Gemifloxacin Side Effects
Medically reviewed by Drugs.com. Last updated on Aug 23, 2024.
Applies to gemifloxacin: oral tablet.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
If you have low potassium levels in the blood, gemifloxacin may increase your risk of having a fast, slow or irregular heartbeat, loss of consciousness, or fainting spells. If these symptoms occur, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.
Serious side effects can occur during treatment with this medicine and can occur without warning. Possible warning signs include: black, tarry stools, blistering, peeling, or loosening of the skin, bloody or cloudy urine, chills, decreased urination, diarrhea, fever, joint or muscle pain, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, or unusual weight gain. Check with your doctor immediately if you notice any of these warning signs.
Gemifloxacin may cause serious liver problems, including hepatitis. Check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while you are using this medicine.
Gemifloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.
Gemifloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can occur while you are taking the medicine or after you finish taking it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant (eg, heart, kidney, or lung). Check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.
Tell your doctor right away if you have the following symptoms while using this medicine: convulsions (seizures), feeling anxious, confused, or depressed, seeing, hearing, or feeling things that are not there, severe headache, trouble sleeping, or unusual thoughts or behaviors.
Some people who take gemifloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn, skin rash, redness, itching, or discoloration. When you begin taking this medicine:
- Stay out of direct sunlight, especially between the hours of 10:00 AM and 3:00 PM, if possible.
- Wear protective clothing, including a hat and sunglasses.
- Apply a sun block product that has a sun protection factor (SPF) of at least 15. Some people may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
- Do not use a sun lamp or tanning bed or booth.
If you have a severe reaction from the sun, check with your doctor.
Gemifloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.
If you are a diabetic patient taking diabetes medicine by mouth: Gemifloxacin may cause hypoglycemia (low blood sugar) in some patients. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. If you experience symptoms of low blood sugar, check with your doctor right away.
- Symptoms of low blood sugar can include: anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty with concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
Less common side effects
- rash
Rare side effects
- 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
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:
Rare side effects
- 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 adverse events
- 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]
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]
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
- 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]
Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.[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]
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References
1. (2003) "Product Information. Factive (gemifloxacin)." *GeneSoft Inc
2. Lowe MN, Lamb HM (2000) "Gemifloxacin." Drugs, 59, 1137-47; discussion 1148
3. Vousden M, Ferguson J, Richards J, Bird N, Allen A (1999) "Evaluation of phototoxic potential of gemifloxacin in healthy volunteers compared with ciprofloxacin." Chemotherapy, 45, p. 512-20
4. Yoo BK, Triller DM, Yong CS, Lodise TP (2004) "Gemifloxacin: a new fluoroquinolone approved for treatment of respiratory infections." Ann Pharmacother, 38, p. 1226-35
5. Bhavnani SM, Andes DR (2005) "Gemifloxacin for the treatment of respiratory tract infections: in vitro susceptibility, pharmacokinetics and pharmacodynamics, clinical efficacy, and safety." Pharmacotherapy, 25, p. 717-40
6. File TM Jr, Mandell LA, Tillotson G, Kostov K, Georgiev O (2007) "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
7. Barrett MJ, Login IS (2009) "Gemifloxacin-associated neurotoxicity presenting as encephalopathy." Ann Pharmacother, 43, p. 782-4
8. Briasoulis A, Agarwal V, Pierce WJ (2011) "QT Prolongation and Torsade de Pointes Induced by Fluoroquinolones: Infrequent Side Effects from Commonly Used Medications." Cardiology, 120, p. 103-110
More about gemifloxacin
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- Drug class: quinolones and fluoroquinolones
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Further information
Gemifloxacin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.