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moxifloxacin

Sold as Vigamox, Avelox. Class: Fluoroquinolones; Fluoroquinolones. First FDA approval 12/10/1999: 27 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

C

Score breakdown (67/100)

Safety ×35%
D
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
A

Safety: 50

Evidence: 44

Regulatory history: 90

Money & lawsuits: 100

Options: 100

FDA boxed warning

WARNING: 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 )]. Because fluoroquinolones, including moxifloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 - 5.13 )] , ...

Independent reviews and post-approval warnings

Prescrire: drug to avoid

Moxifloxacin, a fluoroquinolone antibiotic that is no more effective than other antibiotics of this class, can cause toxic epidermal necrolysis and fulminant hepatitis, and has also been linked to an increased risk of cardiac disorders ( Prescrire Int n° 62, 103, 117; Rev Prescrire n° 371). Another fluoroquinolone such as ciprofloxacin or ofloxacin is a better option. Neurology Alzheimer’s disease. The cholinesterase inhibitors authorised for use in Alzheimer’s disease, as well as memantine, have minimal and transient efficacy in this situation, and none has been shown to slow progression towa...

Prescrire is a French independent review funded only by subscribers, with no industry money. Its annual "drugs to avoid" list (2026 edition, section: Infectious diseases) names drugs it judges more harmful than useful in every authorised indication. Its view is one expert opinion, reached without a conflict of interest.

WHO Essential Medicine

Listed on the WHO Model List of Essential Medicines (antibiotic stewardship group: KeyAccessGroup, WatchGroup): a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.

What the FDA label says

Approved uses

Moxifloxacin 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. Moxifloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.8 ) 1.1 Community Acquired Pneumonia Moxifloxacin tablets are indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]) , Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumonia...

Contraindications

Moxifloxacin tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions ( 5.8 )] . Known hypersensitivity to moxifloxacin tablets or other quinolones ( 4 , 5.8 )

Warnings and precautions

Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. ( 5.6 , 7.5 , 8.5 ) Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin tablets. Discontinue moxifloxacin tablets at first sign of skin rash, jaundice or any other sign of hypersensitivity. ( 5.7 , 5.8 ) Clostridioides difficile- Associated Diarrhea: Evaluate if diarrhea occurs. ( 5.10 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including moxifloxacin tablets, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peri...

Adverse reactions (label)

The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label: Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions ( 5.1 )] 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 )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5 )] QT Prolongation [see Warnings and Precautions ( 5.6 )] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions ( 5.7 )] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions ( 5.10 )] Blood Glucose Disturbances [see Warnings and Precautions ( 5.12 )] Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.13 )] Development of Drug Resistant Bacteria [see Warnings and Prec...

Recent major label changes

Warnings and Precautions, Hypersensitivity Reactions ( 5.8 ) 7/2025

Source: FDA SPL label for Moxifloxacin (Macleods Pharmaceuticals Limited), effective 20260317. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

24,795reports that mention this drug
24,711of those blame this drug, not another one the person was taking
84%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
11.7%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Off Label Use · 2,560Drug Hypersensitivity · 2,449Dyspnoea · 2,376Drug Ineffective · 2,128Pneumonia · 2,128Pain · 1,983Vomiting · 1,920Asthma · 1,888Rash · 1,586Fatigue · 1,567Wheezing · 1,563Neuropathy Peripheral · 1,534Nausea · 1,531Malaise · 1,361Pyrexia · 1,324

Reports per year

20192020202120222023202420252026
2,5242,3761,9091,9612,0452,2502,600966

5,176 reports blaming this drug for every million Medicare prescriptions filled, which is 1.9× the typical drug on this site. (5,780 reports in 2024–2026, against 1,116,701 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

3recall actions on file
6 / 25brand / generic applications
3label changes since 2021
NoREMS program
DateClassFirmReason
02/2019Class IIILupin Pharmaceuticals Inc.Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
02/2019Class IIILupin Pharmaceuticals Inc.Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
07/2018Class IIILupin Pharmaceuticals Inc.Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

267randomized trials (PubMed)
28systematic reviews
704registered trials
28%of completed trials posted results
8%terminated or withdrawn
69%industry-funded

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

708,017Medicare Part D patients (2024)
1,116,701prescriptions filled
$25average cost per fill
$28Mtotal Medicare spend
ProductFills$/fill
Moxifloxacin1,052,157$24
Moxifloxacin HCl64,055$44
Vigamox489$243

Same-class alternatives

2 drugs in the same class grade a letter or more higher than moxifloxacin on this site. Worth asking whether one of them would do the same job for you.

besifloxacindelafloxacinenoxacinfleroxacingatifloxacingemifloxacingrepafloxacinlomefloxacinnorfloxacinpefloxacinsparfloxacintemafloxacintrovafloxacin

Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.

Questions to ask your prescriber

  1. An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?
  2. This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
  3. The most-reported problems in FDA's adverse event data are drug hypersensitivity, dyspnoea. How would we recognize and handle those?
  4. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
  5. Why this one over besifloxacin, ciprofloxacin, delafloxacin? What would make you pick one of those instead?
  6. What result are we expecting, by when, and what is the plan if it does not happen?
  7. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)