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Cipro (ciprofloxacin)
Ciprofloxacin (Cipro) is the most prescribed fluoroquinolone, developed by Bayer and approved in 1987. Highly effective against gram-negative bacteria but carries FDA black box warnings for serious adverse effects. Available generically worldwide.
At a glance
| Generic name | ciprofloxacin |
|---|---|
| Also known as | Cipro, Ciloxan |
| Sponsor | Bayer AG |
| Drug class | Fluoroquinolone antibiotic |
| Target | DNA topoisomerase II, DNA gyrase subunit A, DNA gyrase subunit A |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1987-10-22 (United States) |
Approved indications
- Abdominal abscess
- Acute Moraxella catarrhalis bronchitis
- Acute bacterial bronchitis
- Acute bacterial peritonitis
- Acute bacterial sinusitis
- Acute gonococcal cervicitis
- Acute gonococcal urethritis
- Acute maxillary sinusitis
- Acute osteomyelitis
- Anthrax
- Bacterial Corneal Ulcer Infection
- Bacterial conjunctivitis
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial pneumonia
- Bacterial urinary infection
- Chancroid
- Chronic Bacterial Prostatitis
- Citrobacter Urinary Tract Infection
- Complicated Bacterial Peritonitis
- Complicated Bacteroides Peritonitis
Common side effects
- Ear discomfort
- Ear pain
- Ear pruritus
- Ear debris
- Superimposed ear infection
- Ear congestion
- Erythema
- Ear Precipitate (residue)
- Irritability
- Taste Perversion
Serious adverse events
- Hypersensitivity reactions
- Auricular swelling
- Rash erythematous
- Vomiting
- Headache
- Otorrhea
- Skin exfoliation
- Tinnitus
- Dizziness
- Oral moniliasis
Key clinical trials
- Regeneration of Pulp-Dentin Development in Teeth With Necrotic Pulps and Immature Roots (Phase 1)
- Randomized, Double Blind, Controlled Clinical Trial to Evaluate the Efficacy of Multiple-dose Ciprofloxacin With Single Dose Azithromycin Therapy for Adults With Cholera Due to Multiply Resistant Stra (Phase 3)
- A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST) (Phase 4)
- Randomized, Single-Blinded, Placebo-Controlled Study to Evaluate the Safety and Tolerability, the Pulmonary Deposition and Pharmacokinetics of Ciprofloxacin in Patients With Moderate to Severe Chronic (Phase 1)
- A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults (Phase 2)
- A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract (Phase 3)
- Analysis of MicroBial Metabolites After Eating Refined Food (NA)
- Cipro® XR Excellence in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections (Phase 4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8318817 | 2030-04-27 | Method of Use |
| 9603796 | 2029-04-21 | Compound |
| 9205048 | 2029-04-21 | Method of Use |
| 11040004 | 2037-11-12 | Method of Use |
| 11246863 | 2038-11-27 | Formulation |
| 11369566 | 2029-04-21 | Formulation |
| 9220796 | 2035-07-01 | Formulation |
| 9233068 | 2029-12-11 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cipro CI brief — competitive landscape report
- Cipro updates RSS · CI watch RSS
- Bayer AG portfolio CI