Pefloxacin

Generic name: pefloxacin
Brand names: Peflacine (France/international)
Drug class: Fluoroquinolone Antibiotic
Form: Tablet; IV infusion
Route: Oral, intravenous
Legal status: NOT FDA-approved or currently marketed in the United States. Confirmed Never Authorised in Canada. US, UK, Australia, and New Zealand status could not be independently confirmed with a direct database query in this pass, despite real negative signals in each case.

Supply Rules Vary

Trade names by country:

What pefloxacin is and how it works

Pefloxacin is a fluoroquinolone antibiotic used outside the United States (it has no FDA approval or US marketing) to treat a range of bacterial infections including urinary, respiratory, skin, bone/joint, and gynecological infections. (1)

As with all fluoroquinolones, there are real, serious safety considerations — including a risk to developing joints that makes this medicine unsuitable for children, adolescents still growing, pregnant women, and breastfeeding mothers.

Mechanism of action: how pefloxacin works

Pefloxacin is a fluoroquinolone antibiotic. Distinctively among fluoroquinolones, it is predominantly hepatically eliminated rather than renally eliminated — the basis for its dose-adjustment considerations differing from most other class members. (1) (2)

What pefloxacin is used for

Urinary tract infections, including single-dose treatment of acute uncomplicated cystitis

Treats UTIs, with a single-dose option available for uncomplicated acute cystitis and urethritis in appropriate patients. (1)

Respiratory tract infections

Treats lower respiratory tract infections due to susceptible bacteria. (1)

Skin and soft tissue infections

Treats skin and soft tissue infections, including surgical wound infections. (1)

Bone and joint infections

Treats bone and joint infections due to susceptible bacteria. (1)

Prostatitis and gynecological infections

Treats acute and chronic prostatitis and gynecological infections due to susceptible bacteria. (1)

Gastrointestinal infections and sepsis

Treats gastrointestinal infections and, in appropriate clinical settings, sepsis due to susceptible bacteria. (1)

Before taking pefloxacin

Do not take / not appropriate for

Do not take pefloxacin if you are pregnant or breastfeeding. (pregnancy, breastfeeding) (1)
Do not give pefloxacin to children or adolescents whose bones are still growing, because of a real risk of joint damage seen with this class of antibiotic. (children/adolescents until growth has ceased) (1)
Do not take pefloxacin if you have a known hypersensitivity to pefloxacin or other quinolone antibiotics. (hypersensitivity) (1)

Tell your clinician about

Any tendon problems or previous tendon injury.
Any liver disease — this medicine is mainly cleared by the liver, unlike many other antibiotics in its class.
If you are over 60, take corticosteroids, or have had an organ transplant — these increase tendon-rupture risk with this class of antibiotic.
Any personal or family history of aortic aneurysm or heart valve problems.

(1) (3)

How to take pefloxacin

Typical adult oral dose is 400mg twice daily for 7-10 days, taken with food.
An intravenous form also exists, given as a slow infusion in a clinical setting.
Complete the full course as directed by your prescriber.

(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)

Missed dose

Contact your prescriber or pharmacist for guidance on a missed dose.

Overdose

Seek emergency care or local poison control guidance for a suspected overdose. No specific overdose data for this drug was found in the sources reviewed for this pass. (1)

Side effects

As a fluoroquinolone, this medicine carries the same class-wide serious risks described below, in addition to more common digestive and skin effects reported for antibiotics generally.

Digestive upset, skin reactions

What to notice: Specific rates were not found in the sources reviewed for this pass.

What to do: Mention any new or bothersome symptoms to your clinician. (1)

Tendon pain or swelling

What to notice: Pain, swelling, or inflammation in a tendon (e.g. the Achilles tendon), which can occur during or even months after treatment.

What to do: Stop activity on the affected area and contact your clinician promptly. (3)

Nerve symptoms

What to notice: Numbness, tingling, weakness, or pain in the hands or feet, which can be irreversible.

What to do: Contact your clinician promptly. (3)

Serious warnings

Tendon rupture and tendinitis (fluoroquinolone class warning) — serious

Symptoms: Tendon pain, swelling, or rupture, especially in people over 60, those on corticosteroids, or those with a kidney/lung/heart transplant.

Action: Contact your clinician immediately if tendon symptoms occur; you may be advised to stop the medicine. Rest the affected area and do not take the next dose unless your clinician tells you to. (3)

Peripheral neuropathy (fluoroquinolone class warning) — serious

Symptoms: Numbness, tingling, or weakness in the hands or feet that can be irreversible.

Action: Contact your clinician immediately if these symptoms occur. (3)

Aortic aneurysm/dissection (fluoroquinolone class warning) — serious

Symptoms: Sudden, severe chest, back, or abdominal pain.

Action: Seek emergency care immediately, especially if you have risk factors like existing aneurysm, high blood pressure, or certain genetic conditions. (3)

Joint/cartilage damage in growing bones — serious

Symptoms: Not applicable to adults with mature bones — this is why the medicine is not given to children or adolescents whose growth is not complete.

