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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.

LOPINAVIR\RITONAVIR: 8,294 Adverse Event Reports & Safety Profile

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8,294
Total FAERS Reports
1,118 (13.5%)
Deaths Reported
2,162
Hospitalizations
8,294
As Primary/Secondary Suspect
357
Life-Threatening
89
Disabilities

First Report: 1993 · Latest Report: 20250807

What Are the Most Common LOPINAVIR\RITONAVIR Side Effects?

#1 Most Reported
Off label use
2,010 reports (24.2%)
#2 Most Reported
Foetal exposure during pregnancy
932 reports (11.2%)
#3 Most Reported
Drug interaction
821 reports (9.9%)

All LOPINAVIR\RITONAVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 2,010 24.2% 370 798
Foetal exposure during pregnancy 932 11.2% 147 101
Drug interaction 821 9.9% 189 233
Depression 551 6.6% 135 98
Virologic failure 428 5.2% 20 33
Exposure during pregnancy 395 4.8% 36 71
Diarrhoea 363 4.4% 38 148
Maternal exposure during pregnancy 311 3.8% 31 71
Product use in unapproved indication 282 3.4% 76 135
Nausea 243 2.9% 9 83
Pathogen resistance 234 2.8% 16 25
Lipodystrophy acquired 230 2.8% 0 16
Acute kidney injury 226 2.7% 38 96
Drug ineffective 220 2.7% 30 81
Drug resistance 220 2.7% 19 44
Neurodevelopmental disorder 217 2.6% 0 0
Vomiting 209 2.5% 26 91
Viral mutation identified 207 2.5% 3 4
Abortion spontaneous 192 2.3% 34 40
Condition aggravated 190 2.3% 35 139

Who Reports LOPINAVIR\RITONAVIR Side Effects? Age & Gender Data

Gender: 37.2% female, 62.8% male. Average age: 47.1 years. Most reports from: US. View detailed demographics →

Is LOPINAVIR\RITONAVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 6 0 1
2001 8 0 0
2002 29 1 13
2003 19 3 6
2004 41 0 14
2005 50 8 16
2006 36 5 20
2007 41 6 18
2008 50 1 11
2009 81 6 19
2010 132 23 68
2011 64 7 14
2012 116 25 41
2013 105 2 25
2014 267 22 69
2015 185 12 58
2016 159 20 62
2017 119 15 65
2018 104 9 44
2019 64 0 15
2020 1,642 340 515
2021 53 3 10
2022 69 0 17
2023 41 3 10
2024 28 0 11
2025 19 1 13

View full timeline →

What Is LOPINAVIR\RITONAVIR Used For?

IndicationReports
Hiv infection 3,387
Covid-19 1,549
Product used for unknown indication 840
Covid-19 pneumonia 727
Coronavirus infection 388
Antiretroviral therapy 376
Maternal exposure timing unspecified 278
Acquired immunodeficiency syndrome 125
Antiviral treatment 89
Prophylaxis against hiv infection 86

LOPINAVIR\RITONAVIR vs Alternatives: Which Is Safer?

LOPINAVIR\RITONAVIR vs LOPRAZOLAM LOPINAVIR\RITONAVIR vs LORATADINE LOPINAVIR\RITONAVIR vs LORATADINE\PSEUDOEPHEDRINE LOPINAVIR\RITONAVIR vs LORAZEPAM LOPINAVIR\RITONAVIR vs LORCASERIN LOPINAVIR\RITONAVIR vs LORLATINIB LOPINAVIR\RITONAVIR vs LORMETAZEPAM LOPINAVIR\RITONAVIR vs LORNOXICAM LOPINAVIR\RITONAVIR vs LOSARTAN LOPINAVIR\RITONAVIR vs LOSARTAN\LOSARTAN

Official FDA Label for LOPINAVIR\RITONAVIR

Official prescribing information from the FDA-approved drug label.