ADVERSE REACTIONS
Reactions to Septocaine® 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.
The reported adverse events are derived from clinical trials in the US and UK. Of the 1325 patients treated in the primary clinical trials, 882 were exposed to Septocaine®.
Table 2. Adverse Events in controlled trials with an incidence of 1% or greater in patients administered Septocaine® (articaine hydrochloride 4% (40 mg/mL) with epinephrine 1:100,000 Injection). | Body system | Septocaine®
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%) |
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, malaise, neck pain.
Cardiovascular System - hemorrhage, migraine, syncope, tachycardia.
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.
Respiratory System - pharyngitis, rhinitis.
Skin and Appendages - pruritis, skin disorder.
Special Senses - ear pain, taste perversion.
Urogenital System - dysmenorrhea.
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REPORTS OF SUSPECTED SEPTOCAINE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Septocaine. The information is not vetted and should not be considered as verified clinical evidence.
Possible Septocaine side effects / adverse reactions in 52 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-11-29
Patient: 52 year old female weighing 52.0 kg (114.4 pounds)
Reactions: Nerve Injury
Suspect drug(s):
Septocaine
Possible Septocaine side effects / adverse reactions in 46 year old female
Reported by a consumer/non-health professional from United States on 2011-12-07
Patient: 46 year old female weighing 46.3 kg (101.8 pounds)
Reactions: Paralysis, Hypoaesthesia, Tongue Paralysis, Muscle Tightness, Loss of Consciousness, Paraesthesia, Viith Nerve Paralysis, Speech Disorder, Burning Sensation, Throat Irritation, Joint Swelling, Sinus Disorder, Vision Blurred, Memory Impairment, Feeling Abnormal, Blister
Suspect drug(s):
Septocaine
Indication: Artificial Crown Procedure
Start date: 2009-12-22
End date: 2010-06-07
Septocaine
Indication: Tooth Extraction
Start date: 2009-12-22
End date: 2010-06-07
Possible Septocaine side effects / adverse reactions in 30 year old female
Reported by a consumer/non-health professional from United States on 2011-12-27
Patient: 30 year old female weighing 81.6 kg (179.6 pounds)
Reactions: Nerve Injury, Glossodynia, Hypoaesthesia Oral
Suspect drug(s):
Septocaine
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