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 (≥1/1,000 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).

System Organ       Common       Uncommon       Rare            Very rare                Frequency not Class                                                                                   known (cannot (≥1/100 to   (≥1/1,000 to   (≥1/10,000 to   (<1/10,000)              be estimated <1/10)       <1/100)        <1/1,000)                                from the available data)
Infections and                                                 Superinfection (with infestations                                                   gentamicin-resistant germs),
pseudomembranous colitis (see also section 4.4)1

Blood and                       Dyscrasia                      Thrombocytopaenia, lymphatic system                                               reticulocytopaenia, disorders                                                      leukopaenia, 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 labyrinth                                               hearing loss,            hearing loss, disorders                                               Meniére`s disease,       deafness 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                            necrolysis, Stevens- tissue disorders                                        Johnson syndrome, erythema multiforme,
alopecia

Musculoskeletal                 Muscle pain             Amyostasia and connective                  (myalgia) tissue disorders
Renal and         Renal                  Blood urea nitrogen   Acute renal failure, urinary disorders function               increased             hyperphosphaturia, impairment2            (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/