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Factive

Last reviewed on RxList: 8/9/2016
Factive Side Effects Center

Last reviewed on RxList 01/19/2017

Factive (gemifloxacin mesylate) is a fluoroquinolone antibiotic used to treat different types of bacterial infections. Common side effects of Factive include:

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).

The recommended dose of Factive is 320 mg daily, taken for 5 to 7 days, depending on the condition being treated. 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. During pregnancy, Factive should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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.

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.

Factive Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using gemifloxacin and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeat;
  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations, depression, unusual thoughts or behavior;
  • seizure (convulsions);
  • severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;
  • pale or yellowed skin, dark colored urine, fever, weakness;
  • upper stomach pain, loss of appetite, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • easy bruising or bleeding;
  • numbness, burning, tingling, or unusual pain anywhere in your body;
  • the first sign of any skin rash, no matter how mild; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • nausea, vomiting;
  • dizziness or drowsiness;
  • blurred vision;
  • muscle pain or weakness;
  • feeling nervous, anxious, or restless; or
  • sleep problems (insomnia or nightmares).

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 mostcommonly reported adverse events with a frequency of ?2% forpatients 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 probablyrelated) 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:

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

Related Resources for Factive

Read the Factive User Reviews »

© 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.

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