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Factive Side Effects

Generic name: gemifloxacin

Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.

Note: This document contains side effect information about gemifloxacin. Some of the dosage forms listed on this page may not apply to the brand name Factive.

For the Consumer

Applies to gemifloxacin: oral tablets

Warning

    Serious Adverse Reactions
  • Fluoroquinolones, including gemifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that have occurred together.1 Discontinue immediately and avoid use of fluoroquinolones, including gemifloxacin, in patients who have experienced any of these serious adverse reactions.1 (See Warnings under Cautions.)

  • Fluoroquinolones, including gemifloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.1 Avoid in patients with known history of myasthenia gravis.1

  • Because of risk of serious adverse reactions, use gemifloxacin for treatment of acute bacterial exacerbations of chronic bronchitis only when no other treatment options available.1

Side effects include:

GI effects (diarrhea, nausea, abdominal pain, vomiting), rash, headache, dizziness.

For Healthcare Professionals

Applies to gemifloxacin: oral tablet

Dermatologic

Most side effects reported during postmarketing experience were cutaneous (some were considered serious) and the majority of these were rash. Most rashes occurred in patients younger than 40 years, in women (especially those on hormone replacement therapy), and in patients taking this drug for longer treatment durations (over 7 days).

The phototoxic potential of this drug may be dose-dependent.[Ref]

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Dermatitis, pruritus, urticaria

Rare (less than 0.1%): Eczema, photosensitivity/phototoxicity reactions

Postmarketing reports: Erythema multiforme, skin exfoliation[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting

Uncommon (0.1% to 1%): Constipation, dry mouth, dyspepsia, flatulence, gastritis

Rare (less than 0.1%):Gastroenteritis, nonspecified gastrointestinal disorder

Frequency not reported: Clostridium difficile-associated diarrhea

Postmarketing reports: Antibiotic-associated colitis[Ref]

Nervous system

Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.[Ref]

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Somnolence, taste perversion

Rare (less than 0.1%): Tremor, vertigo, central nervous system effects

Frequency not reported: Seizures, sensory axonal polyneuropathy, sensorimotor axonal polyneuropathy, paresthesias, hypoesthesias, dysesthesias, neurotoxicity (presenting as encephalopathy)

Postmarketing reports: Exacerbation of myasthenia gravis, peripheral neuropathy (may be irreversible), syncope[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST

Uncommon (0.1% to 1%): Increased GGT, increased total bilirubin

Rare (less than 0.1%): Bilirubinemia[Ref]

Other

Uncommon (0.1% to 1%): Fatigue, fungal infection, increased alkaline phosphatase, increased potassium, decreased albumin, decreased sodium, decreased calcium, decreased total protein, decreased potassium, increased sodium

Rare (less than 0.1%): Asthenia, facial edema, flushing, hot flashes, pain, moniliasis, increased LDH, increased calcium

Frequency not reported: Weakness

Postmarketing reports: Facial swelling, peripheral edema[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, hyperglycemia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Increased creatine phosphokinase

Rare (less than 0.1%): Arthralgia, back pain, leg cramps, myalgia

Frequency not reported: Tendinitis

Postmarketing reports: Tendon rupture[Ref]

Hematologic

Uncommon (0.1% to 1%): Increased platelets, decreased neutrophils, increased neutrophils, decreased hematocrit, decreased hemoglobin, decreased platelets, decreased RBCs, increased hematocrit, increased hemoglobin, increased RBCs, leukopenia, thrombocythemia

Rare (less than 0.1%): Anemia, eosinophilia, granulocytopenia, thrombocytopenia

Postmarketing reports: Hemorrhage, increased INR[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia

Rare (less than 0.1%): Nervousness

Renal

Uncommon (0.1% to 1%): Increased BUN, increased serum creatinine

Rare (less than 0.1%): Increased non-protein nitrogen

Frequency not reported: Acute renal failure

Postmarketing reports: Renal failure[Ref]

Genitourinary

Uncommon (0.1% to 1%): Genital moniliasis, genital pruritus, vaginitis

Rare (less than 0.1%): Abnormal urine[Ref]

Ocular

Rare (less than 0.1%): Abnormal vision

Postmarketing reports: Retinal hemorrhage[Ref]

Respiratory

Rare (less than 0.1%): Dyspnea, pharyngitis, pneumonia

Frequency not reported: Bronchitis[Ref]

Cardiovascular

QTc interval prolongation has been reported; no cardiovascular morbidity or mortality due to QTc prolongation occurred during studies. Maximum QTc changes occurred 5 to 10 hours after oral administration of this drug. This effect may be dose-related.[Ref]

Frequency not reported: Ventricular extrasystoles

Postmarketing reports: Prolonged QT, supraventricular tachycardia, transient ischemic attack[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions

Postmarketing reports: Anaphylactic reactions[Ref]

References

1. "Product Information. Factive (gemifloxacin)." *GeneSoft Inc (2003):

2. Lowe MN, Lamb HM "Gemifloxacin." Drugs 59 (2000): 1137-47; discussion 1148

3. Allen A, Bird N, Ferguson J, Richards J, Vousden M "Evaluation of phototoxic potential of gemifloxacin in healthy volunteers compared with ciprofloxacin." Chemotherapy 45 (1999): 512-20

4. Triller DM, Yong CS, Lodise TP, Yoo BK "Gemifloxacin: a new fluoroquinolone approved for treatment of respiratory infections." Ann Pharmacother 38 (2004): 1226-35

5. Andes DR, Bhavnani SM "Gemifloxacin for the treatment of respiratory tract infections: in vitro susceptibility, pharmacokinetics and pharmacodynamics, clinical efficacy, and safety." Pharmacotherapy 25 (2005): 717-40

6. Georgiev O, Kostov K, File TM Jr, Mandell LA, Tillotson G "Gemifloxacin once daily for 5 days versus 7 days for the treatment of community-acquired pneumonia: a randomized, multicentre, double-blind study." J Antimicrob Chemother (2007):

7. Barrett MJ, Login IS "Gemifloxacin-associated neurotoxicity presenting as encephalopathy." Ann Pharmacother 43 (2009): 782-4

8. Agarwal V, Briasoulis A, Pierce WJ "QT Prolongation and Torsade de Pointes Induced by Fluoroquinolones: Infrequent Side Effects from Commonly Used Medications." Cardiology 120 (2011): 103-110

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.