Moxifloxacin hydrochloride: adverse event reports filed with FDA

3,116

reports as suspect product

0% of all reports · about 139 a year

542

reports, 12 months to June 2026

454 in the 12 months before

96.7%

marked serious by the reporter

89.7% across the class

13.4%

record death among outcomes, as reported

419 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Moxifloxacin hydrochloride reports recording the termmedian drug in fluoroquinolone antibacterial

1. Asthmaasthma35.8%1,115
2. Drug hypersensitivityan allergic-type reaction to a medicine30.6%952
3. Dyspnoeashortness of breath27.3%852
4. Wheezingwheezing27.3%851
5. Painpain, site not specified26.6%829
6. Pneumonialung infection23.2%723
7. Rashskin rash23.2%722
8. Vomitingbeing sick22.3%696
9. Off label useused for a purpose or in a way not on the label21.9%681
10. Drug ineffectivethe medicine did not work as expected19.5%608
11. Malaisegeneral feeling of being unwell18.9%589
12. Hypertensionhigh blood pressure18.3%570
13. Drug intolerancethe medicine was not tolerated17.5%545
14. Hypersensitivityan allergic-type reaction16.8%523
15. Fatiguetiredness16.7%521
16. Joint swellinga swollen joint16.7%520
17. Oedemaswelling from fluid16%498
18. Coughcough15.7%490
19. Headachehead pain15.7%489
20. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease15.6%486
21. Hepatic enzyme increasedraised liver enzymes15.6%485
22. Product use issuea problem in how the product was used14.9%465
23. Pyrexiafever14.9%464
24. Infusion related reactiona reaction during or soon after an infusion14.5%453
25. Exposure during pregnancythe medicine was taken during pregnancy14%436
26. Hyperhidrosisexcessive sweating13.8%430
27. Contraindicated product administered13.3%414
28. Treatment failurethe treatment did not work12.5%389
29. Condition aggravatedthe condition being treated got worse12.4%385
30. Upper respiratory tract infectiona cold or similar infection12.1%378

Top 30 of 743 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the fluoroquinolone antibacterial class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 88,718 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 5.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,116 reports.

Drugs most often listed in the same reports

Other products listed in reports where Moxifloxacin hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the fluoroquinolone antibacterial class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Moxifloxacin hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,086) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.