Prescription medicine
Ciprofloxacin Brand names: Cipro, Ciloxan
Ciprofloxacin (Cipro) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 54 generic labelers, and pharmacies paid $0.123 per ciprofloxacin HCl 500 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $1.25 per mL (Cipro 5% suspension).
- Generic listed
- Boxed warning
Check it at the source: the ciprofloxacin FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 19537 record on Drugs@FDA; every ciprofloxacin label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 )]. […]
Used for
From the label: indications and usageCIPRO 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 ( 1.1 )
Bone and Joint Infections ( 1.2 )
Complicated Intra-Abdominal Infections ( 1.3 )
Infectious Diarrhea ( 1.4 )
Typhoid Fever (Enteric Fever) ( 1.5 )
Uncomplicated
Forms and strengths
- 250 mg
- 500 mg
- 750 mg
- 0.5 mg/.25ml
- 2 mg/ml
- 3 mg/ml
- 3 mg/g
- 200 mg/100ml
- 400 mg/200ml
Film-coated tablet; tablet; coated tablet; solution; solution/ drops.
On the market
- Earliest approval on file
- October 22, 1987 Cipro, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 44 first March 16, 2004; 23 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 56 of which 54 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 27, 2038 Otiprio injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.123 per tablet Ciprofloxacin HCl 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 14 since 2012 0 Class I among all firms' recalls; latest March 11, 2025; 2 more by firms not listed as its makers
- FAERS reports
- 96,726 through July 30, 2026
What is ciprofloxacin used for?
From the label: indications and usageCIPRO 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 ( 1.1 )
Bone and Joint Infections ( 1.2 )
Complicated Intra-Abdominal Infections ( 1.3 )
Infectious Diarrhea ( 1.4 )
Typhoid Fever (Enteric Fever) ( 1.5 )
Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 )
Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7)
Plague in adult and pediatric patients ( 1.8 )
Chronic Bacterial Prostatitis ( 1.9 )
Lower Respiratory Tract Infections ( 1.10 )
Acute Exacerbation of […]
Conditions named in the indications of ciprofloxacin's FDA labels, with every medicine labeled for each:
From other ciprofloxacin labelsUrinary tract infections: Infections in Adults CIPRO is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri …
Bacterial infections: INDICATIONS AND USAGE Ciprofloxacin Ophthalmic Solution, USP 0.3% is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
FDA pharmacologic class: Fluoroquinolone Antibacterial and Quinolone Antimicrobial.
Source: FDA drug label (Cipro), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0), via openFDA; the full label on DailyMed
What does the patient leaflet for ciprofloxacin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about CIPRO?CIPRO, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you get any of the following serious side effects while you take CIPRO, you should stop taking CIPRO immediately and get medical help right away. 1. Tendon rupture or swelling of the tendon (tendinitis). • Tendon problems can happen in people of all ages who take CIPRO. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: o pain o swelling o tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites. • The risk of getting tendon problems while you take CIPRO is higher if you: o are over 60 years of age o are taking steroids (corticosteroids) o have had a kidney, heart or lung transplant. • Tendon problems can happen in people who do not have the above risk factors when they take CIPRO. […] Stop taking CIPRO immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: o hear or feel a snap or pop in a tendon area o bruising right after an injury in a tendon area o unable to move the affected area or bear weight The tendon problems may be permanent. 2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including CIPRO. […]
From the patient leaflet: What should I avoid while taking CIPRO?CIPRO can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how CIPRO affects you. • Avoid sunlamps, tanning beds, and try to limit your time in the sun. CIPRO can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get a severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take CIPRO, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.
From the patient leaflet: How should I store CIPRO?CIPRO Tablets • Store at room temperature between 68°F to 77°F (20°C to 25°C). CIPRO Oral Suspension • Store microcapsules and diluent at room temperature up to 77°F (25°C). • Do not freeze. • After your CIPRO treatment is finished, safely throw away any unused oral suspension. Keep CIPRO and all medicines out of the reach of children. General Information about the safe and effective use of CIPRO. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIPRO for a condition for which it is not prescribed. Do not give CIPRO to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about CIPRO. If you would like more information about CIPRO, talk with your healthcare provider. […]
Source: FDA drug label (Cipro), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0), via openFDA; the full label on DailyMed
Is there a generic for ciprofloxacin (Cipro)?
