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)
Drug hypersensitivity10.01.01.001--Not Available
Dry mouth07.06.01.0020.000743%
Dry skin23.03.03.0010.000371%
Dry throat07.06.01.005; 22.02.05.0040.000928%Not Available
Dysgeusia17.02.07.003; 07.14.03.0010.000557%
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.0040.008912%
Dyspnoea22.02.01.004; 02.01.03.0020.008355%
Electrocardiogram QT prolonged13.14.05.0040.000371%
Eosinophilia01.02.04.001--
Epistaxis24.07.01.005; 22.04.03.0010.000743%
Fatigue08.01.01.0020.002971%
Forced expiratory volume decreased13.19.01.0030.000371%
Fungal infection11.03.05.0010.000371%Not Available
Gastrointestinal disorder07.11.01.0010.000371%Not Available
Glossodynia07.14.02.0010.000371%Not Available
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.0060.003156%Not Available
Headache17.14.01.0010.002228%
Hepatic function abnormal09.01.02.0010.000371%Not Available
Hepatitis09.01.07.0040.000371%Not Available
Hip fracture15.08.03.001; 12.04.01.0010.000371%
Hypersensitivity10.01.03.0030.000743%
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023--Not Available
Hypomagnesaemia14.04.02.001--
Hyponatraemia14.05.04.0020.000371%
Hypotension24.06.03.002--
Influenza22.07.02.001; 11.05.03.0010.000928%Not Available
Laryngitis22.07.03.001; 11.01.13.0010.001114%
Leukocytosis01.02.01.0020.000371%
Linear IgA disease23.03.01.015; 10.04.02.0060.001114%Not Available
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