Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Like most general anaesthetics, etomidate may affect respiratory and vascular functions. Like some other general anaesthetics, etomidate may cause involuntary muscle movements.
Besides this, etomidate frequently affects adrenocortical functions.

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 (frequency cannot be estimated from the available data)

Adverse Drug Reactions
Frequency Category
System Organ
Very Commo     Common            Uncommon            Rare                    Not Known Class n         (1/100 to        (1/1,000 to    (≥1/10,000 to      (cannot be estimated from the (1/10)        <1/10)            <1/100)         <1/1,000)               available data) Hypersensitivity1 (such as
Immune System                                                                                anaphylactic shock, Disorders                                                                                   anaphylactic reaction, anaphylactoid reaction)
Endocrine             Cortisol
Adrenal insufficiency
Disorders            decreased
Hypertonia, Muscle
Nervous System                                   contractions                            Convulsion (including grand Dyskinesia    Myoclonus
Disorders                                        involuntary,                                 mal convulsion) Nystagmus, Shivering
Bradycardia,
Extrasystoles,                          Cardiac arrest, Atrioventricular Cardiac Disorders
Ventricular                                    block complete extrasystoles
Vascular
Hypotension        Hypertension                                   Shock Disorders
Respiratory,                                                             Laryngospasm Apnoea2,                                               Respiratory depression2, Thoracic and                                       Hypoventilation,
Hyperventilati                                        Bronchospasm (including fatal Mediastinal                                        Hiccups, Cough on, Stridor                                                    outcome) Disorders
Gastrointestinal                    Vomiting,          Salivary
Disorders                            Nausea         hypersecretion
Skin and
Stevens-Johnson syndrome,
Subcutaneous                          Rash             Erythema
Urticaria
Tissue Disorders
Musculoskeletal and Connective                                      Muscle rigidity                                Trismus Tissue Disorders
General Disorders and
Injection site pain
Administration
Site Conditions
Anaesthetic complication, Delayed
Injury, Poisoning recovery from and Procedural anaesthesia,
Complications
Inadequate analgesia,
Procedural nausea

1) After administration of etomidate, release of histamine has been noted.
Etomidate-Lipuro contains soya-bean oil, which may very rarely cause severe allergic reactions.
2) Respiratory depression and apnoea may occur especially after administration of higher doses of etomidate in combination with central depressant drugs. In patients of 55 years of age or older, respiratory depression and apnoea may occur especially after doses exceeding the recommended maximum dose of 0.2 mg of etomidate per kg body weight.

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))