Undesirable reactions are described in accordance with the system-organ classes MedDRA. The frequency is defined as follows:
Like other local anesthetics, unwanted reactions to
lidocaine are rare and, as a rule, due to increased plasma concentration due to accidental intravascular injection, excess dose or rapid absorption from areas with abundant blood supply,either due to hypersensitivity, idiosyncrasy or reduced patient tolerance. Systemic toxicity reactions are mainly manifested by the central nervous and / or cardiovascular system (see also the "Overdose" section).
Violations from the immune system
Hypersensitivity reactions (allergic or anaphylactoid reactions, anaphylactic shock) - see also disorders of the skin and subcutaneous tissues. Skin allergic test on lidocaine is considered unreliable.
Disorders from the nervous system and mental disorders
Neurological signs of systemic toxicity include dizziness, nervousness, tremor, paresthesia around the mouth, numbness of the tongue, drowsiness, convulsions, coma.
Reactions from the nervous system may be manifested by its excitation or inhibition. Symptoms of CNS stimulation may be short or do not occur at all, so the first manifestations of toxicity can serve as confusion and drowsiness, followed by coma and respiratory insufficiency.
Neurological complications of spinal anesthesia include transient neurologic symptoms, such as lower back pain, buttocks and legs.These symptoms develop, usually within 24 hours after anesthesia and are resolved within a few days. After spinal anesthesia with lidocaine and similar means, individual cases of arachnoiditis and horse tail syndrome with persistent paresthesia, bowel and urinary tract dysfunction, or paralysis of the lower extremities are described. Most cases are due to the hyperbaric concentration of lidocaine or prolonged spinal infusion.
Disturbances on the part of the organ of sight
Signs of lidocaine toxicity can be blurred vision, diplopia and transient amaurosis.
Bilateral amaurosis can also be a consequence of accidental insertion into the optic nerve bed during ophthalmic procedures. After retro and peribulbar anesthesia, inflammation of the eye and diplopia were reported (see section "Special instructions").
Violations from the organ of hearing and labyrinth
Noises in the ears, hyperaemia.
Disorders from the cardiovascular system
Cardiovascular reactions are manifested by arterial hypotension, bradycardia, myocardial depression (negative inotropic effect), arrhythmias, possible, cardiac arrest or circulatory insufficiency.
Disturbances from the respiratory system, chest and mediastinal organs Shortness of breath, bronchospasm. respiratory depression, respiratory arrest.
Disorders from the gastrointestinal tract
Nausea, vomiting.
Disturbances from the skin and subcutaneous tissues
Rash, hives, angioedema, edema of the face.