Adverse reactions : תופעות לוואי

4.8 Undesirable effects

General
The frequency and severity of the undesirable effects of lidocaine depend upon the dose, the method of administration and the patient‘s individual sensitivity.
Symptoms of local toxicity may occur after the administration of lidocaine. Systemic adverse effects may be expected at plasma concentrations of lidocaine exceeding 5-10 mg/l. They become manifest in the form of both CNS symptoms and cardiovascular symptoms (see also section 4.9).
Considering the method of administration systemic undesirable effects are more frequently associated with the use of lidocaine as antiarrhythmic agent.
The possible undesirable effects after administration of lidocaine as local anaesthetic are largely the same as those produced by other amide-type local anaesthetics.
Undesirable effects are listed according to their frequencies as follows: 
Very Common          (≥ 1/10)
Common:              ≥ 1/100 to < 1/10
Uncommon             (≥ 1/1 000 to< 1/100)
Rare:                (≥ 1/10 000 to < 1/1 000)
Very rare            (< 1/10 000)
Not known:           (cannot be estimated from the available data)

Local and regional anaesthesia
Blood and the lymphatic system disorders
Not known: Methaemoglobinaemia

Immune system disorders
Rare: Anaphylactic reactions manifesting as urticaria, oedema, bronchospasm, respiratory distress and circulatory symptoms up to anaphylactic shock.

Nervous system disorders
Common: Transient neurological symptoms especially pain after spinal and epidural anaesthesia (up to 5 days).
Rare: Neurological complications following central nervous blocks – mainly spinal anaesthesia – such as persistent anaesthesia, paraesthesia, paresis up to paraplegia, Cauda equina syndrome (i.e. bilateral leg weakness up to paraplegia, saddle anaesthesia, urinary retention and fecal incontinence), headache accompanied by tinnitus and photophobia.
Cranial nerve lesions, neurosensory deafness (if administered in head and neck regions) Horner’s syndrome, associated with epidural anaesthesia or regional applications in the head/neck region.

Gastrointestinal disorder
Very common: Nausea, vomiting

Injury, poisoning and procedural complications
Rare: Trauma, transient radicular irritation due to spinal anaesthesia, compression of the spinal cord after development of haematoma 
General disorders and administration site conditions
Rare: Shivering (after epidural use)

Antiarrhythmic therapy
The most frequently seen undesirable effects after administration of lidocaine as antiarrhythmic agent are those on the nervous system.
Further heart function and circulation may be affected. Most of the reactions observed are associated with high injection speed or infusion rate.

Immune system disorders
Rare: Anaphylactic reactions manifesting as urticaria, oedema, bronchospasm, respiratory distress and circulatory symptoms up to anaphylactic shock.

Psychiatric disorders
Common: Confusion, restlessness, irritability, euphoria, hallucinations and depression.
Very common: Dysphoria,

Nervous system disorders
Common: Somnolence, dizziness, vertigo, dysarthria, tinnitus, trembling, tingling and paraesthesia (skin), blurred vision, Rare: Muscular twitching, up to generalised convulsions, depressed level of consciousness up to coma.

Cardiac disorders
Rare: Bradycardia, atrioventricular block up to cardiac arrest
Very rare: Ventricular tachycardia

Vascular disorders
Rare: Hypotension
Gastrointestinal disorders
Very common: Nausea, vomiting, dysphagia

Respiratory, thoracic and mediastinal disorders
Rare: Respiratory depression or even arrest.

Information on particular undesirable effects none
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

Elderly patients
In elderly patients the incidence of undesirable effects may be increased (see section 4.4) .

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form (https://sideeffects.health.gov.il)