Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Under certain conditions gentamicin shows ototoxic and/or nephrotoxic effects. Renal impairment is commonly observed in patients treated with gentamicin and is usually reversible upon withdrawal of the drug. In most cases nephrotoxicity is associated with an excessively high dosage or prolonged treatment, pre-existing renal abnormalities or associated with other substances reported to be nephrotoxic.
The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency. Frequencies are defined as very common (1/10);
common (>1/100 to <1/10);
uncommon (>1/1000 to <1/100);
rare (>1/10 000 to <1/1000);
very rare (<1/10 000),
not known (frequency cannot be estimated from the available data).


System Organ     Common       Uncommon       Rare (>1/10 000      Very rare (≤1/10            Frequency not Class            (≥1/100 to   (>1/1 000 to   to ≤1/1 000)         000)                        known <1/10)       <1/100)                                                         (cannot be estimated from the available postmarketing data)
Infections and                                                    Superinfection (with infestations                                                      gentamicin-resistant germs),
pseudomembranous colitis (see also section
4.4)1
Blood and                     Dyscrasia                           Thrombocytopaenia, lymphatic                                                         reticulocytopaenia, system                                                            leukopaenia, disorders                                                         eosinophilia, granulocytopaenia,
anaemia
Immune system                                                     Hypersensitivity disorders                                                         reactions of varying severity, ranging from rash and itching, drug fever to severe acute hypersensitivity reactions (anaphylaxis),
up to anaphylactic shock
Metabolism and                               Hypokalaemia,        Hypophosphataemia nutrition                                    hypocalcaemia,
disorders                                    hypomagnesaemia,
pseudo-Bartter syndrome in patients treated with high doses over a long period
(more than 4 weeks), loss of appetite, weight loss
Psychiatric                                                       Confusion, disorders                                                              hallucinations, mental depression
Nervous system                                   Polyneuropathies,     Encephalopathy, disorders                                        peripheral            convulsions, paraesthesias         neuromuscular blockage, dizziness,
balance disorder,
headache, (see also section 4.4)
Eye disorders                                                          Visual disorders Ear and                                                                Vestibular damage,          Irreversible hearing labyrinth                                                              hearing loss, Meniére`s     loss, deafness disorders                                                              disease, tinnitus, vertigo (see also section
4.4)
Vascular                                                               Hypotension, disorders                                                              hypertension Gastrointestinal                                 Vomiting, nausea,
disorders                                        salivation increased,
stomatitis
Hepatobiliary                                    Aspartate disorders                                        aminotransferase
(AST) increased,
Alanine aminotransferase
(ALT) increased,
alkaline phosphatase (ALP) increased,
reversible increase of serum bilirubin
(all reversible)
Skin and                         Allergic skin   Skin reddening        Toxic epidermal subcutaneous                     exanthema                             necrolysis2, Stevens- tissue disorders                                                       Johnson syndrome2, Erythema multiforme2,
Alopecia
Musculoskeletal                                  Muscle pain           Amyostasia and connective                                   (myalgia) tissue disorders
Renal and           Renal                        Blood urea            Acute renal failure, urinary             function                     nitrogen increased    hyperphosphaturia, disorders           impairment                   (reversible)          aminoaciduria, Fanconi-like syndrome in patients treated with a prolonged course of high-dose, see also section 4.4.
General                                          Increased body        Pain at injection site disorders and                                    temperature administration site conditions

1
Usually in these cases other antibiotics are also involved.
2
May occur as hypersensitivity reactions.

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