Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Azithromycin monohydrate
Drug ID BADD_D00205
Description Azithromycin is a broad-spectrum macrolide antibiotic with a long half-life and a high degree of tissue penetration [A174172]. It was initially approved by the FDA in 1991 [A174175]. It is primarily used for the treatment of respiratory, enteric and genitourinary infections and may be used instead of other macrolides for some sexually transmitted and enteric infections. It is structurally related to erythromycin [A174169]. Azithromycin [9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin] is a part of the _azalide_ subclass of macrolides, and contains a 15-membered ring, with a methyl-substituted nitrogen instead of a carbonyl group at the 9a position on the aglycone ring, which allows for the prevention of its metabolism. This differentiates azithromycin from other types of macrolides [A174175]. In March 2020, a small study was funded by the French government to investigate the treatment of COVID-19 with a combination of azithromycin and the anti-malaria drug [hydroxychloroquine]. The results were positive, all patients taking the combination were virologically cured within 6 days of treatment, however, larger studies are required.[A192546]
Indications and Usage Azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria in order to prevent the development antimicrobial resistance and maintain the efficacy of azithromycin [FDA label]. Azithromycin is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the microorganisms listed in the specific conditions below. Recommended dosages, duration of therapy and considerations for various patient populations may vary among these infections. Refer to the FDA label and "Indications" section of this drug entry for detailed information [FDA label]. **Adults**: Acute bacterial exacerbations of chronic obstructive pulmonary disease due to _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Acute bacterial sinusitis due to _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Community-acquired pneumonia due to _Chlamydophila pneumoniae_, _Haemophilus influenzae_, _Mycoplasma pneumoniae_ or _Streptococcus pneumoniae_ in patients appropriate for oral therapy Pharyngitis/tonsillitis caused by _Streptococcus pyogenes_ as an alternative to first-line therapy in individuals who cannot use first-line therapy. Uncomplicated skin and skin structure infections due to _Staphylococcus aureus_, _Streptococcus pyogenes_, or _Streptococcus agalactiae_. Abscesses usually require surgical drainage. Urethritis and cervicitis due to _Chlamydia trachomatis_ or _Neisseria gonorrhoeae_. Genital ulcer disease in men due to _Haemophilus ducreyi_ (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. **Pediatric Patients** Acute otitis media caused by _Haemophilus influenzae_, _Moraxella catarrhalis_ or _Streptococcus pneumoniae_ Community-acquired pneumonia due to _Chlamydophila pneumoniae_, _Haemophilus influenzae_, _Mycoplasma pneumoniae_ or _Streptococcus pneumoniae_ in patients appropriate for oral therapy. Pharyngitis/tonsillitis caused by _Streptococcus pyogenes_ as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Marketing Status approved
ATC Code J01FA10; S01AA26
DrugBank ID DB00207
KEGG ID D07486; D06390; D02134
MeSH ID D017963
PubChem ID 9897015
TTD Drug ID D03HJK
NDC Product Code 60687-282; 68180-160; 70518-0803; 70518-3094; 70860-100; 70860-125; 17478-307; 60687-314; 63323-398; 65162-758; 68180-161; 71205-119; 71205-427; 66639-011; 51672-4200; 65162-759; 0527-2395; 65162-708; 68083-199; 70095-025; 70232-0006; 70518-3453; 54348-857; 65162-760; 0527-2370; 43063-713; 0904-6909; 55154-8094; 60687-271; 65372-1106; 43063-728; 68180-162; 82584-307; 43063-715; 0904-6708; 46708-866
UNII JTE4MNN1MD
Synonyms Azithromycin | Azythromycin | Sumamed | Toraseptol | Vinzam | CP-62993 | CP 62993 | CP62993 | Zithromax | Azitrocin | Azadose | Ultreon | Zitromax | Azithromycin Dihydrate | Dihydrate, Azithromycin | Azithromycin Monohydrate | Monohydrate, Azithromycin | Goxal | Zentavion
Chemical Information
Molecular Formula C38H74N2O13
CAS Registry Number 117772-70-0
SMILES CCC1C(C(C(N(CC(CC(C(C(C(C(C(=O)O1)C)OC2CC(C(C(O2)C)O)(C)OC)C)OC3C(C(CC(O3)C)N(C) C)O)(C)O)C)C)C)O)(C)O.O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hypotension24.06.03.002--
Injection site pain08.02.03.010; 12.07.03.011---
Jaundice cholestatic09.01.01.005---
Leukopenia01.02.02.001---
Malaise08.01.01.003--
Mucosal inflammation08.01.06.002---
Nausea07.01.07.001--
Nervousness19.06.02.003---
Neutropenia01.02.03.004---
Oedema08.01.07.006; 14.05.06.010---
Oral candidiasis07.05.07.001; 11.03.03.004---
Pancreatitis07.18.01.001--
Paraesthesia17.02.06.005; 23.03.03.094--
Parosmia17.04.04.002; 22.04.03.007---
Pelvic inflammatory disease11.01.10.006; 21.14.04.001---
Platelet count decreased13.01.04.001--
Pruritus23.03.12.001--
Pseudomembranous colitis07.19.01.003; 11.02.02.002---
Psychomotor hyperactivity17.01.02.011; 19.11.02.003---
Pyloric stenosis03.04.05.001; 07.13.04.001---
Rash23.03.13.001---
Seizure17.12.03.001--
Somnolence17.02.04.006; 19.02.05.003--
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Stomatitis07.05.06.005--
Syncope02.11.04.015; 17.02.04.008; 24.06.02.012--
Thrombocytopenia01.08.01.002---
Tinnitus04.04.01.002; 17.04.07.004--
Tongue discolouration07.14.02.006---
Torsade de pointes02.03.04.005---
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