Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Amikacin sulfate
Drug ID BADD_D00104
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 D00865
MeSH ID D000583
PubChem ID 38351
TTD Drug ID D0Y3MO
NDC Product Code 23155-785; 23155-290; 25021-173; 52946-0600; 35369-0005; 0703-9040; 63323-815; 0703-9032; 66603-703; 0641-6166; 38779-0295; 23155-786; 0641-6167; 62991-2002
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 C22H47N5O21S2
CAS Registry Number 39831-55-5
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.OS(= O)(=O)O.OS(=O)(=O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Toxicity to various agents1-phosphatidylinositol 4,5-bisphosphate phosphodiesterase beta-1Q9NQ66T26846Not Available
Toxicity to various agentsPhospholipase A2P04054T31479Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Albuminuria20.02.01.001--Not Available
Anaemia01.03.02.001--
Apnoea22.02.01.001--
Arthralgia15.01.02.001--
Auditory disorder04.02.03.002--Not Available
Azotaemia20.01.01.001--Not Available
Blindness06.02.02.001; 17.17.01.003--Not Available
Blood creatinine increased13.13.01.004--
Deafness04.02.01.001--Not Available
Eosinophilia01.02.04.001--
Headache17.14.01.001--
Hypomagnesaemia14.04.02.001--
Hypotension24.06.03.002--
Nausea07.01.07.001--
Nephropathy toxic20.05.03.002; 12.03.01.010--Not Available
Neuromuscular blockade17.05.04.003--Not Available
Oliguria20.01.03.004--Not Available
Ototoxicity12.03.01.012; 04.03.01.004--Not Available
Paraesthesia17.02.06.005--
Paralysis17.01.04.004--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Red blood cells urine positive13.13.02.003--Not Available
Tremor17.01.06.002--
Vestibular disorder17.02.02.008; 04.04.02.001--
Vomiting07.01.07.003--
White blood cells urine positive13.13.02.004--Not Available
Balance disorder17.02.02.007--Not Available
Renal impairment20.01.03.010--Not Available
Urinary casts present13.13.02.009--Not Available
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