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.

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; headache; mild stomach pain; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Factive:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, 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; decreased urination; excessive hunger, thirst, or urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; fruit-like breath odor; hallucinations; 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, paranoia, restlessness); muscle pain or weakness; nightmares; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness, headache, or light-headedness; shortness of breath or trouble breathing; sleeplessness; stomach pain or cramps; suicidal thoughts or actions; sweating; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); tremors; unusual bruising or bleeding; unusual swelling or weight gain; unusual weakness or tiredness; vaginal odor or discharge; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Factive Side Effects - for the Professional

Factive

In clinical studies, 8119 patients received daily oral doses of 320 mg Factive. 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.

Factive was discontinued because of an adverse event (determined by the investigator to be possibly or probably related to drug) in 2.0% of patients, primarily due to rash (0.8%), nausea (0.3%), diarrhea (0.3%), urticaria (0.2%) 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 (0.4%), vomiting (0.3%), rash (0.3%), abdominal pain (0.2%) and vertigo (0.2%).

The most commonly reported adverse events with a frequency of ≥2% for patients receiving 320 mg Factive versus comparator drug (beta-lactam antibiotics, macrolides or other fluoroquinolones) are as follows: diarrhea 5.0% vs. 6.2%; rash 3.5% vs. 1.1%; nausea 3.7% vs. 4.5%; headache 4.2% vs. 5.2%; abdominal pain 2.2% vs. 2.2%; vomiting 1.6% vs. 2.0%; and dizziness 1.7% vs. 2.6%.

Adverse Events with a Frequency of Less than 1%

Additional drug-related adverse events (possibly or probably related) in the 8119 patients, with a frequency of >0.1% to ≤1% included: abdominal pain, anorexia, constipation, dermatitis, dizziness, dry mouth, dyspepsia, fatigue, flatulence, fungal infection, gastritis, genital moniliasis, genital pruritus, hyperglycemia, increased alkaline phosphatase, increased ALT, increased AST, increased creatine phosphokinase, insomnia, leukopenia, 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, abnormal vision, anemia, arthralgia, asthenia, back pain, bilirubinemia, dyspnea, eczema, eosinophilia, facial edema, flushing, gastroenteritis, granulocytopenia, hot flashes, increased GGT, increased non-protein nitrogen, leg cramps, moniliasis, myalgia, nervousness, non-specified gastrointestinal disorder, pain, pharyngitis, photosensitivity/phototoxicity reactions, pneumonia, thrombocytopenia, tremor, vertigo.

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):

Table 3.  Incidence of Rash by Clinical Indication in Patients Treated with Factive

	ABECB (5 days) N = 2284		CAP (5 days) N = 256		CAP (7 days) N = 643
	n/N	%	n/N	%	n/N	%
* insufficient number of patients in this category for a meaningful analysis
Totals	27/2284	1.2	1/256	0.4	26/643	4.0
Females, < 40 years	NA*		1/37	2.7	8/88	9.1
Females, ≥ 40 years	16/1040	1.5	0/73	0	5/214	2.3
Males, < 40 years	NA*		0/65	0	5/101	5.0
Males, ≥ 40 years	11/1203	0.9	0/81	0	8/240	3.3

.

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

Clinical Chemistry: increased ALT (1.7%), increased AST (1.3%), increased creatine phosphokinase (0.7%), increased alkaline phosphatase (0.4%), increased total bilirubin (0.4%), increased potassium (0.3%), decreased sodium (0.2%), increased blood urea nitrogen (0.3%), decreased albumin (0.3%), increased serum creatinine (0.2%), decreased calcium (0.1%), decreased total protein (0.1%), decreased potassium (0.1%), increased sodium (0.1%), increased lactate dehydrogenase (<0.1%) and increased calcium (<0.1%).

CPK elevations were noted infrequently: 0.7% in Factive patients vs. 0.7% in the comparator patients.

Hematology: increased platelets (1.0%), 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 Factive treated patients had elevated ALT values immediately prior to entry into the study. Of these patients, approximately 15% showed a further elevation of their ALT at the on-therapy visit and 9% 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 to 10 times the upper limit of normal. These elevations were asymptomatic and reversible.

Post-Marketing Adverse Reactions:  The majority of the post-marketing adverse events reported were cutaneous and most of these were rash. Some of these cutaneous adverse events were considered serious. The majority of the rashes occurred in women and in patients under 40 years of age.

The following are additional adverse reactions reported during the post-marketing use of Factive. Since these reactions are reported voluntarily from a population of uncertain size, it is impossible to reliably estimate their frequency or establish a causal relationship to Factive exposure:

• anaphylactic reaction, erythema multiforme, skin exfoliation, facial swelling;

• exacerbation of myasthenia gravis;

• hemorrhage, increased international normalized ratio (INR), retinal hemorrhage;

• peripheral edema;

• renal failure;

• prolonged QT, supraventricular tachycardia, syncope, transient ischemic attack;

• photosensitivity/phototoxicity reaction;

• antibiotic-associated colitis;

• tendon rupture.

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Side Effects by Body System - for Healthcare Professionals

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. Moniliasis, gastroenteritis, and nonspecified gastrointestinal disorder have been reported in 0.1% or less of patients. 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. Eczema and photosensitivity/phototoxicity reaction have been reported in 0.1% or less of patients. 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 of patients. Neurotoxicity presenting as encephalopathy has been reported. Exacerbation of myasthenia gravis has been reported during postmarketing experience.

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%), AST (greater than 0.1% to 1.3%), creatine phosphokinase (0.7% to 1%), GGT (up to 0.5%), alkaline phosphatase (0.4% to 1%), and 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. Asthenia, back pain, facial edema, flushing, hot flashes, increased nonprotein nitrogen, and pain have been reported in 0.1% or less of patients. 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. Abnormal urine (0.1% or less) has been reported.

Hematologic

Hematologic side effects have included leukopenia and thrombocythemia in greater than 0.1% to 1% of patients. Anemia, eosinophilia, granulocytopenia, bilirubinemia, and thrombocytopenia have been reported in 0.1% or less of patients. 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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