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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ENFUVIRTIDE: 758 Adverse Event Reports & Safety Profile

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758
Total FAERS Reports
33 (4.4%)
Deaths Reported
161
Hospitalizations
758
As Primary/Secondary Suspect
20
Life-Threatening
3
Disabilities
Mar 13, 2003
FDA Approved
Discontinued
Status

FDA Application: 021481 ·

First Report: 2001 · Latest Report: 20240208

What Are the Most Common ENFUVIRTIDE Side Effects?

#1 Most Reported
Lipodystrophy acquired
150 reports (19.8%)
#2 Most Reported
Mitochondrial toxicity
149 reports (19.7%)
#3 Most Reported
Eyelid ptosis
149 reports (19.7%)

All ENFUVIRTIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Lipodystrophy acquired 150 19.8% 0 0
Eyelid ptosis 149 19.7% 0 0
Mitochondrial toxicity 149 19.7% 1 1
Diplopia 147 19.4% 0 0
Anxiety 89 11.7% 8 83
Psychotic disorder 85 11.2% 8 82
Depression suicidal 82 10.8% 8 82
Depressive symptom 82 10.8% 8 82
Psychiatric decompensation 82 10.8% 8 82
Psychomotor skills impaired 82 10.8% 8 82
Suicidal ideation 82 10.8% 8 82
Tearfulness 82 10.8% 8 82
Paranoia 81 10.7% 8 81
Dysphagia 80 10.6% 0 0
Progressive external ophthalmoplegia 74 9.8% 0 0
Foetal exposure during pregnancy 64 8.4% 9 0
Injection site reaction 60 7.9% 0 0
Ophthalmoplegia 52 6.9% 0 0
Product use in unapproved indication 45 5.9% 6 44
Blood lactic acid increased 40 5.3% 0 0

Who Reports ENFUVIRTIDE Side Effects? Age & Gender Data

Gender: 18.8% female, 81.2% male. Average age: 48.4 years. Most reports from: CA. View detailed demographics →

Is ENFUVIRTIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 3 0 0
2002 3 0 1
2003 3 1 0
2004 4 0 1
2005 11 0 5
2006 12 1 1
2007 4 1 4
2008 14 0 2
2009 12 0 1
2010 9 0 0
2011 17 0 0
2012 2 0 0
2013 5 1 1
2014 7 1 1
2015 5 0 1
2016 4 0 1
2017 7 0 4
2018 8 0 4
2019 4 0 2
2020 1 0 0
2021 5 2 3
2022 9 0 0
2023 17 0 0
2024 8 0 8

View full timeline →

What Is ENFUVIRTIDE Used For?

IndicationReports
Hiv infection 518
Product used for unknown indication 163
Hiv test positive 28
Antiretroviral therapy 11
Maternal exposure timing unspecified 11
Acquired immunodeficiency syndrome 10
Antiviral treatment 7

ENFUVIRTIDE vs Alternatives: Which Is Safer?

ENFUVIRTIDE vs ENOXAPARIN ENFUVIRTIDE vs ENOXAPARIN - WINTHROP ENFUVIRTIDE vs ENSIFENTRINE ENFUVIRTIDE vs ENTACAPONE ENFUVIRTIDE vs ENTECAVIR ENFUVIRTIDE vs ENTINOSTAT ENFUVIRTIDE vs ENTRECTINIB ENFUVIRTIDE vs ENZALUTAMIDE ENFUVIRTIDE vs EPCORITAMAB ENFUVIRTIDE vs EPCORITAMAB-BYSP

Official FDA Label for ENFUVIRTIDE

Official prescribing information from the FDA-approved drug label.