Reactions 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.
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 Septocaine® (articane hcl and epinephrine injection) containing epinephrine 1:100,000. Table 3 displays the adverse reactions reported in clinical trials where 182 individuals were exposed to Septocaine® (articane hcl and epinephrine injection) containing epinephrine 1:100,000 and 179 individuals were exposed to Septocaine® (articane hcl and epinephrine injection) containing epinephrine 1:200,000.
Adverse reactions observed in at least 1% of patients:
Table 2: Adverse Reactions in Controlled Trials with an Incidence of 1% or Greater in Patients Administered Septocaine® (articane hcl and epinephrine injection) containing Epinephrine 1:100,000
|Body System/Reaction||Septocaine® containing epinephrine
1:100,000 (N=882) Incidence
|Body as a whole|
|Face Edema||13 (1%)|
Table 3: Adverse Reactions in Controlled Trials with an Incidence of 1% or Greater in Patients Administered Septocaine® (articane hcl and epinephrine injection) containing Epinephrine 1:200,000 and Septocaine® (articane hcl and epinephrine injection) containing Epinephrine 1:100,000
|Reaction||Septocaine® (articane hcl and epinephrine injection) withe
|Septocaine® (articane hcl and epinephrine injection) withe
|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%)|
Adverse reactions observed in less than 1% of patients:
Table 4: Adverse Reactions in Controlled Trials with an Incidence of Less than 1% but Considered Clinically Relevant in Patients Administered Septocaine® (articane hcl and epinephrine injection)
|Body as a Whole||Asthenia; back pain; injection site pain; burning sensation above injection site; malaise; neck pain|
|Cardiovascular System||Hemorrhage; migraine; syncope; tachycardia; elevated blood pressure|
|Digestive System||Dyspepsia; glossitis; gum hemorrhage; mouth ulceration; nausea; stomatitis; tongue edemas; tooth disorder; vomiting|
|Hemic and Lymphatic System||Ecchymosis; lymphadenopathy|
|Metabolic and Nutritional System||Edema; thirst|
|Musculoskeletal System||Arthralgia; myalgia; osteomyelitis|
|Nervous System||Dizziness; dry mouth; facial paralysis; hyperesthesia; increased salivation; nervousness; neuropathy; paresthesia; somnolence; exacerbation of Kearns-Sayre Syndrome|
|Respiratory System||Pharyngitis; rhinitis; sinus pain; sinus congestion|
|Skin and Appendages||Pruritus; skin disorder|
|Special Senses||Ear pain; taste perversion|
The following adverse reactions have been identified during postapproval use of Septocaine® (articane hcl and epinephrine injection) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.
Persistent paresthesias of the lips, tongue, and oral tissues have been reported with use of articaine hydrochloride, with slow, incomplete, or no recovery. These postmarketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.
Hypoesthesia has been reported with use of articaine, especially in pediatric age groups, which is usually reversible. Prolonged numbness can result in soft tissue injuries such as that of the lips and tongue in these age groups.
Ischemic injury and necrosis have been described following use of articaine with epinephrine and have been postulated to be due to vascular spasm of terminal arterial branches.
Paralysis of ocular muscles has been reported, especially after posterior, superior alveolar injections of articaine during dental anesthesia. Symptoms include diplopia, mydriasis, ptosis and difficulty in abduction of the affected eye. These symptoms have been described as developing immediately after injection of the anesthetic solution and persisting one minute to several hours, with generally complete recovery.