Gemifloxacin Side Effects

Brand Names: Factive

Please note - some side effects for Gemifloxacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Gemifloxacin - for the Consumer

Gemifloxacin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gemifloxacin:

Diarrhea; dizziness; drowsiness; headache; nausea; stomach upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain or pounding in the chest; dark urine; decreased urination; excessive hunger, thirst, or urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; "fruity"-smelling breath; hallucinations; hoarseness; inability to move or bear weight on a joint or tendon area; joint pain; moderate or severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion depression, nervousness, restlessness, sleeplessness); muscle pain or weakness; nervousness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent diarrhea; severe or persistent dizziness or lightheadedness; shortness of breath; stomach pain/cramps; suicidal thoughts or actions; sweating; tremors; unusual bruising or bleeding; unusual swelling or weight gain; unusual weakness or tiredness; vaginal odor or discharge; vision changes; yellowing of the eyes or skin.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects have included diarrhea (5%), nausea (3.7%), abdominal pain (greater than 0.1% to 2.2%), and vomiting (greater than 0.1% to 1.6%). Anorexia, constipation, dry mouth, dyspepsia, flatulence, and gastritis have been reported in greater than 0.1% to 1% of patients and moniliasis, gastroenteritis, and nonspecified gastrointestinal disorder have been reported in 0.1% or less. Antibiotic-associated colitis has been reported during postmarketing experience.

Dermatologic

Most of the adverse events reported during postmarketing experience were cutaneous (some were considered serious) and the majority of these events were rash. Most of the rashes occurred in patients less than 40 years of age, in women (especially those on hormone replacement therapy), and in patients taking gemifloxacin for longer treatment durations (over 7 days).

The phototoxic potential of gemifloxacin may be dose-dependent.

Dermatologic side effects have included rash (3.5%). Dermatitis, pruritus, and urticaria have been reported in greater than 0.1% to 1% of patients and eczema and photosensitivity/phototoxicity reaction have been reported in 0.1% or less. Erythema multiforme and skin exfoliation have been reported during postmarketing experience.

Nervous system

Nervous system side effects have included headache (4.2%), dizziness (1.7%), insomnia (greater than 0.1% to 1%), and somnolence (greater than 0.1% to 1%). Nervousness, tremor, and vertigo have been reported in 0.1% or less.

Metabolic

Metabolic side effects have included hyperglycemia (greater than 0.1% to 1%), increased potassium (0.3% to 0.5%), decreased sodium (0.2% to 0.3%), decreased calcium (0.1% to 0.2%), decreased albumin (0.3%), decreased total protein (0.1%), decreased potassium (0.1%), increased sodium (0.1%), increased lactate dehydrogenase (less than 0.1%), and increased calcium (less than 0.1%).

Hepatic

Hepatic side effects have included increased ALT (greater than 0.1% to 1.7%), increased AST (greater than 0.1% to 1.3%), increased creatine phosphokinase (0.7% to 1%), increased GGT (up to 0.5%), increased alkaline phosphatase (0.4% to 1%), and increased total bilirubin (0.4%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia, leg cramps, and myalgia in 0.1% or less of patients. Tendon rupture has been reported during postmarketing experience.

Other

Other side effects have included taste perversion, fatigue, and fungal infection in greater than 0.1% to 1% of patients and asthenia, back pain, facial edema, flushing, hot flashes, increased nonprotein nitrogen, and pain in 0.1% or less. Facial swelling and peripheral edema have been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included genital moniliasis, genital pruritus, and vaginitis in greater than 0.1% to 1% of patients, and abnormal urine (0.1% or less).

Hematologic

Hematologic side effects have included leukopenia and thrombocythemia in greater than 0.1% to 1% of patients, and anemia, eosinophilia, granulocytopenia, bilirubinemia, and thrombocytopenia in 0.1% or less. Increased platelets (1%), decreased neutrophils (0.5%), increased neutrophils (0.5%), decreased hematocrit (0.3%), decreased hemoglobin (0.2%), decreased platelets (0.2%), decreased red blood cells (0.1%), increased hematocrit (0.1%), increased hemoglobin (0.1%), and increased red blood cells (0.1%) have also been reported. Hemorrhage and increased international normalized ratio (INR) have been reported during postmarketing experience.

Ocular

Ocular side effects have included abnormal vision (0.1% or less). Retinal hemorrhage has been reported during postmarketing experience.

Respiratory

Respiratory side effects have included dyspnea, pharyngitis, and pneumonia in 0.1% or less of patients. Bronchitis has been reported.

Renal

Renal side effects have included increased blood urea nitrogen (0.3%), increased serum creatinine (0.2%), and acute renal failure. Renal failure has been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included QTc interval prolongation; however, no morbidity or mortality has been reported. Maximum QTc changes have occurred 5 to 10 hours following administration of oral gemifloxacin. This effect may be dose-related. Ventricular extrasystoles have been reported. Prolonged QT, supraventricular tachycardia, syncope, and transient ischemic attack have been reported during postmarketing experience.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reaction during postmarketing experience.

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