Adverse reactions : תופעות לוואי

4.8 Undesirable effects

This list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (<1/10000) and not known (cannot be estimated from the available data).
System Organ Class          Frequency MedDRA Term
Infections and              Uncommon Superinfections or colonisation with resistant Infestations                              bacteria or yeasta
Blood and lymphatic         Rare          Anaemia, eosinophilia system disorders
Immune system               Not known Anaphylactic response (anaphylactic reaction, disorders                                 anaphylactic shock and anaphylactoid reaction), hypersensitivity
Metabolism and              Rare          Hypomagnesaemia nutrition disorders
Nervous system              Not known Paralysisa disorders                   Rare          Tremora, paresthesiaa, headache, balance disordera Eye disorders               Rare          Blindnessb, retinal infarctionb Ear and labyrinth           Rare          Tinnitusa, hypoacusisa
Disorders                   Not known Deafnessa, deafness neurosensorya Vascular disorders          Rare          Hypotension
Respiratory, thoracic       Not known Apnoea, bronchopasm and mediastinal disorders
Gastrointestinal            Uncommon Nausea, vomiting disorders
Skin and subcutaneous Uncommon Rash tissue disorders            Rare          Pruritus, urticaria
Musculoskeletal,            Rare          Arthralgia, muscle twitchinga connective tissue and bone disorders
Renal and urinary           Not known Renal failure acute, nephropathy toxic, cells in disorders                                 urinea
Rare          Oliguriaa, blood creatinine increaseda, albuminuriaa, azotemiaa, red blood cells urinea, white blood cells urinea
General disorders and       Rare          Pyrexia administration site conditions
a See section 4.4.
bAmikacin    is not formulated for intravitreal use. Blindness and retinal infarction have been reported following intravitreous administrations (injection into the eye) of amikacin.
All aminoglycosides have the potential to induce ototoxicity, renal toxicity, and neuromuscular blockade. These toxicities occur more frequently in patients with renal impairment, in patients treated with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended (see section 4.4) 
Renal function changes are usually reversible when the drug is discontinued.

Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance, or both. Amikacin primarily affects auditory function. Cochlear damage includes high frequency deafness and usually occurs before clinical hearing loss can be detected by audiometric testing (see section 4.4).

Macular infarction sometimes leading to permanent loss of vision has been reported following intravitreous administration (injection into the eye) of amikacin.

When the recommended precautions and dosages are followed the incidence of toxic reactions, such as tinnitus, vertigo, and partial reversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting is low. Urinary signs of renal irritation (albumin, casts, and red or white cells), azotaemia and oliguria have been reported although they are rare.

Reporting 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/