Enfuvirtide adverse event reports that FDA received

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

Name type: Generic name

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 March 2026, FDA received 835 adverse event reports that name Enfuvirtide. In these reports the drug is a suspect or interacting product.

In the same period, 1,009 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 5 reports in the 12 months to June 2026 and 19 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, 5 (under 0.1%) name Enfuvirtide. Reports from consumers or other non-health professionals were 7.7% of the reports that name Enfuvirtide 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 Enfuvirtide 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 0 reports that name Enfuvirtide.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 0.

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 98 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 820 of the 835 reports (98.2%).

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 98 terms.

Reaction terms in the reports that name Enfuvirtide, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 835 reports
Lipodystrophy acquiredchanges in body fat distribution	140	16.8%
Eyelid ptosis	136	16.3%
Mitochondrial toxicity	136	16.3%
Diplopiadouble vision	134	16%
Anxiety	88	10.5%
Depression suicidal	88	10.5%
Depressive symptom	88	10.5%
Psychiatric decompensation	88	10.5%
Psychomotor skills impaired	88	10.5%
Psychotic disordera loss of contact with reality	88	10.5%
Suicidal ideationthoughts of suicide	88	10.5%
Tearfulness	88	10.5%
Paranoia	87	10.4%
Dysphagiadifficulty swallowing	74	8.9%
Progressive external ophthalmoplegia	62	7.4%
Depressionlow mood	51	6.1%
Product use in unapproved indicationused for a purpose not on the label	47	5.6%
Ophthalmoplegia	46	5.5%
Drug interactionan interaction between medicines	44	5.3%
Drug resistance	40	4.8%
Viral mutation identified	39	4.7%
Blood lactic acid increased	36	4.3%
Diarrhoealoose or frequent stools	31	3.7%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	31	3.7%
Pathogen resistance	31	3.7%
Deaththe patient died; cause not stated by this term	29	3.5%
HIV infection	29	3.5%
Anaemialow red blood cells	27	3.2%
Virologic failure	27	3.2%
Pyrexiafever	25	3%
Renal failure acute	21	2.5%
Dehydration	19	2.3%
Acquired immunodeficiency syndrome	18	2.2%
Renal failurekidney failure	17	2%
Weight decreasedweight loss	17	2%
Treatment failurethe treatment did not work	16	1.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	15	1.8%
Hepatic enzyme increasedraised liver enzymes	15	1.8%
Aspartate aminotransferase increasedraised liver enzyme (AST)	14	1.7%
Extraocular muscle paresis	14	1.7%
Immune reconstitution syndrome	14	1.7%
Injection site reactiona reaction where the injection was given	14	1.7%
Multiple-drug resistance	14	1.7%
Drug ineffectivethe medicine did not work as expected	13	1.6%
Hepatitis	13	1.6%
Headachehead pain	12	1.4%
Liver disorder	12	1.4%
Lymphadenopathyswollen lymph nodes	12	1.4%
Nauseafeeling sick	12	1.4%
Psychomotor retardation	12	1.4%

Download all 98 terms of Enfuvirtide (CSV)

The counts add to more than 835 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 Enfuvirtide, 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	49	47	9	0	42	0	0	2	2
2005	68	68	26	0	50	0	0	9	0
2006	89	88	18	0	64	0	0	25	1
2007	58	57	10	4	47	6	0	11	1
2008	42	42	9	0	24	2	2	17	0
2009	45	44	3	2	22	5	2	22	1
2010	34	34	6	4	12	5	0	21	0
2011	12	12	0	2	7	0	2	5	0
2012	10	10	2	2	7	2	0	5	0
2013	25	25	7	0	5	0	0	20	0
2014	21	21	2	1	5	0	0	17	0
2015	21	18	1	0	1	0	1	18	3
2016	19	19	1	0	0	0	1	19	0
2017	15	12	1	0	0	0	0	11	3
2018	17	16	2	0	0	0	0	15	1
2019	27	27	1	0	1	0	4	26	0
2020	62	62	2	0	6	0	9	58	0
2021	32	32	2	0	7	0	2	29	0
2022	62	60	1	0	19	0	1	53	2
2023	55	53	4	0	38	0	2	45	2
2024	35	33	3	0	18	0	2	31	2
2025	32	31	7	0	19	0	8	26	1
2026	5	5	2	0	2	1	1	4	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 Enfuvirtide, 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 Enfuvirtide, by the year in which FDA received them
Year	Reports
2004	12
2005	12
2006	38
2007	25
2008	37
2009	234
2010	34
2011	16
2012	10
2013	27
2014	19
2015	22
2016	23
2017	19
2018	25
2019	50
2020	59
2021	29
2022	67
2023	44
2024	21
2025	10
2026	1

Reports that name Enfuvirtide, 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 Enfuvirtide
Age	Reports	Share
Under 2	12	1.4%
2 to 11	1	0.1%
12 to 17	4	0.5%
18 to 44	123	14.7%
45 to 64	317	38%
65 to 74	1	0.1%
75 and over	1	0.1%
Age not given	376	45%

Sex of the patient in the reports that name Enfuvirtide
Sex	Reports	Share
Female	151	18.1%
Male	571	68.4%
Unknown or not given	113	13.5%

Type of reporter in the reports that name Enfuvirtide
Reporter	Reports	Share
Physician	325	38.9%
Pharmacist	7	0.8%
Other health professional	383	45.9%
Lawyer	0	0%
Consumer or non-health professional	64	7.7%
Not given	56	6.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 35.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Enfuvirtide record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	490	58.7%
Antiretroviral therapy	6	0.7%
Acquired immunodeficiency syndrome	4	0.5%
Drug exposure during pregnancy	4	0.5%
Prophylaxis	4	0.5%
End stage AIDS	3	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 835 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for EnfuvirtideThe 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. Enfuvirtide: adverse event reports that FDA received. https://reportedreactions.com/drug/enfuvirtide/ 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 Enfuvirtide as a suspect or interacting product. The 1,009 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 Enfuvirtide 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 Enfuvirtide?

No. It is a count of what people reported to FDA: 835 reports from January 2004 to March 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 (45.9%), physician (38.9%) and consumer or non-health professional (7.7%). 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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