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)
Stevens-Johnson syndrome10.01.03.020; 23.03.01.007; 12.03.01.014; 11.07.01.0050.000371%
Throat irritation22.02.05.013; 07.05.03.0040.000743%Not Available
Thrombocytopenia01.08.01.0020.000557%Not Available
Thrombosis24.01.01.006--Not Available
Tinnitus04.04.01.002; 17.04.07.0040.002971%
Tooth discolouration07.09.02.0010.000557%
Tremor17.01.06.002--
Vomiting07.01.07.003--
Weight decreased13.15.01.0050.001114%
Wheezing22.03.01.0090.000928%
Histiocytosis haematophagic10.02.01.042; 01.05.01.0150.000145%Not Available
Hypoacusis04.02.01.0060.001114%
Balance disorder17.02.02.0070.000371%Not Available
Eye pruritus06.04.05.0060.000371%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Mycobacterium avium complex infection11.04.02.0010.000557%Not Available
Drug resistance08.06.01.0050.000097%Not Available
Infarction24.04.02.017--Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000928%
Drug intolerance08.06.01.0130.001300%Not Available
Renal impairment20.01.03.0100.000557%Not Available
Treatment failure08.06.01.0170.000242%Not Available
Liver injury12.01.02.003; 09.01.07.0220.000557%Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.002414%
Acute kidney injury20.01.03.0160.002785%
Granulomatosis with polyangiitis10.02.02.018; 24.05.02.013; 22.01.01.015; 20.05.01.0130.001300%Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.0210.000371%Not Available
Nosocomial infection11.07.02.0060.000145%Not Available
Sputum retention22.02.03.0120.000371%Not Available
Klebsiella infection11.02.03.0030.000557%Not Available
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