Factive Side Effects

Please note - some side effects for Factive 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 Factive - for the consumer

Factive

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 Factive:

Diarrhea; dizziness; drowsiness; headache; mild diarrhea; nausea; stomachache; taste changes; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; bloody stools; changes in mood or behavior; chest pain or pounding in the chest; confusion; dark urine; decreased urination; depression; excessive hunger, thirst, or urination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; "fruity"-smelling breath; hallucinations; hoarseness; lightheadedness; muscle pain; nervousness; numbness or tingling of the skin; paranoia; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or continuous diarrhea; sleeplessness; stomach pain/cramps; suicidal thoughts; sweating; tendon or joint pain or swelling; tremors; unusual bruising or bleeding; unusual weakness or tiredness; vaginal odor or discharge; vision changes; yellowing of the eyes or skin.

For the professional

Factive

In clinical studies, 6775 patients received daily oral doses of 320 mg gemifloxacin.  In addition, 1797 healthy volunteers and 81 patients with renal or hepatic impairment received single or repeat doses of gemifloxacin in clinical pharmacology studies.  The majority of adverse reactions experienced by patients in clinical trials were considered to be of mild to moderate severity.

Gemifloxacin was discontinued because of an adverse event (possibly or probably related) in 2.2% of patients, primarily due to rash (0.9%), nausea (0.3%), diarrhea (0.3%), urticaria (0.3%) and vomiting (0.2%). Comparator antibiotics were discontinued because of an adverse event at an overall comparable rate of 2.1%, primarily due to diarrhea (0.5%), nausea (0.3%), vomiting (0.3%) and rash (0.3%).

Drug-related adverse events, classified as possibly or probably related with a frequency of ≥1% for patients receiving 320 mg of gemifloxacin versus comparator drug (beta-lactam antibiotics, macrolides or other fluoroquinolones) are as follows:  diarrhea 3.6% vs. 4.6%; rash 2.8% vs. 0.6%; nausea 2.7% vs. 3.2%; headache 1.2% vs. 1.5%; abdominal pain 0.9% vs. 1.1%; vomiting 0.9% vs. 1.1%; dizziness 0.8% vs. 1.5%; and taste perversion 0.3% vs. 1.9%.

Gemifloxacin appears to have a low potential for photosensitivity.  In clinical trials, treatment-related photosensitivity occurred in only 0.039% (3/7659) of patients.

Additional drug-related adverse events (possibly or probably related) in >0.1% to 1% of patients who received 320 mg of gemifloxacin were: abdominal pain, anorexia, arthralgia, constipation, dermatitis, dizziness, dry mouth, dyspepsia, fatigue, flatulence, fungal infection, gastritis, genital moniliasis, hyperglycemia, insomnia, leukopenia, moniliasis, pruritus, somnolence, taste perversion, thrombocythemia, urticaria, vaginitis, and vomiting.

Other adverse events reported from clinical trials which have potential clinical significance and which were considered to have a suspected relationship to the drug, that occurred in ≤0.1% of patients were: abnormal urine, anemia, asthenia, back pain, bilirubinemia, dyspnea, eczema, eosinophilia, flushing, gastroenteritis, granulocytopenia, hot flashes, increased GGT, leg cramps, myalgia, nervousness, non-specified gastrointestinal disorder, pain, pharyngitis, pneumonia, thrombocyotopenia, tremor, vertigo, and vision abnormality.

In clinical trials of acute bacterial exacerbation of chronic bronchitis (ABECB) and community acquired pneumonia (CAP), the incidences of rash were as follows (Table 3):

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Laboratory Changes

The percentages of patients who received multiple doses of gemifloxacin and had a laboratory abnormality are listed below.  It is not known whether these abnormalities were related to gemifloxacin or an underlying condition.

Clinical Chemistry: increased ALT (1.5%), increased AST (1.1%), increased creatine phosphokinase (0.6%), increased potassium (0.5%), decreased sodium (0.3%), increased gammaglutamyl transferase (0.5%), increased alkaline phosphatase (0.3%), increased total bilirubin (0.3%), increased blood urea nitrogen (0.3%), decreased calcium (0.2%), decreased albumin (0.3%), increased serum creatinine (0.2%), decreased total protein (0.1%) and increased calcium (<0.1%).

CPK elevations were noted infrequently:  0.8% in gemifloxacin patients vs. 0.4% in the comparator patients.

Hematology:  increased platelets (0.9%), 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%).

In clinical studies, approximately 7% of the gemifloxacin treated patients had elevated ALT values immediately prior to entry into the study.  Of these patients, approximately 10% showed a further elevation of their ALT at the on-therapy visit and 5% showed a further elevation at the end of therapy visit.  None of these patients demonstrated evidence of hepatocellular jaundice.  For the pooled comparators, approximately 6% of patients had elevated ALT values immediately prior to entry into the study.  Of these patients, approximately 7% showed a further elevation of their ALT at the on-therapy visit and 4% showed a further elevation at the end of therapy visit.

In a clinical trial where 638 patients received either a single 640 mg dose of gemifloxacin or 250 mg bid of ciprofloxacin for 3 days, there was an increased incidence of ALT elevations in the gemifloxacin arm (3.9%) vs. the comparator arm (1.0%). In this study, two patients experienced ALT elevations of 8 to10 times the upper limit of normal. These elevations were asymptomatic and reversible.

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Factive - Includes detailed dosage instructions.

Factive

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