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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.

PROCAINE: 352 Adverse Event Reports & Safety Profile

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352
Total FAERS Reports
16 (4.5%)
Deaths Reported
36
Hospitalizations
352
As Primary/Secondary Suspect
5
Life-Threatening
3
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
USA MINGER Inc.
Manufacturer
Discontinued
Status
Yes
Generic Available

Active Ingredient: PROCAINE HYDROCHLORIDE · Route: TOPICAL · Manufacturer: USA MINGER Inc. · FDA Application: 080384 · HUMAN OTC DRUG · FDA Label: Available

First Report: 19430115 · Latest Report: 20250902

What Are the Most Common PROCAINE Side Effects?

#1 Most Reported
Drug hypersensitivity
154 reports (43.8%)
#2 Most Reported
Atrial fibrillation
47 reports (13.4%)
#3 Most Reported
Post procedural complication
46 reports (13.1%)

All PROCAINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 154 43.8% 0 0
Atrial fibrillation 47 13.4% 0 0
Post procedural complication 46 13.1% 0 0
Feeling abnormal 14 4.0% 2 6
Nausea 13 3.7% 2 4
Pain 12 3.4% 2 4
Asthenia 11 3.1% 3 4
Dizziness 11 3.1% 2 2
Fatigue 11 3.1% 2 4
Headache 11 3.1% 2 3
Rash 9 2.6% 0 1
Anxiety 8 2.3% 2 5
Drug abuse 8 2.3% 6 2
Dyspnoea 8 2.3% 0 0
Extremity necrosis 8 2.3% 0 3
Gangrene 8 2.3% 0 3
Hypersensitivity 8 2.3% 2 3
Off label use 8 2.3% 0 1
Palpitations 8 2.3% 2 3
Pruritus 8 2.3% 0 1

Who Reports PROCAINE Side Effects? Age & Gender Data

Gender: 79.9% female, 20.1% male. Average age: 61.3 years. Most reports from: US. View detailed demographics →

Is PROCAINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2009 1 1 1
2011 3 0 1
2012 2 0 0
2013 2 0 0
2014 7 0 2
2015 13 0 0
2016 12 3 2
2017 8 0 1
2018 12 1 4
2019 3 0 1
2020 2 0 1
2021 7 1 1
2022 4 0 1
2023 9 0 7
2024 1 0 0
2025 3 0 2

View full timeline →

What Is PROCAINE Used For?

IndicationReports
Product used for unknown indication 72
Local anaesthesia 59
Pain 6

PROCAINE vs Alternatives: Which Is Safer?

PROCAINE vs PROCARBAZINE PROCAINE vs PROCHLORPERAZINE PROCAINE vs PROCHLORPERAZINE EDISYLATE PROCAINE vs PROCRIT PROCAINE vs PROCYCLIDINE PROCAINE vs PROGESTERONE PROCAINE vs PROGRAF PROCAINE vs PROHANCE PROCAINE vs PROLIA PROCAINE vs PROMACTA

Official FDA Label for PROCAINE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Tattoo, waxing and hair removal etc.

Dosage & Administration

1. Wnscrew the cap and tear off the seal before using, Tighten the cap in time after use. 2. Wash the skin with soap and warm water making sure it's clean and free of bacteria. 3. Put the cream evenly on the skin (1 mm thick), and cover it with a plastic wrap for 50-60 minsto achieve 4-6 hours of numbness. 4. Before starting the operation, remove the cream and let the skin breathe for 5-10 mins. Whenapplving this cream, Please keep the skin warm for faster absorption.

Warnings

For external use only.

Active Ingredient

Procaine 5%

Inactive Ingredients

WATER PROPYLENE GLYCOL CARBOMER GLYCERIN DISODIUM EDTA HYDROXYACETOPHENONE 1,2-HEXANEDIOL MENTHA ARVENSIS LEAF EXTRACT CHRYSANTHELLUM INDICUM EXTRACT PORTULACA OLERACEA EXTRACT PEG-40 HYDROGENATED CASTOR