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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.

ABACAVIR\LAMIVUDINE: 5,296 Adverse Event Reports & Safety Profile

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5,296
Total FAERS Reports
463 (8.7%)
Deaths Reported
1,354
Hospitalizations
5,296
As Primary/Secondary Suspect
238
Life-Threatening
94
Disabilities

Active Ingredient: ABACAVIR SULFATE\LAMIVUDINE ·

First Report: 19980518 · Latest Report: 20250819

What Are the Most Common ABACAVIR\LAMIVUDINE Side Effects?

#1 Most Reported
Exposure during pregnancy
593 reports (11.2%)
#2 Most Reported
Pyrexia
450 reports (8.5%)
#3 Most Reported
Rash
390 reports (7.4%)

All ABACAVIR\LAMIVUDINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Exposure during pregnancy 593 11.2% 79 69
Pyrexia 450 8.5% 101 126
Rash 390 7.4% 88 78
Foetal exposure during pregnancy 373 7.0% 91 55
Hypertension 325 6.1% 83 61
Headache 316 6.0% 82 37
Hypersensitivity 289 5.5% 87 51
Pain 271 5.1% 83 25
Thrombocytopenia 271 5.1% 88 29
Off label use 267 5.0% 92 22
Virologic failure 263 5.0% 6 18
Hepatic enzyme increased 255 4.8% 83 24
Drug ineffective 254 4.8% 92 38
Fatigue 249 4.7% 87 36
Upper respiratory tract infection 248 4.7% 83 14
Hyperhidrosis 243 4.6% 83 15
Rheumatoid arthritis 240 4.5% 85 11
Asthma 239 4.5% 79 13
Rash erythematous 238 4.5% 82 10
Nausea 236 4.5% 18 86

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

Gender: 41.0% female, 59.0% male. Average age: 45.5 years. Most reports from: FR. View detailed demographics →

Is ABACAVIR\LAMIVUDINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 4 2 4
2001 5 0 5
2002 5 0 5
2003 9 0 8
2004 11 0 2
2005 11 5 8
2006 9 1 7
2007 19 0 8
2008 17 3 6
2009 32 0 5
2010 40 2 22
2011 87 25 32
2012 93 11 44
2013 118 3 48
2014 389 10 122
2015 430 31 178
2016 371 28 136
2017 314 26 106
2018 139 8 56
2019 172 26 65
2020 109 11 19
2021 70 5 17
2022 66 1 6
2023 23 4 0
2024 24 0 8
2025 10 1 7

View full timeline →

What Is ABACAVIR\LAMIVUDINE Used For?

IndicationReports
Hiv infection 3,366
Product used for unknown indication 1,242
Antiretroviral therapy 138
Acquired immunodeficiency syndrome 78
Hiv test positive 60
Maternal exposure timing unspecified 39
Rheumatoid arthritis 22
Antiviral treatment 21
Foetal exposure during pregnancy 19
Acute hiv infection 17

ABACAVIR\LAMIVUDINE vs Alternatives: Which Is Safer?

ABACAVIR\LAMIVUDINE vs ABACAVIR\LAMIVUDINE\ZIDOVUDINE ABACAVIR\LAMIVUDINE vs ABALOPARATIDE ABACAVIR\LAMIVUDINE vs ABATACEPT ABACAVIR\LAMIVUDINE vs ABATACEPT SUBQ /ML ABACAVIR\LAMIVUDINE vs ABCIXIMAB ABACAVIR\LAMIVUDINE vs ABEMACICLIB ABACAVIR\LAMIVUDINE vs ABILIFY ABACAVIR\LAMIVUDINE vs ABIRATERONE ABACAVIR\LAMIVUDINE vs ABIRATERONE\ABIRATERONE ABACAVIR\LAMIVUDINE vs ABOBOTULINUMTOXINA

Official FDA Label for ABACAVIR\LAMIVUDINE

Official prescribing information from the FDA-approved drug label.