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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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.
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