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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.

ELVITEGRAVIR: 211 Adverse Event Reports & Safety Profile

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211
Total FAERS Reports
8 (3.8%)
Deaths Reported
33
Hospitalizations
211
As Primary/Secondary Suspect
1
Life-Threatening
Sep 24, 2014
FDA Approved
Discontinued
Status

FDA Application: 203093 ·

Patent Expires: Oct 26, 2026 · First Report: 2012 · Latest Report: 20230614

What Are the Most Common ELVITEGRAVIR Side Effects?

#1 Most Reported
Pathogen resistance
40 reports (19.0%)
#2 Most Reported
Virologic failure
38 reports (18.0%)
#3 Most Reported
Foetal exposure during pregnancy
31 reports (14.7%)

All ELVITEGRAVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pathogen resistance 40 19.0% 0 1
Virologic failure 38 18.0% 0 1
Drug resistance 31 14.7% 0 1
Foetal exposure during pregnancy 31 14.7% 2 1
Viral mutation identified 29 13.7% 0 1
Drug ineffective 18 8.5% 3 5
Exposure during pregnancy 18 8.5% 0 1
Immune reconstitution inflammatory syndrome 16 7.6% 0 7
Treatment failure 16 7.6% 0 0
Treatment noncompliance 16 7.6% 0 3
Renal dysplasia 15 7.1% 0 0
Blood hiv rna increased 13 6.2% 0 0
Single functional kidney 13 6.2% 0 0
Renal aplasia 11 5.2% 0 0
Abortion spontaneous 8 3.8% 0 0
Drug intolerance 8 3.8% 0 1
Foetal exposure during delivery 8 3.8% 0 0
Premature labour 8 3.8% 0 0
Cholestasis of pregnancy 7 3.3% 0 0
Depression 7 3.3% 0 2

Who Reports ELVITEGRAVIR Side Effects? Age & Gender Data

Gender: 38.8% female, 61.2% male. Average age: 42.4 years. Most reports from: US. View detailed demographics →

Is ELVITEGRAVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 1 0 1
2013 4 0 2
2014 1 0 0
2015 6 0 3
2016 10 0 3
2018 1 0 1
2019 1 0 1
2020 2 0 1
2021 2 0 0
2022 9 0 0
2023 2 0 0

View full timeline →

What Is ELVITEGRAVIR Used For?

IndicationReports
Hiv infection 154
Product used for unknown indication 27
Antiretroviral therapy 7

ELVITEGRAVIR vs Alternatives: Which Is Safer?

ELVITEGRAVIR vs EMAPALUMAB ELVITEGRAVIR vs EMAPALUMAB-LZSG ELVITEGRAVIR vs EMEND ELVITEGRAVIR vs EMICIZUMAB ELVITEGRAVIR vs EMICIZUMAB-KXWH ELVITEGRAVIR vs EMPAGLIFLOZIN ELVITEGRAVIR vs EMPAGLIFLOZIN\LINAGLIPTIN ELVITEGRAVIR vs EMPAGLIFLOZIN\LINAGLIPTIN\METFORMIN ELVITEGRAVIR vs EMPAGLIFLOZIN\METFORMIN ELVITEGRAVIR vs EMTRICITABINE

Official FDA Label for ELVITEGRAVIR

Official prescribing information from the FDA-approved drug label.