Amikacin (Amikacin Sulfate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

All aminoglycosides have the potential to induce auditory, vestibular, and renal toxicity and neuromuscular blockade (see “WARNINGS” box). They occur more frequently in patients with present or past history of renal impairment, of treatment with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended.

Neurotoxicity-Ototoxicity -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.

Neurotoxicity-Neuromuscular Blockage -Acute muscular paralysis and apnea can occur following treatment with aminoglycoside drugs.

Nephrotoxicity -Elevation of serum creatinine, albuminuria, presence of red and white cells, casts, azotemia, and oliguria have been reported. Renal function changes are usually reversible when the drug is discontinued. As would be expected with any aminoglycoside, reports of toxic nephropathy and acute renal failure have been received during postmarketing surveillance.

Other -In addition to those described above, other adverse reactions which have been reported on rare occasions are skin rash, drug fever, headache, paresthesia, tremor, nausea and vomiting, eosinophilia, arthralgia, anemia, hypotension, and hypomagnesemia. Macular infarction sometimes leading to permanent loss of vision has been reported following intravitreous administration (injection into the eye) of amikacin.

REPORTS OF SUSPECTED AMIKACIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Amikacin side effects / adverse reactions in 25 year old male

Reported by a lawyer from France on 2011-10-04

Patient: 25 year old male

Reactions: Photosensitivity Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Emend
    Administration route: Oral
    Start date: 2011-07-08
    End date: 2011-07-08

Emend
    Administration route: Oral
    Start date: 2011-07-09
    End date: 2011-07-13

Valacyclovir Hydrochloride
    Administration route: Oral
    Indication: Antiviral Prophylaxis

Amikacin
    Start date: 2011-07-11
    End date: 2011-07-12

Vfend
    Administration route: Oral
    Indication: Antifungal Prophylaxis

Zofran
    Start date: 2011-07-08
    End date: 2011-07-13

Evoltra
    Start date: 2011-07-08
    End date: 2011-07-12

Tramadol HCL
    Administration route: Oral
    Start date: 2011-07-09
    End date: 2011-07-12

Piperacillin and Tazobactam
    Start date: 2011-07-11
    End date: 2011-07-12

Cytarabine
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-08
    End date: 2011-07-12

Ciprofloxacin
    Start date: 2011-07-13
    End date: 2011-07-15

Other drugs received by patient: Pentacarinat; Hydrea; Bactrim; Fasturtec; Tienam; Targocid

Possible Amikacin side effects / adverse reactions in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2011-10-05

Patient: 50 year old male

Reactions: Hepatotoxicity, Transaminases Increased

Suspect drug(s):
Amikacin
    Indication: Febrile Neutropenia
    Start date: 2011-04-17
    End date: 2011-04-20

Teicoplanin
    Indication: Febrile Neutropenia
    Start date: 2011-04-08
    End date: 2011-04-15

Teicoplanin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-08
    End date: 2011-04-15

Cancidas
    Indication: Febrile Neutropenia
    Start date: 2011-04-10
    End date: 2011-04-20

Acyclovir
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-13
    End date: 2011-04-17

Meropenem
    Indication: Febrile Neutropenia
    Start date: 2011-03-23
    End date: 2011-04-22

Amikacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-17
    End date: 2011-04-20

Acyclovir
    Indication: Febrile Neutropenia
    Start date: 2011-04-13
    End date: 2011-04-17

Meropenem
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-23
    End date: 2011-04-22

Possible Amikacin side effects / adverse reactions in 67 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-07

Patient: 67 year old male

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Idarubicin HCL
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-29
    End date: 2011-08-03

Primaxin
    Indication: Pyrexia
    Start date: 2011-08-04
    End date: 2011-08-16

Vancomycin
    Indication: Pyrexia
    Start date: 2011-07-29
    End date: 2011-08-12

Ofloxacin
    Start date: 2011-07-31
    End date: 2011-08-12

Ambisome
    Start date: 2011-08-02
    End date: 2011-08-12

Cytarabine
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-07-29
    End date: 2011-08-05

Amikacin
    Indication: Pyrexia
    Start date: 2011-08-04
    End date: 2011-08-06

Other drugs received by patient: Zovirax; Belustine; Ceftazidime Sodium