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Factive Side Effects

Generic Name: gemifloxacin

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 tablet

Warning

Oral route (Tablet)

Fluoroquinolones, including gemifloxacin mesylate, are associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue gemifloxacin mesylate and avoid use of fluoroquinolones in patients with these serious adverse reactions. Reserve use of gemifloxacin mesylate for patients with no alternative treatment options for acute bacterial exacerbation of chronic bronchitis. Fluoroquinolones, including gemifloxacin mesylate, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid in patients with known history of myasthenia gravis.

Side effects requiring immediate medical attention

Along with its needed effects, gemifloxacin (the active ingredient contained in Factive) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking gemifloxacin:

Less common

  • Rash

Rare

  • Body aches or pain
  • burning, numbness, tingling, or painful sensations
  • chest pain or tightness
  • chills
  • fever
  • hives or welts, itching skin
  • lightheadedness
  • painful or difficult urination
  • muscle aching or cramping
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • trembling or shaking of the hands or feet
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
  • yellow eyes or skin

Incidence not known

  • Bleeding gums
  • Blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody urine
  • blurred or double vision or other changes in vision
  • bone pain
  • confusion
  • cough
  • coughing up blood
  • decreased frequency or amount of urine
  • difficulty with breathing or swallowing
  • difficulty with chewing or talking
  • dizziness
  • drooping eyelids
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • headache
  • increased blood pressure
  • increased menstrual flow or vaginal bleeding
  • increased sensitivity of the skin to sunlight
  • increased thirst
  • irregular heartbeat, recurrent
  • loss of appetite
  • lower back or side pain
  • muscle pain or weakness
  • nausea
  • numbness or tingling in the face, arms, or legs
  • nosebleeds
  • painful, swollen joints
  • paralysis
  • prolonged bleeding from cuts
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red or black, tarry stools
  • red or dark brown urine
  • redness or other discoloration of the skin
  • sensation of skin burning
  • severe sunburn
  • severe tiredness
  • stomach cramps or tenderness
  • swelling of the face, fingers, or lower legs
  • trouble speaking, thinking, or walking
  • unusual weight gain or loss
  • vomiting
  • watery or bloody diarrhea

Side effects not requiring immediate medical attention

Some side effects of gemifloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

  • Bad, unusual, or unpleasant taste
  • difficulty having a bowel movement
  • dryness or soreness of the throat
  • feeling of constant movement of self or surroundings
  • hoarseness
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating
  • voice changes

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

2. "Product Information. Factive (gemifloxacin)." GeneSoft Inc, San Francisco, CA.

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

4. File TM Jr, Mandell LA, Tillotson G, Kostov K, Georgiev O "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):

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

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

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

8. Briasoulis A, Agarwal V, 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.