Azithromycin
Azasite, 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
Azithromycin dihydrate
+
Trovafloxacin mesylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TROVAN/ZITHROMAX COMPLIANCE PAK | Mylan | N-050762 DISCN | 1998-12-18 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| azasite | New Drug Application | 2022-08-22 |
| azithromycin monohydrate | ANDA | 2023-06-20 |
| zithromax | New Drug Application | 2023-01-31 |
| zmax | New Drug Application | 2011-01-26 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial infections | — | D001424 | A49 |
| chlamydia infections | EFO_0007205 | D002690 | A74.9 |
| haemophilus infections | EFO_1001127 | D006192 | — |
| infectious skin diseases | — | D012874 | — |
| mycoplasma pneumonia | EFO_0007387 | D011019 | J15.7 |
| neisseriaceae infections | EFO_1001377 | D016870 | — |
| nontuberculous mycobacterium infections | EFO_0007461 | D009165 | A31.9 |
| otitis media | EFO_0004992 | D010033 | H66.9 |
| protozoan infections | — | D011528 | B50-B64 |
| staphylococcal infections | — | D013203 | A49.01 |
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Agency Specific
FDA
EMA
No data
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
513 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 | 5 | 21 | 26 | 4 | 6 | 56 | |
| Asthma | D001249 | EFO_0000270 | J45 | — | 6 | 5 | 7 | 2 | 20 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | 3 | 6 | 4 | 4 | 18 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | 7 | 6 | 4 | 18 |
| Malaria | D008288 | EFO_0001068 | B54 | 3 | 3 | 6 | 3 | 2 | 17 |
| Trachoma | D014141 | A71 | — | 1 | 4 | 12 | 1 | 17 | |
| Chlamydia infections | D002690 | EFO_0007205 | A74.9 | — | 2 | 1 | 7 | 3 | 13 |
| Healthy volunteers/patients | — | 9 | — | — | 3 | 1 | 13 | ||
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | 4 | 3 | 5 | 1 | 13 |
| Respiratory tract infections | D012141 | J06.9 | 1 | 2 | 5 | 2 | 3 | 12 |
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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 | 3 | 3 | 3 | — | 13 | 22 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | 1 | 11 | 6 | — | — | 12 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | 2 | 2 | — | 8 | 12 | |
| Sars-cov-2 | D000086402 | — | 6 | 4 | — | — | 9 | ||
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 3 | 5 | — | — | 7 |
| Inflammation | D007249 | 2 | 2 | 4 | — | — | 7 | ||
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 3 | 3 | — | 2 | 6 |
| Chronic periodontitis | D055113 | EFO_0006343 | K05.3 | — | 2 | 1 | — | 2 | 5 |
| Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | 1 | — | 4 | — | — | 5 |
| Infections | D007239 | EFO_0000544 | 3 | — | 1 | — | 1 | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | 1 | — | — | — | 2 |
| Wound infection | D014946 | — | 1 | — | — | 1 | 2 | ||
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | 1 | — | — | — | 2 |
| Ebola hemorrhagic fever | D019142 | EFO_0007243 | A98.4 | 1 | 1 | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | — | 1 | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | 1 | — | — | — | 1 | ||
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Virus diseases | D014777 | B34 | — | 1 | — | — | — | 1 | |
| Glucose metabolism disorders | D044882 | — | 1 | — | — | — | 1 | ||
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
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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 | |
| 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 | EFO_0000540 | M30-M36 | 1 | — | — | — | — | 1 |
| Quorum sensing | D053038 | 1 | — | — | — | — | 1 | ||
| Prebiotics | D056692 | 1 | — | — | — | — | 1 | ||
| Probiotics | D019936 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cryptosporidiosis | D003457 | A07.2 | — | — | — | — | 3 | 3 | |
| Mycoplasma pneumonia | D011019 | EFO_0007387 | J15.7 | — | — | — | — | 2 | 2 |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | — | — | 1 | 1 | |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Immunotherapy | D007167 | — | — | — | — | 1 | 1 | ||
| Cytokine release syndrome | D000080424 | D89.83 | — | — | — | — | 1 | 1 | |
| Pityriasis lichenoides | D017514 | L41.0 | — | — | — | — | 1 | 1 | |
| Whooping cough | D014917 | EFO_0000650 | A37 | — | — | — | — | 1 | 1 |
| Microbiota | D064307 | — | — | — | — | 1 | 1 | ||
| Nutrition disorders | D009748 | EFO_0001069 | — | — | — | — | 1 | 1 |
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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 |
Target
Variants
Clinical Variant
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Financial
Zithromax - Pfizer
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Trends
PubMed Central
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Additional graphs summarizing 49,991 documents
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Safety
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Adverse Events
Top Adverse Reactions
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16,100 adverse events reported
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