PROCAINE: 352 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is PROCAINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 72 |
| Local anaesthesia | 59 |
| Pain | 6 |
PROCAINE vs Alternatives: Which Is Safer?
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