Articadent Side Effects
Please note - some side effects for Articadent may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Articadent Side Effects - for the Professional
Articadent
Reactions to Articadent™ 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, hypersensitivity, or may be idiosyncratic.
The reported adverse events are derived from clinical trials in the US and UK. Table 1 displays the adverse events reported in clinical trials where 882 individuals were exposed to 4% Articadent™ with epinephrine 1:100,000 and Table 2 displays the adverse events reported in clinical trials where 182 individuals were exposed to 4% Articadent™ with epinephrine 1:100,000 and 179 individuals were exposed to 4% Articadent™ with epinephrine 1:200,000.
| Body System | 4% Articadent™ with epinephrine 1:100,000 N (%) |
|---|---|
| Number of patients | 882 (100%) |
| 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%) |
| Number of patients exposed to drug | 4% Articadent™ with epinephrine 1:100,000 (N=182) |
4% Articadent™ with epinephrine 1:200,000 (N=179) |
|---|---|---|
| Number of patients that reported any Adverse Event | 35 | 33 |
| Pain | 14 (7.6%) | 11 (6.1%) |
| Headache | 6 (3.2%) | 9 (5.0%) |
| Positive blood aspiration into syringe | 6 (3.2%) | 3 (1.6%) |
| Swelling | 5 (2.7%) | 3 (1.6%) |
| Trismus | 3 (1.6%) | 1 (0.5%) |
| Nausea and emesis | 0 (0%) | 3 (1.6%) |
| Sleepiness | 1 (0.5%) | 2 (1.1%) |
| Numbness and tingling | 2 (1.0%) | 1 (0.5%) |
| Palpitation | 2 (1.0%) | 0 (0%) |
| Ear symptoms (earache, otitis media) | 2 (1.0%) | 1 (0.5%) |
| Cough, persistent cough | 2 (1.0%) | 0 (0%) |
The following list includes adverse and intercurrent events that were recorded in 1 or more patients, but occurred at an overall rate of less than one percent, and were considered clinically relevant.
Body as a Whole: abdominal pain, accidental injury, 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: constipation, diarrhea, 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.
Urogenital System: dysmenorrhea.
Persistent paresthesias of the lips, tongue, and oral tissues have been reported with use of articaine hydrochloride, with slow, incomplete, or no recovery. These post-marketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.
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.
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