Gemifloxacin Side Effects
Medically reviewed by Drugs.com. Last updated on Aug 23, 2023.
Applies to gemifloxacin: oral tablet.
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.
Serious side effects of Gemifloxacin
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:
- Body aches or pain
- burning, numbness, tingling, or painful sensations
- chest pain or tightness
- hives or welts, itching skin
- 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
- coughing up blood
- decreased frequency or amount of urine
- difficulty with breathing or swallowing
- difficulty with chewing or talking
- drooping eyelids
- fast, pounding, or irregular heartbeat or pulse
- 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
- numbness or tingling in the face, arms, or legs
- painful, swollen joints
- 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
- watery or bloody diarrhea
Other side effects of Gemifloxacin
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:
- Bad, unusual, or unpleasant taste
- difficulty having a bowel movement
- dryness or soreness of the throat
- feeling of constant movement of self or surroundings
- redness of the face, neck, arms, and occasionally, upper chest
- sudden sweating
- 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
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)
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%): 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
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
Rare (less than 0.1%): Dyspnea, pharyngitis, pneumonia
Frequency not reported: Bronchitis[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: Ventricular extrasystoles
Frequency not reported: Hypersensitivity reactions
Postmarketing reports: Anaphylactic reactions[Ref]
More about gemifloxacin
- Check interactions
- Compare alternatives
- Reviews (10)
- Latest FDA alerts (6)
- Dosage information
- During pregnancy
- Drug class: quinolones and fluoroquinolones
- En español
Related treatment guides
1. Product Information. Factive (gemifloxacin). *GeneSoft Inc. 2003.
2. Lowe MN, Lamb HM. Gemifloxacin. Drugs. 2000;59:1137-47; discussion 1148.
3. Vousden M, Ferguson J, Richards J, Bird N, Allen A. Evaluation of phototoxic potential of gemifloxacin in healthy volunteers compared with ciprofloxacin. Chemotherapy. 1999;45:512-20.
4. Yoo BK, Triller DM, Yong CS, Lodise TP. Gemifloxacin: a new fluoroquinolone approved for treatment of respiratory infections. Ann Pharmacother. 2004;38:1226-35.
5. Bhavnani SM, Andes DR. Gemifloxacin for the treatment of respiratory tract infections: in vitro susceptibility, pharmacokinetics and pharmacodynamics, clinical efficacy, and safety. Pharmacotherapy. 2005;25:717-40.
6. 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.
7. Barrett MJ, Login IS. Gemifloxacin-associated neurotoxicity presenting as encephalopathy. Ann Pharmacother. 2009;43:782-4.
8. Briasoulis A, Agarwal V, Pierce WJ. QT Prolongation and Torsade de Pointes Induced by Fluoroquinolones: Infrequent Side Effects from Commonly Used Medications. Cardiology. 2011;120:103-110.
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.