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Gemifloxacin Side Effects

For the Consumer

Applies to gemifloxacin: oral tablet

Along with its needed effects, gemifloxacin 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


  • Body aches or pain
  • burning, numbness, tingling, or painful sensations
  • chest pain or tightness
  • chills or fever
  • hives or welts or itching skin
  • itching skin
  • painful or difficult urination
  • shortness of breath
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • 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

  • Abdominal or stomach tenderness
  • blistering, peeling, or loosening of the skin
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • changes in urination
  • changes in vision
  • confusion
  • diarrhea
  • difficulty with breathing or swallowing
  • difficulty with chewing or talking
  • dizziness
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • joint or muscle pain
  • muscle weakness
  • nausea or vomiting
  • numbness or tingling in the face, arms, or legs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness or other discoloration of the skin
  • severe sunburn
  • swelling of the face, fingers, or lower legs
  • weight gain

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:


  • Acid or sour stomach
  • bad, unusual, or unpleasant taste
  • difficulty having a bowel movement (stool)
  • dizziness or lightheadedness
  • dryness or soreness of the throat
  • feeling of constant movement of self or surroundings
  • hoarseness
  • muscle aching or cramping
  • pain in the joints
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating
  • trembling or shaking of the hands or feet
  • voice changes

For Healthcare Professionals

Applies to gemifloxacin: oral tablet


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]


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]


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]


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]


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


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]


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]


Uncommon (0.1% to 1%): Insomnia

Rare (less than 0.1%): Nervousness


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]


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

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


Rare (less than 0.1%): Abnormal vision

Postmarketing reports: Retinal hemorrhage[Ref]


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

Frequency not reported: Bronchitis[Ref]


Frequency not reported: Ventricular extrasystoles

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

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: Hypersensitivity reactions

Postmarketing reports: Anaphylactic reactions[Ref]


1. 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):

2. 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

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

4. 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

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

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

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.