Gemifloxacin: Side Effects, Uses & Monitoring
FACTIVE is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
- Data source
- FDA labeling via NIH DailyMed (label 63f60426…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Females, < 40 years | 9.1% |
| Males, < 40 years | 5% |
| Totals | 4% |
| Males, ≥ 40 years | 3.3% |
| Females, ≥ 40 years | 2.3% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
FACTIVE is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES. ) Acute bacterial exacerbation of chronic bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis . Because fluoroquinolones, including FACTIVE, have been associated with serious adverse reactions (see WARNINGS ) and for some patients ABECB is self-limiting, reserve FACTIVE for treatment of ABECB in patients who have no alternative treatment options. Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae . *MDRSP: multi-drug resistant Streptococcus pneumoniae , includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae ), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolid…
Conditions associated with Gemifloxacin in labeling
Bronchitis
Inflammation of the bronchial tubes, usually viral, causing a productive cough that can last several weeks....
COPD
A group of progressive lung diseases, including emphysema and chronic bronchitis, that cause airflow obstructi...
Chlamydia Infection
A common sexually transmitted bacterial infection that often causes no symptoms but can lead to pelvic pain, d...
Pneumonia
Infection of the lung tissue that can cause cough, fever, chills, and difficulty breathing. Can be caused by b...
Frequently Asked Questions
What is Gemifloxacin used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Gemifloxacin?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Gemifloxacin. Individual risk varies.
Does Gemifloxacin require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Gemifloxacin.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.