Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The following adverse events have been reported:
MedDRA
Frequency† Undesirable Effects
System Organ Class
Immune system                Rare          Anaphylactic reaction* disorders
Metabolism and nutrition     Uncommon Anorexia disorders
Psychiatric disorders        Common   Hallucination,     Abnormal dreams,          Nightmare,
Confusion,         Agitation,
Abnormal behaviour
Uncommon Anxiety
Rare          Delirium*, Disorientation*
Flashback*, Dysphoria*, Insomnia,
Nervous system               Common        Nystagmus, Hypertonia, Tonic- disorders                                  clonic movements
Eye disorders                Common        Diplopia
Not known     Intraocular pressure increased
Cardiac disorders            Common        Blood pressure increased, Heart rate increased
Uncommon Bradycardia, Arrhythmia
Vascular disorders           Uncommon Hypotension
Respiratory, thoracic and Common   Respiratory rate increased mediastinal disorders
Uncommon Respiratory depression,
Laryngospasm
Rare     Obstructive airways disorder*,
Apnoea*

Gastrointestinal              Common        Nausea, Vomiting disorders
Rare          Salivary hypersecretion*
Hepatobiliary disorders       Not known     Liver function test abnormal, Drug- induced liver injury**
Skin and subcutaneous         Common        Erythema, Rash morbilliform tissue disorders
Renal and urinary             Rare          Haemorrhagic cystitis*, ***, Cystitis*, disorders
General disorders and         Uncommon      Injection site pain, Injection site rash administration site conditions
† Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to
<1/1,000); Not known (frequency cannot be estimated from the available data) * ADR identified during post-marketing use ** Extended period use (>3 days) or drug abuse
*** Long term use (1 month to several years), especially in the setting of ketamine abuse.
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/