6
2022	470	457	33	4	115	4	48	400	13
2023	520	506	36	11	100	8	48	476	14
2024	269	264	16	10	89	6	24	230	5
2025	200	191	10	3	68	1	11	172	9
2026	123	121	21	8	48	1	19	109	2

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 Tenofovir disoproxil fumarate, 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 Tenofovir disoproxil fumarate, by the year in which FDA received them
Year	Reports
2004	51
2005	58
2006	57
2007	141
2008	116
2009	91
2010	113
2011	187
2012	155
2013	158
2014	350
2015	698
2016	681
2017	729
2018	806
2019	628
2020	618
2021	336
2022	424
2023	480
2024	267
2025	165
2026	91

Reports that name Tenofovir disoproxil fumarate, 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 Tenofovir disoproxil fumarate
Age	Reports	Share
Under 2	176	2.4%
2 to 11	23	0.3%
12 to 17	65	0.9%
18 to 44	1,645	22.2%
45 to 64	1,546	20.9%
65 to 74	350	4.7%
75 and over	104	1.4%
Age not given	3,491	47.2%

Sex of the patient in the reports that name Tenofovir disoproxil fumarate
Sex	Reports	Share
Female	2,115	28.6%
Male	2,930	39.6%
Unknown or not given	2,355	31.8%

Type of reporter in the reports that name Tenofovir disoproxil fumarate
Reporter	Reports	Share
Physician	2,134	28.8%
Pharmacist	142	1.9%
Other health professional	3,787	51.2%
Lawyer	14	0.2%
Consumer or non-health professional	1,020	13.8%
Not given	303	4.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 23.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Tenofovir disoproxil fumarate record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	3,705	50.1%
Hepatitis b	888	12%
Chronic hepatitis b	669	9%
Antiretroviral therapy	259	3.5%
Prophylaxis against HIV infection	110	1.5%
Acquired immunodeficiency syndrome	87	1.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 7,400 reports.

Drugs in the same reports

Other drugs that the reports of Tenofovir disoproxil fumarate name, in any role, in order of name
Drug	Reports that name the two
Abacavir	477
Darunavir	468
Dolutegravir	573
Efavirenz	1,735
Emtricitabine	1,236
Lamivudine	3,077
Nevirapine	749
Raltegravir	505
Ritonavir	955
Zidovudine	865

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

Tenofovir disoproxil same ingredient
Viread same ingredient
Tenofovir alafenamide same class
Triumeq same class
Lamivudine and zidovudine same class
Lamivudine same class
Tenofovir/Emtricitabine next in the A to Z list
Tenoretic next in the A to Z list
Tenofovir next in the A to Z list
Tenormin next in the A to Z list
Teniposide next in the A to Z list
Tepezza 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 Tenofovir disoproxil fumarateThe 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. Tenofovir disoproxil fumarate: adverse event reports that FDA received. https://reportedreactions.com/drug/tenofovir-disoproxil-fumarate/ 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 Tenofovir disoproxil fumarate as a suspect or interacting product. The 1,293 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 Tenofovir disoproxil fumarate 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 Tenofovir disoproxil fumarate?

No. It is a count of what people reported to FDA: 7,400 reports from February 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 (51.2%), physician (28.8%) and consumer or non-health professional (13.8%). 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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