Tenofovir adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Tenofovir
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 June 2026, FDA received 5,108 adverse event reports that name Tenofovir. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 3,270 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 152 reports in the 12 months to June 2026 and 197 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, 152 (under 0.1%) name Tenofovir. Reports from other health professionals were 64.7% of the reports that name Tenofovir 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 Tenofovir 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 Tenofovir.
In January to March 2026, FDA received 39.
In April to June 2025, FDA received 33.

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 401 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 all 5,108 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 401 terms.

Reaction terms in the reports that name Tenofovir, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 5,108 reports
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	519	10.2%
Virologic failure	420	8.2%
Drug resistance	357	7%
Exposure during pregnancythe medicine was taken during pregnancy	303	5.9%
Drug interactionan interaction between medicines	299	5.9%
Deaththe patient died; cause not stated by this term	227	4.4%
Immune reconstitution inflammatory syndrome	202	4%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	174	3.4%
Treatment failurethe treatment did not work	168	3.3%
Drug ineffectivethe medicine did not work as expected	146	2.9%
Premature babya baby born early	141	2.8%
Acute kidney injurysudden loss of kidney function	126	2.5%
Vomitingbeing sick	120	2.3%
Anaemialow red blood cells	115	2.3%
Nauseafeeling sick	113	2.2%
Treatment noncompliancethe treatment was not taken as directed	112	2.2%
Pyrexiafever	111	2.2%
Renal failurekidney failure	111	2.2%
Diarrhoealoose or frequent stools	106	2.1%
Lipodystrophy acquiredchanges in body fat distribution	106	2.1%
Premature delivery	106	2.1%
Renal impairmentreduced kidney function	104	2%
Nephropathy toxic	95	1.9%
Fanconi syndrome	90	1.8%
Pathogen resistance	88	1.7%
Condition aggravatedthe condition being treated got worse	86	1.7%
Abortion spontaneousmiscarriage	85	1.7%
Lactic acidosisa build-up of lactic acid in the blood	85	1.7%
Renal failure acute	85	1.7%
Off label useused for a purpose or in a way not on the label	82	1.6%
Alanine aminotransferase increasedraised liver enzyme (ALT)	73	1.4%
Hepatitis Bhepatitis B infection	73	1.4%
CSF HIV escape syndrome	72	1.4%
Eyelid ptosis	70	1.4%
Fanconi syndrome acquired	69	1.4%
Fatiguetiredness	68	1.3%
Weight decreasedweight loss	68	1.3%
Drug exposure during pregnancythe medicine was taken during pregnancy	66	1.3%
Abdominal painstomach or belly pain	65	1.3%
Hypophosphataemia	65	1.3%
Hepatic failureliver failure	64	1.3%
Mitochondrial toxicity	61	1.2%
Astheniaweakness or lack of energy	60	1.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	60	1.2%
Aspartate aminotransferase increasedraised liver enzyme (AST)	59	1.2%
Viral mutation identified	59	1.2%
Metabolic acidosistoo much acid in the body fluids	57	1.1%
Osteoporosisthinning of the bones	57	1.1%
Immune reconstitution syndrome	55	1.1%
Diplopiadouble vision	54	1.1%

Download all 401 terms of Tenofovir (CSV)

The counts add to more than 5,108 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 Tenofovir, 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	115	105	12	14	54	6	8	37	10
2005	137	131	18	14	68	4	5	67	6
2006	90	88	18	6	41	5	0	45	2
2007	93	91	14	6	31	3	4	57	2
2008	104	102	16	2	45	2	5	63	2
2009	144	141	17	10	55	1	3	94	3
2010	79	78	21	4	30	3	7	49	1
2011	30	29	2	1	14	0	0	18	1
2012	50	48	2	1	20	0	1	29	2
2013	141	139	42	5	48	2	4	78	2
2014	150	147	37	15	78	4	2	75	3
2015	119	114	9	2	45	1	3	82	5
2016	617	612	80	3	74	3	29	516	5
2017	672	670	184	3	51	1	11	480	2
2018	464	453	58	18	81	2	34	394	11
2019	470	457	43	12	101	2	61	405	13
2020	363	355	44	6	80	0	29	301	8
2021	230	222	41	4	60	2	22	195	8
2022	315	306	25	4	51	6	23	276	9
2023	208	205	32	19	55	10	33	184	3
2024	224	214	16	21	69	9	24	183	10
2025	184	174	15	8	59	2	11	140	10
2026	109	103	24	2	44	3	18	93	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 Tenofovir, 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, by the year in which FDA received them
Year	Reports
2004	92
2005	118
2006	134
2007	96
2008	107
2009	136
2010	102
2011	32
2012	67
2013	150
2014	163
2015	125
2016	613
2017	698
2018	525
2019	460
2020	369
2021	212
2022	291
2023	186
2024	201
2025	152
2026	77

Reports that name Tenofovir, 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
Age	Reports	Share
Under 2	82	1.6%
2 to 11	14	0.3%
12 to 17	43	0.8%
18 to 44	1,114	21.8%
45 to 64	925	18.1%
65 to 74	136	2.7%
75 and over	43	0.8%
Age not given	2,751	53.9%

Sex of the patient in the reports that name Tenofovir
Sex	Reports	Share
Female	1,073	21%
Male	1,705	33.4%
Unknown or not given	2,330	45.6%

Type of reporter in the reports that name Tenofovir
Reporter	Reports	Share
Physician	989	19.4%
Pharmacist	143	2.8%
Other health professional	3,307	64.7%
Lawyer	8	0.2%
Consumer or non-health professional	413	8.1%
Not given	248	4.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 26.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Tenofovir record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	2,796	54.7%
Antiretroviral therapy	302	5.9%
Chronic hepatitis b	177	3.5%
Hepatitis b	175	3.4%
Prophylaxis against HIV infection	148	2.9%
Acquired immunodeficiency syndrome	52	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 5,108 reports.

Drugs in the same reports

Other drugs that the reports of Tenofovir name, in any role, in order of name
Drug	Reports that name the two
Abacavir	492
Darunavir	400
Didanosine	469
Efavirenz	1,268
Emtricitabine	1,561
Lamivudine	1,942
Lopinavir	429
Nevirapine	781
Ritonavir	1,125
Zidovudine	797

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

Teniposide next in the A to Z list
Tenofovir alafenamide next in the A to Z list
Tenecteplase next in the A to Z list
Tenofovir disoproxil next in the A to Z list
Tenapanor hydrochloride next in the A to Z list
Tenofovir disoproxil fumarate next in the A to Z list
Temsirolimus next in the A to Z list
Tenofovir/Emtricitabine next in the A to Z list
Temozolomide next in the A to Z list
Tenoretic next in the A to Z list
Temodar next in the A to Z list
Tenormin next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for TenofovirThe 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: adverse event reports that FDA received. https://reportedreactions.com/drug/tenofovir/ 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 as a suspect or interacting product. The 3,270 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 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?

No. It is a count of what people reported to FDA: 5,108 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 (64.7%), physician (19.4%) and consumer or non-health professional (8.1%). 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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