Prescription medicine
Levofloxacin First approved as Levaquin
Levofloxacin (Levaquin) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 44 generic labelers, and pharmacies paid $0.259 per levofloxacin 750 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the levofloxacin FDA label on DailyMed (effective July 10, 2024, Lupin Pharmaceuticals, Inc.); the NDA 20635 record on Drugs@FDA; every levofloxacin label on DailyMed.
Highlights of the record
FDA label of July 10, 2024; 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.
See full prescribing information for complete boxed warning. Fluoroquinolones, including levofloxacin, 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 levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1 )] Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )]. […]
Used for
From the label: indications and usageLevofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ).
Forms and strengths
- 250 mg
- 500 mg
- 750 mg
- 5 mg/ml
- 15 mg/ml
- 25 mg/ml
- 250 mg/50ml
- 500 mg/100ml
- 500 mg/20ml
- 750 mg/150ml
- 750 mg/30ml
Film-coated tablet; injection (solution); tablet; solution; injection (solution) (concentrate).
On the market
- Earliest approval on file
- December 20, 1996 Levaquin In Dextrose 5% In Plastic Container, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 43 first December 20, 2010; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 44 of which 44 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.259 per tablet Levofloxacin 750 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 13 since 2012 1 Class I among all firms' recalls; latest January 5, 2023; 6 more by firms not listed as its makers
- FAERS reports
- 59,954 through July 30, 2026
What is levofloxacin used for?
From the label: indications and usageLevofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). […]
Conditions named in the indications of levofloxacin's FDA labels, with every medicine labeled for each:
From other levofloxacin labelsUrinary tract infections: 5-day Treatment Regimen Levofloxacin tablets USP are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies ( 14.7 )].
FDA pharmacologic class: Fluoroquinolone Antibacterial.
Source: FDA drug label (Levofloxacin), Lupin Pharmaceuticals, Inc., effective July 10, 2024 (SPL set 4be13bd5-0c39-43c3-9232-b1226ccd4dbc), via openFDA; the full label on DailyMed
What does the patient leaflet for levofloxacin 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 levofloxacin tablets?Levofloxacin, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you have any of the following serious side effects while you take levofloxacin tablets, you should stop taking levofloxacin tablets 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 levofloxacin. Tendons are tough cords of tissue that connect muscles to bones. Some tendon problems include: pain swelling tears and swelling of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites. The risk of getting tendon problems while you take levofloxacin is higher if you: are over 60 years of age are taking steroids (corticosteroids) 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 levofloxacin. […] Stop taking levofloxacin tablets immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: hear or feel a snap or pop in a tendon area bruising right after an injury in a tendon area 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 levofloxacin. […]
From the patient leaflet: What should I avoid while taking levofloxacin tablets?Levofloxacin tablets 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 levofloxacin tablet affects you. Avoid sunlamps, tanning beds, and try to limit your time in the sun. Levofloxacin tablets can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take levofloxacin tablets, 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 levofloxacin tablets?Store levofloxacin tablets at room temperature between 59°F to 86° F (15°C to 30°C). Keep levofloxacin tablets in a tightly closed container.
Source: FDA drug label (Levofloxacin), Lupin Pharmaceuticals, Inc., effective July 10, 2024 (SPL set 4be13bd5-0c39-43c3-9232-b1226ccd4dbc), via openFDA; the full label on DailyMed
Is there a generic for levofloxacin (Levaquin)?
The FDA approved the first generic levofloxacin on December 20, 2010. 43 generic applications are approved; 21 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 levofloxacin from 44 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for levofloxacin (Levaquin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.259 per Levofloxacin 750 mg tablet, down 11% from $0.289 on October 8, 2025. 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.
- Levofloxacin 750 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Levofloxacin 25 mg/mL solution | Generic | $1.63 per mL | n/a | +9% |
| Levofloxacin 250 mg tablet | Generic | $0.109 per tablet | $3.26 | -4% |
| Levofloxacin 500 mg tablet | Generic | $0.133 per tablet | $4.00 | -11% |
| Levofloxacin 750 mg tablet | Generic | $0.259 per tablet | $7.76 | -11% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has levofloxacin been recalled?
The FDA's Enforcement Report lists 19 recalls naming levofloxacin since 2012: 1 Class I (the most serious), 12 Class II, 6 Class III; 4 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of levofloxacin 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 |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| January 5, 2023 | Class III | MACLEODS PHARMA USA, INC | Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles. |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| September 25, 2018 | Class III | Baxter Healthcare Corporation | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. |
| August 1, 2018 | Class III | Baxter Healthcare Corporation | Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. |
| March 27, 2018 | Class II | AuroMedics Pharma LLC | Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap |
| January 12, 2018 | Class I | AuroMedics Pharma LLC | Presence of Particulate Matter; contains visible particulate matter identified as mold. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the levofloxacin label say about other medicines?
The levofloxacin label names 13 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name levofloxacin. 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 | Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. |
| Cimetidine | drug interactions | No significant effect of probenecid or cimetidine on the C max of levofloxacin was observed in a clinical study involving healthy volunteers. |
| Cyclosporine | drug interactions | No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected in a clinical study involving healthy volunteers. |
| Digoxin | drug interactions | No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. |
| Epinephrine | warnings and precautions | Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated [see Adverse Reactions ( 6 ) and Patient Counseling Information ( 17 )]. |
| Glyburide | warnings and precautions | Blood Glucose Disturbances Fluoroquinolones, including levofloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. |
| Probenecid | drug interactions | No significant effect of probenecid or cimetidine on the C max of levofloxacin was observed in a clinical study involving healthy volunteers. |
| Procainamide | warnings and precautions | Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. |
| Quinidine | warnings and precautions | Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. |
| Sotalol | warnings and precautions | Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. |
| Sucralfate | drug interactions | Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of levofloxacin tablets with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and … |
| Theophylline | drug interactions | No significant effect of levofloxacin on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers. |
| Warfarin | drug interactions | Interacting Drug: Warfarin; Interaction: Effect may be enhanced. Monitor prothrombin time, INR and watch for bleeding () |
Other labels that name levofloxacin
Source: FDA drug label (Levofloxacin), Lupin Pharmaceuticals, Inc., effective July 10, 2024 (SPL set 4be13bd5-0c39-43c3-9232-b1226ccd4dbc), via openFDA; the full label on DailyMed
What do FAERS reports show for levofloxacin?
The FDA Adverse Event Reporting System holds 59,954 reports that list levofloxacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8,134 are coded as a death and 27,956 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 levofloxacin?
27 other medicines are given the same way (oral) and in the same FDA class as levofloxacin or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 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 |
|---|---|---|---|---|
| Ciprofloxacin | Bacterial infections, Urinary tract infections | 46 labelers | $0.123 per tablet 500 mg tablet | No current entry |
| Moxifloxacin | Bacterial infections | 15 labelers | $1.34 per tablet 400 mg tablet | A presentation being discontinued |
| Doxycycline | Bacterial infections, Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Amoxicillin and clavulanate | Bacterial infections, Urinary tract infections | 31 labelers | $0.0693 per mL 600-42.9 mg/5 mL sus | No current entry |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections, Urinary tract infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Nitrofurantoin | Bacterial infections, Urinary tract infections | 47 labelers | $0.165 per capsule 50 mg capsule | A presentation being discontinued |
Every medicine labeled for the same conditions as levofloxacin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does levofloxacin compare with medicines for the same use?
23 side-by-side pages set levofloxacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to levofloxacin
- 27 medicines for the same use
- Other fluoroquinolones
- the pharmacologic class, with prices and generics
- Levofloxacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other