Adverse reactions : תופעות לוואי

4.8    Undesirable effects
There have been no controlled clinical trials conducted to systematically assess the adverse events profile of sodium nitrite.
The medical literature has reported the following adverse events in association with sodium nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed.
System organ class                 Frequency              Undesirable effect Cardiac and vascular               Not known              Syncope, hypotension*, disorders                                                 tachycardia, palpitations, dysrhythmia*
Blood and lymphatic                Not known              Methemoglobinemia* system disorders
Nervous system                    Not known              Headache, dizziness, blurred disorders                                                vision, seizures, confusion, coma*
Gastrointestinal                  Not known              Nausea, vomiting, abdominal disorders                                                pain
Respiratory, thoracic             Not known              Tachypnea, dyspnea and mediastinal disorders
Skin disorders                    Not known              Urticaria General disorders and             Not known              Anxiety, diaphoresis, administration site                                      lightheadedness, injection site conditions                                               tingling, cyanosis, acidosis 

*Description of selected adverse reactions
Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of sodium nitrite at doses less than twice those recommended for the treatment of cyanide poisoning.
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