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Gemifloxacin Side Effects

For the Consumer

Applies to gemifloxacin: oral tablet

In addition to its needed effects, some unwanted effects may be caused by gemifloxacin. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking gemifloxacin:

Less common:
  • Rash
Rare
  • 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

Minor Side Effects

Some of the side effects that can occur with gemifloxacin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Rare
  • 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

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

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]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions
Postmarketing reports: Anaphylactic reactions[Ref]

References

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

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

Not all side effects for gemifloxacin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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