Ciprofloxacin
Cetraxal, Ciloxan, Cipro, Ciprodex, Ciprofloxacin, Ciprofloxacin /, Ciprofloxacin / Ciprofloxacin, Otovel (ciprofloxacin) is a small molecule pharmaceutical. Ciprofloxacin was first approved as Cipro on 1987-10-22. It is used to treat anthrax, bacterial conjunctivitis, bacterial infections, bacterial skin diseases, and bacteroides infections amongst others in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Cetraxal, Ciloxan, Cipro, Ciprofloxacin (discontinued: Cipro, Ciprofloxacin, Otiprio, Proquin)
CombinationsCipro, Ciprodex, Ciprofloxacin, Ciprofloxacin dexamethasone, Ciprofloxacin hydrocortisone, Otovel (discontinued: Cipro, Ciprofloxacin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ciprofloxacin hydrochloride
Ciprofloxacin
Ciprofloxacin
+
Ciprofloxacin hydrochloride
Ciprofloxacin hydrochloride
+
Fluocinolone acetonide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OTOVEL | LAB SALVAT | N-208251 RX | 2016-04-29 | 1 products, RLD, RS |
Ciprofloxacin hydrochloride
+
Hydrocortisone
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cetraxal | New Drug Application | 2024-10-09 |
| ciloxan | New Drug Application | 2024-07-30 |
| cipro | New Drug Application | 2024-11-08 |
| cipro hc | New Drug Application | 2025-08-18 |
| ciprodex | New Drug Application | 2011-08-23 |
| ciprofloxacin | ANDA | 2025-11-17 |
| ciprofloxacin and dexamethasone | ANDA | 2025-08-30 |
| ciprofloxacin and fluocinolone acetonide | NDA authorized generic | 2024-10-09 |
| ciprofloxacin hcl | ANDA | 2024-12-31 |
| ciprofloxacin hcl ophthalmic | ANDA | 2022-10-28 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ciprofloxacin, Otiprio, Alk Abello | |||
| 11246863 | 2038-11-27 | DP | |
| 11040004 | 2037-11-12 | U-2252 | |
| 9220796 | 2035-07-01 | DP | |
| 8318817 | 2030-04-27 | U-1792 | |
| 9233068 | 2029-12-11 | DP | |
| 9205048 | 2029-04-21 | U-1793 | |
| 9603796 | 2029-04-21 | DS, DP | U-2252 |
| 11369566 | 2029-04-21 | DP | |
| Ciprofloxacin Hydrochloride / Fluocinolone Acetonide, Otovel, Laboratorios Salvat | |||
| 8932610 | 2030-03-24 | DP | U-1578 |
| Ciprofloxacin / Dexamethasone, Ciprodex, Sandoz | |||
| 8846650 | 2025-06-04 | DP | U-1578 |
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01M: Quinolone antibacterials
— J01MA: Fluoroquinolone antibacterials, systemic
— J01MA02: Ciprofloxacin
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA10: Ciprofloxacin and metronidazole
— J01RA11: Ciprofloxacin and tinidazole
— J01RA12: Ciprofloxacin and ornidazole
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AE: Fluoroquinolone antiinfectives, ophthalmologic
— S01AE03: Ciprofloxacin
— S02: Otologicals
— S02A: Antiinfective drugs, otologic
— S02AA: Antiinfectives
— S02AA15: Ciprofloxacin
— S03: Ophthalmological and otological preparations
— S03A: Antiinfectives, ophthalmologic and otologic
— S03AA: Antiinfectives
— S03AA07: Ciprofloxacin
Clinical
Clinical Trials
425 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | — | 1 | 4 | — | 5 |
| Pseudomonas infections | D011552 | EFO_0001076 | A41.52 | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiectasis | D001987 | — | J47 | — | 1 | 2 | — | 1 | 4 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | — | 2 | 3 |
| Bacterial infections | D001424 | — | A49 | — | — | 2 | — | — | 2 |
| Cholera | D002771 | — | A00 | — | — | 1 | — | — | 1 |
| Healthcare-associated pneumonia | D000077299 | — | — | — | — | 1 | — | — | 1 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 1 | — | — | 1 |
| Community-acquired pneumonia | D000098968 | — | — | — | — | 1 | — | — | 1 |
| Neurologic manifestations | D009461 | — | — | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Joint diseases | D007592 | — | M12.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | — | — | 1 | 3 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 4 | — | — | — | 1 | 5 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 4 | — | — | — | — | 4 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | — | — | 2 | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | — | — | 1 | 2 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anthrax | D000881 | — | A22 | — | — | — | — | 3 | 3 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 2 | 2 |
| Cholecystitis | D002764 | — | K81 | — | — | — | — | 2 | 2 |
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 2 | 2 |
| Cholangitis | D002761 | HP_0030151 | K83.0 | — | — | — | — | 2 | 2 |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | — | — | — | 1 | 1 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ciprofloxacin |
| INN | ciprofloxacin |
| Description | Ciprofloxacin is a quinolone that is quinolin-4(1H)-one bearing cyclopropyl, carboxylic acid, fluoro and piperazin-1-yl substituents at positions 1, 3, 6 and 7, respectively. It has a role as an antiinfective agent, a topoisomerase IV inhibitor, an antibacterial drug, an EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor, a DNA synthesis inhibitor, an antimicrobial agent, an environmental contaminant and a xenobiotic. It is a quinolone antibiotic, a fluoroquinolone antibiotic, a member of cyclopropanes, a N-arylpiperazine, a quinolone, an aminoquinoline and a quinolinemonocarboxylic acid. It is a conjugate base of a ciprofloxacin(1+). It is a tautomer of a ciprofloxacin zwitterion. |
| Classification | Small molecule |
| Drug class | antibacterials (quinolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O |
Identifiers
| PDB | — |
| CAS-ID | 85721-33-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL8 |
| ChEBI ID | 100241 |
| PubChem CID | 2764 |
| DrugBank | DB00537 |
| UNII ID | 5E8K9I0O4U (ChemIDplus, GSRS) |
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Ciprofloxacin
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Ciprofloxacin
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Dexamethasone
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Ciprofloxacin
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Hydrocortisone
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Trends
PubMed Central
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Additional graphs summarizing 6,765 documents
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Safety
Black-box Warning
Black-box warning for: Ciprofloxacin, Ciprofloxacin hcl, Ciprofloxacin hydrochloride, Ciprofloxacin in dextrose, Proquin, Proquin xr
Adverse Events
Top Adverse Reactions
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63,477 adverse events reported
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