CIPRO (ciprofloxacin) · Bayer
CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections • Bone and Joint Infections • Complicated Intra-Abdominal Infections • Infectious Diarrhea • Typhoid Fever (Enteric Fever) • Uncomplicated Cervical and Urethral Gonorrhea • Inhalational Anthrax post-exposure in adult and pediatric patients • Plague in adult...
Details
- Status
- Prescription
- First Approved
- 1987-10-22
- Routes
- ORAL, INJECTION
- Dosage Forms
- FOR SUSPENSION, TABLET, INJECTABLE
CIPRO Approval History
What CIPRO Treats
15 indicationsCIPRO is approved for 15 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Skin and Skin Structure Infections
- Bone and Joint Infections
- Complicated Intra-Abdominal Infections
- Infectious Diarrhea
- Typhoid Fever
- Gonorrhea
- Inhalational Anthrax
- Plague
- Chronic Bacterial Prostatitis
- Lower Respiratory Tract Infections
- Acute Exacerbation of Chronic Bronchitis
- Urinary Tract Infections
- Acute Uncomplicated Cystitis
- Pyelonephritis
- Acute Sinusitis
CIPRO Boxed Warning
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including CIPRO ® , have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )], including: • Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2 )]. • Peripheral neuropathy [see Warnings and Precautions ( 5.3 )]...
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including CIPRO ® , have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )], including: • Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2 )]. • Peripheral neuropathy [see Warnings and Precautions ( 5.3 )]. • Central nervous system effects [see Warnings and Precautions ( 5.4 )]. Discontinue CIPRO immediately and avoid the use of fluoroquinolones, including CIPRO, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1 )] . • Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis . [see Warnings and Precautions ( 5.5 )]. • Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1-5.16 )] , reserve CIPRO for use in patients who have no alternative treatment options for the following indications: • Acute exacerbation of chronic bronchitis [see Indications and Usage ( 1.10 )]. • Acute uncomplicated cystitis [see Indications and Usage ( 1.11 )]. • Acute sinusitis [see Indications and Usage ( 1.12 )]. WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning. • Fluoroquinolones, including CIPRO ® , have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including: • Tendinitis and tendon rupture ( 5.2 ) • Peripheral neuropathy ( 5.3 ) • Central nervous system effects ( 5.4 ) Discontinue CIPRO immediately and avoid
CIPRO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
76 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04791579 | Pro00108452 | Ph 2 | recruiting | Antibiotic Prophylaxis for Neurogenic Bladder Botox |
| NCT01243437 results posted | CDC-NCEZID-5859 | Ph 2 | completed | A Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin in the Treatment of Plague in Humans |
| NCT04948463 ELSA-FN | 74690 | Ph 4 | completed | Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia |
| NCT05294588 | 21-0498 DMID 21-0018, U01AI162457-01 | Ph 2 | completed | Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae |
| NCT05274672 | 022-046 | Ph 4 | withdrawn | Role of Prophylactic Postoperative Antibiotics in HoLEP |
| NCT03012360 TAVeM2 | 2015_66 2016-000735-41 | Ph 4 | terminated | Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis |
| NCT03850379 results posted | 12124) | Ph 2 | completed | Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant |
| NCT05846399 CATBITE | 2092043 | Ph 4 | recruiting | CAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE) |
| NCT04523987 | PA02/07/18 | Ph 1 | active not recruiting | A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. |
| NCT05844735 | PDY16917 U1111-1255-5054 | Ph 1 | completed | A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566 |
| NCT04444440 | Pro00101838 | Ph 4 | recruiting | Antibiotic Prophylaxis for Bladder Botox |
| NCT07150065 | 107 | Ph 2 | completed | Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever |
| NCT07016165 | KE/FK/0517/EC/2025 | Ph 4 | recruiting | Ciprofloxacin vs Ceftazidime for Empirical Treatment of High-Risk Neutropenic Fever in Children With Hematologic Malignancies |
| NCT07028424 PANORAMIX | PANORAMIX G-116 PRODIGE 105 | Ph 2 | not yet recruiting | PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment |
| NCT01753115 results posted | EBS.AVA.009 | Ph 2 | completed | Ciprofloxacin BioThrax Co-Administration Study |
| NCT03692715 APPEAL | CLUE | Ph 4 | completed | Antibiotic Prophylaxis Before Shock Wave Lithotripsy |
| NCT04110340 IMASOY | 45-18 | Ph 3 | completed | Ciprofloxacin Versus an Aminoglycoside Followed by Ciprofloxacin for Bubonic Plague |