Action: Do not use in this population. (1)

Interactions

Medicine or test	Effect	Action
Antacids and mineral supplements	Fluoroquinolones, including pefloxacin, have reduced absorption when taken with antacids or mineral-containing products.	Separate timing from antacids/mineral supplements — discuss the specific interval with your pharmacist. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Hepatic impairment — the key dose-adjustment consideration for this specific drug

Unlike most other fluoroquinolones, which are cleared mainly by the kidneys, pefloxacin is cleared mainly by the liver. This means liver function, not kidney function, is the main consideration for dose adjustment with this particular antibiotic. (2)

Pregnancy and breastfeeding — contraindicated

Pefloxacin should not be used during pregnancy or breastfeeding. (1)

Children and adolescents — contraindicated until growth is complete

This medicine should not be given to children or adolescents whose bones are still growing, because of a real risk of joint or cartilage damage documented with this class of antibiotic. (1)

Monitoring

Before starting

Confirm the patient is not pregnant/breastfeeding and, if a minor, has completed bone growth.
Review liver function.
Review any personal/family history of tendon problems or aortic aneurysm.

During treatment

Watch for tendon pain or swelling.
Watch for numbness, tingling, or weakness in the hands or feet.
Watch for sudden severe chest, back, or abdominal pain.

(3)

Storage

Store at controlled room temperature per the product's specific packaging instructions.

Professional information

Clinician-facing context only. This medicine's evidence base is lower-confidence than other Growth Sprint 1 medicines — secondary summaries of French/international information, not a directly-fetched primary regulator document. Reconfirm against a directly-fetched RCP/SmPC before relying on this content for clinical decisions.

Outside the United States (France/international)

Indication: Full indication list above, per secondary-sourced information

Dose summary: Oral 400mg BID x7-10 days with food; IV 400mg/100mL 5% dextrose over 1h BID.

Renal context: Hepatic (not renal) elimination is the key dosing consideration for this drug. (1) (2)

United States

Indication: Not FDA-approved / not currently marketed.

Dose summary: Not applicable.

Renal context: Not applicable.

United Kingdom, Australia, New Zealand

Indication: Unable to verify in this pass — real negative signals found in each case but no direct, conclusive database query performed.

Dose summary: Not available.

Renal context: Not available. (5)

Canada

Indication: Never authorised — confirmed absent from the Health Canada Drug Product Database.

Dose summary: Not applicable.

Renal context: Not available. (4)

Mechanism of action

Hepatic guidance

The primary elimination route for this drug — liver function is the key dosing consideration, unlike most other fluoroquinolones.

Overdose note

No drug-specific overdose data found in the sources reviewed for this pass; general fluoroquinolone-class supportive-care principles would apply, per clinical judgment. (1) (2)

Frequently asked questions

Is pefloxacin available in the United States?

No — pefloxacin does not have FDA approval and is not currently marketed in the United States.

Why is pefloxacin not given to children?

Fluoroquinolone antibiotics, including pefloxacin, carry a real, documented risk of joint and cartilage damage in growing bones, so this medicine is avoided in children and adolescents until their growth is complete, as well as in pregnancy and breastfeeding. (1)

How is pefloxacin different from other fluoroquinolones?

Most fluoroquinolones are cleared mainly by the kidneys, but pefloxacin is cleared mainly by the liver — so liver function, not kidney function, is the main consideration for adjusting its dose. (2)

What is the mechanism of action of pefloxacin?

What is the generic name of Pefloxacin?

The generic name is pefloxacin. It is sold under brand names including Peflacine (France/international). (1)

What class of drug is pefloxacin?

Pefloxacin is classed as: Fluoroquinolone Antibiotic. (1)

References

Pefloxacin indications, dosing, and contraindications (secondary summary of French prescribing information)Secondary clinical summaries (Vinmec, Pediatric Oncall) citing French/HAS prescribing information · not US — France/international · accessed 2026-07-27 · source 1
Pefloxacin's hepatic (not renal) elimination pathwayScienceDirect topic overview / secondary pharmacology summary · class_level_not_country_specific · accessed 2026-07-27 · source 2
Fluoroquinolone class boxed warnings: tendon rupture (2008), peripheral neuropathy (2013), aortic aneurysm/dissection (2018)FDA (class-wide boxed warnings), carried over from the Antibiotics family research pack · class_level_not_pefloxacin_specific · accessed 2026-07-27 · source 3
DPD active-ingredient API query for pefloxacin (zero results)Health Canada Drug Product Database, public API · Canada · accessed 2026-07-27 · source 4
Systemic fluoroquinolone antibiotics: Safety reminder (2025)Medsafe (New Zealand) · New Zealand · accessed 2026-07-27 · source 5

Brand names by country

Single-ingredient pefloxacin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

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