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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.

DOLUTEGRAVIR\LAMIVUDINE: 3,176 Adverse Event Reports & Safety Profile

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3,176
Total FAERS Reports
116 (3.7%)
Deaths Reported
335
Hospitalizations
3,176
As Primary/Secondary Suspect
52
Life-Threatening
16
Disabilities

Active Ingredient: DOLUTEGRAVIR SODIUM\LAMIVUDINE ·

First Report: 19940101 · Latest Report: 20250826

What Are the Most Common DOLUTEGRAVIR\LAMIVUDINE Side Effects?

#1 Most Reported
Product dose omission issue
1,089 reports (34.3%)
#2 Most Reported
Inappropriate schedule of product administration
256 reports (8.1%)
#3 Most Reported
Product dose omission in error
234 reports (7.4%)

All DOLUTEGRAVIR\LAMIVUDINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product dose omission issue 1,089 34.3% 1 16
Inappropriate schedule of product administration 256 8.1% 0 2
Product dose omission in error 234 7.4% 0 2
Product use issue 194 6.1% 3 4
Drug ineffective 137 4.3% 3 4
Pathogen resistance 137 4.3% 0 2
Intentional dose omission 112 3.5% 0 0
Viral load increased 104 3.3% 0 4
Rash 99 3.1% 2 14
Treatment noncompliance 97 3.1% 1 7
Viral mutation identified 94 3.0% 0 0
Adverse drug reaction 93 2.9% 0 0
Incorrect dose administered 92 2.9% 0 0
Off label use 92 2.9% 3 3
Fatigue 78 2.5% 3 6
Headache 74 2.3% 2 7
Nausea 73 2.3% 3 8
Weight increased 73 2.3% 0 12
Blood hiv rna increased 72 2.3% 0 5
Diarrhoea 72 2.3% 1 14

Who Reports DOLUTEGRAVIR\LAMIVUDINE Side Effects? Age & Gender Data

Gender: 28.2% female, 71.8% male. Average age: 47.5 years. Most reports from: US. View detailed demographics →

Is DOLUTEGRAVIR\LAMIVUDINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 8 0 5
2004 1 0 1
2008 2 0 2
2012 4 0 4
2013 3 0 0
2016 1 0 1
2017 8 0 5
2018 15 0 4
2019 50 0 4
2020 115 5 22
2021 144 1 36
2022 214 11 18
2023 302 21 17
2024 388 13 45
2025 185 6 24

View full timeline →

What Is DOLUTEGRAVIR\LAMIVUDINE Used For?

IndicationReports
Hiv infection 1,603
Product used for unknown indication 1,305
Hiv infection cdc group iii 51
Antiretroviral therapy 28
Acquired immunodeficiency syndrome 22
Hiv carrier 20
Hiv test positive 13
Hiv test 12
Antiviral treatment 5
Hepatitis c 5

DOLUTEGRAVIR\LAMIVUDINE vs Alternatives: Which Is Safer?

DOLUTEGRAVIR\LAMIVUDINE vs DOLUTEGRAVIR\LAMIVUDINE\TENOFOVIR DISOPROXIL DOLUTEGRAVIR\LAMIVUDINE vs DOLUTEGRAVIR\RILPIVIRINE DOLUTEGRAVIR\LAMIVUDINE vs DOMPERIDONE DOLUTEGRAVIR\LAMIVUDINE vs DOMPERIDONE\PANTOPRAZOLE DOLUTEGRAVIR\LAMIVUDINE vs DONANEMAB-AZBT DOLUTEGRAVIR\LAMIVUDINE vs DONEPEZIL DOLUTEGRAVIR\LAMIVUDINE vs DONEPEZIL\DONEPEZIL DOLUTEGRAVIR\LAMIVUDINE vs DONEPEZIL\MEMANTINE DOLUTEGRAVIR\LAMIVUDINE vs DONEPEZIL\OMEPRAZOLE\OMEPRAZOLE DOLUTEGRAVIR\LAMIVUDINE vs DONOR HUMAN STOOL

Official FDA Label for DOLUTEGRAVIR\LAMIVUDINE

Official prescribing information from the FDA-approved drug label.