The FDA approved the first generic ciprofloxacin on March 16, 2004. 44 generic applications are approved; 23 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists ciprofloxacin from 54 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Cipro tablets; a patent listed only for Otiprio injection runs to November 27, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1987 earliest approval on file
- 2004 first generic approved
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ciprofloxacin (Cipro)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.123 per Ciprofloxacin HCl 500 mg tablet, down 9% from $0.135 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ciprofloxacin HCl 500 mg tablet (generic)
- Cipro 5% suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ciprofloxacin 0.2% ear solution | Generic | $6.35 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -13% |
| Ciprofloxacin 0.3% eye drop | Generic | $1.50 per mL | n/a | -8% |
| Ciprofloxacin HCl 250 mg tablet | Generic | $0.0751 per tablet | $2.25 | -18% |
| Ciprofloxacin HCl 500 mg tablet | Generic | $0.123 per tablet | $3.69 | -9% |
| Ciprofloxacin HCl 750 mg tablet | Generic | $0.250 per tablet | $7.51 | -2% |
| Ciloxan 0.3% ointment | Brand | $74.31 per gram | n/a | -0.1% |
| Cipro 10% suspension | Brand | $1.46 per mL | n/a | -0.2% |
| Cipro 5% suspension | Brand | $1.25 per mL | n/a | -0.5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ciprofloxacin been recalled?
The FDA's Enforcement Report lists 16 recalls naming ciprofloxacin since 2012: 0 Class I (the most serious), 14 Class II, 2 Class III; 4 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of ciprofloxacin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 11, 2025 | Class II | FDC Limited | Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle |
| December 16, 2024 | Class II | FDC Limited | Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle |
| July 23, 2024 | Class II | FDC Limited | Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. |
| October 13, 2022 | Class II | Akorn, Inc. | CGMP Deviations: |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| July 2, 2019 | Class II | Altaire Pharmaceuticals, Inc. | Lack of Assurance of Sterility |
| March 16, 2016 | Class III | Actavis Pharma Inc | Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the … |
| May 28, 2015 | Class II | Lincare, Inc. not a listed maker | Lack of Assurance of Sterility: Sterility of product is not assured. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ciprofloxacin label say about other medicines?
The ciprofloxacin label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 47 other medicines name ciprofloxacin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | … patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. |
| Caffeine | drug interactions | Caffeine/Xanthine Derivatives; Use with caution Reduced clearance resulting in elevated levels and prolongation of serum half-life; CIPRO inhibits the formation of paraxanthine after caffeine administration (or pentoxifylline containing products). Monitor for xanthine toxicity and adjust dose as necessary. |
| Clozapine | drug interactions | Clozapine; Use with caution; Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with CIPRO are advised. |
| Cyclosporine | drug interactions | Cyclosporine Use with caution (transient elevations in serum creatinine) Monitor renal function (in particular serum creatinine) when CIPRO is co-administered with cyclosporine. |
| Duloxetine | drug interactions | Duloxetine; Avoid Use Five-fold increase in duloxetine exposure; If unavoidable, monitor for duloxetine toxicity |
| Epinephrine | warnings and precautions | Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated [see Adverse Reactions ( 6.1 , 6.2 )]. |
| Glimepiride | drug interactions | Oral antidiabetic drugs; Use with caution Glucose-lowering effect potentiated; Hypoglycemia sometimes severe has been reported when CIPRO and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. … |
| Glyburide | drug interactions | Oral antidiabetic drugs; Use with caution Glucose-lowering effect potentiated; Hypoglycemia sometimes severe has been reported when CIPRO and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. … |
| Lanthanum | drug interactions | Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations (magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate); sucralfate; Videx ® (didanosine) chewable/buffered tablets or pediatric powder; other highly buffered drugs; … |
| Methotrexate | drug interactions | Methotrexate; Use with caution Inhibition of methotrexate renal tubular transport potentially leading to increased methotrexate plasma levels; Potential increase in the risk of methotrexate associated toxic reactions. … |
