Prescription medicine
Moxifloxacin Brand names: Vigamox; first approved as Avelox
Moxifloxacin (Avelox) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 32 generic labelers, and pharmacies paid $1.60 per mL (Moxifloxacin 0.5% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the moxifloxacin FDA label on DailyMed (effective March 17, 2026, Macleods Pharmaceuticals Limited); the NDA 21085 record on Drugs@FDA; every moxifloxacin label on DailyMed.
Highlights of the record
FDA label of March 17, 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 andEXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin tablets, 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 moxifloxacin tablets immediately and avoid the use of fluoroquinolones, including moxifloxacin tablets, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1 )]. Fluoroquinolones, including moxifloxacin tablets, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin tablets in patients with known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )]. […]
Used for
From the label: indications and usageMoxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: Community Acquired Pneumonia ( 1.1 ) Skin and Skin Structure Infections: Uncomplicated ( 1.2 ) and Complicated ( 1.3 ) Complicated Intra-Abdominal Infections ( 1.4 ) Plague ( 1.5 ) Acute Bacterial Sinusitis ( 1.6 ) Acu
Forms and strengths
- 400 mg
- 5 mg/ml
- 400 mg/250ml
Solution/ drops; film-coated tablet; solution; injection (solution).
On the market
- Earliest approval on file
- December 10, 1999 Avelox, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first February 18, 2014; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 36 of which 32 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- May 29, 2029 Moxeza solution/drops; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.60 per mL Moxifloxacin 0.5% eye drops
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 10 since 2012 0 Class I among all firms' recalls; latest May 14, 2024; 6 more by firms not listed as its makers
- FAERS reports
- 20,168 through July 30, 2026
What is moxifloxacin used for?
From the label: indications and usageMoxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: Community Acquired Pneumonia ( 1.1 ) Skin and Skin Structure Infections: Uncomplicated ( 1.2 ) and Complicated ( 1.3 ) Complicated Intra-Abdominal Infections ( 1.4 ) Plague ( 1.5 ) Acute Bacterial Sinusitis ( 1.6 ) Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs. […]
Conditions named in the indications of moxifloxacin's FDA labels, with every medicine labeled for each:
From other moxifloxacin labelsBacterial infections: Skin and Skin Structure Infections Moxifloxacin tablets are indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus …
FDA pharmacologic class: Fluoroquinolone Antibacterial and Quinolone Antimicrobial.
Source: FDA drug label (Moxifloxacin), Macleods Pharmaceuticals Limited, effective March 17, 2026 (SPL set 182ecd0f-714f-42f0-9b16-fb604cf15786), via openFDA; the full label on DailyMed
What does the patient leaflet for moxifloxacin 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 moxifloxacin tablets?Moxifloxacin tablets are in a class of antibiotics called fluoroquinolones. Moxifloxacin tablets can cause serious side effects that can happen at the same time and could result in death. If you get any of the following serious side effects, you should stop taking moxifloxacin tablets and get medical help right away. Talk with your healthcare provider about whether you should continue to take moxifloxacin tablets 1.Tendon rupture or swelling of the tendon (tendinitis). Tendon problems can happen in people of all ages who take moxifloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites. […] Stop taking moxifloxacin 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 put weight on the area. 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 moxifloxacin tablets. […]
From the patient leaflet: What should I avoid while taking moxifloxacin tablets?Moxifloxacin 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 moxifloxacin tablets affects you. Avoid sunlamps, tanning beds, and try to limit your time in the sun. Moxifloxacin 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 taking moxifloxacin 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 moxifloxacin tablets?Store moxifloxacin tablets at room temperature between 68°F to 77°F (20°C to 25°C) Keep Moxifloxacin tablets away from moisture (humidity). Keep moxifloxacin tablets and all medicines out of the reach of children. General Information about the safe and effective use of moxifloxacin tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use moxifloxacin tablets for a condition for which it is not prescribed. Do not give moxifloxacin tablets 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 moxifloxacin tablets. If you would like more information about moxifloxacin tablets, talk with your healthcare provider. […]
Source: FDA drug label (Moxifloxacin), Macleods Pharmaceuticals Limited, effective March 17, 2026 (SPL set 182ecd0f-714f-42f0-9b16-fb604cf15786), via openFDA; the full label on DailyMed
Is there a generic for moxifloxacin (Avelox)?
The FDA approved the first generic moxifloxacin on February 18, 2014. 25 generic applications are approved; 20 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists moxifloxacin from 32 labelers under a generic (ANDA) application and from 3 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 Avelox tablets; a patent listed only for Moxeza solution/drops runs to May 29, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1999 earliest approval on file
- 2014 first generic approved
- 2029 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 moxifloxacin (Avelox)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.60 per mL (Moxifloxacin 0.5% eye drops), down 14% from $1.85 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.
