Factive

• Generic Name: gemifloxacin mesylate
• Brand Name: Factive
• Drug Class: Fluoroquinolones

Factive (Gemifloxacin Mesylate) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Consumer Information
• Professional Information

 

Factive Side Effects Center

What Is Factive?

Factive (gemifloxacin mesylate) is a fluoroquinolone antibiotic used to treat different types of bacterial infections.

What Are Side Effects of Factive?

Common side effects of Factive include:

• nausea,
• vomiting,
• diarrhea,
• dizziness,
• drowsiness,
• lightheadedness,
• headache,
• trouble sleeping (insomnia or nightmares),
• blurred vision,
• muscle pain or weakness,
• nervousness,
• anxiety, or
• restlessness.

Tell your doctor if you have unlikely but serious side effects of Factive including:

• skin that sunburns more easily (sun sensitivity),
• unusual bruising or bleeding,
• signs of a new infection (e.g., new or persistent fever, persistent sore throat),
• unusual change in the amount of urine, or
• signs of liver problems (e.g., unusual tiredness, stomach or abdominal pain, persistent nausea or vomiting, yellowing eyes or skin, or dark urine).

Dosage for Factive

The recommended dose of Factive is 320 mg daily, taken for 5 to 7 days, depending on the condition being treated.

What Drugs, Substances, or Supplements Interact with Factive?

Factive may interact with probenecid, blood thinners, diuretics (water pills), antibiotics, antidepressants, anti-malaria medications, medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicines, narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or oral steroid medications. Tell your doctor all medications you use.

Factive During Pregnancy or Breastfeeding

During pregnancy, Factive should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Factive (gemifloxacin mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Factive Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Gemifloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking this medicine and call your doctor at once if you have:

• low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
• nerve symptoms in your hands, arms, legs, or feet--numbness, weakness, tingling, burning pain;
• serious mood or behavior changes--nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
• signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, gemifloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using gemifloxacin and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
• the first sign of any skin rash, no matter how mild;
• muscle weakness, breathing problems;
• jaundice (yellowing of the skin or eyes);
• a seizure (convulsions); or
• increased pressure inside the skull--severe headaches, ringing in your ears, vision problems, pain behind your eyes.

Common side effects may include:

• nausea, vomiting, stomach pain, diarrhea;
• headache;
• dizziness; or
• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Factive (Gemifloxacin Mesylate)

 

Factive Professional Information

SIDE EFFECTS

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. (See PRECAUTIONS.)

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	%
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
* insufficient number of patients in this category for a meaningful analysis

(See PRECAUTIONS).

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:

• peripheral neuropathy that may be irreversible;
• 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 (See PRECAUTIONS.);
• antibiotic-associated colitis;
• tendon rupture.

Read the entire FDA prescribing information for Factive (Gemifloxacin Mesylate)

&Copy; Factive Patient Information is supplied by Cerner Multum, Inc. and Factive Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.