| NCT03862170 BRP30 | AA-HCLM-14-033 | Ph 3 | terminated | Antibiotic Prophylaxis for HDR Brachytherapy in the Treatment of Prostate Cancer |
| NCT06709196 REINFORCE | 2024-514312-27-00 2024-514312-27-00 | Ph 4 | recruiting | Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis |
| NCT05462496 | STUDY-21-01814 | Ph 2 | recruiting | Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer |
| NCT02765256 Holiday results posted | 823635 | Ph 2 | completed | Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease |
| NCT02598362 | 2014-004638-24 | Ph 4 | completed | Pharmacokinetics of Ciprofloxacin in Pediatric Patients |
| NCT02620007 TEOREM | P140503 | Ph 2 | terminated | Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease |
| NCT04147260 results posted | 1407-0037 | Ph 1 | completed | Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin |
| NCT03854929 CIPAZ | 26EN | Ph 4 | completed | Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery |
| NCT03262142 Target-ABC | coptrin2 | Ph 4 | terminated | Targeted AntiBiotics for Chronic Pulmonary Diseases |
| NCT03228108 pro-SWAP | pro-SWAP104622 | Ph 4 | completed | Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy. |
| NCT04698057 ACACIA | ACACIA | Ph 3 | withdrawn | Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial. |
| NCT02790138 EARNEST results posted | Vedolizumab-4004 U1111-1171-0918, 2015-003472-78 | Ph 4 | completed | A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis |
| NCT03476317 Holiday results posted | 17-014343 5K23DK109136-02 | Ph 2 | completed | Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease |
| NCT04870138 results posted | 09-0106 LptA | Ph 1 | completed | Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial) |
| NCT03177720 | ELF Cipro | Ph 1 | completed | Evaluation of Innovative Tools in Development of Antibiotics |
| NCT00654108 | 07-0052 | Ph 1 | completed | Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects |
| NCT00832286 | 07-0053 | Ph 1 | completed | Longitudinal Study of the Human Intestinal Microbiome |
| NCT03840811 results posted | 09-0106 | Ph 1 | completed | Experimental Human Infection With Neisseria Gonorrhoeae |
| NCT02300220 results posted | 14IC2031 2012-002198-72 | Ph 3 | completed | Targeted Retreatment of COPD Exacerbations |
| NCT03354598 results posted | IT001-301 | Ph 3 | completed | Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women |
| NCT03357614 results posted | IT001-302 | Ph 3 | completed | Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults |
| NCT03358576 results posted | IT001-303 | Ph 3 | completed | Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI) |
| NCT00992329 | HP-00043432 HHSF223200810030C | Ph 1 | completed | Impact of Formulation on Ciprofloxacin Oral Absorption |
| NCT02816112 REaCT-TC2 | OTT 16-03 | Ph 4 | completed | Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia |
| NCT01888822 | MarPic63 | Ph 4 | terminated | Antibiotic Prophylaxis in Laparoscopic Cholecystectomy |
| NCT01789203 results posted | Pro00007510 IRB0612-0114 | Ph 4 | completed | Ciprofloxacin for Prevention of BK Infection |
| NCT01783106 APRiCCOT | Royal_Liverpool 2008-001137-99 | Ph 2 | completed | Antibiotics and Hydroxychloroquine in Crohn's |
| NCT03366207 results posted | IT004-401 | Ph 4 | completed | Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI) |
| NCT03431675 | Cipro chemoprophylaxis 2018 | Ph 4 | withdrawn | Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018 |
| NCT02068846 results posted | 12-0036 1R21DE023046-01A1 | Ph 3 | completed | BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent |
| NCT01659866 results posted | STU00059558 EAM-237 | Ph 4 | completed | Antibiotic Prophylaxis for Transrectal Prostate Biopsy |
| NCT01505634 results posted | 7655-003 2011-005707-32, MK-7655-003 | Ph 2 | completed | Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003) |
| NCT01952444 results posted | AH110 | Ph 1 | completed | Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers |
Showing 50 of 76 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CIPRO FDA Label Details
Indications & Usage
FDA Label (PDF)CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections • Bone and Joint Infections • Complicated Intra-Abdominal Infections • Infectious Diarrhea • Typhoid Fever (Enteric Fever) • Uncomplicated Cervical and Urethral Gonorrhea • Inhalational Anthrax post-exposure in adult and pediatric patients • Plague in adult and pediatric patients • Chronic Bacterial Prostatitis • Lower Respiratory Tract Infections • Acute ...
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including CIPRO ® , have been associated with disabling and potentially irreversible serious adverse reactions that...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.