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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.

SAQUINAVIR: 792 Adverse Event Reports & Safety Profile

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792
Total FAERS Reports
57 (7.2%)
Deaths Reported
137
Hospitalizations
792
As Primary/Secondary Suspect
22
Life-Threatening
6
Disabilities
Dec 17, 2004
FDA Approved
Discontinued
Status

FDA Application: 020628 ·

First Report: 1996 · Latest Report: 20240401

What Are the Most Common SAQUINAVIR Side Effects?

#1 Most Reported
Lipodystrophy acquired
186 reports (23.5%)
#2 Most Reported
Eyelid ptosis
169 reports (21.3%)
#3 Most Reported
Mitochondrial toxicity
165 reports (20.8%)

All SAQUINAVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Lipodystrophy acquired 186 23.5% 0 0
Eyelid ptosis 169 21.3% 0 0
Mitochondrial toxicity 165 20.8% 0 1
Diplopia 161 20.3% 0 0
Foetal exposure during pregnancy 105 13.3% 9 27
Dysphagia 103 13.0% 5 5
Viral mutation identified 82 10.4% 0 2
Drug resistance 77 9.7% 5 10
Progressive external ophthalmoplegia 74 9.3% 0 0
Pathogen resistance 67 8.5% 0 2
Ophthalmoplegia 66 8.3% 0 0
Virologic failure 66 8.3% 0 15
Blood lactic acid increased 60 7.6% 1 10
Treatment failure 51 6.4% 1 0
Anaemia 41 5.2% 2 25
Drug ineffective 37 4.7% 13 13
Fatigue 34 4.3% 4 6
Pyrexia 32 4.0% 5 26
Hypertension 24 3.0% 0 11
Multiple-drug resistance 24 3.0% 0 8

Who Reports SAQUINAVIR Side Effects? Age & Gender Data

Gender: 27.5% female, 72.5% male. Average age: 44.3 years. Most reports from: CA. View detailed demographics →

Is SAQUINAVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 12 1 8
2001 26 2 8
2002 6 3 3
2003 8 0 0
2005 20 0 0
2006 10 0 3
2007 3 0 0
2008 7 0 0
2009 17 1 0
2010 5 0 0
2011 17 6 1
2012 6 2 2
2013 5 3 0
2014 18 4 13
2015 15 0 7
2016 1 1 0
2017 2 0 0
2018 17 4 10
2019 3 0 3
2021 4 0 3
2022 6 0 0
2024 5 0 5

View full timeline →

What Is SAQUINAVIR Used For?

IndicationReports
Hiv infection 526
Product used for unknown indication 110
Antiretroviral therapy 62
Acquired immunodeficiency syndrome 14
Hiv-2 infection 10
Hepatitis c 8
Maternal exposure timing unspecified 8
Antiviral treatment 7
Chronic hepatitis c 7
Hiv test positive 7

SAQUINAVIR vs Alternatives: Which Is Safer?

SAQUINAVIR vs SARECYCLINE SAQUINAVIR vs SARGRAMOSTIM SAQUINAVIR vs SARILUMAB SAQUINAVIR vs SATRALIZUMAB SAQUINAVIR vs SATRALIZUMAB-MWGE SAQUINAVIR vs SAXAGLIPTIN SAQUINAVIR vs SCHOLL'S INGROWN TOENAIL PAIN RELIEVER SAQUINAVIR vs SCOPOLAMINE SAQUINAVIR vs SCOPOLAMINE HYDROBROMIDE SAQUINAVIR vs SEBELIPASE ALFA

Official FDA Label for SAQUINAVIR

Official prescribing information from the FDA-approved drug label.