Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Azithromycin
Drug ID BADD_D00203
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 D06390; D07486
MeSH ID D017963
PubChem ID 447043
TTD Drug ID D03HJK
NDC Product Code 65862-641; 16571-696; 0093-2026; 43386-471; 50111-788; 55695-003; 59651-007; 59762-3120; 68071-4812; 68788-7598; 71205-021; 71335-1755; 82982-021; 50111-787; 50111-789; 53002-6221; 59762-3110; 60760-808; 70710-1457; 71205-216; 38779-2246; 24658-708; 50090-2509; 50090-6226; 50090-6296; 55700-852; 59762-3130; 59762-3140; 60760-502; 63629-8251; 68071-2672; 68788-7549; 68788-8222; 69452-173; 70518-2562; 70771-1423; 70771-1425; 72189-088; 62332-252; 62332-253; 63187-007; 63187-594; 68071-2543; 68071-4779; 70518-2433; 70771-1422; 71205-519; 71205-674; 72189-314; 0781-8089; 61294-9990; 65427-310; 69452-172; 42291-084; 42806-149; 43386-470; 63187-093; 63187-604; 67296-1870; 68071-2266; 68788-7636; 68788-8124; 70518-0599; 70518-3217; 16571-695; 42291-082; 42806-150; 50090-2491; 50090-6267; 63629-7784; 68071-2937; 68071-5238; 68788-8229; 68788-8246; 69306-250; 70518-2708; 70518-3169; 70518-3254; 70518-3508; 70710-1458; 71205-196; 71205-503; 71205-566; 71335-1252; 71610-001; 76420-213; 65862-642; 69452-171; 45865-536; 63187-622; 68071-2297; 0409-0144; 70771-1424; 80425-0219; 24658-706; 42291-083; 42806-151; 46708-057; 46708-253; 50090-4458; 53002-2225; 59651-008; 59762-3051; 62332-251; 62756-512; 68071-1527; 68071-2622; 68071-2905; 68071-2963; 68788-8260; 70518-0784; 71205-158; 71205-253; 72189-015; 72189-087; 46708-058; 53002-2231; 53002-5228; 59762-2198; 63187-169; 63187-189; 67296-1510; 67457-700; 68071-2529; 68788-8125; 70710-1459; 71205-424; 0781-8090; 0781-8091; 50090-5366; 50090-6436; 55695-002; 55700-731; 63629-8034; 68788-7507; 70710-1460; 71205-645; 71335-1195; 72189-093; 76420-006; 51943-120; 0093-2027; 42806-147; 50090-4720; 53002-0473; 55150-174
UNII J2KLZ20U1M
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 C38H72N2O12
CAS Registry Number 83905-01-5
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
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)
Dyspnoea02.11.05.003; 22.02.01.0040.000203%
Dysuria20.02.02.002--
Ear infection11.01.05.001; 04.03.01.006--Not Available
Ear pain04.03.01.0030.000014%
Eczema23.03.04.006--
Enteritis07.08.03.002--
Eosinophil count increased13.01.06.004--Not Available
Eosinophilia01.02.04.0010.000013%
Eosinophilic pneumonia22.01.01.004; 01.02.04.0030.000006%Not Available
Erythema23.03.06.0010.000068%Not Available
Erythema multiforme23.03.01.003; 10.01.03.0150.000006%
Extravasation08.01.03.008--Not Available
Eye discharge06.04.05.0010.000043%Not Available
Eye disorder06.08.03.0010.000014%Not Available
Eye irritation06.04.05.0030.000312%Not Available
Eye pain06.08.03.0020.000134%
Eye swelling06.08.03.0030.000107%Not Available
Eyelid oedema10.01.05.001; 06.04.04.004; 23.04.01.0030.000009%Not Available
Eyelid ptosis17.17.02.004; 06.05.01.0020.000021%Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.0030.000013%
Faeces discoloured07.01.03.0020.000006%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.002--
Fungal infection11.03.05.001--Not Available
Fungal skin infection23.11.03.006; 11.03.05.002--Not Available
Gamma-glutamyltransferase increased13.03.04.024--
Gastritis07.08.02.001--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.0010.000055%Not Available
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