Azithromycin
Azasite, Azithromycin, Trovan/zithromax Compliance, Zithromax (azithromycin) is a small molecule pharmaceutical. Azithromycin was first approved as Zithromax on 1991-11-01. It is used to treat bacterial infections, chlamydia infections, haemophilus infections, infectious skin diseases, and mycoplasma pneumonia amongst others in the USA. It is known to target motilin receptor.
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Commercial
Trade Name
FDA
EMA
Azasite, Zithromax (generic drugs available since 2005-11-14, discontinued: Zmax)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Azithromycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZITHROMAX | Mylan | N-050693 RX | 1994-09-28 | 1 products, RLD, RS |
| ZITHROMAX | Mylan | N-050710 RX | 1995-10-19 | 2 products, RLD, RS |
| ZITHROMAX | Mylan | N-050711 RX | 1996-07-18 | 1 products, RLD |
| ZITHROMAX | Mylan | N-050733 RX | 1997-01-30 | 1 products, RLD, RS |
| ZITHROMAX | Mylan | N-050784 RX | 2002-05-24 | 1 products, RLD |
| AZASITE | Thea Pharma | N-050810 RX | 2007-04-27 | 1 products, RLD, RS |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azasite | New Drug Application | 2023-01-06 |
| azithromycin | ANDA | 2024-02-13 |
| azithromycin azithromycin dihydrate | ANDA | 2022-09-29 |
| azithromycin dihydrate | ANDA | 2024-02-06 |
| azithromycin monohydrate | ANDA | 2023-12-18 |
| zithromax | New Drug Application | 2024-01-04 |
| zmax | New Drug Application | 2011-01-26 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01F: Macrolides, lincosamides and streptogramins
— J01FA: Macrolides
— J01FA10: Azithromycin
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA07: Azithromycin, fluconazole and secnidazole
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AA: Antibiotics, ophthalmologic
— S01AA26: Azithromycin
Clinical
Clinical Trials
665 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | 9 | 29 | 37 | 4 | 20 | 90 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | 3 | 9 | 7 | 9 | 28 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 6 | 5 | 9 | 5 | 25 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | 3 | 6 | 6 | 4 | 20 |
| Malaria | D008288 | EFO_0001068 | B54 | 4 | 3 | 6 | 4 | 2 | 19 |
| Trachoma | D014141 | — | A71 | — | 1 | 4 | 13 | 1 | 18 |
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | 2 | 1 | 9 | 6 | 18 |
| Respiratory tract infections | D012141 | — | J06.9 | 1 | 2 | 6 | 4 | 4 | 16 |
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | 4 | 4 | 5 | 1 | 14 |
| Healthy volunteers/patients | — | — | — | 9 | — | — | 3 | 1 | 13 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 4 | 3 | — | 15 | 25 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | 2 | 11 | 6 | — | — | 13 |
| Sars-cov-2 | D000086402 | — | — | 1 | 8 | 4 | — | 1 | 13 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | — | 2 | 2 | — | 9 | 13 |
| Inflammation | D007249 | MP_0001845 | — | 2 | 2 | 6 | — | — | 9 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 3 | 3 | — | 3 | 7 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 1 | 2 | 3 | — | 2 | 7 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 3 | 1 | — | 2 | 6 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 2 | 1 | — | 2 | 5 |
| Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | 1 | — | 4 | — | — | 5 |
Show 46 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cryptosporidiosis | D003457 | — | A07.2 | 1 | 1 | — | — | 3 | 4 |
| Coronavirus | D017934 | — | — | — | 1 | — | — | 2 | 3 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | 1 | — | — | 1 | 3 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | 1 | 2 | — | — | 1 | 3 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 3 | — | — | — | 3 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 1 | — | — | 1 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | 1 | 2 |
| Wound infection | D014946 | — | — | — | 1 | — | — | 1 | 2 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | 1 | — | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial eye infections | D015818 | — | — | 5 | — | — | — | — | 5 |
| Pulmonary infarction | D054060 | EFO_1001408 | — | 1 | — | — | — | — | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Acute chest syndrome | D056586 | EFO_0007129 | — | 1 | — | — | — | — | 1 |
| Fasting | D005215 | EFO_0002756 | — | 1 | — | — | — | — | 1 |
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | 1 | — | — | — | — | 1 |
| Quorum sensing | D053038 | — | — | 1 | — | — | — | — | 1 |
| Prebiotics | D056692 | — | — | 1 | — | — | — | — | 1 |
Show 5 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumococcal infections | D011008 | EFO_0000772 | J13 | — | — | — | — | 2 | 2 |
| Whooping cough | D014917 | EFO_0000650 | A37 | — | — | — | — | 2 | 2 |
| Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 2 | 2 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
Show 48 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Azithromycin |
| INN | azithromycin |
| Description | Azithromycin is a macrolide antibiotic useful for the treatment of bacterial infections. It has a role as an antibacterial drug, an environmental contaminant and a xenobiotic. |
| Classification | Small molecule |
| Drug class | antibiotics (Streptomyces strains) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O |
Identifiers
| PDB | — |
| CAS-ID | 83905-01-5 |
| RxCUI | 1299904 |
| ChEMBL ID | CHEMBL529 |
| ChEBI ID | 2955 |
| PubChem CID | 447043 |
| DrugBank | DB00207 |
| UNII ID | F94OW58Y8V (ChemIDplus, GSRS) |
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Zithromax – Pfizer
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Estimated US medical usage
Azithromycin
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Trends
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Safety
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Adverse Events
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29,499 adverse events reported
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