| Olanzapine | warnings and precautions | Co-administration of CIPRO and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine and zolpidem), results in increased plasma concentrations of the co-administered drug and could lead to clinically significant pharmacodynamic … |
| Phenytoin | drug interactions | Phenytoin; Use with caution Altered serum levels of phenytoin (increased and decreased); To avoid the loss of seizure control associated with decreased phenytoin levels and to prevent phenytoin overdose-related adverse reactions upon CIPRO discontinuation in patients receiving both agents, monitor phenytoin therapy … |
| Probenecid | drug interactions | Probenecid; Use with caution (interferes with renal tubular secretion of CIPRO and increases CIPRO serum levels); Potentiation of CIPRO toxicity may occur. |
| Procainamide | warnings and precautions | … myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. |
Every other medicine the ciprofloxacin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Quinidine | warnings and precautions | … bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and … |
| Ropinirole | drug interactions | Ropinirole; Use with caution; Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with CIPRO … |
| Salicylic acid | drug interactions | NSAIDs; Use with caution; Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical … |
| Sevelamer | drug interactions | … (magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate); sucralfate; Videx ® (didanosine) chewable/buffered tablets or pediatric powder; … |
| Sildenafil | drug interactions | Sildenafil Use with caution Two-fold increase in exposure Monitor for sildenafil toxicity [see Clinical Pharmacology ( 12.3 ) ]. |
| Sotalol | warnings and precautions | … (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. |
| Sucralfate | drug interactions | Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations (magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate); … |
| Theophylline | drug interactions | Theophylline; Avoid Use (Plasma Exposure Likely to be Increased and Prolonged); Concurrent administration of CIPRO with theophylline may result in increased risk of a patient developing central … |
| Tizanidine | contraindications | Concomitant administration with tizanidine is contraindicated [see Drug Interactions ( 7 )]. |
| Warfarin | drug interactions | Monitor prothrombin time and INR frequently during and shortly after co-administration of CIPRO with an oral anti-coagulant (for example, warfarin). |
| Zolpidem | drug interactions | Zolpidem; Avoid Use; Co-administration with ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended |
Other labels that name ciprofloxacin
Source: FDA drug label (Cipro), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0), via openFDA; the full label on DailyMed
What do FAERS reports show for ciprofloxacin?
The FDA Adverse Event Reporting System holds 96,726 reports that list ciprofloxacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,732 are coded as a death and 37,612 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ciprofloxacin?
14 other medicines are given the same way (oral) and in the same FDA class as ciprofloxacin or labeled mainly for the same use (diarrhea), the same class first. Diarrhea lists all 16 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Levofloxacin | Bacterial infections, Urinary tract infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
| Moxifloxacin | Bacterial infections | 15 labelers | $1.34 per tablet 400 mg tablet | A presentation being discontinued |
| Bismuth subsalicylate | Diarrhea | none listed | $0.0817 per tablet 262 mg tablet chewable | No current entry |
| Loperamide | Diarrhea | 98 labelers | $0.0549 per capsule 2 mg capsule | No current entry |
| Sulfamethoxazole and trimethoprim | Diarrhea, Bacterial infections, Urinary tract infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
| Dimethicone and loperamide | Diarrhea | 33 labelers | $0.286 per unit Gs anti-diarrheal-antigas cplt | No current entry |
| Atropine and diphenoxylate | Diarrhea | 19 labelers | $0.139 per tablet 2.5-0.025 mg tablet | No current entry |
| Vancomycin | Diarrhea, Bacterial infections | 8 labelers | $1.33 per capsule 125 mg capsule | A presentation being discontinued |
Every medicine labeled for the same conditions as ciprofloxacin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ciprofloxacin compare with medicines for the same use?
24 side-by-side pages set ciprofloxacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ciprofloxacin
- 14 medicines for the same use
- Other fluoroquinolones
- the pharmacologic class, with prices and generics
- Ciprofloxacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other