Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Amikacin
Drug ID BADD_D00103
Description Amikacin is a semi-synthetic aminoglycoside antibiotic that is derived from kanamycin A.[FDA label] Amikacin is synthesized by acylation with the l-(-)-γ-amino-α-hydroxybutyryl side chain at the C-1 amino group of the deoxystreptamine moiety of kanamycin A.[A39531] Amikacin's unique property is that it exerts activity against more resistant gram-negative bacilli such as Acinetobacter baumanii and Pseudomonas aeruginosa. Amikacin also exerts excellent activity against most aerobic gram-negative bacilli from the Enterobacteriaceae family, including Nocardia and some Mycobacterium (M. avium-intracellulare, M. chelonae, and M. fortuitum)[L4680]. M. avium-intracellulare (MAC) is a type of nontuberculous mycobacteria (NTM) found in water and soil. Symptoms of this disease include a persistent cough, fatigue, weight loss, night sweats, and shortness of breath and the coughing up of blood.[L4680] Several forms of amikacin are used currently, including an intravenous (IV) or intramuscular (IM) injection.[F1949] In September 2018, a liposomal inhalation suspension of this drug was approved by the FDA for the treatment of lung disease caused by Mycobacterium avium complex (MAC) bacteria in a small population of patients with the disease who do not respond to traditional treatment.[L4680,L4681]
Indications and Usage For short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species. Amikacin may also be used to treat Mycobacterium avium and Mycobacterium tuberculosis infections.
Marketing Status Prescription; Discontinued
ATC Code D06AX12; J01GB06; S01AA21
DrugBank ID DB00479
KEGG ID D02543
MeSH ID D000583
PubChem ID 37768
TTD Drug ID D0Y3MO
NDC Product Code 71558-590
Synonyms Amikacin | Yectamid | Amikacina Medical | Medical, Amikacina | Amikacina Normon | Normon, Amikacina | Amikafur | Amikalem | Amikason's | Amikayect | Amikin | Biklin | Biclin | Amiklin | Amukin | BB-K8 | BB K8 | BBK8 | BB-K 8 | BB K 8 | BBK 8 | Gamikal | Kanbine | Oprad | A.M.K | Amikacin Sulfate | Sulfate, Amikacin
Chemical Information
Molecular Formula C22H43N5O13
CAS Registry Number 37517-28-5
SMILES C1C(C(C(C(C1NC(=O)C(CCN)O)OC2C(C(C(C(O2)CO)O)N)O)O)OC3C(C(C(C(O3)CN)O)O)O)N
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Toxicity to various agentsPhospholipase A2P04054T31479Not Available
Toxicity to various agents1-phosphatidylinositol 4,5-bisphosphate phosphodiesterase beta-1Q9NQ66T26846Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Lung disorder22.02.07.0010.000557%Not Available
Malaise08.01.01.0030.001300%
Muscular weakness17.05.03.005; 15.05.06.0010.000557%
Nasopharyngitis22.07.03.002; 11.01.13.0020.000371%Not Available
Nausea07.01.07.0010.003713%
Nephropathy toxic20.05.03.002; 12.03.01.010--Not Available
Neuropathy peripheral17.09.03.0030.000557%Not Available
Neurotoxicity17.02.10.002; 12.03.01.011--Not Available
Neutropenia01.02.03.0040.000743%Not Available
Oliguria20.01.03.004--Not Available
Oral discomfort07.05.05.0010.000371%Not Available
Ototoxicity04.03.01.004; 12.03.01.0120.000743%Not Available
Oxygen saturation decreased13.02.01.0040.001485%Not Available
Palpitations02.01.02.0030.000743%
Paraesthesia17.02.06.005--
Paralysis17.01.04.004--Not Available
Pathogen resistance11.01.08.0490.000291%Not Available
Pneumonia22.07.01.003; 11.01.09.0030.001857%Not Available
Premature baby18.04.02.0010.000928%Not Available
Productive cough22.02.03.0050.002228%
Pruritus23.03.12.0010.001485%
Pyrexia08.05.02.0030.002042%
Rash23.03.13.001--Not Available
Renal tubular necrosis20.01.07.0030.000743%Not Available
Respiratory disorder22.02.07.0020.000371%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000097%
Sepsis11.01.11.0030.000145%
Skin discolouration23.03.03.0050.000743%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Sputum increased22.02.03.0070.000557%Not Available
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