Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The safety of fentanyl IV was evaluated in 376 subjects who participated in 20 clinical trials evaluating fentanyl IV as an anaesthetic. These subjects took at least 1 dose of fentanyl IV and provided safety data. Based on pooled safety data from these clinical trials, the most commonly reported (≥5% incidence) Adverse Reactions were (with % incidence): nausea (26.1); vomiting (18.6); muscle rigidity (10.4); hypotension (8.8); hypertension (8.8); bradycardia (6.1); and sedation (5.3).
Including the above-mentioned adverse reactions, Table 1 displays adverse reactions that have been reported with the use of fentanyl IV from either clinical trials or post- marketing experience.
The displayed frequency categories use the following convention: 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); and not known (cannot be estimated from the available clinical trial data).



Table 1: Adverse Reactions
Adverse Reactions
System Organ                                    Frequency Category
Class                Very               Common             Uncommon             Not Known Common         (≥ 1/100 to < 1/10)    (≥ 1/1,000 to <
(≥ 1/10)                                  1/100)
Immune System                                                               Hypersensitivity Disorders                                                                   (such as anaphylactic shock,
anaphylactic reaction, urticaria)
Psychiatric                           Agitation             Euphoric mood          Delirium Disorders                                                                          Drug dependence (see section 4.4)

Nervous System      Muscle            Dyskinesia;           Headache               Convulsions; Disorders           rigidity (which   Sedation;                                    Loss may also          Dizziness                                    of consciousness; involve the                                                    Myoclonus thoracic muscles)
Eye Disorders                         Visual disturbance
Cardiac                               Bradycardia;                                 Cardiac arrest Disorders                             Tachycardia;
Arrhythmia
Vascular                              Hypotension;          Phlebitis; Disorders                             Hypertension;         Blood
Venous pain           pressure fluctuation
Respiratory,                          Laryngospasm;         Hyperventilation;      Respiratory Thoracic                              Bronchospasm;         Hiccups                depression and Mediastinal                       Apnoea
Disorders
Gastrointestinal    Nausea;
Disorders           Vomiting
Skin and                              Allergic dermatitis                          Pruritus Subcutaneous
Tissue Disorders
General                                                     Chills;                Drug withdrawal Disorders and                                               Hypothermia            syndrome (see Administration                                              Drug withdrawal        section 4.4) Site Conditions                                             syndrome

Injury, Poisoning                     Postoperative         Airway and Procedural                        confusion             complication Complications                                               of anaesthesia 

When a neuroleptic is used with fentanyl, the following adverse reactions may be observed: chills and/or shivering, restlessness, postoperative hallucinatory episodes and extrapyramidal symptoms (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/