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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.

COBICISTAT\DARUNAVIR ETHANOLATE: 1,647 Adverse Event Reports & Safety Profile

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1,647
Total FAERS Reports
183 (11.1%)
Deaths Reported
384
Hospitalizations
1,647
As Primary/Secondary Suspect
65
Life-Threatening
10
Disabilities

First Report: 19820326 · Latest Report: 20250925

What Are the Most Common COBICISTAT\DARUNAVIR ETHANOLATE Side Effects?

#1 Most Reported
Off label use
140 reports (8.5%)
#2 Most Reported
Drug interaction
102 reports (6.2%)
#3 Most Reported
Death
100 reports (6.1%)

All COBICISTAT\DARUNAVIR ETHANOLATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 140 8.5% 16 48
Drug interaction 102 6.2% 4 36
Death 100 6.1% 97 2
Foetal exposure during pregnancy 92 5.6% 31 22
Nausea 79 4.8% 0 11
Virologic failure 70 4.3% 8 15
Rash 61 3.7% 1 13
Diarrhoea 60 3.6% 1 10
Headache 55 3.3% 0 3
Drug ineffective 51 3.1% 6 17
Vomiting 46 2.8% 2 8
Fatigue 44 2.7% 6 9
Treatment noncompliance 43 2.6% 0 9
Exposure during pregnancy 39 2.4% 2 0
Hospitalisation 37 2.3% 0 37
Immune reconstitution inflammatory syndrome 35 2.1% 7 27
Toxicity to various agents 34 2.1% 4 20
Foetal growth restriction 33 2.0% 22 12
Blood creatinine increased 32 1.9% 2 4
Viral mutation identified 32 1.9% 0 0

Who Reports COBICISTAT\DARUNAVIR ETHANOLATE Side Effects? Age & Gender Data

Gender: 32.5% female, 67.5% male. Average age: 49.4 years. Most reports from: US. View detailed demographics →

Is COBICISTAT\DARUNAVIR ETHANOLATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 2 0 0
2012 1 0 1
2013 4 0 1
2014 1 0 0
2015 35 0 5
2016 93 4 28
2017 140 3 29
2018 115 4 25
2019 94 22 32
2020 98 10 21
2021 38 8 12
2022 12 3 3
2023 27 12 4
2024 27 9 10
2025 9 4 1

View full timeline →

What Is COBICISTAT\DARUNAVIR ETHANOLATE Used For?

IndicationReports
Hiv infection 784
Product used for unknown indication 521
Covid-19 105
Acquired immunodeficiency syndrome 19
Antiviral treatment 15
Covid-19 pneumonia 15
Antiretroviral therapy 13
Hiv test positive 12
Acute hiv infection 11
Hepatitis c 7

COBICISTAT\DARUNAVIR ETHANOLATE vs Alternatives: Which Is Safer?

COBICISTAT\DARUNAVIR ETHANOLATE vs COBICISTAT\DARUNAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE COBICISTAT\DARUNAVIR ETHANOLATE vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR COBICISTAT\DARUNAVIR ETHANOLATE vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR ALAFENAMIDE COBICISTAT\DARUNAVIR ETHANOLATE vs COBICISTAT\ELVITEGRAVIR\EMTRICITABINE\TENOFOVIR DISOPROXIL COBICISTAT\DARUNAVIR ETHANOLATE vs COBIMETINIB COBICISTAT\DARUNAVIR ETHANOLATE vs COCAETHYLENE COBICISTAT\DARUNAVIR ETHANOLATE vs COCAINE COBICISTAT\DARUNAVIR ETHANOLATE vs COCOA BUTTER\PHENYLEPHRINE COBICISTAT\DARUNAVIR ETHANOLATE vs COD LIVER OIL COBICISTAT\DARUNAVIR ETHANOLATE vs CODEINE

Official FDA Label for COBICISTAT\DARUNAVIR ETHANOLATE

Official prescribing information from the FDA-approved drug label.