What the label lists and what reports show
Articaine and epinephrine side effects
Articaine and epinephrine's FDA label: “The most common adverse reactions (incidence >2%) are headache and pain.” FAERS holds 742 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypoaesthesia (43 reports).
- No generic listed
Check it at the source: the articaine and epinephrine FDA label on DailyMed (effective March 26, 2026, Novocol Pharmaceutical of Canada, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence >2%) are headache and pain.
Table 3: Adverse Reactions in Controlled Trials with an Incidence of 1% or Greater in Patients Administered Articaine HCl and Epinephrine containing Epinephrine 1:200,000 and Articaine HCl and Epinephrine containing…
| Reaction | Articaine HCl and epinephrine 1:200,000 (N=179) Incidence | Articaine HCl and epinephrine 1:100,000 (N=182) Incidence |
|---|---|---|
| Any adverse reaction | 33 (18%) | 35 (19%) |
| Pain | 11 (6.1%) | 14 (7.6%) |
| Headache | 9 (5%) | 6 (3.2%) |
| Positive blood aspiration into syringe | 3 (1.6%) | 6 (3.2%) |
| Swelling | 3 (1.6%) | 5 (2.7%) |
| Trismus | 1 (0.5%) | 3 (1.6%) |
| Nausea and emesis | 3 (1.6%) | 0 (0%) |
| Sleepiness | 2 (1.1%) | 1 (0.5%) |
| Numbness and tingling | 1 (0.5%) | 2 (1%) |
| Palpitation | 0 (0%) | 2 (1.%) |
| Ear symptoms (earache, otitis media) | 1 (0.5%) | 2 (1%) |
| Cough, persistent cough | 0 (0%) | 2 (1%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedReactions to articaine are characteristic of those associated with other amide-type local anesthetics. Adverse reactions to this group of drugs may also result from excessive plasma levels (which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation), injection technique, volume of injection, or hypersensitivity or they may be idiosyncratic. The most common adverse reactions (incidence >2%) are headache and pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Septodont at 1-800-872-8305 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The reported adverse reactions are derived from clinical trials in the United States and the United Kingdom. Table 2 displays the adverse reactions reported in clinical trials where 882 individuals were exposed to Articaine HCl and Epinephrine containing epinephrine 1:100,000. …
Source: FDA drug label, NDA020971 (Deproco), as published by Novocol Pharmaceutical of Canada, Inc., effective March 26, 2026 (SPL set 636cbf11-819c-48f8-915d-ac5fb38bd352), via openFDA; the full label on DailyMed
What do FAERS reports show?
742 reports list articaine and epinephrine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 61 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Articaine and epinephrine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions