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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.

INDINAVIR: 728 Adverse Event Reports & Safety Profile

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Total FAERS Reports
15 (2.1%)
Deaths Reported
114
Hospitalizations
728
As Primary/Secondary Suspect
16
Life-Threatening
10
Disabilities
Apr 19, 2000
FDA Approved
Discontinued
Status

Active Ingredient: INDINAVIR SULFATE · FDA Application: 020685 ·

First Report: 199407 · Latest Report: 20240401

What Are the Most Common INDINAVIR Side Effects?

#1 Most Reported
Lipodystrophy acquired
195 reports (26.8%)
#2 Most Reported
Eyelid ptosis
158 reports (21.7%)
#3 Most Reported
Mitochondrial toxicity
156 reports (21.4%)

All INDINAVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Lipodystrophy acquired 195 26.8% 0 19
Eyelid ptosis 158 21.7% 0 0
Mitochondrial toxicity 156 21.4% 0 0
Diplopia 155 21.3% 0 0
Virologic failure 100 13.7% 3 19
Drug resistance 93 12.8% 4 9
Viral mutation identified 93 12.8% 0 2
Pathogen resistance 85 11.7% 0 16
Dysphagia 82 11.3% 0 0
Foetal exposure during pregnancy 76 10.4% 2 29
Progressive external ophthalmoplegia 74 10.2% 0 0
Ophthalmoplegia 58 8.0% 0 0
Blood lactic acid increased 54 7.4% 0 12
Treatment failure 42 5.8% 0 0
Drug ineffective 40 5.5% 1 6
Multiple-drug resistance 39 5.4% 0 8
Hypertension 32 4.4% 0 11
Anaemia 31 4.3% 1 8
Dyslipidaemia 30 4.1% 0 8
Fatigue 28 3.9% 0 2

Who Reports INDINAVIR Side Effects? Age & Gender Data

Gender: 29.9% female, 70.1% male. Average age: 45.2 years. Most reports from: CA. View detailed demographics →

Is INDINAVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 18 0 11
2001 29 0 5
2002 7 0 2
2003 10 1 2
2004 8 0 7
2005 16 0 0
2006 4 0 0
2008 7 0 1
2009 5 0 0
2011 9 0 0
2013 1 0 0
2014 6 0 0
2016 1 0 1
2017 4 0 0
2018 8 1 4
2019 2 0 1
2020 2 0 2
2021 6 0 4
2022 2 0 0
2024 5 0 5

View full timeline →

What Is INDINAVIR Used For?

IndicationReports
Hiv infection 536
Product used for unknown indication 67
Antiretroviral therapy 44
Acquired immunodeficiency syndrome 11
Chronic hepatitis c 5

INDINAVIR vs Alternatives: Which Is Safer?

INDINAVIR vs INDOMETHACIN INDINAVIR vs INDOMETHACIN\INDOMETHACIN INDINAVIR vs INEBILIZUMAB-CDON INDINAVIR vs INEXIUM INDINAVIR vs INFLIXIMAB INDINAVIR vs INFLIXIMAB-ABDA INDINAVIR vs INFLIXIMAB-AXXQ INDINAVIR vs INFLIXIMAB-DYYB INDINAVIR vs INFLIXIMAB, RECOMBINANT INDINAVIR vs INFLUENZA A VIRUS A/CALIFORNIA/7/2009 LIVE ANTIGEN\INFLUENZA A VIRUS A/TEXAS/50/2012 LIVE ANTIGEN\INFLUENZA B VIRUS B/BRISBANE/60/2008 LIVE ANTIGEN\INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 LIVE ANTIGEN

Official FDA Label for INDINAVIR

Official prescribing information from the FDA-approved drug label.