Septocaine Side Effects
Please note - some side effects for Septocaine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Septocaine Side Effects - for the Professional
Septocaine
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® containing epinephrine 1:100,000. Table 3 displays the adverse reactions reported in clinical trials where 182 individuals were exposed to Septocaine® containing epinephrine 1:100,000 and 179 individuals were exposed to Septocaine® containing epinephrine 1:200,000.
Adverse reactions observed in at least 1% of patients:
| Body System/Reaction | Septocaine® containing epinephrine 1:100,000 (N=882) Incidence |
|---|---|
| Body as a whole | |
| Face Edema | 13 (1%) |
| Headache | 31 (4%) |
| Infection | 10 (1%) |
| Pain | 114 (13%) |
| Digestive system | |
| Gingivitis | 13 (1%) |
| Nervous system | |
| Paresthesia | 11 (1%) |
| Reaction | Septocaine® with epinephrine 1:200,000 (N=179) Incidence |
Septocaine® with 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%) |
Adverse reactions observed in less than 1% of patients:
| Body System | Reactions |
|---|---|
| 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 |
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Septocaine®. 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.
TopSide Effects by Body System - for Healthcare Professionals
Other
Other side effects including pain (up to 13%), headache (up to 5%), positive blood aspiration into syringe (3.2%), swelling (2.7%), face edema (1%), infection (1%), neck pain, abdominal pain, ear pain, taste perversion, and accidental injury have been reported.
Gastrointestinal
Gastrointestinal side effects including nausea and emesis (1.6%), gingivitis (1%), constipation, diarrhea, dyspepsia, glossitis, gum hemorrhage, mouth ulceration, nausea, stomatitis, tongue edema, tooth disorder, and vomiting have been reported.
Musculoskeletal
Musculoskeletal side effects including trismus (1.6%), arthralgia, myalgia, back pain, and osteomyelitis have been reported.
General
General side effects including sleepiness (1.1%), malaise, and asthenia have been reported.
Nervous system
Nervous system side effects including paresthesia (1%), numbness and tingling (1%), dizziness, dry mouth, facial paralysis, hyperesthesia, increased salivation, nervousness, neuropathy, paresthesia, somnolence, and exacerbation of Kearns-Sayre syndrome have been reported.
Persistent paresthesias of the lips, tongue, and oral tissues have been reported with use of articaine, with slow, incomplete, or no recovery. These events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.
Cardiovascular
Cardiovascular side effects including palpitation (1.0%), hemorrhage, migraine, syncope, tachycardia, and elevated blood pressure have been reported.
Respiratory
Respiratory side effects including pharyngitis, rhinitis, sinus pain, and sinus congestion have been reported.
Hematologic
Hematologic side effects including ecchymosis and lymphadenopathy have been reported.
Metabolic
Metabolic side effects including edema and thirst have been reported.
Local
Local side effects including injection site pain and a burning
sensation above the injection site have been reported.
Dermatologic
Dermatologic side effects including pruritus and skin disorder have been reported.
Genitourinary
Genitourinary side effects including dysmenorrhea have been reported.
TopMore Septocaine resources
- Septocaine Prescribing Information (FDA)
- Septocaine Concise Consumer Information (Cerner Multum)
- Septocaine Monograph (AHFS DI)
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