Skip to content
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.

ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE: 5,583 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
5,583
Total FAERS Reports
343 (6.1%)
Deaths Reported
966
Hospitalizations
5,583
As Primary/Secondary Suspect
165
Life-Threatening
86
Disabilities

Active Ingredient: ABACAVIR SULFATE\DOLUTEGRAVIR SODIUM\LAMIVUDINE ·

First Report: 1996 · Latest Report: 20250912

What Are the Most Common ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE Side Effects?

#1 Most Reported
Product dose omission issue
805 reports (14.4%)
#2 Most Reported
Nausea
266 reports (4.8%)
#3 Most Reported
Headache
259 reports (4.6%)

All ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product dose omission issue 805 14.4% 0 18
Nausea 266 4.8% 6 56
Headache 259 4.6% 50 45
Exposure during pregnancy 255 4.6% 55 22
Fatigue 216 3.9% 48 21
Pyrexia 210 3.8% 60 58
Rash 207 3.7% 54 45
Diarrhoea 197 3.5% 1 34
Product use issue 190 3.4% 51 10
Insomnia 187 3.4% 2 19
Foetal exposure during pregnancy 154 2.8% 38 25
Malaise 152 2.7% 6 34
Product dose omission 145 2.6% 0 5
Drug ineffective 141 2.5% 54 19
Vomiting 141 2.5% 4 44
Pain 138 2.5% 56 17
Hypertension 126 2.3% 48 41
Death 120 2.2% 119 8
Depression 116 2.1% 5 20
Blood hiv rna increased 115 2.1% 0 10

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

Gender: 28.7% female, 71.3% male. Average age: 45.7 years. Most reports from: US. View detailed demographics →

Is ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2001 5 0 5
2002 2 0 0
2004 2 0 1
2005 2 0 2
2007 4 0 4
2008 4 0 0
2009 4 1 0
2010 7 1 5
2011 5 0 3
2012 23 4 5
2013 6 0 1
2014 48 5 14
2015 252 12 76
2016 385 18 107
2017 407 27 126
2018 397 12 81
2019 298 21 74
2020 183 9 26
2021 131 13 31
2022 196 10 20
2023 199 10 23
2024 189 9 12
2025 89 3 8

View full timeline →

What Is ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE Used For?

IndicationReports
Hiv infection 3,129
Product used for unknown indication 1,701
Acquired immunodeficiency syndrome 63
Antiretroviral therapy 46
Hiv infection cdc group iii 43
Hiv test positive 37
Asymptomatic hiv infection 17
Hiv test 17
Acute hiv infection 14
Hepatitis c 14

ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs Alternatives: Which Is Safer?

ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABACAVIR\LAMIVUDINE ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABACAVIR\LAMIVUDINE\ZIDOVUDINE ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABALOPARATIDE ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABATACEPT ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABCIXIMAB ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABEMACICLIB ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABILIFY ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABIRATERONE ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABIRATERONE\ABIRATERONE ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE vs ABOBOTULINUMTOXINA

Official FDA Label for ABACAVIR\DOLUTEGRAVIR\LAMIVUDINE

Official prescribing information from the FDA-approved drug label.