Ciprofloxacin
Cetraxal, Ciloxan, Cipro, Ciprodex, 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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Novartis Pharmaceuticals
Searched
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| musculoskeletal diseases | D009140 |
| digestive system diseases | D004066 |
| respiratory tract diseases | D012140 |
| otorhinolaryngologic diseases | D010038 |
| eye diseases | D005128 |
| urogenital diseases | D000091642 |
| hemic and lymphatic diseases | D006425 |
| skin and connective tissue diseases | D017437 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Cetraxal, Ciloxan, Cipro (generic drugs available since 2004-06-09, discontinued: Otiprio, Proquin)
CombinationsCipro, Ciprodex, Otovel (generic drugs available since 2004-06-09, discontinued: Cipro)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ciprofloxacin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CIPRO | Bayer | N-020780 RX | 1997-09-26 | 2 products, RLD, RS |
Show 4 discontinued
Ciprofloxacin
+
Ciprofloxacin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CIPRO XR | Bayer | N-021473 DISCN | 2002-12-13 | 2 products |
Hide discontinued
Ciprofloxacin
+
Dexamethasone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CIPRODEX | Novartis | N-021537 RX | 2003-07-18 | 1 products, RLD, RS |
Ciprofloxacin hydrochloride
Ciprofloxacin hydrochloride
+
Fluocinolone acetonide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OTOVEL | Laboratorios Salvat | N-208251 RX | 2016-04-29 | 1 products, RLD, RS |
Ciprofloxacin hydrochloride
+
Hydrocortisone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CIPRO HC | Novartis | N-020805 RX | 1998-02-10 | 1 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anthrax | — | D000881 | A22 |
| bacterial conjunctivitis | EFO_1000829 | D003234 | H10.0 |
| bacterial infections | — | D001424 | A49 |
| bacterial skin diseases | — | D017192 | — |
| bacteroides infections | EFO_1000832 | D001442 | — |
| campylobacter infections | EFO_0007190 | D002169 | — |
| cystitis | EFO_1000025 | D003556 | N30 |
| diarrhea | HP_0002014 | D003967 | R19.7 |
| dysentery | EFO_1001869 | D004403 | — |
| escherichia coli infections | EFO_1001318 | D004927 | B96.20 |
Show 18 more
Agency Specific
FDA
EMA
No data
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, Novartis | |||
| 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
245 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 | — | 4 | 8 | 13 | 4 | 29 |
| Infections | D007239 | EFO_0000544 | 1 | 1 | 2 | 4 | 3 | 10 | |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | 2 | 2 | 1 | 2 | 9 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 3 | 1 | 2 | 1 | 1 | 8 |
| Prostatic neoplasms | D011471 | C61 | — | 1 | 2 | 2 | 1 | 6 | |
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 2 | 1 | 1 | — | 4 |
| Neutropenia | D009503 | D70 | — | — | 2 | 1 | 1 | 4 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 2 | 1 | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | 2 | — | 3 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | — | 2 | 1 | — | 3 |
Show 31 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Otitis externa | D010032 | EFO_0009560 | H60 | 1 | 4 | 7 | — | — | 11 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 6 | 1 | — | — | 7 |
| Bacterial infections | D001424 | A49 | 3 | 1 | 2 | — | 2 | 7 | |
| Bronchiectasis | D001987 | HP_0002110 | J47 | — | 2 | 2 | — | 1 | 5 |
| Neoplasms | D009369 | C80 | 1 | — | 2 | — | 1 | 4 | |
| Lymphoma | D008223 | C85.9 | 1 | — | 1 | — | 1 | 3 | |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 1 | 1 | — | — | 3 |
| Cholera | D002771 | A00 | — | — | 2 | — | — | 2 | |
| Plague | D010930 | EFO_0007481 | A20 | — | 1 | 1 | — | — | 2 |
| Communicable diseases | D003141 | — | — | 1 | — | 1 | 2 |
Show 16 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anthrax | D000881 | A22 | 2 | 2 | — | — | — | 4 | |
| Otitis | D010031 | 1 | 3 | — | — | — | 3 | ||
| Ear diseases | D004427 | EFO_1001455 | H93.9 | 1 | 3 | — | — | — | 3 |
| Otorhinolaryngologic diseases | D010038 | 1 | 3 | — | — | — | 3 | ||
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 1 | 1 | — | — | — | 2 |
| Diabetic foot | D017719 | EFO_1001459 | 1 | 1 | — | — | 1 | 2 | |
| Systemic inflammatory response syndrome | D018746 | EFO_1001478 | R65.10 | — | 1 | — | — | 1 | 2 |
| Leukemia | D007938 | C95 | 1 | 1 | — | — | 1 | 2 | |
| Gonorrhea | D006069 | DOID_7551 | A54 | — | 1 | — | — | 1 | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
Show 15 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 10 | — | — | — | 2 | 12 | ||
| Pharmacokinetics | D010599 | 2 | — | — | — | 1 | 3 | ||
| Rhinoscleroma | D012226 | EFO_0007470 | 2 | — | — | — | — | 2 | |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | 1 | — | — | — | — | 1 | ||
| Brain injuries | D001930 | S06.9 | 1 | — | — | — | — | 1 | |
| Alcoholic liver cirrhosis | D008104 | EFO_1000802 | K70.3 | 1 | — | — | — | — | 1 |
| Alcoholic hepatitis | D006519 | EFO_1001345 | K70.1 | 1 | — | — | — | — | 1 |
| Phase i metabolic detoxication | D050216 | 1 | — | — | — | — | 1 | ||
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | — | — | — | 2 | 2 |
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 2 | 2 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Chronic bronchitis | D029481 | J42 | — | — | — | — | 1 | 1 | |
| Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | — | — | — | 1 | 1 | |
| Periapical diseases | D010483 | EFO_0010688 | — | — | — | — | 1 | 1 | |
| Coronary artery disease | D003324 | I25.1 | — | — | — | — | 1 | 1 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Myelodysplastic syndromes | D009190 | D46 | — | — | — | — | 1 | 1 | |
| Myeloproliferative disorders | D009196 | D47.1 | — | — | — | — | 1 | 1 |
Show 15 more
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 | 2551 |
| ChEMBL ID | CHEMBL8 |
| ChEBI ID | 100241 |
| PubChem CID | 2764 |
| DrugBank | DB00537 |
| UNII ID | 5E8K9I0O4U (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Ciprofloxacin, Proquin
Adverse Events
Top Adverse Reactions
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2,290 adverse events reported
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