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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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Septocaine
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®.
| 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.
TopMore resources:
Septocaine Parenteral-Local - Includes detailed dosage instructions.
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