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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\RILPIVIRINE: 1,216 Adverse Event Reports & Safety Profile

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1,216
Total FAERS Reports
73 (6.0%)
Deaths Reported
176
Hospitalizations
1,216
As Primary/Secondary Suspect
34
Life-Threatening
15
Disabilities

Active Ingredient: DOLUTEGRAVIR SODIUM\RILPIVIRINE HYDROCHLORIDE ·

First Report: 19730519 · Latest Report: 20250909

What Are the Most Common DOLUTEGRAVIR\RILPIVIRINE Side Effects?

#1 Most Reported
Product dose omission issue
281 reports (23.1%)
#2 Most Reported
Fatigue
53 reports (4.4%)
#3 Most Reported
Product use issue
51 reports (4.2%)

All DOLUTEGRAVIR\RILPIVIRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product dose omission issue 281 23.1% 1 4
Fatigue 53 4.4% 4 2
Product use issue 51 4.2% 7 3
Death 47 3.9% 45 2
Rash 46 3.8% 4 7
Viral load increased 45 3.7% 0 5
Diarrhoea 42 3.5% 0 7
Weight increased 40 3.3% 0 1
Headache 38 3.1% 4 0
Nausea 34 2.8% 1 1
Condition aggravated 33 2.7% 2 7
Depression 33 2.7% 0 2
Drug ineffective 33 2.7% 4 2
Drug interaction 33 2.7% 0 17
Hypertension 29 2.4% 4 10
Pathogen resistance 29 2.4% 0 6
Hospitalisation 27 2.2% 1 25
Pain 26 2.1% 3 0
Viral mutation identified 26 2.1% 0 6
Insomnia 25 2.1% 0 2

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

Gender: 26.5% female, 73.5% male. Average age: 53.8 years. Most reports from: US. View detailed demographics →

Is DOLUTEGRAVIR\RILPIVIRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 6 0 0
2010 1 0 0
2014 6 0 6
2015 8 1 1
2016 8 0 2
2017 7 1 1
2018 67 1 8
2019 99 3 19
2020 40 3 11
2021 41 2 14
2022 69 6 11
2023 96 16 5
2024 105 12 10
2025 44 3 3

View full timeline →

What Is DOLUTEGRAVIR\RILPIVIRINE Used For?

IndicationReports
Hiv infection 556
Product used for unknown indication 502
Antiretroviral therapy 18
Hiv infection cdc group iii 12
Hiv test positive 10
Acquired immunodeficiency syndrome 9
Hiv test 9
Hiv carrier 7

DOLUTEGRAVIR\RILPIVIRINE vs Alternatives: Which Is Safer?

DOLUTEGRAVIR\RILPIVIRINE vs DOMPERIDONE DOLUTEGRAVIR\RILPIVIRINE vs DOMPERIDONE\PANTOPRAZOLE DOLUTEGRAVIR\RILPIVIRINE vs DONANEMAB-AZBT DOLUTEGRAVIR\RILPIVIRINE vs DONEPEZIL DOLUTEGRAVIR\RILPIVIRINE vs DONEPEZIL\DONEPEZIL DOLUTEGRAVIR\RILPIVIRINE vs DONEPEZIL\MEMANTINE DOLUTEGRAVIR\RILPIVIRINE vs DONEPEZIL\OMEPRAZOLE\OMEPRAZOLE DOLUTEGRAVIR\RILPIVIRINE vs DONOR HUMAN STOOL DOLUTEGRAVIR\RILPIVIRINE vs DOPAMINE DOLUTEGRAVIR\RILPIVIRINE vs DOPAMINE\DOPAMINE

Official FDA Label for DOLUTEGRAVIR\RILPIVIRINE

Official prescribing information from the FDA-approved drug label.