- Moxifloxacin HCl 400 mg tablet (generic)
- Vigamox 0.5% eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Moxifloxacin 0.5% eye drops | Generic | $1.60 per mL | n/a | -14% |
| Moxifloxacin HCl 400 mg tablet | Generic | $1.34 per tablet | $40.12 | -26% |
| Vigamox 0.5% eye drops | Brand | $31.81 per mL | n/a | +0.9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is moxifloxacin in shortage?
No moxifloxacin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated October 29, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Moxifloxacin, Injection, 400mg per 250mL (NDC 63323-850-74) | Fresenius Kabi USA, LLC | To Be Discontinued | October 29, 2025 |
Every moxifloxacin presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has moxifloxacin been recalled?
The FDA's Enforcement Report lists 16 recalls naming moxifloxacin since 2012: 0 Class I (the most serious), 12 Class II, 4 Class III; 5 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of moxifloxacin 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 |
|---|---|---|---|
| May 14, 2024 | Class II | Imprimis NJOF, LLC | Lack of Assurance of Sterility |
| February 20, 2024 | Class II | Denver Solutions, LLC DBA Leiters Health not a listed maker | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. |
| 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. |
| November 2, 2022 | Class II | Direct Rx | cGMP deviation: discontinue of stability support for product. |
| October 13, 2022 | Class II | Akorn, Inc. | CGMP Deviations: |
| January 14, 2022 | Class II | Aurobindo Pharma USA Inc. | Failed Impurities/Degradation Specifications |
| December 6, 2021 | Class II | Edge Pharma, LLC | Lack of Assurance of Sterility |
| November 29, 2021 | Class II | Denver Solutions, LLC DBA Leiters Health not a listed maker | Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the moxifloxacin label say about other medicines?
The moxifloxacin label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 21 other medicines name moxifloxacin. 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 | … Uncorrected hypokalemia or hypomagnesemia Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents Other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants Elderly patients using intravenous … |
| Erythromycin | warnings and precautions | … example, amiodarone, sotalol) antiarrhythmic agents Other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants Elderly patients using intravenous moxifloxacin may be more susceptible to drug-associated QT prolongation [see Use In Specific Populations ( 8.5 … |
| Fluorescein | warnings and precautions | Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. |
| Procainamide | warnings and precautions | … and acute myocardial ischemia, Uncorrected hypokalemia or hypomagnesemia Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents Other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants Elderly … |
| Quinidine | warnings and precautions | … bradycardia and acute myocardial ischemia, Uncorrected hypokalemia or hypomagnesemia Class IA (for example, quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic agents Other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic … |
| Sotalol | drug interactions | Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous moxifloxacin in dogs. |
| Sucralfate | drug interactions | DRUG INTERACTIONS Interacting Drug Interaction Multivalent cation-containing products including: antacids, sucralfate, multivitamins Decreased moxifloxacin tablets absorption. |
| Warfarin | drug interactions | Take moxifloxacin tablets at least 4 hours before or 8 hours after these products. ( 2.2 , 7.1 , 12.3 ) Warfarin Anticoagulant effect enhanced. |
Other labels that name moxifloxacin
Source: FDA drug label (Moxifloxacin), Macleods Pharmaceuticals Limited, effective March 17, 2026 (SPL set 182ecd0f-714f-42f0-9b16-fb604cf15786), via openFDA; the full label on DailyMed
What do FAERS reports show for moxifloxacin?
The FDA Adverse Event Reporting System holds 20,168 reports that list moxifloxacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,667 are coded as a death and 6,896 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 moxifloxacin?
24 other medicines are given the same way (oral) and in the same FDA class as moxifloxacin 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 | 46 labelers | $0.123 per tablet 500 mg tablet | No current entry |
| Levofloxacin | Bacterial infections | 35 labelers | $0.259 per tablet 750 mg tablet | No current entry |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
| Azithromycin | Bacterial infections | 47 labelers | $0.266 per tablet 250 mg tablet | A presentation being discontinued |
| Cephalexin | Bacterial infections | 36 labelers | $0.120 per capsule 500 mg capsule | No current entry |
| Metronidazole | Bacterial infections | 40 labelers | $0.102 per tablet 250 mg tablet | In shortage |
| Clindamycin | Bacterial infections | 40 labelers | $0.103 per capsule 150 mg capsule | In shortage |
| Sulfamethoxazole and trimethoprim | Bacterial infections | 42 labelers | $0.0448 per tablet Sulfamethoxazole-tmp ds tablet | No current entry |
Every medicine labeled for the same conditions as moxifloxacin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does moxifloxacin compare with medicines for the same use?
13 side-by-side pages set moxifloxacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to moxifloxacin
- 24 medicines for the same use
- Other fluoroquinolones
- the pharmacologic class, with prices and generics
- Moxifloxacin side effects
- the label's list beside FAERS reports
- Moxifloxacin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other