Published: 4 September 2025
Publications
Systemic fluoroquinolone antibiotics: Safety reminder
Published: 4 September 2025
Prescriber Update 46(3): 38–40
September 2025
In March 2025 the Medicines Adverse Reactions Committee (MARC) reviewed several safety concerns related to systemic fluoroquinolone antibiotics. The MARC recommended that the data sheets for these medicines be updated. See the Medsafe website for the
meeting minutes and the
report to the MARC.
The data sheets of available products have been updated to state that serious, prolonged, and disabling adverse reactions, such as tendonitis/tendon rupture, peripheral neuropathy and psychiatric reactions, are potentially irreversible.
Fluoroquinolones
Systemically acting fluoroquinolone antibiotics currently available include ciprofloxacin, moxifloxacin and norfloxacin. All fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions and antibiotic resistance.1,2
The data sheets for these products have been updated to state that fluoroquinolones should only be prescribed when other antibiotics normally used to treat the infection are inappropriate (ie, these medicines should only be used second line).
Refer to local guidelines for information on antimicrobial prescribing.
Key safety concerns
Table 1 provides a summary of key safety concerns associated with fluoroquinolones.
Reports of serious, prolonged, disabling and potentially irreversible adverse reactions include (but are not limited to) tendonitis/tendon rupture, peripheral neuropathy and psychiatric reactions.
Patients of any age and without pre-existing risk factors have experienced these adverse reactions. These reactions can occur shortly after initiation of treatment, or in the case of tendon rupture, may occur months after stopping therapy.1,3,4 Remind patients to seek medical attention if they experience signs/symptoms during or following treatment.
Table 1: Safety concerns with systemic fluoroquinolone antibioticsa
| Body system | Adverse reactions |
|---|---|
| Cardiac |
QT prolongation Aortic aneurysm and dissection Kounis syndrome |
| Hepatobiliary | Fulminant hepatitis leading to liver failure |
| Musculoskeletal |
Tendonitis Tendon rupture Exacerbation of symptoms of myasthenia gravis |
| Nervous system |
Peripheral neuropathy Seizures |
| Psychiatric |
Anxiety reactions Depression* Psychotic reactions* *which may progress to suicidal ideation |
| Skin/subcutaneous tissue |
Photosensitivity reactions Toxic epidermal necrolysis Stevens-Johnson syndrome Acute generalised exanthematous pustulosis Drug reaction with eosinophilia and systemic symptoms |
- Not an exhaustive list. Refer to the data sheets for full information.
Sources: Moxifloxacin, norfloxacin and ciprofloxacin data sheets, available at: www.medsafe.govt.nz/Medicines/infoSearch.asp (accessed 27 June 2025).
New Zealand case reports
The New Zealand Pharmacovigilance database continues to receive adverse reaction reports associated with fluoroquinolones. Since January 2015, the majority of reports are for ciprofloxacin and relate to tendon adverse reactions. Table 2 shows the top five adverse reactions reported with a fluoroquinolone antibiotic.
Table 2: Top five adverse reaction terms reported with fluoroquinolone antibiotics, 1 January 2015 to 27 June 2025
| Adverse reaction (MedDRA preferred term) | Number of reports |
|---|---|
| Tendonitis | 62 |
| Tendon disorder | 21 |
| Tendon rupture | 12 |
| Arthralgia | 12 |
| Paraesthesia | 10 |
Source: New Zealand Pharmacovigilance database (accessed 27 June 2025).
References
- Bayer New Zealand Limited. 2025. Avelox New Zealand Data Sheet 4 June 2025. URL: www.medsafe.govt.nz/profs/datasheet/a/AveloxtabIVinf.pdf (accessed 27 June 2025).
- Fletcher-Lartey S, Dronavalli M, Alexander K, et al. 2019. Trends in antimicrobial resistance patterns in Neisseria gonorrhoeae in Australia and New Zealand: A meta-analysis and systematic review. Antibiotics 8(4): 191. URL: www.mdpi.com/2079-6382/8/4/191 (accessed 27 June 2025).
- Teva Pharma NZ Limted. 2025. Arrow-Norfloxacin New Zealand Data Sheet 19 May 2025. URL: www.medsafe.govt.nz/profs/datasheet/a/ArrowNorfloxacintab.pdf (accessed 27 June 2025).
- Ipca Pharma (NZ) Pty Limited. 2023. Ipca Ciprofloxacin New Zealand Data Sheet 12 September 2024. URL: www.medsafe.govt.nz/profs/Datasheet/i/Ipca-Ciprofoxacintab.pdf (accessed 2 July 2025).
