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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.

ARTICAINE\EPINEPHRINE: 1,554 Adverse Event Reports & Safety Profile

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1,554
Total FAERS Reports
16 (1.0%)
Deaths Reported
164
Hospitalizations
1,554
As Primary/Secondary Suspect
75
Life-Threatening
47
Disabilities

Active Ingredient: ARTICAINE HYDROCHLORIDE\EPINEPHRINE BITARTRATE ·

First Report: 20010301 · Latest Report: 20250912

What Are the Most Common ARTICAINE\EPINEPHRINE Side Effects?

#1 Most Reported
Drug ineffective
719 reports (46.3%)
#2 Most Reported
Dyspnoea
79 reports (5.1%)
#3 Most Reported
Hypoaesthesia
73 reports (4.7%)

All ARTICAINE\EPINEPHRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 719 46.3% 0 1
Dyspnoea 79 5.1% 2 38
Hypoaesthesia 73 4.7% 0 1
Dizziness 65 4.2% 1 19
Paraesthesia 65 4.2% 0 6
Hypoaesthesia oral 56 3.6% 0 0
Loss of consciousness 50 3.2% 4 12
Hypersensitivity 49 3.2% 0 27
Nausea 46 3.0% 1 23
Pain 46 3.0% 0 3
Injection site pain 40 2.6% 0 3
Hypertension 39 2.5% 1 24
Malaise 39 2.5% 0 6
Swelling face 38 2.5% 0 9
Pallor 36 2.3% 0 9
Pruritus 35 2.3% 0 18
Erythema 32 2.1% 0 21
Palpitations 32 2.1% 0 8
Vomiting 31 2.0% 0 8
Anaphylactic shock 30 1.9% 2 13

Who Reports ARTICAINE\EPINEPHRINE Side Effects? Age & Gender Data

Gender: 59.5% female, 40.5% male. Average age: 42.0 years. Most reports from: US. View detailed demographics →

Is ARTICAINE\EPINEPHRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 5 1 1
2009 1 0 0
2010 1 0 0
2011 7 0 0
2012 14 0 5
2013 14 0 3
2014 25 0 2
2015 88 0 5
2016 127 1 7
2017 103 0 11
2018 134 3 15
2019 150 3 10
2020 52 0 7
2021 56 0 8
2022 47 0 15
2023 99 2 20
2024 88 1 24
2025 25 0 6

View full timeline →

What Is ARTICAINE\EPINEPHRINE Used For?

IndicationReports
Dental local anaesthesia 654
Local anaesthesia 602
Tooth extraction 39
Dental care 32
Anaesthesia 30
Product used for unknown indication 29
Endodontic procedure 19
Tooth restoration 16
Tooth repair 10
Infiltration anaesthesia 8

ARTICAINE\EPINEPHRINE vs Alternatives: Which Is Safer?

ARTICAINE\EPINEPHRINE vs ASCIMINIB ARTICAINE\EPINEPHRINE vs ASCORBIC ACID ARTICAINE\EPINEPHRINE vs ASCORBIC ACID\FERROUS ARTICAINE\EPINEPHRINE vs ASCORBIC ACID\FERROUS\FOLIC ACID ARTICAINE\EPINEPHRINE vs ASCORBIC ACID\POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM ASCORBATE\SODIUM\SODIUM ARTICAINE\EPINEPHRINE vs ASENAPINE ARTICAINE\EPINEPHRINE vs ASFOTASE ALFA ARTICAINE\EPINEPHRINE vs ASIAN GINSENG ARTICAINE\EPINEPHRINE vs ASMANEX TWISTHALER ARTICAINE\EPINEPHRINE vs ASPARAGINASE

Official FDA Label for ARTICAINE\EPINEPHRINE

Official prescribing information from the FDA-approved drug label.